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What the label lists and what reports show

Tolmetin side effects

Tolmetin's FDA label lists its adverse reactions in its own words. FAERS holds 169 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is drug hypersensitivity (34 reports).

  • Generic listed
  • Boxed warning

Check it at the source: the tolmetin FDA label on DailyMed (effective July 20, 2026, Chartwell RX, LLC); the FDA FAERS public dashboard.

What does the patient leaflet say about side effects?

From the patient leaflet: 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 Anti-inflammatory 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. […]

Source: FDA drug label, Chartwell RX, LLC, effective July 20, 2026 (SPL set 66fa5e73-477c-4bbc-b7d3-f4a69aad4460), via openFDA; the full label on DailyMed

What does the label list?

From the label: adverse reactions

The adverse reactions which have been observed in clinical trials encompass observations in about 4,370 patients treated with tolmetin sodium, over 800 of whom have undergone at least one year of therapy. These adverse reactions, reported below by body system, are among those typical of nonsteroidal anti-inflammatory drugs and, as expected, gastrointestinal complaints were most frequent. In clinical trials with tolmetin, about 10% of patients dropped out because of adverse reactions, mostly gastrointestinal in nature. Incidence Greater Than 1% The following adverse reactions which occurred more frequently than 1 in 100 were reported in controlled clinical trials: Gastrointestinal: nausea (11%), dyspepsia * , gastrointestinal distress * , abdominal pain * , diarrhea 1 * , flatulence * , vomiting * , constipation, gastritis, and peptic ulcer. …

Source: FDA drug label, 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?

169 reports list tolmetin among the medicines taken, 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. Of the 23 reactions below, 10 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

The 25 most reported reactions

  • Drug Hypersensitivity34
  • Headache (named in the label)16
  • Fatigue14
  • Vomiting (named in the label)12
  • Nausea (named in the label)11
  • Renal Failure (named in the label)11
  • Asthenia (named in the label)10
  • Depression10
  • Feeling Abnormal10
  • Arthralgia9
  • Dizziness (named in the label)9
  • Drug Ineffective (a use or a product term, not a reaction)9
  • Dyspnoea9
  • Pain9
  • Back Pain7
  • Cardiac Failure Congestive7
  • Hypertension (named in the label)7
  • Pain In Extremity7
  • Condition Aggravated (a use or a product term, not a reaction)6
  • Constipation (named in the label)6
  • Dehydration6
  • Diarrhoea (named in the label)6
  • Malaise6
  • Musculoskeletal Stiffness6
  • Urinary Tract Infection (named in the label)6

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Tolmetin: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions