What the label lists and what reports show
Captopril side effects
Captopril's FDA label lists its adverse reactions in its own words. FAERS holds 9,557 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 dyspnoea (609 reports).
- Generic listed
- Boxed warning
Check it at the source: the captopril FDA label on DailyMed (effective February 6, 2026, AiPing Pharmaceutical, Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsReported incidences are based on clinical trials involving approximately 7000 patients. Renal: About one of 100 patients developed proteinuria (see WARNINGS ). Each of the following has been reported in approximately 1 to 2 of 1000 patients and are of uncertain relationship to drug use: renal insufficiency, renal failure, nephrotic syndrome, polyuria, oliguria, and urinary frequency. Hematologic: Neutropenia/agranulocytosis has occurred (see WARNINGS ). Cases of anemia, thrombocytopenia, and pancytopenia have been reported. Dermatologic: Rash, often with pruritus, and sometimes with fever, arthralgia, and eosinophilia, occurred in about 4 to 7 (depending on renal status and dose) of 100 patients, usually during the first four weeks of therapy. It is usually maculopapular, and rarely urticarial. …
Source: FDA drug label, AiPing Pharmaceutical, Inc., effective February 6, 2026 (SPL set 3b789f16-b291-4012-be39-af3beec3ff9a), via openFDA; the full label on DailyMed
What do FAERS reports show?
9,557 reports list captopril among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,564 are coded as a death and 4,816 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 20 reactions below, 14 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?
- Captopril: 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