Prescription medicine
Tolmetin First approved as Tolectin
Tolmetin (Tolectin) is a prescription medicine with an FDA approval on record since 1976. FDA's NDC Directory lists it from 5 generic labelers.
- Generic listed
- Boxed warning
Check it at the source: the tolmetin FDA label on DailyMed (effective July 20, 2026, Chartwell RX, LLC); the NDA 17628 record on Drugs@FDA; every tolmetin label on DailyMed.
Highlights of the record
FDA label of July 20, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
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 ]. Tolmetin sodium tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery [see CONTRAINDICATIONS and WARNINGS ]. Gastrointestinal Risk NSAIDs cause an increased risk of serious gastrointestinal 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 are at greater risk for serious gastrointestinal events (see WARNINGS ).
Used for
From the label: indications and usageCarefully consider the potential benefits and risks of tolmetin sodium tablets and other treatment options before deciding to use tolmetin sodium tablets.
Forms and strengths
- 200 mg
- 400 mg
- 600 mg
Capsule; tablet; film-coated tablet.
On the market
- Earliest approval on file
- March 24, 1976 Tolectin 600, Ortho Mcneil Janssen; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 14 first November 27, 1991; 2 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 5 of which 5 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 169 through July 30, 2026
What is tolmetin used for?
From the label: indications and usageCarefully consider the potential benefits and risks of tolmetin sodium tablets and other treatment options before deciding to use tolmetin sodium tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Tolmetin sodium tablets are indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis. Tolmetin sodium tablets are indicated in the treatment of acute flares and the long-term management of the chronic disease. Tolmetin sodium tablets are also indicated for treatment of juvenile rheumatoid arthritis. […]
Conditions named in the indications of tolmetin's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Nonsteroidal Anti-inflammatory Drug.
Source: FDA drug label (Tolmetin Sodium), Chartwell RX, LLC, effective July 20, 2026 (SPL set 66fa5e73-477c-4bbc-b7d3-f4a69aad4460), via openFDA; the full label on DailyMed
What does the patient leaflet for tolmetin say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?Increased risk of a heart attack or stroke that can lead to death. This risk may happen early in treatment and may increase: with increasing doses of NSAIDS 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 longer use of NSAIDs smoking drinking alcohol older age poor health advanced liver disease bleeding problems NSAIDs should only be used: exactly as prescribed at the lowest dose possible for your treatment for the shortest time needed
Source: FDA drug label (Tolmetin Sodium), Chartwell RX, LLC, effective July 20, 2026 (SPL set 66fa5e73-477c-4bbc-b7d3-f4a69aad4460), via openFDA; the full label on DailyMed
Is there a generic for tolmetin (Tolectin)?
The FDA approved the first generic tolmetin on November 27, 1991. 14 generic applications are approved; 2 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists tolmetin from 5 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1976 earliest approval on file
- 1991 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the tolmetin label say about other medicines?
The tolmetin label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Aspirin | contraindications | Tolmetin should not be given to patients who have experienced asthma, urticaria or allergic-type reactions after taking aspirin or other NSAIDs. |
Source: FDA drug label (Tolmetin Sodium), Chartwell RX, LLC, effective July 20, 2026 (SPL set 66fa5e73-477c-4bbc-b7d3-f4a69aad4460), via openFDA; the full label on DailyMed
What do FAERS reports show for tolmetin?
The FDA Adverse Event Reporting System holds 169 reports that list tolmetin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 9 are coded as a death and 44 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as tolmetin?
21 other medicines are given the same way (oral) and in the same FDA class as tolmetin or labeled mainly for the same use (osteoarthritis), the same class first. Osteoarthritis lists all 27 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Ibuprofen | Osteoarthritis, Rheumatoid arthritis | 273 labelers | $0.0573 per tablet 800 mg tablet | No current entry |
| Naproxen | Osteoarthritis, Rheumatoid arthritis | 146 labelers | $0.0565 per tablet 500 mg tablet | No current entry |
| Celecoxib | Osteoarthritis, Rheumatoid arthritis | 65 labelers | $0.0762 per capsule 200 mg capsule | No current entry |
| Diclofenac | Osteoarthritis, Rheumatoid arthritis | 67 labelers | $0.0619 per tablet 75 mg tablet | A presentation being discontinued |
| Meloxicam | Osteoarthritis, Rheumatoid arthritis | 43 labelers | $0.0166 per tablet 7.5 mg tablet | No current entry |
| Etodolac | Osteoarthritis, Rheumatoid arthritis | 30 labelers | $0.262 per tablet 400 mg tablet | No current entry |
| Indomethacin | Osteoarthritis, Rheumatoid arthritis | 25 labelers | $0.210 per capsule 75 mg capsule | No current entry |
| Nabumetone | Osteoarthritis, Rheumatoid arthritis | 28 labelers | $0.128 per tablet 500 mg tablet | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to tolmetin
- 21 medicines for the same use
- Other NSAIDs
- the pharmacologic class, with prices and generics
- Tolmetin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other