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Fluoxetine 20 mg Capsule, 1,000-count — NDC 72241-0008-11 package photo

Fluoxetine 20 mg Capsule, 1,000-count

by Modavar Pharmaceuticals LLC · 1000 CAPSULE in 1 BOTTLE (72241-008-11)
NDC 72241-0008-11
🏷️ FDA NDC (as labeled) 72241-008-11 billing pads the product segment with a zero
This package
Contains1,000-count Cost per ea$0.0289 NADAC Per package$28.90 / 1000 capsules Pack sizes4 compare ↓
Also priced by: Medicaid pays $0.1816/unit · Part D plans $0.0968/unit — full pricing hub ↓
Also comes in: 30 capsules 72241-0008-22 100 capsules 72241-0008-05 500 capsules 72241-0008-10
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 72241-008-11
Product NDC 72241-008
11-digit billing NDC 72241000811
NCPDP billing unit EA — each (per item)
RxCUI 310384, 310385, 313989
UNII I9W7N6B1KJ
UPC 0372241008115, 0372241007224, 0372241008221, 0372241009228
Application # ANDA206993
SPL Set ID 05b0781b-50e2-4311-bde0-430b96e2ef8e
Established class (EPC) Serotonin Reuptake Inhibitor
Mechanism of action Serotonin Uptake Inhibitors
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-09-08
Route ORAL
Dosage form CAPSULE
Substance FLUOXETINE HYDROCHLORIDE
GPI-14 58160040000120
GCN Seq No 046214
GCN 16354
HICL code 001655
Ingredient (HICL) Fluoxetine Hcl
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H2
Therapeutic class — intermediate (HIC2) Psychoactive Drugs
HIC3 code H2S
Therapeutic class — specific (HIC3) Selective Serotonin Reuptake Inhibitor (Ssris)
AHFS code 28:16.04.20
AHFS class Selective-Serotonin Reuptake Inhibitors
FDB label name FLUOXETINE HCL 20 MG CAPSULE
FDB brand name Fluoxetine Hcl
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB1 · RLD · RS
Why two NDCs? The FDA registers this code as 72241-008-11 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 72241-0008-11. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Serotonin Reuptake Inhibitor class.

Pharmacologic class Serotonin Reuptake Inhibitor
Drug family (ATC) Selective serotonin reuptake inhibitors
How it works Serotonin Uptake Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerModavar Pharmaceuticals LLC
Application holderCADILA PHARMACEUTICALS LTD
FDA applicationANDA206993 (ANDA)
Labeler code72241
First marketedSep 2021
Product typeHuman Prescription Drug
Portfolio59 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name FLUOXETINE HCL 20 MG CAPSULE Ingredient Fluoxetine Hcl
📖 What it is MedlinePlus · NLM

Fluoxetine is used to treat depression, obsessive-compulsive disorder (bothersome thoughts that won't go away and the need to perform certain actions over and over), some eating disorders, and panic attacks (sudden, unexpected attacks of extreme fear and worry about these attacks). Fluoxetine is also used to relieve the symptoms of premenstrual dysphoric disorder. It is also used along with olanzapine to treat depression and episodes of depression in people with bipolar I disorder (manic-depressive disorder; a disease that causes episodes of depression, episodes of mania, and other abnormal mo...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Most people don't feel a noticeable difference right away — that's completely normal. It typically takes several weeks to start feeling the full benefit, and some people need a few...
  • How long does it take for fluoxetine to actually start working?
  • It's really important not to stop on your own, even if you feel great. Stopping suddenly can cause discontinuation symptoms, and your condition may come back. The good news is that...
  • Can I stop taking fluoxetine if I start feeling better?
📖 Read our full Fluoxetine guide →
1
Nutrient depletion considerations

Fluoxetine may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Fluoxetine nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color Green / Yellow / Orange
ShapeCapsule
ImprintC30
Size21 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII 5138Q19F1X
    Ammonia is a colorless gas made from nitrogen and hydrogen. It's used in medicines as a pH buffer to maintain the correct acidity level and help keep the product stable.
  • UNII 8PJ61P6TS3
    Butyl alcohol is a clear liquid organic solvent derived from petroleum or natural sources. In medicines, it helps dissolve active ingredients and serves as a solvent in liquid formulations and some topical products.
  • UNII H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • UNII EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • UNII XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
  • UNII 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
  • UNII ND2M416302
    Isopropyl alcohol is a clear liquid solvent derived from petroleum. In medicines, it dissolves active ingredients and other components, helps the product flow smoothly, and aids in sterilization during manufacturing.
  • UNII WZH3C48M4T
    Potassium hydroxide is a strong alkaline chemical used in medicines to adjust and maintain the pH level of liquid formulations, helping keep the product stable and the active ingredients effective.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII MB5IUD6JUA
    Shellac is a natural resin secreted by lac beetles, purified and processed into a coating material. It seals and protects tablets and capsules, controls how quickly the medicine dissolves, and gives pills their glossy finish.
  • UNII 368GB5141J
    A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

14 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $0.029 $28.90 / 1000 capsules
Medicaid paysCMS SDUD · 12 mo $0.1816 $181.60 / 1000 capsules
Medicare drug plans payPart D · Q2 2026 $0.0968 $96.80 / 1000 capsules
NADAC price history (per ea) — tap or hover for the price & month
Jan 2024 Jan 2026 Apr 2026 Aug 2026 $0.033 $0.029
▼ Down 13% over the last 11 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Fluoxetine 20 mg 00904-7346-61 Major 100 capsules $0.029 AB Availability likely —
Fluoxetine 20 mg 16714-0721-02 NorthStar 100 capsules $0.029 AB Availability likely —
Fluoxetine 20 mg 23155-0029-01 Heritage 100 capsules $0.029 AB1 Availability likely —
Fluoxetine 20 mg 49483-0702-01 TIME 100 capsules $0.029 AB1 Availability likely —
Fluoxetine 20 mg 50111-0648-01 Teva 100 capsules $0.029 AB1 Discontinued —
Fluoxetine 20 mg 50228-0114-01 ScieGen 100 capsules $0.029 AB1 Availability likely —
Fluoxetine Hydrochloride 20 mg 65862-0193-01 Aurobindo 100 capsules $0.029 — Availability likely —
Fluoxetine 20 mg 68001-0400-00 BluePoint 100 capsules $0.029 AB Availability likely —
Fluoxetine 20 mg 68001-0671-00 BluePoint 100 capsules $0.029 AB Availability likely —
Fluoxetine 20 mg 68645-0130-54 Legacy 30 capsules $0.029 AB1 Availability likely —
Fluoxetine 20 mg 69367-0236-01 Westminster 100 capsules $0.029 AB1 Discontinued —
Fluoxetine 20 mgthis 72241-0008-11 Modavar 1000 capsules $0.029 AB1 Availability likely —
Fluoxetine 20 mg 82009-0101-10 QUALLENT 1000 capsules $0.029 AB Availability likely —
Fluoxetine 20 mg 42543-0726-01 Vensun 100 capsules $0.030 AB1 FDA listed +5%
Prozac 20 mg 00777-3105-02 Dista 100 capsules $13.981 — Availability likely +48360%
Fluoxetine 20 mg 00615-7625-05 NCS 15 capsules — AB1 FDA listed —
Fluoxetine 20 mg 17224-0174-21 Calvin 21 capsules — AB1 FDA listed —
Fluoxetine 20 mg 25000-0148-08 MARKSANS 100 capsules — AB1 FDA listed —
Fluoxetine 20 mg 42571-0388-01 Micro 100 capsules — AB1 Discontinued —
Fluoxetine 20 mg 42708-0025-30 QPharma 30 capsules — AB1 FDA listed —
Fluoxetine 20 mg 42708-0182-30 QPharma 30 capsules — AB FDA listed —
Fluoxetine 20 mg 42708-0200-30 QPharma 30 capsules — AB FDA listed —
Fluoxetine 20 mg 43063-0712-21 PD-Rx 21 capsules — AB FDA listed —
Fluoxetine 20 mg 45865-0174-30 Medsource 30 capsules — AB1 FDA listed —
Fluoxetine 20 mg 46708-0272-30 Alembic 30 capsules — AB1 FDA listed —
Fluoxetine 20 mg 50090-0745-00 A-S 30 capsules — AB FDA listed —
Fluoxetine 20 mg 50090-6081-00 A-S 30 capsules — AB FDA listed —
Fluoxetine 20 mg 50090-6574-00 A-S 30 capsules — AB1 FDA listed —
Fluoxetine 20 mg 50090-6986-00 A-S 90 capsules — AB FDA listed —
Fluoxetine 20 mg 50090-7225-00 A-S 30 capsules — AB1 FDA listed —
Fluoxetine 20 mg 50090-7226-00 A-S 90 capsules — AB1 FDA listed —
Fluoxetine 20 mg 50090-7951-00 A-S 30 capsules — AB FDA listed —
Fluoxetine 20 mg 50090-7952-00 A-S 90 capsules — AB FDA listed —
Fluoxetine 20 mg 51655-0100-26 Northwind 90 capsules — AB FDA listed —
Fluoxetine 20 mg 51655-0274-26 Northwind 90 capsules — AB1 FDA listed —
Fluoxetine 20 mg 55154-2638-00 Cardinal 10 capsules — AB FDA listed —
Fluoxetine 20 mg 59651-0899-26 Aurobindo 2500 capsules — AB FDA listed —
Fluoxetine 20 mg 60760-0311-90 St. 90 capsules — AB1 FDA listed —
Fluoxetine 20 mg 62332-0023-30 Alembic 30 capsules — AB1 FDA listed —
Fluoxetine 20 mg 63187-0069-30 Proficient 30 capsules — AB FDA listed —
Fluoxetine 20 mg 63629-1610-01 Bryant 30 capsules — AB FDA listed —
Fluoxetine 20 mg 67046-1670-03 Coupler 30 capsules — AB1 FDA listed —
Fluoxetine 20 mg 67296-1898-03 Redpharm 30 capsules — AB1 FDA listed —
Fluoxetine 20 mg 68071-3284-01 NuCare 15 capsules — AB FDA listed —
Fluoxetine 20 mg 68071-4033-01 NuCare 15 capsules — AB1 FDA listed —
Fluoxetine 20 mg 68071-5240-03 NuCare 30 capsules — AB1 FDA listed —
Fluoxetine 20 mg 68071-5276-01 NuCare 100 capsules — AB1 FDA listed —
Fluoxetine 20 mg 68788-7909-01 Preferred 100 capsules — AB1 FDA listed —
Fluoxetine 20 mg 70518-0417-01 REMEDYREPACK 30 capsules — AB FDA listed —
Fluoxetine 20 mg 70518-4420-00 REMEDYREPACK 30 capsules — AB1 FDA listed —
Fluoxetine 20 mg 70518-4543-00 REMEDYREPACK 30 capsules — AB FDA listed —
Fluoxetine 20 mg 70518-4576-00 REMEDYREPACK 30 capsules — AB FDA listed —
Fluoxetine 20 mg 71205-0125-30 Proficient 30 capsules — AB1 FDA listed —
Fluoxetine 20 mg 71205-0178-30 Proficient 30 capsules — AB1 FDA listed —
Fluoxetine 20 mg 71205-0975-00 Proficient 100 capsules — AB1 FDA listed —
Fluoxetine 20 mg 71209-0041-01 Cadila 30 capsules — AB1 FDA listed —
Fluoxetine 20 mg 71335-0923-01 Bryant 30 capsules — AB1 FDA listed —
Fluoxetine 20 mg 71335-0924-01 Bryant 30 capsules — AB1 FDA listed —
Fluoxetine 20 mg 71335-2020-01 Bryant 30 capsules — AB1 FDA listed —
Fluoxetine 20 mg 71610-0699-30 Aphena 30 capsules — AB1 FDA listed —
Fluoxetine HCL 20 mg 72189-0656-30 Direct_rx 30 capsules — AB1 FDA listed —
Fluoxetine 20 mg 72603-0489-01 NorthStar 100 capsules — AB FDA listed —
Fluoxetine 20 mg 72789-0545-21 PD-Rx 21 capsules — AB1 FDA listed —
Fluoxetine 20 mg 77771-0114-01 RADHA 100 capsules — AB1 FDA listed —
Fluoxetine 20 mg 80425-0313-01 Advanced 30 capsules — AB1 FDA listed —
Fluoxetine 20 mg 82868-0098-30 Northwind 30 capsules — AB1 FDA listed —
Fluoxetine 20 mg 83008-0047-30 Quality 30 capsules — AB1 Discontinued —
Fluoxetine 20 mg 83209-0721-06 Boswell 6 capsules — AB FDA listed —
Fluoxetine 20 mg 87441-0031-01 Unit 30 capsules — AB FDA listed —
Fluoxetine 20 mg 70518-1619-02 REMEDYREPACK 30 capsules — AB1 FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2021
On the market since
Sep 2021
📍
2026
Currently FDA-listed
5 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 72241-0008-11, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
96.1K
Units reimbursed last 4 qtrs
4.7M
Gross reimbursed last 4 qtrs
$861.1K
Avg / prescription
$8.96
Avg / unit
$0.1816
Latest quarter Q4 2025
27.1KRx
Medicaid pays / ea
$0.1816
gross reimbursed
vs
NADAC / ea
$0.0289
acquisition cost
=
Spread
+$0.1527
+528% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
34% FFS 66% MCO
Fee-for-service · 33,131 Rx Managed care · 63,011 Rx
State Medicaid map
Alaska: no data reported AK Maine: 331,806 units · 23,785 per 100k residents ME Washington: 37,994 units · 486 per 100k residents WA Idaho: 6,210 units · 316 per 100k residents ID Montana: 5,602 units · 495 per 100k residents MT North Dakota: 1,336 units · 171 per 100k residents ND Minnesota: 216,431 units · 3,773 per 100k residents MN Wisconsin: 39,976 units · 676 per 100k residents WI Michigan: 46,139 units · 460 per 100k residents MI New York: 324,268 units · 1,657 per 100k residents NY Vermont: 55,986 units · 8,653 per 100k residents VT New Hampshire: 49,133 units · 3,504 per 100k residents NH Oregon: no data reported OR Nevada: 4,634 units · 145 per 100k residents NV Wyoming: 420 units · 71.9 per 100k residents WY South Dakota: 36,040 units · 3,922 per 100k residents SD Iowa: 758,503 units · 23,651 per 100k residents IA Illinois: 85,646 units · 682 per 100k residents IL Indiana: 10,654 units · 155 per 100k residents IN Ohio: 344,222 units · 2,921 per 100k residents OH Pennsylvania: 597,904 units · 4,613 per 100k residents PA New Jersey: 57,127 units · 615 per 100k residents NJ Massachusetts: 102,786 units · 1,468 per 100k residents MA California: 70,805 units · 182 per 100k residents CA Utah: 18,698 units · 547 per 100k residents UT Colorado: 18,369 units · 313 per 100k residents CO Nebraska: 63,725 units · 3,222 per 100k residents NE Missouri: 104,176 units · 1,681 per 100k residents MO Kentucky: 40,670 units · 899 per 100k residents KY West Virginia: 41,771 units · 2,360 per 100k residents WV Virginia: 82,248 units · 944 per 100k residents VA Maryland: 143,103 units · 2,316 per 100k residents MD Connecticut: 55,176 units · 1,525 per 100k residents CT Rhode Island: 17,679 units · 1,615 per 100k residents RI Arizona: 7,774 units · 105 per 100k residents AZ New Mexico: 10,840 units · 513 per 100k residents NM Kansas: 35,025 units · 1,191 per 100k residents KS Arkansas: 55,811 units · 1,820 per 100k residents AR Tennessee: 66,006 units · 926 per 100k residents TN North Carolina: 95,334 units · 880 per 100k residents NC South Carolina: 13,635 units · 254 per 100k residents SC Delaware: 6,368 units · 618 per 100k residents DE Oklahoma: 189,028 units · 4,664 per 100k residents OK Louisiana: 273,045 units · 5,970 per 100k residents LA Mississippi: 55,343 units · 1,882 per 100k residents MS Alabama: 18,845 units · 369 per 100k residents AL Georgia: 32,217 units · 292 per 100k residents GA D.C.: 5,232 units · 771 per 100k residents DC Hawaii: 1,302 units · 90.7 per 100k residents HI Texas: 82,606 units · 271 per 100k residents TX Florida: 20,773 units · 91.9 per 100k residents FL
Units reimbursed · per 100k residents
71.923,785
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Maine 23,785 /100k
2 Iowa 23,651 /100k
3 Vermont 8,653 /100k
4 Louisiana 5,970 /100k
5 Oklahoma 4,664 /100k
6 Pennsylvania 4,613 /100k
7 South Dakota 3,922 /100k
8 Minnesota 3,773 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1000 capsules this page72241-0008-11 96,142 Rx · $861,134
100 capsules72241-0008-05 511 Rx · $5,598
500 capsules72241-0008-10 No Medicaid data
30 capsules72241-0008-22 No Medicaid data
Drug total (last 4 qtrs): 96,653 Rx · 4,759,074 units · $866,732 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
72241-0008-05 100 CAPSULE in 1 BOTTLE (72241-008-05) $0.0289 / ea $2.89 2021-09-08 Active
72241-0008-10 500 CAPSULE in 1 BOTTLE (72241-008-10) — — 2021-09-08 Active
72241-0008-11 You're viewing this 1000 CAPSULE in 1 BOTTLE (72241-008-11) $0.0289 / ea $28.85 2021-09-08 Active
72241-0008-22 30 CAPSULE in 1 BOTTLE (72241-008-22) — — 2021-09-08 Active

