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What the label lists and what reports show

Enalapril and hydrochlorothiazide side effects

Enalapril and hydrochlorothiazide's FDA label lists its adverse reactions in its own words. FAERS holds 911 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 (54 reports).

  • Generic listed
  • Boxed warning

Check it at the source: the enalapril and hydrochlorothiazide FDA label on DailyMed (effective August 31, 2020, Bausch Health US, LLC); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

VASERETIC has been evaluated for safety in more than 1500 patients, including over 300 patients treated for one year or more. In clinical trials with VASERETIC no adverse experiences peculiar to this combination drug have been observed. Adverse experiences that have occurred have been limited to those that have been previously reported with enalapril or hydrochlorothiazide. The most frequent clinical adverse experiences in controlled trials were: dizziness (8.6 percent), headache (5.5 percent), fatigue (3.9 percent) and cough (3.5 percent). Generally, adverse experiences were mild and transient in nature. Adverse experiences occurring in greater than two percent of patients treated with VASERETIC in controlled clinical trials are shown below.

Source: FDA drug label, Bausch Health US, LLC, effective August 31, 2020 (SPL set bf3007e2-8fcc-48de-8fd5-55e95033d62f), via openFDA; the full label on DailyMed

What do FAERS reports show?

911 reports list enalapril and hydrochlorothiazide among the medicines taken, each a report of something that happened, not proof the medicine caused it; 61 are coded as a death and 507 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

  • Drug Interaction (a use or a product term, not a reaction)58
  • Diarrhoea (named in the label)54
  • Nausea (named in the label)48
  • Fall45
  • Renal Failure Acute44
  • Dizziness (named in the label)38
  • Vomiting (named in the label)36
  • Hypotension (named in the label)35
  • Hyponatraemia (named in the label)34
  • Renal Failure (named in the label)34
  • Dyspnoea (named in the label)32
  • Drug Ineffective (a use or a product term, not a reaction)31
  • Fatigue (named in the label)30
  • Headache (named in the label)29
  • Hypertension (a use or a product term, not a reaction)29
  • Asthenia (named in the label)28
  • Hypokalaemia (named in the label)28
  • Anaemia (named in the label)26
  • Blood Pressure Increased26
  • Malaise26
  • Myocardial Infarction (named in the label)26
  • Anxiety25
  • Condition Aggravated (a use or a product term, not a reaction)25
  • Pain24
  • Syncope (named in the label)24

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

What next?

Enalapril and hydrochlorothiazide: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions