Skip to main content
PlainMeds

What the label lists and what reports show

Lisinopril side effects

Lisinopril's FDA label lists its adverse reactions in its own words. FAERS holds 304,309 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 fatigue (19,911 reports).

  • Generic listed
  • Boxed warning

Check it at the source: the lisinopril FDA label on DailyMed (effective January 2, 2025, Upsher-Smith Laboratories, LLC); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

Common adverse reactions (events 2% greater than placebo) by use: Hypertension: headache, dizziness and cough ( 6.1 ) Heart Failure: hypotension and chest pain ( 6.1 ) Acute Myocardial Infarction: hypotension ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Upsher-Smith Laboratories, LLC at 1-855-899-9180 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience 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. Hypertension In clinical trials in patients with hypertension treated with Zestril, 5.7% of patients on Zestril discontinued with adverse reactions. …

A table the label prints in its adverse reactions section without a title; its column headings name the groups compared

ReactionHigh Dose (n=1568)Low Dose (n=1596)
Dizziness19%12%
Hypotension11%7%
Creatinine increased10%7%
Hyperkalemia6%4%
Syncope7%5%

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, NDA019777 (Twi Pharms), as published by Upsher-Smith Laboratories, LLC, effective January 2, 2025 (SPL set 838c2d78-d2d8-4981-9ec9-e50ef9e1a5d8), via openFDA; the full label on DailyMed

What do FAERS reports show?

304,309 reports list lisinopril among the medicines taken, each a report of something that happened, not proof the medicine caused it; 25,263 are coded as a death and 97,537 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, 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

  • Fatigue (named in the label)19,911
  • Nausea18,497
  • Drug Ineffective (a use or a product term, not a reaction)17,620
  • Diarrhoea (named in the label)17,311
  • Dyspnoea13,983
  • Pain13,637
  • Dizziness (named in the label)13,524
  • Headache (named in the label)13,015
  • Off Label Use (a use or a product term, not a reaction)11,050
  • Vomiting11,046
  • Asthenia (named in the label)10,951
  • Arthralgia (named in the label)9,649
  • Acute Kidney Injury9,547
  • Chronic Kidney Disease9,125
  • Fall9,117
  • Hypertension (a use or a product term, not a reaction)8,718
  • Rash (named in the label)8,572
  • Malaise8,418
  • Death (an outcome recorded in the report)8,365
  • Cough (named in the label)8,162
  • Weight Decreased8,091
  • Pruritus (named in the label)7,988
  • Pain In Extremity7,839
  • Renal Failure (named in the label)7,640
  • Anxiety7,327

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

What next?

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