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Diclofenac Sodium Gel 10 mg/g Gel, 1 g — NDC 72189-479-01 (Billing 72189-0479-01)

by Direct_Rx · 1 g in 1 TUBE

This is a package of 1 g of Diclofenac Sodium Gel 10 mg/g Gel from Direct_Rx, marketed since May 2023 and currently FDA-listed. It is this product's only package size.

NDC 72189-0479-01
🏷️ FDA NDC (as labeled) 72189-479-01 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 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 →

This page is curated, coded, and maintained by

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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 72189-479-01
Product NDC 72189-479
11-digit billing NDC 72189047901
NCPDP billing unit GM — per gram (weight)
RxCUI 855633
UNII QTG126297Q
Application # ANDA210986
SPL Set ID fce9b3eb-ae79-a090-e053-6294a90ad20e
Established class (EPC) Anti-Inflammatory Agents; Nonsteroidal Anti-inflammatory Drug
Mechanism of action Cyclooxygenase Inhibitors
Physiologic effect Decreased Prostaglandin Production
Chemical class Non-Steroidal
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-05-30
Route TOPICAL
Dosage form GEL
Substance DICLOFENAC SODIUM

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

GCN Seq No 018293
GCN 45680
HICL code 003733
Ingredient (HICL) Diclofenac Sodium
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q5
Therapeutic class — intermediate (HIC2) Agents Acting Principally On The Skin
HIC3 code Q5E
Therapeutic class — specific (HIC3) Topical Anti-Inflammatory, Nsaids
AHFS code 28:08.04.04
AHFS class Reversible Cox-1/Cox-2 Inhibitors
FDB label name DICLOFENAC SODIUM 1% GEL
FDB brand name Diclofenac Sodium
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 018293
  • GCN: 45680
  • HICL (First Databank): 003733
  • AHFS class code: 28:08.04.04
  • RxCUI (RxNorm): 855633
Why two NDCs? The FDA registers this code as 72189-479-01 — 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 → 72189-0479-01. 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 Nonsteroidal Anti-inflammatory Drug class.

Pharmacologic class Nonsteroidal Anti-inflammatory Drug
Drug family (ATC) Other dermatologicals, Acetic acid derivatives and related substances, Antiinflammatory preparations, non-steroids for topical use
How it works Cyclooxygenase 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.

