What the label lists and what reports show
Nabumetone side effects
Nabumetone's FDA label: “The most frequently reported adverse reactions were related to the gastrointestinal tract and included diarrhea, dyspepsia, and abdominal pain.” FAERS holds 6,395 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 pain (466 reports).
- Generic listed
- Boxed warning
Check it at the source: the nabumetone FDA label on DailyMed (effective January 13, 2025, ScieGen Pharmaceuticals Inc); 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 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. […]
Source: FDA drug label, ScieGen Pharmaceuticals Inc, effective January 13, 2025 (SPL set 80c6888d-03b4-44f3-b94d-bcf5154ceae5), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most frequently reported adverse reactions were related to the gastrointestinal tract and included diarrhea, dyspepsia, and abdominal pain.
From the label: adverse reactions, continuedAdverse reaction information was derived from blinded-controlled and open-labelled clinical trials and from worldwide marketing experience. In the description below, rates of the more common events (greater than 1%) and many of the less common events (less than 1%) represent results of US clinical studies. Of the 1,677 patients who received nabumetone during US clinical trials, 1,524 were treated for at least 1 month, 1,327 for at least 3 months, 929 for at least a year, and 750 for at least 2 years. More than 300 patients have been treated for 5 years or longer. The most frequently reported adverse reactions were related to the gastrointestinal tract and included diarrhea, dyspepsia, and abdominal pain. Incidence ≥ 1%–Probably Causally Related Gastrointestinal: Diarrhea (14%), dyspepsia (13%), abdominal pain (12%), constipation * , flatulence * , nausea * , positive stool guaiac * , dry mouth, gastritis, stomatitis, vomiting. Central Nervous System: Dizziness * , headache * , fatigue, increased sweating, insomnia, nervousness, somnolence. Dermatologic: Pruritus * , rash * . Special Senses: Tinnitus * . Miscellaneous: Edema * . * Incidence of reported reaction between 3% and 9%. Reactions occurring in 1% to 3% of the patients are unmarked. …
Source: FDA drug label, ScieGen Pharmaceuticals Inc, effective January 13, 2025 (SPL set 80c6888d-03b4-44f3-b94d-bcf5154ceae5), via openFDA; the full label on DailyMed
What do FAERS reports show?
6,395 reports list nabumetone among the medicines taken, each a report of something that happened, not proof the medicine caused it; 363 are coded as a death and 1,515 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, 12 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.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Nabumetone: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions