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lisinopril Side Effects

Also known as: Prinivil, Zestril

Analysis of 297,692 adverse event reports submitted to the FDA from 2001 to 2025.

Total Reports

297,692

Death-Related

24,562

8.3% of reports

Hospitalizations

95,486

32.1% of reports

Top Indication

Product Used For Unknown Indication

Most Reported Adverse Reactions

FATIGUE
19,346
NAUSEA
17,996
DRUG INEFFECTIVE
17,185
DIARRHOEA
16,771
DYSPNOEA
13,650
PAIN
13,303
DIZZINESS
13,194
HEADACHE
12,600
ASTHENIA
10,668
VOMITING
10,619
OFF LABEL USE
10,492
ACUTE KIDNEY INJURY
9,385
ARTHRALGIA
9,325
CHRONIC KIDNEY DISEASE
9,109
FALL
8,899
HYPERTENSION
8,529
RASH
8,289
DEATH
8,184
MALAISE
8,161
COUGH
7,956

Who Reports Side Effects

Gender Distribution

Female 145,314 (52%)
Male 134,986 (48%)
Unknown 336

Age Distribution

0-17 1,869 (1%)
18-44 17,385 (9%)
45-64 81,105 (41%)
65-74 53,342 (27%)
75+ 43,583 (22%)

Reporting Trend by Year

2001 2025

Reactions in Death Reports

Top reactions reported in 24,562 reports where death was an outcome. These are voluntarily reported and do not establish causation.

Reaction Reports
DEATH 8,144
COMPLETED SUICIDE 2,989
FATIGUE 1,605
DYSPNOEA 1,581
PAIN 1,523
PNEUMONIA 1,511
RENAL FAILURE 1,440
DIARRHOEA 1,409
VOMITING 1,338
HYPERTENSION 1,317
TOXICITY TO VARIOUS AGENTS 1,278
OFF LABEL USE 1,260
ASTHENIA 1,259
NAUSEA 1,230
DECREASED APPETITE 1,207
ACUTE KIDNEY INJURY 1,169
GENERAL PHYSICAL HEALTH DETERIORATION 1,158
ARTHRALGIA 1,119
INJURY 1,111
CARDIAC ARREST 1,084

Reactions in Hospitalization Reports

Top reactions in 95,486 reports where hospitalization was an outcome.

Reaction Reports
DYSPNOEA 6,853
NAUSEA 6,491
DIARRHOEA 5,952
FATIGUE 5,829
PNEUMONIA 5,737
VOMITING 5,604
ASTHENIA 5,266
FALL 5,228
ACUTE KIDNEY INJURY 4,895
PAIN 4,774
DIZZINESS 4,701
MYOCARDIAL INFARCTION 4,594
ANGIOEDEMA 4,301
HYPOTENSION 4,259
HYPERTENSION 4,160
CHEST PAIN 3,770
CARDIAC FAILURE CONGESTIVE 3,747
HEADACHE 3,713
DEHYDRATION 3,661
CEREBROVASCULAR ACCIDENT 3,563

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What the FAERS Data Reveals About lisinopril Side Effects

The FDA Adverse Event Reporting System (FAERS) contains 297,692 voluntary reports linked to lisinopril and its brand equivalents (Prinivil, Zestril), spanning 2001 through 2025. Of those, 24,562 (8.3%) listed death as an outcome and 95,486 (32.1%) involved hospitalization. The most common indication reported alongside adverse events was Product Used For Unknown Indication.

Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 52% were female and 48% male; age distribution skews toward 45-64, with 81,105 reports in that bracket. The single most reported reaction is fatigue with 19,346 submissions, followed by nausea and drug ineffective.

FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice — speak with a licensed clinician about any side-effect concerns.