What the label lists and what reports show
Enalaprilat side effects
Enalaprilat's FDA label lists its adverse reactions in its own words. FAERS holds 250 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 heart rate decreased (19 reports).
- Generic listed
- Boxed warning
Check it at the source: the enalaprilat FDA label on DailyMed (effective June 7, 2024, Dr. Reddys Laboratories Inc); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsEnalaprilat has been found to be generally well tolerated in controlled clinical trials involving 349 patients (168 with hypertension, 153 with congestive heart failure and 28 with coronary artery disease). The most frequent clinically significant adverse experience was hypotension (3.4 percent), occurring in eight patients (5.2 percent) with congestive heart failure, three (1.8 percent) with hypertension and one with coronary artery disease. Other adverse experiences occurring in greater than one percent of patients were: headache (2.9 percent) and nausea (1.1 percent). Adverse experiences occurring in 0.5 to 1 percent of patients in controlled clinical trials included: myocardial infarction, fatigue, dizziness, fever, rash and constipation. Angioedema: Angioedema has been reported in patients receiving enalaprilat, with an incidence higher in black than in non-black patients. …
Source: FDA drug label, Dr. Reddys Laboratories Inc, effective June 7, 2024 (SPL set 5d398da1-020c-ccb1-a775-ce8e0b29d621), via openFDA; the full label on DailyMed
What do FAERS reports show?
250 reports list enalaprilat among the medicines taken, each a report of something that happened, not proof the medicine caused it; 29 are coded as a death and 113 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 22 reactions below, 4 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
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Enalaprilat: 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