Clinical

Label name DICLOFENAC SODIUM 1% GEL Ingredient Diclofenac Sodium
📗 Our plain-language guide HelloPharmacist
  • It's an NSAID used for pain and inflammation. Depending on the form, that may be arthritis, period pain, acute pain, strains and sprains, or migraine attacks. Check that your produ...
  • Take oral forms by mouth and apply gels, solutions and patches to the skin as directed. Use the lowest dose for the shortest time that works. Food won't change how much you absorb,...
  • Stomach upset, nausea, gas, diarrhea or constipation, headache and dizziness are common. Skin products can cause dryness, redness or irritation where applied. Call me or your docto...
  • Get emergency help for chest pain, trouble breathing, weakness on one side, black or bloody stools, vomiting blood, or swelling of the face or tongue. Stop it and call for a new ra...
📖 Read our full Diclofenac guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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 gPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
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 Marketing startMarketing endStatus
72189-0479-01 You're viewing this Main listing 1 g in 1 TUBE 2023-05-30 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
good sense arthritis pain 10 mg/g 00113-1189-01 L. 1 tube $0.081 — Availability likely —
Good Sense Arthritis Pain 10 mg/g 00113-8175-01 L. 1 tube $0.081 — Availability likely —
Diclofenac Sodium 10 mg/g 45802-0953-01 Padagis 1 tube $0.081 — Availability likely —
Diclofenac Sodium 10 mg/g 68001-0621-45 BluePoint 1 tube $0.081 — Availability likely —
Diclofenac sodium 10 mg/g 69097-0720-44 Cipla 1 tube $0.081 — Availability likely —
Diclofenac sodium 10 mg/g 69238-2053-01 Amneal 1 tube $0.081 — Availability likely —
Diclofenac Sodium 10 mg/g 70512-0106-10 SOLA 1 tube $0.081 — Availability likely —
Arthritis Pain 10 mg/g 70677-1125-01 Strategic 1 tube $0.081 — Availability likely —
Foster And Thrive Arthritis Pain 10 mg/g 70677-1293-01 Strategic 1 tube $0.081 — Availability likely —
Diclofenac Sodium 10 mg/g 76282-0103-39 EXELAN 1 tube $0.081 — Availability likely —
Arthritis Pain Reliever 10 mg/g 83324-0306-01 QUALITY 1 tube $0.081 — Availability likely —
Arthritis Pain Reliever 10 mg/g 46122-0752-37 AmerisourceBergen 1 tube $0.117 — Availability likely —
Diclofenac sodium 10 mg/g 70000-0555-01 CARDINAL 1 tube $0.117 — Availability likely —
Voltaren Arthritis Pain 10 mg/g 00067-8152-01 Haleon 1 tube — — FDA listed —
Voltaren Arthritis Pain 00067-8153-01 Haleon 1 kit — — FDA listed —
Voltaren Arthritis Pain 00067-8154-01 Haleon 1 kit — — FDA listed —
Aleve Arthritis Pain Gel 1 mg/g 00280-0039-01 Bayer 1 tube — — FDA listed —
Diclofenac sodium 10 mg/g 00363-1210-17 Walgreens 1 tube — — FDA listed —
Arthritis Pain Relieving 10 mg/g 00363-3003-02 Walgreen 1 tube — — FDA listed —
arthritis pain relieving 10 mg/g 00363-5123-01 Walgreen 1 tube — — Discontinued —
Diclofenac Sodium Topical Gel 1% 10 mg/g 00363-7065-10 Walgreens 1 tube — — FDA listed —
Diclofenac sodium 10 mg/g 00536-1294-31 Rugby 1 tube — — FDA listed —
up and up arthritis pain reliever 10 mg/g 11673-0569-01 Target 1 tube — — FDA listed —
Diclofenac Sodium 10 mg/g 11822-0870-01 Rite 1 tube — — FDA listed —
Diclofenac sodium 10 mg/g 21130-0028-10 Safeway, 1 tube — — FDA listed —
signature care arthritis pain 10 mg/g 21130-0313-01 Safeway 1 tube — — Discontinued —
Diclofenac Sodium 10 mg/g 21922-0044-29 Encube 1 tube — — Discontinued —
Diclofenac Sodium Topical Gel 1% 10 mg/g 30142-0025-10 Kroger 1 tube — — FDA listed —
Diclofenac Sodium 10 mg/g 30142-0277-10 KROGER 1 tube — — FDA listed —
topcare athritis pain reliever 10 mg/g 36800-0526-01 Topco 1 tube — — FDA listed —
arthritis pain reliever 10 mg/g 37808-0087-01 H 1 tube — — FDA listed —
equaline arthritis pain relieving 10 mg/g 41163-0087-01 United 1 tube — — FDA listed —
Aspercreme Arthritis .01 g/g 41167-0571-00 Chattem, 1 tube — — FDA listed —
Aspercreme Arthritis .01 g/g 41167-0573-02 Chattem, 1 tube — — FDA listed —
arthritis pain relieving 10 mg/g 41250-0674-01 Meijer 1 tube — — FDA listed —
CareOne arthritis pain relief 10 mg/g 41520-0788-01 American 1 tube — — FDA listed —
arthritis pain reliever 10 mg/g 42507-0150-01 HyVee 1 tube — — FDA listed —
Diclofenac Sodium 10 mg/g 43598-0885-10 Dr. 1 tube — — FDA listed —
Diclofenac Sodium 10 mg/g 43598-0977-05 Dr. 1 tube — — FDA listed —
equate arthritis pain 10 mg/g 49035-0262-01 Wal-Mart 1 tube — — FDA listed —
Diclofenac sodium 10 mg/g 49035-0269-17 EQUATE 1 tube — — FDA listed —
Diclofenac Sodium 10 mg/g 50090-4020-00 A-S 1 tube — — FDA listed —
Diclofenac Sodium 10 mg/g 50090-4030-00 A-S 1 tube — — FDA listed —
Voltaren Arthritis Pain 10 mg/g 50090-6202-00 A-S 24 tubes — — Discontinued —
Diclofenac Sodium 10 mg/g 50090-6998-00 A-S 1 tube — — FDA listed —
Diclofenac Sodium 10 mg/g 50090-7243-00 A-S 1 tube — — FDA listed —
good sense arthritis pain 10 mg/g 50090-7250-00 A-S 1 tube — — FDA listed —
