Home › NDC Lookup › Ingredients › Ketotifen Fumarate › 00065-4011-05
Zaditor ketotifen fumarate .25 mg/mL Solution — NDC 00065-4011-05 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Zaditor ketotifen fumarate .25 mg/mL Solution — NDC 0065-4011-05 (Billing 00065-4011-05)

by Alcon Laboratories, Inc. · 1 BOTTLE, DROPPER in 1 CARTON / 5 mL in 1 BOTTLE, DROPPER

This is a package of Zaditor ketotifen fumarate .25 mg/mL Solution from Alcon Laboratories, Inc., marketed since Jan 2013 and currently FDA-listed; retail pharmacies pay about $2.23 per mL (NADAC). It is the main listing for this product, which comes in 3 package sizes.

NDC 00065-4011-05
🏷️ FDA NDC (as labeled) 0065-4011-05 billing pads the labeler segment with a zero
This package
Contains5 mL in 1 bottle, dropper Cost per mL$2.23 NADAC Per package$11.14 / 5 ml Pack sizes3 compare ↓
Also priced by: Medicaid pays $3.98/unit — full pricing hub ↓
Main listing for product 0065-4011 · Also comes in: 2 bottles 0065-4011-06 3 bottles 0065-4011-11
OTC Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

NDC database record

One package, one record: these facts belong to NDC 0065-4011-05 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
0065 labeler · 4011 product · 05 package
Package marketed since
Mar 13, 2013
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0300654011057
Medicaid fills, this package
10,099 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026
Past resolved recalls for this product (1)
Class II · Jun 29, 2022 · Terminated — CGMP Deviations: products were stored outside the drug label specifications. (Mckesson Medical-Surgical Inc. Corporate Office) · FDA recall D-1317-2022

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0065-4011-05
Product NDC 0065-4011
11-digit billing NDC 00065401105
NCPDP billing unit ML — per mL (volume)
RxCUI 284380, 311237
UNII HBD503WORO
UPC 0300654011057
Application # ANDA077200
SPL Set ID ac66b1e4-c2b0-a4c3-09e3-ebd44a2f7c9f
Established class (EPC) Histamine-1 Receptor Inhibitor
Mechanism of action Histamine H1 Receptor Antagonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2013-01-08
Route OPHTHALMIC
Dosage form SOLUTION
Substance KETOTIFEN FUMARATE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 86802040102011
GPI class Zaditor
GCN Seq No 043118
GCN 92451
HICL code 006554
Ingredient (HICL) Ketotifen Fumarate
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q6
Therapeutic class — intermediate (HIC2) Ophthalmic Preparations
HIC3 code Q6R
Therapeutic class — specific (HIC3) Eye Antihistamines
AHFS code 52:02.00.00
AHFS class Antiallergic Agents
FDB label name ZADITOR 0.025% (0.035%) DROPS
FDB brand name Zaditor
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 043118
  • GCN: 92451
  • GPI-14 (Medi-Span): 86802040102011
  • HICL (First Databank): 006554
  • AHFS class code: 52:02.00.00
  • RxCUI (RxNorm): 284380
Why two NDCs? The FDA registers this code as 0065-4011-05 — a 4-4-2 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 labeler segment → 00065-4011-05. 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 Histamine-1 Receptor Inhibitor class.

Pharmacologic class Histamine-1 Receptor Inhibitor
Drug family (ATC) Other antihistamines for systemic use, Other antiallergics
How it works Histamine H1 Receptor Antagonists
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.

