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What the label lists and what reports show

Benazepril side effects

Benazepril's FDA label: “The most common reasons for discontinuation were headache (0.6%) and cough (0.5%).” FAERS holds 7,283 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 nausea (450 reports).

  • Generic listed
  • Boxed warning

Check it at the source: the benazepril FDA label on DailyMed (effective September 30, 2025, Validus Pharmaceuticals LLC); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

The most common reasons for discontinuation were headache (0.6%) and cough (0.5%).

From the label: adverse reactions, continued

ADVERSE REACTIONS Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Lotensin has been evaluated for safety in over 6000 patients with hypertension; over 700 of these patients were treated for at least one year. The overall incidence of reported adverse events was similar in Lotensin and placebo patients. The reported side effects were generally mild and transient, and there was no relation between side effects and age, duration of therapy, or total dosage within the range of 2 to 80 mg. Discontinuation of therapy because of a side effect was required in approximately 5% of U.S. patients treated with Lotensin and in 3% of patients treated with placebo. The most common reasons for discontinuation were headache (0.6%) and cough (0.5%). Adverse reactions seen in at least 1% greater frequency in patients treated with Lotensin than placebo were headache (6% vs. 4%), dizziness (4% vs. 2%), somnolence (2% vs. 0%) and postural dizziness (2% vs. 0%). …

Source: FDA drug label, Validus Pharmaceuticals LLC, effective September 30, 2025 (SPL set 2abb091b-a53e-46b0-9b84-e5ee8f2bdd8e), via openFDA; the full label on DailyMed

What do FAERS reports show?

7,283 reports list benazepril among the medicines taken, each a report of something that happened, not proof the medicine caused it; 579 are coded as a death and 2,485 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, 12 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

  • Nausea (named in the label)450
  • Drug Ineffective (a use or a product term, not a reaction)427
  • Fatigue (named in the label)414
  • Dizziness (named in the label)397
  • Dyspnoea (named in the label)387
  • Pain365
  • Diarrhoea364
  • Headache (named in the label)355
  • Myocardial Infarction (a use or a product term, not a reaction)312
  • Hypertension (a use or a product term, not a reaction)302
  • Asthenia (named in the label)274
  • Vomiting (named in the label)260
  • Cough (named in the label)259
  • Anxiety (named in the label)253
  • Cerebrovascular Accident248
  • Arthralgia (named in the label)242
  • Chest Pain242
  • Cardiac Failure Congestive241
  • Renal Failure (named in the label)239
  • Pruritus (named in the label)238
  • Fall216
  • Pain In Extremity213
  • Blood Pressure Increased211
  • Weight Decreased210
  • Depression198

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

What next?

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