Motrin Arthritis Pain 9.3 mg/g 50580-0574-01 Kenvue 1 tube — — FDA listed —
Arthritis Pain Reliever 10 mg/g 51316-0012-15 CVS 1 tube — — FDA listed —
Arthritis Pain Reliever 10 mg/g 51316-0073-76 CVS 1 tube — — FDA listed —
Diclofenac Sodium Topical 10 mg/g 51316-0804-01 CVS 1 tube — — FDA listed —
Arthritis Pain 10 mg/g 53943-0523-01 Discount 1 tube — — FDA listed —
Arthritis Pain Reliever 10 mg/g 55319-0969-17 Family 1 tube — — FDA listed —
Salonpas 10 mg/g 55328-0801-10 Hisamitsu 1 tube — — FDA listed —
DG health arthritis pain 10 mg/g 55910-0424-02 Dolgencorp 1 tube — — FDA listed —
Dg Health Arthritis Pain 10 mg/g 55910-0926-50 Dolgencorp 1 tube — — FDA listed —
Arthritis Pain Reliever 10 mg/g 56062-0471-02 Publix 1 tube — — FDA listed —
arthritis pain reliever 10 mg/g 56062-0878-01 Publix 1 tube — — FDA listed —
Diclofenac Sodium 10 mg/g 57483-0185-11 INNOVUS 1 tube — — FDA listed —
Crcle Diclofenac Sodium Topical Gel 1% 10 mg/g 57483-0596-01 Innovus 1 tube — — FDA listed —
Diclofenac Sodium 10 mg/g 57896-0140-01 GERI-CARE 1 tube — — FDA listed —
Diclofenac Sodium 10 mg/g 57896-0147-01 GERI-CARE 1 tube — — FDA listed —
Diclofenac Sodium 10 mg/g 58602-0604-07 Aurohealth 1 tube — — FDA listed —
Diclofenac Sodium 58602-0606-21 Aurohealth 1 kit — — FDA listed —
Diclofenac Sodium 10 mg/g 58602-0609-07 Aurohealth 1 tube — — FDA listed —
VennGel One 59088-0709-00 PureTek 1 kit — — FDA listed —
Arthritis Pain Reliever 10 mg/g 59640-0198-01 H 1 tube — — FDA listed —
Arthritis Pain Reliever 10 mg/g 59726-0012-50 P 1 tube — — FDA listed —
Diclofenac Sodium 10 mg/g 62379-0401-02 Simple 1 tube — — FDA listed —
Diclofenac Sodium 10 mg/g 63187-0753-00 Proficient 1 tube — — FDA listed —
Diclofenac Sodium 10 mg/g 63868-0730-01 Chain 1 tube — — FDA listed —
Diclofenac sodium 10 mg/g 63941-0812-53 Best 1 tube — — FDA listed —
Diclofenac sodium 10 mg/g 63981-0112-15 Costco 3 tubes — — FDA listed —
Diclofenac sodium 10 mg/g 63981-0211-15 Costco 3 tubes — — FDA listed —
kirkland signature arthritis pain relief 10 mg/g 63981-0599-05 Costco 3 tubes — — FDA listed —
kirkland signature arthritis pain relief 10 mg/g 63981-0799-05 Costco 3 tubes — — FDA listed —
Diclofenac Sodium 10 mg/g 67296-2155-01 Redpharm 1 tube — — FDA listed —
Arthritis Pain Reliever 10 mg/g 68016-0171-00 Chain 1 tube — — FDA listed —
Diclofenac Sodium 10 mg/g 68071-2239-01 NuCare 1 tube — — FDA listed —
Diclofenac Sodium 10 mg/g 68071-3456-01 NuCare 1 tube — — FDA listed —
Diclofenac Sodium 10 mg/g 68071-3665-01 NuCare 1 tube — — FDA listed —
diclofenac sodium 10 mg/g 68071-3671-01 NuCare 1 tube — — FDA listed —
Members Mark Arthritis Pain Reliever 10 mg/g 68196-0523-05 Sam's 3 tubes — — FDA listed —
members mark arthritis pain reliever 10 mg/g 68196-0870-05 Sam's 3 tubes — — FDA listed —
berkley and jensen arthritis pain 68391-0205-00 BJWC 1 kit — — FDA listed —
Diclofenac Sodium 10 mg/g 68788-7772-01 Preferred 1 tube — — FDA listed —
Diclofenac Sodium 10 mg/g 69842-0729-01 CVS 1 tube — — FDA listed —
Diclofenac sodium 10 mg/g 69842-0974-06 CVS 2 tubes — — FDA listed —
Diclofenac Sodium 10 mg/g 71205-0552-00 Proficient 1 tube — — FDA listed —
good sense arthritis pain 10 mg/g 71205-0670-00 Proficient 1 tube — — FDA listed —
Diclofenac Sodium 10 mg/g 71205-0747-00 Proficient 1 tube — — FDA listed —
Diclofenac Sodium 10 mg/g 72036-0014-10 Harris 1 tube — — FDA listed —
Gencare-Arthritis Pain Relief .01 g/g 72090-0017-01 Pioneer 1 tube — — FDA listed —
Diclofenac Sodium Gel 10 mg/gthis 72189-0479-01 Direct_Rx 1 g — — FDA listed —
Amazon Basic Care Arthritis Pain 10 mg/g 72288-0624-03 Amazon.com 1 tube — — FDA listed —
basic care arthritis pain 10 mg/g 72288-0870-01 Amazon.com 1 tube — — FDA listed —
Arthritis Pain Reliever 10 mg/g 72476-0212-17 Care 1 tube — — Discontinued —
Curist Arthritis Relief 1 g/100g 72559-0020-24 Little 1 tube — — FDA listed —
Diclofenac sodium 10 mg/g 73469-2053-01 Scholl's 1 tube — — FDA listed —
Diclofenac Sodium Topical 1% 1 mg/100g 73581-0104-15 YYBA 1 tube — — FDA listed —
Diclofenac Sodium Topical Gel, 1% 1 g/100g 73715-0005-01 Mohnark 50 g — — Discontinued —
Topcare Arthritis Pain Reliever 10 mg/g 76162-0804-01 Topco 1 tube — — FDA listed —
Diclofenac Sodium 10 mg/g 76420-0091-01 Asclemed 100 g — — FDA listed —
Diclofenac Sodium 10 mg/g 76420-0691-01 Asclemed 1 tube — — FDA listed —
Arthritis Pain Relieving 10 mg/g 79481-0499-00 Meijer, 1 tube — — FDA listed —
Equate Arthritis Pain 10 mg/g 79903-0391-01 WALMART 1 tube — — FDA listed —
Diclofenac Sodium 10 mg/g 80425-0233-01 Advanced 1 tube — — FDA listed —
Up And Up Arthritis Pain Reliever 10 mg/g 82442-0251-01 Target 1 tube — — FDA listed —
Diclofenac Sodium 10 mg/g 83008-0037-00 Quality 1 tube — — FDA listed —
Diclofenac Sodium 10 mg/g 84386-0120-01 Aurobindo 1 tube — — FDA listed —
Diclofenac sodium 10 mg/g 85766-0136-01 Sportpharm 1 tube — — FDA listed —
Diclofenac Sodium 10 mg/g 85766-0137-01 Sportpharm 1 tube — — FDA listed —
Diclofenac Sodium 10 mg/g 85766-0160-01 Sportpharm 1 tube — — 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