Clinical

Label name ZADITOR 0.025% (0.035%) DROPS Ingredient Ketotifen Fumarate
📖 What it is MedlinePlus · NLM

Ophthalmic ketotifen is used to relieve the itching of allergic pinkeye. Ketotifen is in a class of medications called antihistamines. It works by blocking histamine, a substance in the body that causes allergic symptoms.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It relieves or prevents itchy eyes from allergies. The drops give temporary relief from itching due to pollen, ragweed, grass, and animal hair and dander. The ACUVUE Theravision le...
  • If you are an adult or a child 3 or older, use 1 drop in each affected eye twice a day, 8 to 12 hours apart. Don't use them more than twice daily. If your child is under 3, check w...
  • Take your contact lenses out before using the drops. Then wait at least 10 minutes before putting them back in. If you use other eye products too, leave at least 5 minutes between...
  • Stop the drops and talk to a doctor if you have eye pain, changes in vision, redness, or itching that gets worse or lasts more than 72 hours. With the ACUVUE Theravision lens, take...
📖 Read our full Ketotifen guide →
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.

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 mLPer package
Retail pharmacies payNADAC · weekly $2.229 $11.14 / 5 ml
Medicaid paysCMS SDUD · 12 mo $3.98 $19.90 / 5 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per mL) — tap or hover for the price & month
Oct 2021 Oct 2023 Apr 2026 Sep 2026 $2.339 $2.029
▲ Up 7% over the last 16 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.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
00065-4011-05 You're viewing this Main listing 1 BOTTLE, DROPPER in 1 CARTON / 5 mL in 1 BOTTLE, DROPPER $2.23 / mL $11.14 2013-03-13 — Active
00065-4011-06 0065-4011-06 2 BOTTLE, DROPPER in 1 CARTON / 5 mL in 1 BOTTLE, DROPPER $1.87 / mL $18.70 2013-01-08 — Active
00065-4011-11 0065-4011-11 3 BOTTLE, DROPPER in 1 CARTON / 5 mL in 1 BOTTLE, DROPPER — — 2015-02-13 — Active

Per mL, this pack runs about 19% above the cheapest pack (NDC 00065-4011-06, $1.87 vs $2.23 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 98% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 bottle, dropper in 1 carton / 5 ml in 1 bottle, dropper.
What NDC number is used to bill for this package of Zaditor ketotifen fumarate .25 mg/mL Solution?
Use the 11-digit billing form listed in the identifiers section of this page. 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.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ketotifen Fumarate .25 mg/mL 00536-1252-40 Rugby 1 bottle $1.294 — Availability likely save 42%
Eye Itch Relief .25 mg/mL 70000-0522-01 Cardinal 1 bottle $1.294 — Availability likely save 42%
Ketotifen Fumarate Ophthalmic Solution .25 mg/mL 70244-0041-01 Sentiss 1 bottle $1.294 — Availability likely save 42%
Ketotifen Fumarate Ophthalmic Solution .25 mg/mL 72485-0617-10 Armas 1 bottle $1.294 — Availability likely save 42%
Ketotifen Fumarate .25 mg/mL 76385-0106-17 Unichem 1 bottle $1.294 — Availability likely save 42%
Eye Itch Relief .35 mg/mL 70000-0124-01 CARDINAL 1 bottle $1.322 — FDA listed save 41%
Alaway .25 mg/mL 24208-0601-05 Bausch 1 bottle $2.083 — FDA listed save 7%
Zaditor .25 mg/mLthis 00065-4011-05 Alcon 1 bottle $2.229 — Availability likely —
Eye Itch Relief .35 mg/mL 00363-0038-05 Walgreen 1 bottle — — FDA listed —
Eye Itch Relief .25 mg/mL 11673-0064-05 Target 1 bottle — — FDA listed —
Eye Itch Releif .25 mg/mL 11822-5533-01 Rite 1 bottle — — Discontinued —
Eye Itch Relief .25 mg/mL 21130-0601-05 Safeway 1 bottle — — FDA listed —
Eye Itch Relief .25 mg/mL 30142-0398-05 Kroger 1 bottle — — FDA listed —
Eye Itch Relief .25 mg/mL 36800-0097-05 TOPCO 1 bottle — — FDA listed —
Equate Eye Itch Relief .25 mg/mL 49035-0231-10 Wal-Mart 1 bottle — — FDA listed —
Ketotifen Fumarate .25 mg/mL 50090-6472-00 A-S 1 bottle — — FDA listed —
Eye Itch Relief .25 mg/mL 50090-7253-00 A-S 1 bottle — — FDA listed —
Eye Itch Relief .25 mg/mL 50804-0601-05 PERRIGO 1 bottle — — FDA listed —
Eye Itch Relief .25 mg/mL 67296-2245-05 Redpharm 1 bottle — — FDA listed —
Ketotifen Fumarate Ophthalmic Solution .25 mg/mL 68788-4084-05 Preferred 1 bottle — — FDA listed —
Ketotifen Fumarate .25 mg/mL 68788-8715-05 Preferred 1 bottle — — FDA listed —
Eye Itch Relief .25 mg/mL 69842-0275-05 CVS 1 bottle — — FDA listed —
Ketotifen Fumarate .35 mg/mL 71205-0115-05 Proficient 1 bottle — — 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