You're viewing the largest of 4 pack sizes for this product.

This pack effectively ties for the lowest per-ea cost of the 2 priced pack sizes ($0.0289 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 99% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 72241-0008-11?
NDC 72241-0008-11 is a 1,000-count package — 1000 capsule in 1 bottle.
What is the difference between NDC 72241-0008-11 and NDC 72241-0008-22?
Both are Fluoxetine 20 mg Capsule — the drug itself is identical. NDC 72241-0008-11 is the 1,000-count package, while NDC 72241-0008-22 is the 30 capsules package.
What NDC number is used to bill for this package of Fluoxetine 20 mg Capsule?
Bill NDC 72241-0008-11 — the 11-digit billing format is 72241000811. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide
🚨 Boxed Warning 220 words ▾

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS • Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older [see Warnings and Precautions (5.1)]. • In patients of all ages who are started on antidepressant therapy, monitor closely for worsening and for emergence of suicidal thoughts and behaviors.

Advise families and caregivers of the need for close observation and communication with the prescriber [see Warnings and Precautions (5.1)]. • Fluoxetine is not approved for use in children less than 7 years of age [see Warnings and Precautions (5.1) and Use in Specific Populations (8.4)] . When using fluoxetine and olanzapine in combination, also refer to Boxed Warning section of the package insert for Symbyax. WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning. •Increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants ( 5.1 ). •Monitor for worsening and emergence of suicidal thoughts and behaviors ( 5.1 ).

When using fluoxetine and olanzapine in combination, also refer to Boxed Warning section of the package insert for Symbyax.

🎯 Indications and Usage ~1 min read ▾

1 INDICATIONS & USAGE Fluoxetine capsules are indicated for the treatment of: • Acute and maintenance treatment of Major Depressive Disorder [ see Clinical Studies (14.1)]. • Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [ see Clinical Studies (14.2 )]. • Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [ see Clinical Studies (14.3 )]. • Acute treatment of Panic Disorder, with or without agoraphobia [ see Clinical Studies (14.4 ) ].

Fluoxetine capsules and Olanzapine in Combination is indicated for the treatment of: • Acute treatment of depressive episodes associated with Bipolar I Disorder. • Treatment Resistant Depression (Major Depressive Disorder in patient, who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode). Fluoxetine capsules monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression.

When using fluoxetine capsules and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax ® . Fluoxetine capsules are a selective serotonin reuptake inhibitor indicated for: • Acute and maintenance treatment of Major Depressive Disorder (MDD) ( 1 ) • Acute and maintenance treatment of Obsessive Compulsive Disorder (OCD) ( 1 ) • Acute and maintenance treatment of Bulimia Nervosa ( 1 ) • Acute treatment of Panic Disorder, with or without agoraphobia ( 1 ) Fluoxetine capsules and olanzapine in combination for treatment of: • Acute Depressive Episodes Associated with Bipolar I Disorder ( 1 ) • Treatment Resistant Depression (1)

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE & ADMINISTRATION Indication Adult Pediatric MDD ( 2.1 ) 20 mg/day in am (initial dose ) 10 to 20 mg/day (initial dose ) OCD ( 2.2 ) 20 mg/day in am (initial dose ) 10 mg/day (initial dose ) Bulimia Nervosa ( 2.3 ) 60 mg/day in am Panic Disorder ( 2.4 ) 10 mg/day (initial dose ) Depressive Episode s Associated with Bipolar I Disorder ( 2.5 ) Oral in combination with olanzapine : 5 mg of oral olanzapine and 20 mg of fluoxetine once daily (initial dose) Oral in combination with olanzapine: 2.5 mg of oral olanzapine and 20 mg of fluoxetine once daily (initial dose) Treatment Resistant Depression ( 2.6 ) Oral in combination with olanzapine: 5 mg of oral olanzapine and 20 mg of fluoxetine once daily (initial dose) • A lower or less frequent dosage should be used in patients with hepatic impairment, the elderly, and for patients with concurrent disease or on multiple concomitant medications ( 2.7 ) Fluoxetine capsules and olanzapine in combination: • Dosage adjustments should be made with the individual components according to efficacy and tolerability ( 2.5 , 2.6 ) • Fluoxetine monotherapy is not indicated for the treatment of Depressive Episodes associated with Bipolar I Disorder or treatment resistant depression ( 2.5 , 2.6 ) • Safety of the coadministration of doses above 18 mg olanzapine with 75 mg fluoxetine has not been evaluated in adults ( 2.5 , 2.6 ) • Safety of the coadministration of doses above 12 mg olanzapine with 50 mg fluoxetine has not been evaluated in children and adolescents ages 10 to 17 ( 2.5 )

2.1Major Depressive Disorder Initial Treatment Adult - Initiate fluoxetine capsules 20 mg/day orally in the morning. Consider a dose increase after several weeks if insufficient clinical improvement is observed. Administer doses above 20 mg/day once daily in the morning or twice daily (i.e., morning and noon).

The maximum fluoxetine dose should not exceed 80 mg/day. In controlled trials used to support the efficacy of fluoxetine, patients were administered morning doses ranging from 20 to 80 mg/day. Studies comparing fluoxetine 20, 40, and 60 mg/day to placebo indicate that 20 mg/day is sufficient to obtain a satisfactory response in Major Depressive Disorder in most cases [ see Clinical Studies (14.1) ].

Pediatric (children and adolescents) - Initiate fluoxetine capsules 10 or 20 mg/day. After 1 week at 10 mg/day, increase the dose to 20 mg/day. However, due to higher plasma levels in lower weight children, the starting and target dose in this group may be 10 mg/day.

Consider a dose increase to 20 mg/day after several weeks if insufficient clinical improvement is observed. In the short-term (8 to 9 week) controlled clinical trials of fluoxetine supporting its effectiveness in the treatment of Major Depressive Disorder, patients were administered fluoxetine doses of 10 to 20 mg/day [ see Clinical Studies (14.1)]. All patients - As with other drugs effective in the treatment of Major Depressive Disorder, the full effect may be delayed until 4 weeks of treatment or longer.

Periodically reassess to determine the need for maintenance treatment. Switching Patients to a Tricyclic Antidepressant (TCA) - Dosage of a TCA may need to be reduced, and plasma TCA concentrations may need to be monitored temporarily when fluoxetine is coadministered or has been recently discontinued [ see Warnings and Precautions (5.2) and Drug Interactions (7.7) ].

2.2Obsessive Compulsive Disorder Initial Treatment Adult - Initiate fluoxetine capsules 20 mg/day, orally in the morning. Consider a dose increase after several weeks if insufficient clinical improvement is observed. The full therapeutic effect may be delayed until 5 weeks of treatment or longer.

Administer doses above 20 mg/day once daily in the morning or twice daily (i.e., morning and noon). A dose range of 20 to 60 mg/day is recommended; however, doses of up to 80 mg/day have been well tolerated in open studies of OCD. The maximum fluoxetine dose should not exceed 80 mg/day.…

💊 Dosage Forms and Strengths 102 words ▾

3 DOSAGE FORMS & STRENGTHS • Fluoxetine Capsules USP, 10 mg are white to off white powder filled in size ''4'' hard gelatin capsules with green opaque cap and green opaque body imprinted ''C28'' • Fluoxetine Capsules USP, 20 mg are white to off white powder filled in size ''2'' hard gelatin capsules with green opaque cap and yellow opaque body imprinted ''C29'' • Fluoxetine Capsules USP, 40 mg white to off white powder filled in size ''0'' hard gelatin capsules with green opaque cap and orange opaque body imprinted ''C30'' • Capsules: 10 mg, 20 mg, 40 mg ( 3 )

⛔ Contraindications ~2 min read ▾

4 CONTRAINDICATIONS When using fluoxetine and olanzapine in combination, also refer to the Contraindications section of the package insert for Symbyax. • Serotonin Syndrome and MAOIs: Do not use MAOIs intended to treat psychiatric disorders with fluoxetine or within 5 weeks of stopping treatment with fluoxetine. Do not use fluoxetine capsules within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start fluoxetine in a patient who is being treated with linezolid or intravenous methylene blue ( 4.1 ) • Pimozide: Do not use.

Risk of QT prolongation and drug interaction ( 4.2 , 5.11 , 7.7, 7.8 ) • Thioridazine: Do not use. Risk of QT interval prolongation and elevated thioridazine plasma levels. Do not use thioridazine within 5 weeks of discontinuing fluoxetine ( 4.2, 5.11, 7.7 , 7.8) • When using fluoxetine and olanzapine in combination, also refer to the Contraindications section of the package insert for Symbyax ( 4 )

4.1Monoamine Oxidase Inhibitors (MAOIs) The use of MAOIs intended to treat psychiatric disorders with fluoxetine capsules or within 5 weeks of stopping treatment with fluoxetine capsules is contraindicated because of an increased risk of serotonin syndrome. The use of fluoxetine capsules within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated [ see Dosage and Administration (2.9) and Warnings and Precautions (5.2)]. Starting fluoxetine capsules in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome [ see Dosage and Administration (2.10) and Warnings and Precautions (5.2)].

4.2Other Contraindications The use of fluoxetine capsules is contraindicated with the following: • Pimozide [ see Warnings and Precautions (5.11) and Drug Interactions (7.7 , 7.8)] • Thioridazine [ see Warnings and Precautions (5.11) and Drug Interactions (7.7 , 7.8)] Pimozide and thioridazine prolong the QT interval. Fluoxetine capsules can increase the levels of pimozide and thioridazine through inhibition of CYP2D6. Fluoxetine capsules can also prolong the QT interval.

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS When using fluoxetine and olanzapine in combination, also refer to the Warnings and Precautions section of the package insert for Symbyax. • Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults: Monitor for clinical worsening and suicidal thinking and behavior ( 5.1 ) • Serotonin Syndrome: Serotonin syndrome has been reported with SSRIs and SNRIs, including fluoxetine, both when taken alone, but especially when co-administered with other serotonergic agents. If such symptoms occur, discontinue fluoxetine and serotonergic agents and initiate supportive treatment.

If concomitant use of fluoxetine with other serotonergic drugs is clinically warranted, patients should be made aware of a potential increased risk for serotonin syndrome, particularly during treatment initiation and dose increases. ( 5.2 ) • Allergic Reactions and Rash: Discontinue upon appearance of rash or allergic phenomena ( 5.3 ) • Activation of Mania/Hypomania: Screen for Bipolar Disorder and monitor for mania/hypomania ( 5.4 ) • Seizures: Use cautiously in patients with a history of seizures or with conditions that potentially lower the seizure threshold ( 5.5 ) • Altered Appetite and Weight: Significant weight loss has occurred ( 5.6 ) • Increased Risk of Bleeding: May increase the risk of bleeding.

Use with NSAIDs, aspirin, warfarin, or other drugs that affect coagulation may potentiate the risk of gastrointestinal or other bleeding ( 5.7 ) • Angle-Closure Glaucoma: Angle-closure glaucoma has occurred in patients with untreated anatomically narrow angles treated with antidepressants. ( 5.8 ) • Hyponatremia: Has been reported with fluoxetine in association with syndrome of inappropriate antidiuretic hormone (SIADH). Consider discontinuing if symptomatic hyponatremia occurs ( 5.9 ) • Anxiety and Insomnia: May occur ( 5.10 ) • QT Prolongation: QT prolongation and ventricular arrhythmia including Torsades de Pointes have been reported with fluoxetine use.

Use with caution in conditions that predispose to arrhythmias or increased fluoxetine exposure. Use cautiously in patients with risk factors for QT prolongation ( 4.2 , 5.11 ) • Potential for Cognitive and Motor Impairment: Has potential to impair judgment, thinking, and motor skills. Use caution when operating machinery ( 5.13 ) • Long Half-Life: Changes in dose will not be fully reflected in plasma for several weeks ( 5.14 ) • Fluoxetine and Olanzapine in Combination: When using fluoxetine and olanzapine in combination, also refer to the Warnings and Precautions section of the package insert for Symbyax ( 5.16 ) • Sexual Dysfunction : Fluoxetine may cause symptoms of sexual dysfunction (5.17)

5.1Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults Patients with Major Depressive Disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide.

There has been a long-standing concern, however, that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment. Pooled analyses of short-term placebo-controlled trials of antidepressant drugs (SSRIs and others) showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (ages 18 to 24) with Major Depressive Disorder (MDD) and other psychiatric disorders.

Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction with antidepressants compared to p…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the labeling: • Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults [ see Boxed Warning and Warnings and Precautions (5.1)] • Serotonin Syndrome [ see Warnings and Precautions (5.2)] • Allergic Reactions and Rash [ see Warnings and Precautions (5.3) ] • Screening Patients for Bipolar Disorder and Monitoring for Mania/Hypomania [ see Warnings and Precautions (5.4)] • Seizures [ see Warnings and Precautions (5.5)] • Altered Appetite and Weight [ see Warnings and Precautions (5.6)] • Increased Risk of Bleeding [ see Warnings and Precautions (5.7)] • Angle-Closure Glaucoma [ see Warnings and Precautions (5.8)] • Hyponatremia [ see Warnings and Precautions (5.9)] • Anxiety and Insomnia [ see Warnings and Precautions (5.10)] • QT Prolongation [see Warnings and Precautions (5.11)] • Potential for Cognitive and Motor Impairment [ see Warnings and Precautions (5.13)] • Discontinuation Adverse Reactions [ see Warnings and Precautions (5.15)] • Sexual Dysfunction [see Warnings and Precautions (5.17)] When using fluoxetine and olanzapine in combination, also refer to the Adverse Reactions section of the package insert for Symbyax.

Most common adverse reactions (≥5% and at least twice that for placebo) associated with: Major Depressive Disorder, Obsessive Compulsive Disorder, Bulimia, and Panic Disorder: abnormal dreams, abnormal ejaculation, anorexia, anxiety, asthenia, diarrhea, dry mouth, dyspepsia, flu syndrome, impotence, insomnia, libido decreased, nausea, nervousness, pharyngitis, rash, sinusitis, somnolence, sweating, tremor, vasodilatation, and yawn ( 6.1 ) Fluoxetine and olanzapine in combination -Also refer to the Adverse Reactions section of the package insert for Symbyax ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Modavar Pharmaceuticals LLC at Toll free number: 800 688 4697 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect or predict the rates observed in practice. Multiple doses of fluoxetine have been administered to 10,782 patients with various diagnoses in US clinical trials. In addition, there have been 425 patients administered fluoxetine in panic clinical trials.

The stated frequencies represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse reaction of the type listed. A reaction was considered treatment-emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation. Incidence in Major Depressive Disorder, OCD, bulimia, and Panic Disorder placebo-controlled clinical trials (excluding data from extensions of trials) — Table 3 enumerates the most common treatment-emergent adverse reactions associated with the use of fluoxetine (incidence of at least 5% for fluoxetine and at least twice that for placebo within at least 1 of the indications) for the treatment of Major Depressive Disorder, OCD, and bulimia in US controlled clinical trials and Panic Disorder in US plus non-US controlled trials.

Table 5 enumerates treatment-emergent adverse reactions that occurred in 2% or more patients treated with fluoxetine and with incidence greater than placebo who participated in US Major Depressive Disorder, OCD, and bulimia controlled clinical trials and US plus non-US Panic Disorder controlled clinical trials. Table 4 provides combined data for the pool of studies that are provided separately by indication in Table 3. Table 3: Most Common Treatment-Emergent Adverse Reactions: Incidence in Major Depressive Disorder, OCD, Bulimia, and Panic Disorder Placebo-Controlled Clinical Trials 1,2 Percentage of Patients Reporting Event Major Depressive Disorder OCD Bu…

🔄 Drug Interactions ~3 min read ▾

7 DRUG INTERACTIONS As with all drugs, the potential for interaction by a variety of mechanisms (e.g., pharmacodynamic, pharmacokinetic drug inhibition or enhancement, etc.) is a possibility. • Monoamine Oxidase Inhibitors (MAOIs): ( 2.9 , 2.10 , 4.1 , 5.2 ) • Drugs Metabolized by CYP2D6: Fluoxetine is a potent inhibitor of CYP2D6 enzyme pathway ( 7.7 ) • Tricyclic Antidepressants (TCAs): Monitor TCA levels during coadministration with fluoxetine or when fluoxetine has been recently discontinued ( 5.2 , 7.7 ) • CNS Acting Drugs: Caution should be used when taken in combination with other centrally acting drugs ( 7.2 ) • Benzodiazepines: Diazepam – increased t ½ , alprazolam - further psychomotor performance decrement due to increased levels ( 7.7 ) • Antipsychotics: Potential for elevation of haloperidol and clozapine levels ( 7.7 ) • Anticonvulsants: Potential for elevated phenytoin and carbamazepine levels and clinical anticonvulsant toxicity ( 7.7 ) • Serotonergic Drugs: ( 2.9 , 2.10 , 4.1 , 5.2 ) • Drugs that Interfere with Hemostasis (e.g.

NSAIDs, Aspirin, Warfarin): May potentiate the risk of bleeding ( 7.4 ) • Drugs Tightly Bound to Plasma Proteins: May cause a shift in plasma concentrations ( 7.6 , 7.7 ) • Olanzapine: When used in combination with fluoxetine, also refer to the Drug Interactions section of the package insert for Symbyax ( 7.7 ) • Drugs that Prolong the QT Interval: Do not use fluoxetine with thioridazine or pimozide. Use with caution in combination with other drugs that prolong the QT interval ( 4.2 , 5.11 , 7.7 , 7.8 )

7.1Monoamine Oxidase Inhibitors (MAOI) [See Dosage and Administration (2.9, 2.10), Contraindications (4.1), and Warnings and Precautions (5.2)].

7.2CNS Acting Drugs Caution is advised if the concomitant administration of fluoxetine and such drugs is required. In evaluating individual cases, consideration should be given to using lower initial doses of the concomitantly administered drugs, using conservative titration schedules, and monitoring of clinical status [see Clinical Pharmacology (12.3)].

7.3Other Serotonergic Drugs The concomitant use of serotonergic drugs (including other SSRIs, SNRIs, triptans, tricyclic antidepressants, opioids, lithium, buspirone, amphetamines, tryptophan, and St. John's Wort) with fluoxetine increases the risk of serotonin syndrome. Monitor patients for signs and symptoms of serotonin syndrome, particularly during treatment initiation and dosage increases.

If serotonin syndrome occurs, consider discontinuation of fluoxetine and/or concomitant serotonergic drugs [see Warnings and Precautions (5.2) ].

7.4Drugs that Interfere with Hemostasis (e.g., NSAIDs, Aspirin, Warfarin) Serotonin release by platelets plays an important role in hemostasis. Epidemiological studies of the case-control and cohort design that have demonstrated an association between use of psychotropic drugs that interfere with serotonin reuptake and the occurrence of upper gastrointestinal bleeding have also shown that concurrent use of an NSAID or aspirin may potentiate this risk of bleeding. Altered anticoagulant effects, including increased bleeding, have been reported when SNRIs or SSRIs are coadministered with warfarin.

Patients receiving warfarin therapy should be carefully monitored when fluoxetine is initiated or discontinued [see Warnings and Precautions (5.7)].

7.5Electroconvulsive Therapy (ECT) There are no clinical studies establishing the benefit of the combined use of ECT and fluoxetine. There have been rare reports of prolonged seizures in patients on fluoxetine receiving ECT treatment.

7.6Potential for Other Drugs to affect Fluoxetine Drugs Tightly Bound to Plasma Proteins - Because fluoxetine is tightly bound to plasma proteins, adverse effects may result from displacement of protein-bound fluoxetine by other tightly-bound drugs [ see Clinical Pharmacology (12.3) ].

7.7Potential for Fluoxetine to affect Other Drugs Pimozide - Concomitant use in patients taking pimozide…

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS When using fluoxetine and olanzapine in combination, also refer to the Use in Specific Populations section of the package insert for Symbyax. • Pregnanc y: SSRI use, particularly later in pregnancy, may increase risk for persistent pulmonary hypertension and symptoms of poor adaptation (respiratory distress, temperature instability, feeding difficulty, hypotonia, tremor, irritability) in the neonate ( 8.1 ) • Pediatric Use: Safety and effectiveness of fluoxetine in patients <8 years of age with Major Depressive Disorder and <7 years of age with OCD have not been established.

Safety and effectiveness of fluoxetine and olanzapine in combination in patients <10 years of age for depressive episodes associated with Bipolar I Disorder have not been established. ( 8.4 ) • Hepatic Impairment: Lower or less frequent dosing may be appropriate in patients with cirrhosis ( 8.6 )

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/clinical-and-researchprograms/pregnancyregistry/antidepressants/. Risk Summary Based on data from published observational studies, exposure to SSRIs, particularly in the month before delivery, has been associated with a less than 2-fold increase in the risk of postpartum hemorrhage [see Warnings and Precautions (5.7) and Clinical Considerations].

Available data from published epidemiologic studies and postmarketing reports over several decades have not established an increased risk of major birth defects or miscarriage. Some studies have reported an increased incidence of cardiovascular malformations; however, these studies results do not establish a causal relationship ( see Data ). There are risks associated with untreated depression in pregnancy and risks of persistent pulmonary hypertension of the newborn (PPHN) ( see Data ) and poor neonatal adaptation with exposure to selective serotonin reuptake inhibitors (SSRIs), including fluoxetine, during pregnancy ( see Clinical Considerations ).

In rats and rabbits treated with fluoxetine during the period of organogenesis, there was no evidence of developmental effects at doses up to 1.6 and 3.9 times, respectively, the maximum recommended human dose (MRHD) of 60 mg/day given to adolescents on a mg/m 2 basis. However, in other reproductive studies in rats, an increase in stillborn pups, a decrease in pup weight, and an increase in pup deaths early after birth occurred at doses that are 1.5 times (during gestation) and 0.97 time (during gestation and lactation) the MRHD given to adolescents on a mg/m 2 basis.

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Women who discontinue antidepressants during pregnancy are more likely to experience a relapse of major depression than women who continue antidepressants. This finding is from a prospective, longitudinal study that followed 201 pregnant women with a history of major depressive disorder who were euthymic and taking antidepressants at the beginning of pregnancy. Consider the risk of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum.

Maternal Adverse Reactions Use of fluoxetine in the month before delivery may be associated with an increased risk of postpartum hemorrhage [see Warnings and Precautions (5.7) ]. Fetal/…

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/clinical-and-researchprograms/pregnancyregistry/antidepressants/. Risk Summary Based on data from published observational studies, exposure to SSRIs, particularly in the month before delivery, has been associated with a less than 2-fold increase in the risk of postpartum hemorrhage [see Warnings and Precautions (5.7) and Clinical Considerations].

Available data from published epidemiologic studies and postmarketing reports over several decades have not established an increased risk of major birth defects or miscarriage. Some studies have reported an increased incidence of cardiovascular malformations; however, these studies results do not establish a causal relationship ( see Data ). There are risks associated with untreated depression in pregnancy and risks of persistent pulmonary hypertension of the newborn (PPHN) ( see Data ) and poor neonatal adaptation with exposure to selective serotonin reuptake inhibitors (SSRIs), including fluoxetine, during pregnancy ( see Clinical Considerations ).

In rats and rabbits treated with fluoxetine during the period of organogenesis, there was no evidence of developmental effects at doses up to 1.6 and 3.9 times, respectively, the maximum recommended human dose (MRHD) of 60 mg/day given to adolescents on a mg/m 2 basis. However, in other reproductive studies in rats, an increase in stillborn pups, a decrease in pup weight, and an increase in pup deaths early after birth occurred at doses that are 1.5 times (during gestation) and 0.97 time (during gestation and lactation) the MRHD given to adolescents on a mg/m 2 basis.

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Women who discontinue antidepressants during pregnancy are more likely to experience a relapse of major depression than women who continue antidepressants. This finding is from a prospective, longitudinal study that followed 201 pregnant women with a history of major depressive disorder who were euthymic and taking antidepressants at the beginning of pregnancy. Consider the risk of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum.

Maternal Adverse Reactions Use of fluoxetine in the month before delivery may be associated with an increased risk of postpartum hemorrhage [see Warnings and Precautions (5.7) ]. Fetal/Neonatal adverse reactions Neonates exposed to fluoxetine and other SSRI or SNRIs late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. Such complications can arise immediately upon delivery.

Reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremors, jitteriness, irritability, and constant crying. These findings are consistent with either a direct toxic effect of SSRIs and SNRIs or possibly a drug discontinuation syndrome. It should be noted that, in some cases, the clinical picture is consistent with serotonin syndrome [see Warnings and Precautions ( 5.2 )].

Data Human Data — It has been shown that SSRIs (including fluoxetine) can cross the placenta. Published epidemiologica…

🧒 Pediatric Use ~3 min read ▾

8.4Pediatric Use Use of fluoxetine in children — The efficacy of fluoxetine for the treatment of Major Depressive Disorder was demonstrated in two 8- to 9-week placebo-controlled clinical trials with 315 pediatric outpatients ages 8 to ≤18 [ see Clinical Studies (14.1)]. The efficacy of fluoxetine for the treatment of OCD was demonstrated in one 13-week placebo-controlled clinical trial with 103 pediatric outpatients ages 7 to <18 [see Clinical Studies (14.2)]. The safety and effectiveness in pediatric patients <8 years of age in Major Depressive Disorder and <7 years of age in OCD have not been established.

Fluoxetine pharmacokinetics were evaluated in 21 pediatric patients (ages 6 to ≤18) with Major Depressive Disorder or OCD [see Clinical Pharmacology (12.3)]. The acute adverse reaction profiles observed in the 3 studies (N=418 randomized; 228 fluoxetine-treated, 190 placebo-treated) were generally similar to that observed in adult studies with fluoxetine. The longer-term adverse reaction profile observed in the 19-week Major Depressive Disorder study (N=219 randomized; 109 fluoxetine-treated, 110 placebo-treated) was also similar to that observed in adult trials with fluoxetine [see Adverse Reactions (6.1)].

Manic reaction, including mania and hypomania, was reported in 6 (1 mania, 5 hypomania) out of 228 (2.6%) fluoxetine-treated patients and in 0 out of 190 (0%) placebo-treated patients. Mania/hypomania led to the discontinuation of 4 (1.8%) fluoxetine-treated patients from the acute phases of the 3 studies combined. Consequently, regular monitoring for the occurrence of mania/hypomania is recommended.

As with other SSRIs, decreased weight gain has been observed in association with the use of fluoxetine in children and adolescent patients. After 19 weeks of treatment in a clinical trial, pediatric subjects treated with fluoxetine gained an average of 1.1 cm less in height and 1.1 kg less in weight than subjects treated with placebo. In addition, fluoxetine treatment was associated with a decrease in alkaline phosphatase levels.

The safety of fluoxetine treatment for pediatric patients has not been systematically assessed for chronic treatment longer than several months in duration. In particular, there are no studies that directly evaluate the longer-term effects of fluoxetine on the growth, development and maturation of children and adolescent patients. Therefore, height and weight should be monitored periodically in pediatric patients receiving fluoxetine [see Warnings and Precautions (5.6)].

Fluoxetine is approved for use in pediatric patients with MDD and OCD [see Box Warning and Warnings and Precautions (5.1)]. Anyone considering the use of fluoxetine in a child or adolescent must balance the potential risks with the clinical need. Animal Data — Significant toxicity on muscle tissue, neurobehavior, reproductive organs, and bone development has been observed following exposure of juvenile rats to fluoxetine from weaning through maturity.

Oral administration of fluoxetine to rats from weaning postnatal day 21 through adulthood day 90 at 3, 10, or 30 mg/kg/day was associated with testicular degeneration and necrosis, epididymal vacuolation and hypospermia (at 30 mg/kg/day corresponding to plasma exposures [AUC] approximately 5 to 10 times the average AUC in pediatric patients at the MRHD of 20 mg/day), increased serum levels of creatine kinase (at AUC as low as 1 to 2 times the average AUC in pediatric patients at the MRHD of 20 mg/day), skeletal muscle degeneration and necrosis, decreased femur length/growth and body weight gain (at AUC 5 to 10 times the average AUC in pediatric patients at the MRHD of 20 mg/day).

The high dose of 30 mg/kg/day exceeded a maximum tolerated dose. When animals were evaluated after a drug-free period (up to 11 weeks after cessation of dosing), fluoxetine was associated with neurobehavioral abnormalities (decreased reactivity at AUC as low as approximately 0.1 to 0.2 times the average AUC…

🧓 Geriatric Use 148 words ▾

8.5Geriatric Use US fluoxetine clinical trials included 687 patients ≥65 years of age and 93 patients ≥75 years of age. The efficacy in geriatric patients has been established [ see Clinical Studies (14.1 )]. For pharmacokinetic information in geriatric patients, [see Clinical Pharmacology (12.4)].

No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. SNRIs and SSRIs, including fluoxetine, have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse reaction [see Warnings and Precautions (5.9)].

Clinical studies of olanzapine and fluoxetine in combination did not include sufficient numbers of patients ≥65 years of age to determine whether they respond differently from younger patients.

🆘 Overdosage 109 words ▾

10 OVERDOSAGE The following have been reported with fluoxetine overdosage: • Seizures, which may be delayed, and altered mental status including coma. • Cardiovascular toxicity, which may be delayed, including QRS and QTc interval prolongation, wide complex tachyarrhythmias, torsade de pointes, and cardiac arrest. Hypertension most commonly seen, but rarely can see hypotension alone or with co-ingestants including alcohol. • Serotonin syndrome (patients with a multiple drug overdosage with other pro-serotonergic drugs may have a higher risk).

Gastrointestinal decontamination with activated charcoal should be considered in patients who present early after a fluoxetine overdose. Consider contacting a Poison Center (1-800-221-2222) or a medical toxicologist for additional overdosage management recommendations.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Although the exact mechanism of fluoxetine is unknown, it is presumed to be linked to its inhibition of CNS neuronal uptake of serotonin.

12.2Pharmacodynamics Studies at clinically relevant doses in man have demonstrated that fluoxetine blocks the uptake of serotonin into human platelets. Studies in animals also suggest that fluoxetine is a much more potent uptake inhibitor of serotonin than of norepinephrine. Antagonism of muscarinic, histaminergic, and α 1 -adrenergic receptors has been hypothesized to be associated with various anticholinergic, sedative, and cardiovascular effects of classical tricyclic antidepressant (TCA) drugs.

Fluoxetine binds to these and other membrane receptors from brain tissue much less potently in vitro than do the tricyclic drugs.

12.3Pharmacokinetics Systemic Bioavailability — In man, following a single oral 40 mg dose, peak plasma concentrations of fluoxetine from 15 to 55 ng/mL are observed after 6 to 8 hours. Food does not appear to affect the systemic bioavailability of fluoxetine, although it may delay its absorption by 1 to 2 hours, which is probably not clinically significant. Thus, fluoxetine may be administered with or without food.

Protein Binding — Over the concentration range from 200 to 1,000 ng/mL, approximately 94.5% of fluoxetine is bound in vitro to human serum proteins, including albumin and α 1 -glycoprotein. The interaction between fluoxetine and other highly protein-bound drugs has not been fully evaluated, but may be important. Enantiomers — Fluoxetine is a racemic mixture (50/50) of R -fluoxetine and S -fluoxetine enantiomers.

In animal models, both enantiomers are specific and potent serotonin uptake inhibitors with essentially equivalent pharmacologic activity. The S -fluoxetine enantiomer is eliminated more slowly and is the predominant enantiomer present in plasma at steady state. Metabolism — Fluoxetine is extensively metabolized in the liver to norfluoxetine and a number of other unidentified metabolites.

The only identified active metabolite, norfluoxetine, is formed by demethylation of fluoxetine. In animal models, S -norfluoxetine is a potent and selective inhibitor of serotonin uptake and has activity essentially equivalent to R - or S -fluoxetine. R -norfluoxetine is significantly less potent than the parent drug in the inhibition of serotonin uptake.

The primary route of elimination appears to be hepatic metabolism to inactive metabolites excreted by the kidney. Variability in Metabolism — A subset (about 7%) of the population has reduced activity of the drug metabolizing enzyme cytochrome P450 2D6 (CYP2D6). Such individuals are referred to as ''poor metabolizers'' of drugs such as debrisoquin, dextromethorphan, and the TCAs.

In a study involving labeled and unlabeled enantiomers administered as a racemate, these individuals metabolized S -fluoxetine at a slower rate and thus achieved higher concentrations of S -fluoxetine. Consequently, concentrations of S -norfluoxetine at steady state were lower. The metabolism of R -fluoxetine in these poor metabolizers appears normal.

When compared with normal metabolizers, the total sum at steady state of the plasma concentrations of the 4 active enantiomers was not significantly greater among poor metabolizers. Thus, the net pharmacodynamic activities were essentially the same. Alternative, nonsaturable pathways (non-2D6) also contribute to the metabolism of fluoxetine.