🏛️
2023
On the market since
May 2023
📍
2026
Currently FDA-listed
3 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.

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

  • 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 4Q93RCW27E
    A synthetic polymer made from acrylic acid that's crosslinked for stability. It acts as a thickener and gelling agent in creams and gels, helping the medicine spread evenly and maintain its texture.
  • UNII 8D9H4QU99H
    A synthetic fatty acid ester derived from coconut oil, used as an emulsifier and solubilizer to help mix oil and water-based ingredients and improve how the body absorbs certain drugs.
  • 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 T5L8T28FGP
    Mineral oil is a clear, odorless liquid derived from crude oil. It acts as a lubricant and emollient in medications, helping pills slide smoothly during manufacturing and aiding moisture retention in topical products.
  • UNII YRC528SWUY
    A waxy emulsifier made from plant-derived fatty alcohols. It helps blend oil and water-based ingredients together and improves how the medicine spreads and absorbs.
  • 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 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.

8 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.

Manufacturer & labeler

LabelerDirect_Rx
Application holderENCUBE ETHICALS PRIVATE LTD
FDA applicationANDA210986 (ANDA)
Labeler code72189
First marketedMay 2023
Product typeHuman Prescription Drug
Portfolio352 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.

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 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Medication Guide
🚨 Boxed Warning 148 words ▾

WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS Cardiovascular Thrombotic Events Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use [see WARNINGS AND PRECAUTIONS (5.1)]. Diclofenac Sodium Topical Gel, 1% is contraindicated in the setting of coronary artery bypass graft (CABG) surgery [see CONTRAINDICATIONS (4) and WARNINGS AND PRECAUTIONS (5.1)] Gastrointestinal Bleeding, Ulceration, and Perforation NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal.

These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events [see WARNINGS AND PRECAUTIONS (5.2)].

🎯 Indications and Usage 45 words ▾

Diclofenac sodium topical gel is indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands. Diclofenac sodium topical gel has not been evaluated for use on the spine, hip, or shoulder.

⏱️ Dosage and Administration ~3 min read ▾

Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see WARNINGS AND PRECAUTIONS (5)].

2.1Dosing Card [See the patient Instructions for Use] The dosing card can be found attached to the inside of the carton. The proper amount of diclofenac sodium topical gel should be measured using the dosing card supplied in the drug product carton. The dosing card is made of clear polypropylene.

The dosing card should be used for each application of drug product. The gel should be applied within the rectangular area of the dosing card up to the 2 gram or 4 gram line (2 g for each elbow, wrist, or hand, and 4 g for each knee, ankle, or foot). The 2 g line is 2.25 inches long.

The 4 g line is 4.5 inches long. The dosing card containing diclofenac sodium topical gel can be used to apply the gel. The hands should then be used to gently rub the gel into the skin.

After using the dosing card, hold with fingertips, rinse, and dry. If treatment site is the hands, patients should wait at least one (1) hour to wash their hands.

2.2Lower extremities, including the feet, ankles, or knees Apply the gel (4 g) to the affected foot, ankle, or knee 4 times daily. Diclofenac sodium topical gel should be gently massaged into the skin ensuring application to the entire affected foot, or knee or ankle. The entire foot includes the sole, top of the foot and the toes. Do not apply more than 16 g daily to any single joint of the lower extremities.

2.3Upper extremities including the hands, wrists, or elbows Apply the gel (2 g) to the affected hand, wrist, or elbow 4 times daily. Diclofenac sodium topical gel should be gently massaged into the skin ensuring application to the entire affected hand, wrist, or elbow. The entire hand includes the palm, back of the hands, and the fingers.

Do not apply more than 8 g daily to any single joint of the upper extremities. Total dose should not exceed 32 g per day, over all affected joints.

2.4Special Precautions Avoid showering/bathing for at least 1 hour after the application. Inform patient to wash his/her hands after use, unless the hands are the treated joint. If diclofenac sodium topical gel is applied to the hand(s) for treatment; inform patient not to wash the treated hand(s) for at least 1 hour after the application.

Do not apply diclofenac sodium topical gel to open wounds. Avoid contact of diclofenac sodium topical gel with eyes and mucous membranes. Do not apply external heat and/or occlusive dressings to treated joints.

Avoid exposure of the treated joint(s) to natural or artificial sunlight. Avoid concomitant use of diclofenac sodium topical gel on the treated skin site with other topical products, including sunscreens, cosmetics, lotions, moisturizers, insect repellants, or other topical medications Concomitant use of diclofenac sodium topical gel with oral non-steroidal anti-inflammatory drugs (NSAIDs) has not been evaluated, and may increase adverse NSAIDs effects. Do not use combination therapy with diclofenac sodium topical gel and an oral NSAID unless the benefit outweighs the risk and conduct periodic laboratory evaluations.

Avoid wearing of clothing or gloves for at least 10 minutes after applying diclofenac sodium topical gel

💊 Dosage Forms and Strengths 5 words ▾

Diclofenac sodium topical gel, 1%

⛔ Contraindications 80 words ▾

Diclofenac sodium topical gel is contraindicated in the following patients: Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac or any components of the drug product [see WARNINGS AND PRECAUTIONS(5.7, 5.9)] History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients [see WARNINGS AND PRECAUTIONS(5.7, 5.8)] In the setting of coronary artery bypass graft (CABG) surgery [see WARNINGS AND PRECAUTIONS (5.1)]

⚠️ Warnings and Cautions ~3 min read ▾

5.1Cardiovascular Thrombotic Events Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (MI) and stroke, which can be fatal. Based on available data, it is unclear that the risk for CV thrombotic events is similar for all NSAIDs. The relative increase in serious CV thrombotic events over baseline conferred by NSAID use appears to be similar in those with and without known CV disease or risk factors for CV disease.

However, patients with known CV disease or risk factors had a higher absolute incidence of excess serious CV thrombotic events, due to their increased baseline rate. Some observational studies found that this increased risk of serious CV thrombotic events began as early as the first weeks of treatment. The increase in CV thrombotic risk has been observed most consistently at higher doses.

