amlodipine Side Effects
Also known as: Norvasc
Analysis of 257,862 adverse event reports submitted to the FDA from 2003 to 2025.
Total Reports
257,862
Death-Related
28,135
10.9% of reports
Hospitalizations
104,040
40.3% of reports
Top Indication
Product Used For Unknown Indication
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 28,135 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 7,743 |
| COMPLETED SUICIDE | 5,086 |
| TOXICITY TO VARIOUS AGENTS | 2,638 |
| PNEUMONIA | 1,371 |
| ACUTE KIDNEY INJURY | 1,341 |
| CARDIAC ARREST | 1,235 |
| DYSPNOEA | 1,166 |
| HYPOTENSION | 1,065 |
| OFF LABEL USE | 1,022 |
| RENAL FAILURE | 988 |
| SEPSIS | 967 |
| DIARRHOEA | 963 |
| NAUSEA | 825 |
| ASTHENIA | 759 |
| FATIGUE | 753 |
| VOMITING | 750 |
| CARDIO-RESPIRATORY ARREST | 745 |
| RESPIRATORY FAILURE | 743 |
| FALL | 680 |
| DECREASED APPETITE | 671 |
Reactions in Hospitalization Reports
Top reactions in 104,040 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| DYSPNOEA | 7,038 |
| ACUTE KIDNEY INJURY | 6,232 |
| HYPOTENSION | 6,099 |
| DIARRHOEA | 5,849 |
| PNEUMONIA | 5,830 |
| FALL | 5,823 |
| NAUSEA | 5,689 |
| FATIGUE | 5,147 |
| VOMITING | 5,039 |
| ASTHENIA | 4,309 |
| DIZZINESS | 4,029 |
| OFF LABEL USE | 3,968 |
| TOXICITY TO VARIOUS AGENTS | 3,936 |
| PYREXIA | 3,863 |
| MALAISE | 3,718 |
| HYPERTENSION | 3,689 |
| PAIN | 3,553 |
| HEADACHE | 3,325 |
| ANAEMIA | 3,281 |
| DRUG INEFFECTIVE | 3,155 |
Nearby — Related Medications
What the FAERS Data Reveals About amlodipine Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 257,862 voluntary reports linked to amlodipine and its brand equivalents (Norvasc), spanning 2003 through 2025. Of those, 28,135 (10.9%) listed death as an outcome and 104,040 (40.3%) 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, 53% were female and 47% male; age distribution skews toward 45-64, with 59,928 reports in that bracket. The single most reported reaction is fatigue with 15,697 submissions, followed by diarrhoea and nausea.
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.
Read our methodology — how this data is sourced, computed, and verified.