This explains how fluoxetine achieves a steady-state concentration rather than increasing without limit. Because fluoxetine's metabolism, like that of a number of other compounds including TCAs and other selective serotonin reuptake inhibitors (SSRIs), involves the CYP2D6 system, concomitant therapy with drugs also metabolized by this enzyme system (such as the TCAs) may lead to drug interactions [ see Drug Interactions (7.7)]. Accumulation and Slow Elimination — The relatively slow elimination of fluoxe…

🧬 Mechanism of Action 27 words ▾

12.1Mechanism of Action Although the exact mechanism of fluoxetine is unknown, it is presumed to be linked to its inhibition of CNS neuronal uptake of serotonin.

📦 How Supplied / Storage and Handling 182 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied Fluoxetine capsules USP, 10 mg* White to off white powder filled in size "4" hard gelatin capsules with green opaque cap and green opaque body imprinted "C28" Bottles of 30 NDC 72241-007-22 Bottles of 100 NDC 72241-007-05 Bottles of 500 NDC 72241-007-10 Bottles of 1,000 NDC 72241-007-11 Fluoxetine Capsules USP, 20 mg* White to off white powder filled in size "2" hard gelatin capsules with green opaque cap and yellow opaque body imprinted "C29" Bottles of 30 NDC 72241-008-22 Bottles of 100 NDC 72241-008-05 Bottles of 500 NDC 72241-008-10 Bottles of 1,000 NDC 72241-008-11 Fluoxetine Capsules USP, 40 mg* White to off white powder filled in size "0" hard gelatin capsules with green opaque cap and orange opaque body imprinted "C30" Bottles of 30 NDC 72241-009-22 Bottles of 100 NDC 72241-009-05 Bottles of 500 NDC 72241-009-10 *Fluoxetine base equivalent.

Protect from light and preserve in tight containers.

16.2Storage and Handling Store at 20° to 25°C (68° to 77°F); excursion permitted to 15° to 30°C (59° to 86° F). [See USP Controlled Room Temperature]

📋 Description 136 words ▾

11 DESCRIPTION Fluoxetine capsules, USP are a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl) oxy] propylamine hydrochloride and has the empirical formula of C 17 H 18 F 3 NO•HCl. Its molecular weight is 345.79.

The structural formula is: Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol), 20 mg (64.7 μmol), or 40 mg (129.3 μmol) of fluoxetine. The capsules also contain the following inactive ingredients: pregelatinized starch, gelatin, sodium lauryl sulphate, titanium dioxide, iron oxide yellow, FD&C Blue No.1.

In addition 40 mg also contains FD&C Yellow No.6. The imprinting ink contains shellac, black iron oxide, propylene glycol, potassium hydroxide, dehydrated alcohol, isopropyl alcohol, butyl alcohol and strong ammonia solution. fluoxetine-spl-stru-fig1

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking fluoxetine as monotherapy or in combination with olanzapine. When using fluoxetine and olanzapine in combination, also refer to the Patient Counseling Information section of the package insert for Symbyax.

General Information Healthcare providers should instruct their patients to read the Medication Guide before starting therapy with fluoxetine and to reread it each time the prescription is renewed. Healthcare providers should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with fluoxetine and should counsel them in its appropriate use. Healthcare providers should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents.

Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. Patients should be advised of the following issues and asked to alert their healthcare provider if these occur while taking fluoxetine. When using fluoxetine and olanzapine in combination, also refer to the Medication Guide for Symbyax.

Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults Patients, their families, and their caregivers should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down. Families and caregivers of patients should be advised to look for the emergence of such symptoms on a day-to-day basis, since changes may be abrupt.

Such symptoms should be reported to the patient's prescriber or health professional, especially if they are severe, abrupt in onset, or were not part of the patient's presenting symptoms. Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior and indicate a need for very close monitoring and possibly changes in the medication [ see Box Warning and Warnings and Precautions ( 5.1 ) ]. Serotonin Syndrome Patients should be cautioned about the risk of serotonin syndrome with the concomitant use of fluoxetine and other serotonergic agents including triptans, tricyclic antidepressants, opioids, lithium, tryptophan, buspirone, amphetamines, and St.

John's Wort [ see Contraindications ( 4.1 ), Warnings and Precautions ( 5.2 ), and Drug Interactions ( 7.3 ) ]. Patients should be advised of the signs and symptoms associated with serotonin syndrome that may include mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular changes (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).

Patients should be cautioned to seek medical care immediately if they experience these symptoms. Allergic Reactions and Rash Patients should be advised to notify their healthcare provider if they develop a rash or hives [ see Warnings and Precautions ( 5.3 ) ]. Patients should also be advised of the signs and symptoms associated with a severe allergic reaction, including swelling of the face, eyes, or mouth, or have trouble breathing.

Patients should be cautioned to seek medical care immediately if they experience these symptoms. Increased Risk of Bleeding Patients should be cautioned about the concomitant use of fluoxetine and NSAIDs, aspirin, warfarin, or other drugs that affect coagu…

💬 Medication Guide ~3 min read ▾

Medication Guide Fluoxetine Capsules, USP (floo OX e teen) for oral use Read the Medication Guide that comes with fluoxetine capsules before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment.

Talk with your healthcare provider if there is something you do not understand or want to learn more about. What is the most important information I should know about fluoxetine capsules? Fluoxetine capsules and other antidepressant medicines may cause serious side effects, including: 1.

Suicidal thoughts or actions: • Fluoxetine capsules and other antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, or young adults within the first few months of treatment or when the dose is changed. • Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions. • Watch for these changes and call your healthcare provider right away if you notice: • New or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe. • Pay particular attention to such changes when fluoxetine capsules is started or when the dose is changed.

Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms. Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency, especially if they are new, worse, or worry you: • attempts to commit suicide • acting on dangerous impulses • acting aggressive or violent • thoughts about suicide or dying • new or worse depression • new or worse anxiety or panic attacks • feeling agitated, restless, angry or irritable • trouble sleeping • an increase in activity or talking more than what is normal for you • other unusual changes in behavior or mood Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency.

Fluoxetine capsules may be associated with these serious side effects: 2. Serotonin Syndrome. This condition can be life-threatening and may include: • agitation, hallucinations, coma or other changes in mental status • coordination problems or muscle twitching (overactive reflexes) • racing heartbeat, high or low blood pressure • sweating or fever • nausea, vomiting, or diarrhea • muscle rigidity • dizziness • flushing • tremor • seizures 3.

Severe allergic reactions: • trouble breathing • swelling of the face, tongue, eyes or mouth • rash, itchy welts (hives) or blisters, alone or with fever or joint pain 4. Abnormal bleeding: Fluoxetine capsules and other antidepressant medicines may increase your risk of bleeding or bruising, especially if you take the blood thinner warfarin (Coumadin ® , Jantoven ® ), a non-steroidal anti-inflammatory drug (NSAIDs, like ibuprofen or naproxen), or aspirin. 5.

Visual problems: • eye pain • changes in vision • swelling or redness in or around the eye Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are. 6.

Seizures or convulsions 7. Manic episodes: • greatly increased energy • severe trouble sleeping • racing thoughts • reckless behavior • unusually grand ideas • excessive happiness or irritability • talking more or faster than usual 8. Changes in appetite or weight.

Children and adolescents should have height and weight monitored during treatment. 9. Low salt (sodium) levels in the blood.

Elderly people may be at greater risk for this. Symptoms may include: • headache • weakness or feeling unsteady • confusion, problems concentrating or thinking or memory problems 10. Changes in the electrical activity of your heart (QT prolongation and ventricular arrhythmia including Torsades de Pointes).

This condition can be life threatening. The symptoms may include: • fast, slow, or i…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.