To minimize the potential risk for an adverse CV event in NSAID-treated patients, use the lowest effective dose for the shortest duration possible. Physicians and patients should remain alert for the development of such events, throughout the entire treatment course, even in the absence of previous CV symptoms. Patients should be informed about the symptoms of serious CV events and the steps to take if they occur.

There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use of aspirin and an NSAID, such as diclofenac, increases the risk of serious gastrointestinal (GI) events [see WARNINGS AND PRECAUTIONS (5.2)]. Status Post Coronary Artery Bypass Graft (CABG) Surgery Two large, controlled clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10-14 days following CABG surgery found an increased incidence of myocardial infarction and stroke.

NSAIDs are contraindicated in the setting of CABG [see CONTRAINDICATIONS (4)]. Post-MI Patients Observational studies conducted in the Danish National Registry have demonstrated that patients treated with NSAIDs in the post-MI period were at increased risk of reinfarction, CV-related death, and all-cause mortality beginning in the first week of treatment. In this same cohort, the incidence of death in the first year post-MI was 20 per 100 person years in NSAID-treated patients compared to 12 per 100 person years in non-NSAID exposed patients.

Although the absolute rate of death declined somewhat after the first year post-MI, the increased relative risk of death in NSAID users persisted over at least the next four years of follow-up. Avoid the use of diclofenac sodium topical gel in patients with a recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. If diclofenac sodium topical gel is used in patients with a recent MI, monitor patients for signs of cardiac ischemia.

5.2Gastrointestinal Bleeding, Ulceration, and Perforation NSAIDs, including diclofenac, cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the esophagus, stomach, small intestine, or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs. Only one in five patients who develop a serious upper GI adverse event on NSAID therapy is symptomatic.

Upper GI ulcers, gross bleeding, or perforation caused by NSAIDs occurred in approximately 1% of patients treated for 3-6 months, and in about 2%-4% of patients treated for one year. However, even short-term NSAID therapy is not without risk. Risk Factors for GI Bleeding, Ulceration, and Perforation Patients with a prior history of peptic ulcer disease and/or GI bleeding who used NSAIDs had a greater than 10-fold increased risk for developing a GI bleed compared to patients without these risk factors.…

🤒 Adverse Reactions ~3 min read ▾

The following adverse reactions are discussed in greater detail in other sections of the labeling: Cardiovascular Thrombotic Events [see WARNINGS AND PRECAUTIONS (5.1) ] GI Bleeding, Ulceration and Perforation [see WARNINGS AND PRECAUTIONS (5.2) ] Hepatotoxicity [see WARNINGS AND PRECAUTIONS (5.3) ] Hypertension [see WARNINGS AND PRECAUTIONS (5.4) ] Heart Failure and Edema [see WARNINGS AND PRECAUTIONS (5.5) ] Renal Toxicity and Hyperkalemia [see WARNINGS AND PRECAUTIONS (5.6) ] Anaphylactic Reactions [see WARNINGS AND PRECAUTIONS (5.7) ] Serious Skin Reactions [see WARNINGS AND PRECAUTIONS (5.9) ] Hematologic Toxicity [see WARNINGS AND PRECAUTIONS (5.11) ]

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 with rates in the clinical trials of another drug and may not reflect the rates observed in practice. During clinical development, 913 patients were exposed to diclofenac sodium topical gel in randomized, double-blind, multicenter, vehicle-controlled, parallel-group studies in osteoarthritis of the superficial joints of the extremities.

Of these, 513 patients received diclofenac sodium topical gel for osteoarthritis of the knee and 400 were treated for osteoarthritis of the hand. Additionally, 583 patients were exposed to diclofenac sodium topical gel in an uncontrolled, open-label, long-term safety trial in osteoarthritis of the knee. Of these, 355 patients were treated for osteoarthritis of 1 knee and 228 were treated for osteoarthritis of both knees.

Duration of exposure ranged from 8 to 12 weeks for the placebo-controlled studies, and up to 12 months for the open-label safety trial. Short-Term Placebo-Controlled Trials: Adverse reactions observed in at least 1% of patients treated with diclofenac sodium topical gel: Non-serious adverse reactions that were reported during the short-term placebo-controlled studies comparing diclofenac sodium topical gel and placebo (vehicle gel) over study periods of 8 to 12 weeks (16 g per day), were application site reactions. These were the only adverse reactions that occurred in >1% of treated patients with a greater frequency in the diclofenac sodium topical gel group (7%) than the placebo group (2%).

Table 1 lists the types of application site reactions reported. Application site dermatitis was the most frequent type of application site reaction and was reported by 4% of patients treated with diclofenac sodium topical gel, compared to 1% of placebo patients. Table 1.

Non-serious Application Site Adverse Reactions (≥1% diclofenac sodium topical gel Patients) – Short-term Controlled Trials Adverse Reaction† Diclofenac sodium topical gel, 1% N=913 Placebo (vehicle) N=876 N (%) N (%) Any application site reaction 62 (7) 19 (2) Application site dermatitis 32 (4) 6 (<1) Application site pruritus 7 (<1) 1 (<1) Application site erythema 6 (<1) 3 (<1) Application site paresthesia 5 (<1) 3 (<1) Application site dryness 4 (<1) 3 (<1) Application site vesicles 3 (<1) 0 Application site irritation 2 (<1) 0 Application site papules 1 (<1) 0 †Preferred Term according to MedDRA 9.1.

