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What the label lists and what reports show

Quinapril side effects

Quinapril's FDA label lists its adverse reactions in its own words. FAERS holds 7,842 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 fall (907 reports).

  • Generic listed
  • In shortage
  • Boxed warning

Check it at the source: the quinapril FDA label on DailyMed (effective December 14, 2023, Lupin Pharmaceuticals, Inc.); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

Hypertension Quinapril has been evaluated for safety in 4960 subjects and patients. Of these, 3203 patients, including 655 elderly patients, participated in controlled clinical trials. Quinapril has been evaluated for long-term safety in over 1400 patients treated for 1 year or more. Adverse experiences were usually mild and transient. In placebo-controlled trials, discontinuation of therapy because of adverse events was required in 4.7% of patients with hypertension. Adverse experiences probably or possibly related to therapy or of unknown relationship to therapy occurring in 1% or more of the 1563 patients in placebo-controlled hypertension trials who were treated with quinapril are shown below. …

Source: FDA drug label, Lupin Pharmaceuticals, Inc., effective December 14, 2023 (SPL set 8ded0773-3aec-4e89-9836-d22a5a84abf0), via openFDA; the full label on DailyMed

What do FAERS reports show?

7,842 reports list quinapril among the medicines taken, each a report of something that happened, not proof the medicine caused it; 613 are coded as a death and 2,827 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 23 reactions below, 10 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

  • Fall907
  • Pain757
  • Hypotension (named in the label)716
  • Constipation (named in the label)713
  • Balance Disorder645
  • Cognitive Disorder634
  • Orthostatic Hypotension (named in the label)622
  • Sedation578
  • Mobility Decreased545
  • Depressed Level Of Consciousness537
  • Sedation Complication537
  • Toxicity To Various Agents535
  • Blood Calcium Decreased525
  • Creatinine Renal Clearance Decreased517
  • Drug Ineffective (a use or a product term, not a reaction)510
  • Dyspnoea (named in the label)505
  • Nausea (named in the label)445
  • Diarrhoea (named in the label)375
  • Fatigue (named in the label)371
  • Dizziness (named in the label)288
  • Asthenia282
  • Malaise (named in the label)269
  • Off Label Use (a use or a product term, not a reaction)256
  • Weight Decreased255
  • Cough (named in the label)239

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

What next?

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