🏛️
2013
On the market since
Jan 2013
📍
2026
Currently FDA-listed
13 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.

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.

🧪 Avoiding an ingredient? See Ketotifen inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

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

  • UNII F5UM2KM3W7
    Benzalkonium chloride is a chemical compound that works as a preservative and antimicrobial agent in medications. It prevents bacterial and fungal growth in liquid formulations to keep the product safe during storage and use.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

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

The official label also statesbenzalkonium chloride 0.01%, glycerol, purified water, sodium hydroxide and/or hydrochloric acid

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

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.

Manufacturer & labeler

LabelerAlcon Laboratories, Inc.
Application holderALCON PHARMACEUTICALS LTD
FDA applicationANDA077200 (ANDA)
Labeler code00065
First marketedJan 2013
Product typeHuman Otc Drug
Portfolio55 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.

FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 14 words ▾

Use Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.

⏱️ Dosage and Administration 37 words ▾

Directions Adults and children 3 years of age and older: Put 1 drop in the affected eye(s) twice daily, every 8-12 hours, no more than twice per day. Children under 3 years of age: Consult a doctor

⚠️ Warnings 31 words ▾

Warnings For external use only Do Not Use if solution changes color or becomes cloudy if you are sensitive to any ingredient in this product to treat contact lens related irritation

🧪 Active Ingredient 11 words ▾

Active ingredient Purpose Ketotifen (0.025%) (equivalent to ketotifen fumarate 0.035%) Antihistamine

🧪 Inactive Ingredients 13 words ▾

Inactive ingredients benzalkonium chloride 0.01%, glycerol, purified water, sodium hydroxide and/or hydrochloric acid

🎯 Purpose 11 words ▾

Active ingredient Purpose Ketotifen (0.025%) (equivalent to ketotifen fumarate 0.035%) Antihistamine

📄 When Using This Product 37 words ▾

When using this product do not touch tip of container to any surface to avoid contamination remove contact lenses before use wait at least 10 minutes before reinserting contact lenses after use replace cap after each use

📄 Stop Use and Ask a Doctor If 31 words ▾

Stop use and ask a doctor if you experience any of the following: eye pain changes in vision redness of the eye itching worsens or lasts for more than 72 hours

📄 Keep Out of Reach of Children 19 words ▾

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

📄 Other Information 12 words ▾

Other information Only for use in the eye. Store between 4°-25°C (39°-77°F).

📄 Questions or Comments 25 words ▾

Questions? In the US, call toll-free 1-800-757-919 5 [email protected] www.systane.com Serious side effects associated with use of this product may be reported to this number.

📄 Package Label / Principal Display Panel 189 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Systane ® ZADITOR ® ketotifen fumarate ophthalmic solution 0.035% ANTIHISTAMINE EYE DROPS EYE ITCH RELIEF Works in minutes Original prescription strength For ages 3 years and older up to 12 HOURS Alcon STERILE 30 DAY SUPPLY 5mL (0.17 FL OZ) Systane® ZADITOR® Original Prescription Strength Up to 12 Hour Itch Relief Works in Minutes For Ages 3 Years and Older 30 DAY SUPPLY TAMPER EVIDENT: For your protection, this bottle has a seal imprinted with Alcon around the neck. Do not use if seal is damaged or missing at time of purchase.