In the placebo-controlled trials, the discontinuation rate due to adverse reactions was 5% for patients treated with diclofenac sodium topical gel for patients in the placebo group. Application site reactions, including application site dermatitis, were the most frequent reason for treatment discontinuation. Long-Term Open-Label Safety Trial: In the open-label, long-term safety study, distribution of adverse reactions was similar to that in the placebo-controlled studies.

In this study, where patients were treated for up to 1 year with diclofenac sodium topical gel up to 32 g per day, application site dermatitis was observed in 11% of patients. Adverse reactions that led to the discontinuation of the study drug were experienced in 12% of patients. The most common adverse reactio…

🔄 Drug Interactions ~3 min read ▾

See Table 2 for clinically significant drug interactions with diclofenac. Table 2: Clinically Significant Drug Interactions with Diclofenac Drugs That Interfere with Hemostasis Clinical Impact: Diclofenac and anticoagulants such as warfarin have a synergistic effect on bleeding. The concomitant use of diclofenac and anticoagulants have an increased risk of serious bleeding compared to the use of either drug alone.

Serotonin release by platelets plays an important role in hemostasis. Case-control and cohort epidemiological studies showed that concomitant use of drugs that interfere with serotonin reuptake and an NSAID may potentiate the risk of bleeding more than an NSAID alone. Intervention: Monitor patients with concomitant use of diclofenac sodium topical gel with anticoagulants (e.g., warfarin), antiplatelet agents (e.g., aspirin), selective serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine reuptake inhibitors (SNRIs) for signs of bleeding [see WARNINGS AND PRECAUTIONS (5.11) ] .

Aspirin Clinical Impact: Controlled clinical studies showed that the concomitant use of NSAIDs and analgesic doses of aspirin does not produce any greater therapeutic effect than the use of NSAIDs alone. In a clinical study, the concomitant use of an NSAID and aspirin was associated with a significantly increased incidence of GI adverse reactions as compared to use of the NSAID alone [see WARNINGS AND PRECAUTIONS (5.2)]. Intervention: Concomitant use of diclofenac sodium topical gel and analgesic doses of aspirin is not generally recommended because of the increased risk of bleeding [see WARNINGS AND PRECAUTIONS (5.11) ] .

Diclofenac sodium topical gel is not a substitute for low dose aspirin for cardiovascular protection. ACE Inhibitors, Angiotensin Receptor Blockers, and Beta-Blockers Clinical Impact: •NSAIDs may diminish the antihypertensive effect of angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), or beta-blockers (including propranolol). In patients who are elderly, volume-depleted (including those on diuretic therapy), or have renal impairment, co-administration of an NSAID with ACE inhibitors or ARBs may result in deterioration of renal function, including possible acute renal failure.

These effects are usually reversible. Intervention: During concomitant use of diclofenac sodium topical gel and ACE- inhibitors, ARBs, or beta- blockers, monitor blood pressure to ensure that the desired blood pressure is obtained. During concomitant use of diclofenac sodium topical gel and ACE-inhibitors or ARBs in patients who are elderly, volume-depleted, or have impaired renal function, monitor for signs of worsening renal function [see WARNINGS AND PRECAUTIONS (5.6) ] .

When these drugs are administered concomitantly, patients should be adequately hydrated. Assess renal function at the beginning of the concomitant treatment and periodically thereafter. Diuretics Clinical Impact: Clinical studies, as well as post-marketing observations, showed that NSAIDs reduced the natriuretic effect of loop diuretics (e.g., furosemide) and thiazide diuretics in some patients.

This effect has been attributed to the NSAID inhibition of renal prostaglandin synthesis. Intervention: During concomitant use of diclofenac sodium topical gel with diuretics, observe patients for signs of worsening renal function, in addition to assuring diuretic efficacy including antihypertensive effects [see WARNINGS AND PRECAUTIONS (5.6) ] . Digoxin Clinical Impact: The concomitant use of diclofenac with digoxin has been reported to increase the serum concentration and prolong the half-life of digoxin.

Intervention: During concomitant use of diclofenac sodium topical gel and digoxin, monitor serum digoxin levels. Lithium Clinical Impact: NSAIDs have produced elevations in plasma lithium levels and reductions in renal lithium clearance. The mean minimum lithium concentration increased 15%, and the renal clearance decreased by approximately…

👥 Use in Specific Populations ~3 min read ▾

8.1Pregnancy Pregnancy Category C prior to 30 weeks gestation; Category D starting 30 weeks gestation Risk Summary Use of NSAIDs, including diclofenac sodium topical gel, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs, including diclofenac sodium topical gel, in pregnant women starting at 30 weeks of gestation (third trimester). There are no adequate and well-controlled studies of diclofenac sodium topical gel in pregnant women.

Human and animal studies indicate that diclofenac crosses the placenta. Data from observational studies regarding potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive. In the general U.S. population, all clinically recognized pregnancies, regardless of drug exposure, have a background rate of 2-4% for major malformations, and 15-20% for pregnancy loss.

In animal reproduction studies, no evidence of teratogenicity was observed in mice, rats, or rabbits given diclofenac during the period of organogenesis at doses up to approximately 5, 5, and 10 times, respectively, the maximum recommended topical dose of diclofenac sodium topical gel, despite the presence of maternal and fetal toxicity at these doses [see Data]. Based on animal data, prostaglandins have been shown to have an important role in endometrial vascular permeability, blastocyst implantation, and decidualization.

In animal studies, administration of prostaglandin synthesis inhibitors such as diclofenac, resulted in increased pre- and post-implantation loss. Clinical Considerations Labor or Delivery There are no studies on the effects of diclofenac sodium topical gel during labor or delivery. In animal studies, NSAIDS, including diclofenac, inhibit prostaglandin synthesis, cause delayed parturition, and increase the incidence of stillbirth.

