What the label lists and what reports show
Sulindac side effects
Sulindac's FDA label lists its adverse reactions in its own words. FAERS holds 2,402 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 (185 reports).
- Generic listed
- Boxed warning
Check it at the source: the sulindac FDA label on DailyMed (effective December 20, 2024, Epic Pharma, 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. Get emergency help right away if you get any of the following symptoms: • shortness of breath or trouble breathing • chest pain • weakness in one part or side of your body • slurred speech • swelling of the face or throat. […]
Source: FDA drug label, Epic Pharma, LLC, effective December 20, 2024 (SPL set 96c73bd2-4577-487d-a642-bd8f91e94c3a), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe following adverse reactions were reported in clinical trials or have been reported since the drug was marketed. The probability exists of a causal relationship between sulindac and these adverse reactions. The adverse reactions which have been observed in clinical trials encompass observations in 1,865 patients, including 232 observed for at least 48 weeks. Incidence Greater Than 1% Gastrointestinal The most frequent types of adverse reactions occurring with sulindac are gastrointestinal; these include gastrointestinal pain (10%), dyspepsia***, nausea*** with or without vomiting, diarrhea***, constipation***, flatulence, anorexia and gastrointestinal cramps. Dermatologic Rash***, pruritus Central Nervous System Dizziness***, headache***, nervousness. Special Senses Tinnitus. Miscellaneous Edema (see WARNINGS ). …
Source: FDA drug label, Epic Pharma, LLC, effective December 20, 2024 (SPL set 96c73bd2-4577-487d-a642-bd8f91e94c3a), via openFDA; the full label on DailyMed
What do FAERS reports show?
2,402 reports list sulindac among the medicines taken, each a report of something that happened, not proof the medicine caused it; 132 are coded as a death and 625 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, 11 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?
- Sulindac: 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