Alcon Laboratories, Inc. Fort Worth, TX 76134 USA Country of Origin: Italy 300048650-0821 ACTUAL SIZE LOT: EXP.: Systane ® ZADITOR ® ketotifen fumarate ophthalmic solution 0.035% ANTIHISTAMINE EYE DROPS EYE ITCH RELIEF 5mL (0.17 FL OZ) STERILE Only for use in the eye. Store between 4° - 25°C (39° - 77°F).

TAMPER EVIDENT: For your protection, this bottle has a seal imprinted with Alcon around the neck. Do not use if seal is damaged or missing at time of purchase. Manufactured by: Alcon Laboratories, Inc.

6201 South Freeway, Fort Worth, TX 76134 H15433-1018

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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 this package alone, 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 – Q1 2026 · 5 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
10.1K
Units reimbursed last 4 qtrs
55.7K
Gross reimbursed last 4 qtrs
$221.7K
Avg / prescription
$21.95
Avg / unit
$3.9810
Latest quarter Q1 2026
1.9KRx
Medicaid pays / mL
$3.9810
gross reimbursed
vs
NADAC / mL
$2.2285
acquisition cost
=
Spread
+$1.7525
+79% vs cost
What Medicaid paid per mL (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 ⓘ
76% FFS 24% MCO
Fee-for-service · 7,672 Rx Managed care · 2,427 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: 280 units · 24.7 per 100k residents MT North Dakota: no data reported ND Minnesota: 145 units · 2.5 per 100k residents MN Wisconsin: 2,120 units · 35.9 per 100k residents WI Michigan: 555 units · 5.5 per 100k residents MI New York: 4,693 units · 24.0 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: 3,300 units · 28.0 per 100k residents OH Pennsylvania: 3,090 units · 23.8 per 100k residents PA New Jersey: 545 units · 5.9 per 100k residents NJ Massachusetts: no data reported MA California: 32,515 units · 83.4 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: 70 units · 3.5 per 100k residents NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: 2,000 units · 113 per 100k residents WV Virginia: 1,495 units · 17.2 per 100k residents VA Maryland: 250 units · 4.0 per 100k residents MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: 565 units · 7.6 per 100k residents AZ New Mexico: 690 units · 32.6 per 100k residents NM Kansas: no data reported KS Arkansas: 215 units · 7.0 per 100k residents AR Tennessee: 80 units · 1.1 per 100k residents TN North Carolina: no data reported NC South Carolina: 1,160 units · 21.6 per 100k residents SC Delaware: no data reported DE Oklahoma: 570 units · 14.1 per 100k residents OK Louisiana: no data reported LA Mississippi: 215 units · 7.3 per 100k residents MS Alabama: no data reported AL Georgia: 1,140 units · 10.3 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
1.1113
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 West Virginia 113 /100k
2 California 83.4 /100k
3 Wisconsin 35.9 /100k
4 New Mexico 32.6 /100k
5 Ohio 28.0 /100k
6 Montana 24.7 /100k
7 New York 24.0 /100k
8 Pennsylvania 23.8 /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.
1 bottle this page00065-4011-05 10,099 Rx · $221,710
2 bottles00065-4011-06 226 Rx · $4,747
3 bottles00065-4011-11 No Medicaid data
Drug total (last 4 qtrs): 10,325 Rx · 57,313 units · $226,457 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Zaditor (this brand).

Top reported reactions

Treatment Failure2,490
Pruritus188
Eye Irritation173
Fatigue164
Headache157
Hypersensitivity156
Nausea154

Age at onset

Child9
Adolescent9
Adult218
Elderly124

Reporter sex

4,925 reports

Serious outcomes

Hospitalization441
Disabling41
Life-threatening35
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 2,375 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.
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.