What the label lists and what reports show

Enalapril side effects

Enalapril's FDA label lists its adverse reactions in its own words. FAERS holds 60,702 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 diarrhoea (3,137 reports).

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Check it at the source: the enalapril FDA label on DailyMed (effective January 23, 2026, Bausch Health US LLC); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions
VASOTEC has been evaluated for safety in more than 10,000 patients, including over 1000 patients treated for one year or more. VASOTEC has been found to be generally well tolerated in controlled clinical trials involving 2987 patients. For the most part, adverse experiences were mild and transient in nature. In clinical trials, discontinuation of therapy due to clinical adverse experiences was required in 3.3 percent of patients with hypertension and in 5.7 percent of patients with heart failure. The frequency of adverse experiences was not related to total daily dosage within the usual dosage ranges. In patients with hypertension the overall percentage of patients treated with VASOTEC reporting adverse experiences was comparable to placebo. …

Adverse Reactions Occurring in Greater Than 1% of Patients With Hypertension

This table is printed in the Epaned label published by Azurity Pharmaceuticals, Inc. of December 16, 2025; the label quoted above does not print one.

Reaction	Enalapril Maleate Tablets (n = 2314) Incidence (discontinuation)	Placebo (n = 230) Incidence
Fatigue	3.0 (<0.1)	2.6
Orthostatic Effects	1.2 (<0.1)	0.0
Asthenia	1.1 (0.1)	0.9
Cough	1.3 (0.1)	0.9
Rash	1.4 (0.4)	0.4

Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.

Source: FDA drug label, Bausch Health US LLC, effective January 23, 2026 (SPL set 39631f1f-5d19-43c1-b504-bf56d991ed97), via openFDA; the full label on DailyMed

What do FAERS reports show?

60,702 reports list enalapril among the medicines taken, each a report of something that happened, not proof the medicine caused it; 6,506 are coded as a death and 29,024 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 21 reactions below, 15 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

Diarrhoea (named in the label)3,137
Dyspnoea (named in the label)3,011
Nausea (named in the label)2,988
Drug Ineffective (a use or a product term, not a reaction)2,869
Fatigue (named in the label)2,696
Dizziness (named in the label)2,539
Drug Interaction (a use or a product term, not a reaction)2,428
Vomiting (named in the label)2,214
Acute Kidney Injury2,155
Pain2,113
Headache (named in the label)2,083
Asthenia (named in the label)1,998
Hypertension (a use or a product term, not a reaction)1,963
Hypotension (named in the label)1,903
Off Label Use (a use or a product term, not a reaction)1,872
Malaise1,854
Fall1,782
Pneumonia (named in the label)1,702
Pyrexia1,684
Renal Failure (named in the label)1,584
Anaemia (named in the label)1,563
Arthralgia (named in the label)1,560
Cough (named in the label)1,398
Myocardial Infarction (named in the label)1,394
Pain In Extremity1,389

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

What next?

Enalapril: 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