nicardipine Side Effects
Also known as: Cardene
Analysis of 4,175 adverse event reports submitted to the FDA from 2002 to 2025.
Total Reports
4,175
Death-Related
564
13.5% of reports
Hospitalizations
2,241
53.7% of reports
Top Indication
Hypertension
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 564 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| CARDIAC ARREST | 62 |
| DEATH | 57 |
| CEREBRAL HAEMORRHAGE | 37 |
| RESPIRATORY FAILURE | 34 |
| ACUTE KIDNEY INJURY | 32 |
| SEPSIS | 31 |
| HYPOTENSION | 29 |
| RENAL FAILURE | 29 |
| OFF LABEL USE | 28 |
| PYREXIA | 28 |
| HYPERKALAEMIA | 26 |
| MULTIPLE ORGAN DYSFUNCTION SYNDROME | 26 |
| HYPERGLYCAEMIA | 25 |
| PNEUMONIA | 25 |
| VOMITING | 25 |
| HYPONATRAEMIA | 24 |
| DRUG INEFFECTIVE | 23 |
| HYPERLACTACIDAEMIA | 21 |
| CEREBRAL INFARCTION | 20 |
| SEPTIC SHOCK | 20 |
Reactions in Hospitalization Reports
Top reactions in 2,241 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| ACUTE KIDNEY INJURY | 157 |
| OFF LABEL USE | 111 |
| HYPERTENSION | 110 |
| HYPOTENSION | 102 |
| DRUG INTERACTION | 99 |
| DRUG INEFFECTIVE | 96 |
| PYREXIA | 93 |
| ANAEMIA | 70 |
| FALL | 69 |
| MATERNAL EXPOSURE DURING PREGNANCY | 65 |
| VOMITING | 63 |
| RENAL FAILURE | 61 |
| DIARRHOEA | 59 |
| HYPONATRAEMIA | 58 |
| DYSPNOEA | 57 |
| PNEUMONIA | 55 |
| CONFUSIONAL STATE | 54 |
| PREMATURE BABY | 54 |
| BRADYCARDIA | 51 |
| CONDITION AGGRAVATED | 49 |
Nearby — Related Medications
What the FAERS Data Reveals About nicardipine Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 4,175 voluntary reports linked to nicardipine and its brand equivalents (Cardene), spanning 2002 through 2025. Of those, 564 (13.5%) listed death as an outcome and 2,241 (53.7%) involved hospitalization. The most common indication reported alongside adverse events was Hypertension.
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 75+, with 938 reports in that bracket. The single most reported reaction is acute kidney injury with 226 submissions, followed by premature baby and off label use.
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.