Data Animal data Reproductive and developmental studies in animals demonstrated that diclofenac sodium administration during organogenesis did not produce teratogenicity despite the induction of maternal toxicity and fetal toxicity in mice at oral doses up to 20 mg/kg/day (approximately 5 times the maximum recommended human dose (MRHD) of diclofenac sodium topical gel based on bioavailability and body surface area (BSA) comparison), and in rats and rabbits at oral doses up to 10 mg/kg/day (approximately 5 and 10 times the MRHD based on bioavailability and BSA comparison).

In a study in which pregnant rats were orally administered 2 or 4 mg/kg diclofenac (approximately 1 and 2 times the MRHD based on bioavailability and BSA comparison) from Gestation Day 15 through Lactation Day 21, significant maternal toxicity (peritonitis, mortality) was noted. These maternally toxic doses were associated with dystocia, prolonged gestation, reduced fetal weights and growth, and reduced fetal survival.

8.2Lactation Risk Summary Based on available data, diclofenac may be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for CATAFLAM and any potential adverse effects on the breastfed infant from the CATAFLAM or from the underlying maternal condition. Data One woman treated orally with a diclofenac salt, 150 mg/day, had a milk diclofenac level of 100 mcg/L, equivalent to an infant dose of about 0.03 mg/kg/day.

Diclofenac was not detectable in breast milk in 12 women using diclofenac (after either 100 mg/day orally for 7 days or a single 50 mg intramuscular dose administered in the immediate postpartum period).

8.3Females and Males of Reproductive Potential Infertility Females Based on the mechanism of action, the use of prostaglandin-mediated NSAIDs, including diclofenac sodium topical gel, may delay or prevent rupture of ovarian follicles, which has been associated with reversible infertility in some women. Published animal studies have shown that administration of prostaglandin synthesis inhibi…

🆘 Overdosage 94 words ▾

Symptoms following acute NSAID overdosages have been typically limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which have been generally reversible with supportive care. Gastrointestinal bleeding has occurred. Hypertension, acute renal failure, respiratory depression, and coma have occurred, but were rare [see WARNINGS AND PRECAUTIONS(5.1, 5.2, 5.4, 5.6)].

Manage patients with symptomatic and supportive care following an NSAID overdosage. There are no specific antidotes. Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding.

For additional information about overdosage treatment, contact a poison control center (1-800-222-1222).

🧬 Clinical Pharmacology ~3 min read ▾

12.1Mechanism of Action Diclofenac has analgesic, anti-inflammatory, and antipyretic properties. The mechanism of action of diclofenac sodium topical gel, like that of other NSAIDs, is not completely understood but involves inhibition of cyclooxygenase (COX-1 and COX-2). Diclofenac is a potent inhibitor of prostaglandin synthesis in vitro.

Diclofenac concentrations reached during therapy have produced in vivo effects. Prostaglandins sensitize afferent nerves and potentiate the action of bradykinin in inducing pain in animal models. Prostaglandins are mediators of inflammation.

Because diclofenac is an inhibitor of prostaglandin synthesis, its mode of action may be due to a decrease of prostaglandins in peripheral tissues.

12.3Pharmacokinetics The pharmacokinetics of diclofenac sodium topical gel were assessed in healthy volunteers following repeated applications during 7 days of diclofenac sodium topical gel to 1 knee (4 x 4 g per day) or to 2 knees and 2 hands (4 x 12 g per day) versus the recommended oral dose of diclofenac sodium for the treatment of osteoarthritis (3 x 50 mg per day). A summary of the pharmacokinetic parameters is presented in Table 2. Table 3.

Pharmacokinetic Parameters and Comparison of diclofenac sodium topical gel to Oral Diclofenac Sodium Tablets After Repeated Administration Treatment Cmax (ng/mL) Mean ± SD % of Oral (CI) Tmax (hr) Median Range AUC0-24 (ng●h/mL) Mean ± SD % of Oral (CI) Diclofenac sodium topical gel, 1% 4 x 4 g per day (=160 mg diclofenac sodium per day) 15 ± 7.3 0.6% (0.5-0.7) 14 (0-24) 233 ± 128 5.8% (5-6.7) Diclofenac sodium topical gel, 1% 4 x 12 g per day (=480 mg diclofenac sodium per day) 53.8 ± 32 2.2% (1.9-2.6) 10 (0-24) 807 ± 478 19.7% (17-22.8) Diclofenac sodium tablets, orally 3 x 50 mg per day (=150 mg diclofenac sodium per day) 2270 ± 778 100% 6.5 (1-14) 3890 ± 1710 100% Cmax = maximum plasma concentration, tmax = time of Cmax.

AUC0-24=area under the concentration time curve. SD=standard deviation. CI=confidence interval.

Systemic exposure (area under the concentration-time curve) and maximum plasma concentrations of diclofenac are significantly lower with diclofenac sodium topical gel than with comparable oral treatment of diclofenac sodium. Systemic exposure with recommended use of diclofenac sodium topical gel (4 x 4 g per day applied to 1 knee) is on average 17 times lower than with oral treatment. (Basis: treatment with diclofenac sodium topical gel of 1 knee, 4 times a day versus 50 mg, 3 times a day of oral diclofenac tablets.) The amount of diclofenac sodium that is systemically absorbed from diclofenac sodium topical gel is on average 6% of the systemic exposure from an oral form of diclofenac sodium.

