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What the label lists and what reports show

Perindopril side effects

Perindopril's FDA label: “Most common adverse events (incidence greater than or equal to 5%) are cough, dizziness and back pain.” FAERS holds 5,567 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 dyspnoea (361 reports).

  • Generic listed
  • Boxed warning

Check it at the source: the perindopril FDA label on DailyMed (effective March 13, 2024, Aurobindo Pharma Limited); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

Most common adverse events (incidence greater than or equal to 5%) are cough, dizziness and back pain.

From the label: adverse reactions, continued

Because clinical trials are conducted under widely varying conditions, adverse event rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Hypertension: Most common adverse events (incidence greater than or equal to 5%) are cough, dizziness and back pain. (6.1) Stable Coronary Artery Disease: Most common adverse events leading to discontinuation were cough, drug intolerance, and hypotension. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience The following adverse reactions are discussed elsewhere in labeling: Anaphylactoid reactions, including angioedema [see Warnings and Precautions (5.1) ] Hypotension [see Warnings and Precautions (5.2) ] Neutropenia and agranulocytosis [see Warnings and Precautions (5.3) ] Impaired renal function [see Warnings and Precautions (5.5) ] Hyperkalemia [see Warnings and Precautions (5.6) ] Cough [see Warnings and Precautions (5.7) ] Hypertension Perindopril erbumine has been evaluated for safety in approximately 3,400 patients with hypertension in U.S. and foreign clinical trials. …

Source: FDA drug label, Aurobindo Pharma Limited, effective March 13, 2024 (SPL set 87768fbf-7c63-47da-8925-0316f343d6ef), via openFDA; the full label on DailyMed

What do FAERS reports show?

5,567 reports list perindopril among the medicines taken, each a report of something that happened, not proof the medicine caused it; 589 are coded as a death and 2,852 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 20 reactions below, 9 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

  • Dyspnoea361
  • Malaise320
  • Off Label Use (a use or a product term, not a reaction)296
  • Fall288
  • Drug Ineffective (a use or a product term, not a reaction)265
  • Fatigue262
  • Diarrhoea (named in the label)259
  • Hypertension (a use or a product term, not a reaction)259
  • Headache (named in the label)255
  • Drug Interaction (a use or a product term, not a reaction)254
  • Nausea254
  • Arthralgia (named in the label)234
  • Vomiting (named in the label)225
  • Dizziness (named in the label)205
  • Cough (named in the label)188
  • Hypotension (named in the label)184
  • Pain In Extremity164
  • Asthenia (named in the label)162
  • Renal Failure Acute161
  • Condition Aggravated (a use or a product term, not a reaction)160
  • Pyrexia159
  • Rash (named in the label)159
  • Pain153
  • Cardiac Failure151
  • Abdominal Pain143

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

What next?

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