The average peak plasma concentration with recommended use of diclofenac sodium topical gel (4 x 4 g per day applied to 1 knee) is 158 times lower than with the oral treatment. The pharmacokinetics of diclofenac sodium topical gel has been tested under conditions of moderate heat (application of a heat patch for 15 minutes prior to gel application) and of moderate exercise (first gel application followed by a 20-minute treadmill exercise). No clinically relevant differences of systemic absorption and of tolerability were found between applications of diclofenac sodium topical gel (4 x 4 g per day on 1 knee) with and under the conditions tested.

However, the pharmacokinetics of diclofenac sodium topical gel were not tested under the condition of heat application following gel application. Therefore, concurrent use of diclofenac sodium topical gel and heat is not recommended. Drug Interaction Studies Aspirin: When NSAIDs were administered with aspirin, the protein binding of NSAIDs were reduced, although the clearance of free NSAID was not altered.

The clinical significance of this interaction is not known. See Table 2 for clinically significant drug interactions of NSAIDs with aspirin [see DRUG INTERACTIONS (7) ].

📦 How Supplied / Storage and Handling 49 words ▾

Diclofenac sodium topical gel, 1% is an opaque white gel and is available in tubes containing 100 grams of the topical gel in each tube. Each tube contains diclofenac sodium in a gel base (10 mg of diclofenac sodium per gram of gel or 1%). 100 grams tube……………………………….NDC 72189-479-01

📦 Storage and Handling 29 words ▾

Storage Store at room temperature 68°F to 77°F (20°C to 25°C) [See USP Controlled Room Temperature]. Keep from freezing. Store the dosing card with your diclofenac sodium topical gel.

📋 Description 102 words ▾

Diclofenac sodium topical gel, 1% is a nonsteroidal anti-inflammatory drug (NSAID) for topical use only. The chemical name is 2-[(2,6-dichlorophenyl) amino]benzene- acetic acid, monosodium salt. The molecular weight is 318.14.

Its molecular formula is C14H10Cl2NNaO2, and it has the following chemical structure: It contains the active ingredient, diclofenac sodium, in an opaque, white gel base. Diclofenac sodium is a white to slightly yellow crystalline powder. Diclofenac sodium is a benzeneacetic acid derivative.

The inactive ingredients in diclofenac sodium topical gel include: Carbomer homopolymer Type C, cocoyl caprylocaprate, isopropyl alcohol, mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, purified water, strong ammonia solution.

💬 Medication Guide ~3 min read ▾

Medication Guide for Nonsteroidal Anti-inflammatory Drugs (NSAIDs) What is the most important information I should know about medicines called Nonsteroidal Antiinflammatory Drugs (NSAIDs)? NSAIDs can cause serious side effects, including: Increased risk of a heart attack or stroke that can lead to death. This risk may happen early in treatment and may increase: o with increasing doses of NSAIDs o with longer use of NSAIDs Do not take NSAIDs right before or after a heart surgery called a “coronary artery bypass graft (CABG)." Avoid taking NSAIDs after a recent heart attack, unless your healthcare provider tells you to.

You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack. Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach and intestines: anytime during use without warning symptoms that may cause death The risk of getting an ulcer or bleeding increases with: past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs taking medicines called “corticosteroids”, “anticoagulants”, “SSRIs”, or “SNRIs” increasing doses of NSAIDs o older age longer use of NSAIDs o poor health smoking o advanced liver disease drinking alcohol o bleeding problems NSAIDs should only be used: exactly as prescribed at the lowest dose possible for your treatment for the shortest time needed What are NSAIDs?

NSAIDs are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as different types of arthritis, menstrual cramps, and other types of short-term pain. Who should not take NSAIDs? Do not take NSAIDs: if you have had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAIDs. right before or after heart bypass surgery.

Before taking NSAIDS, tell your healthcare provider about all of your medical conditions, including if you: have liver or kidney problems have high blood pressure have asthma are pregnant or plan to become pregnant. Talk to your healthcare provider if you are considering taking NSAIDs during pregnancy. You should not take NSAIDs after 29 weeks of pregnancy. are breastfeeding or plan to breast feed.

Tell your healthcare provider about all of the medicines you take, including prescription or over-thecounter medicines, vitamins or herbal supplements. NSAIDs and some other medicines can interact with each other and cause serious side effects. Do not start taking any new medicine without talking to your healthcare provider first.

What are the possible side effects of NSAIDs? NSAIDs can cause serious side effects, including: See “What is the most important information I should know about medicines called Nonsteroidal Antiinflammatory Drugs (NSAIDs)? new or worse high blood pressure heart failure liver problems including liver failure kidney problems including kidney failure low red blood cells (anemia) life-threatening skin reactions life threatening allergic reactions Other side effects of NSAIDs include: stomach pain, constipation, diarrhea, gas, heartburn, nausea, vomiting, and dizziness.

Get emergency help right away if you get any of the following symptoms: shortness of breath or trouble breathing • slurred speech chest pain • swelling of the face or throat weakness in one part or side of your body Stop taking your NSAID and call your healthcare provider right away if you get any of the following symptoms: nausea • vomit blood more tired or weaker than usual • there is blood in your bowel movement or diarrhea • it is black and sticky like tar itching • unusual weight gain your skin or eyes look yellow • skin rash or blisters with fever indigestion or stomach pain • swelling of the arms, legs, hands and feet flu-like symptoms If you take too much of your NSAID, call your healthcare provider or get medical help right away.

These are not all the possible side effects of NSAIDs. For more information, ask your healthcare provider…

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

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