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nisoldipine Side Effects

Also known as: Sular

Analysis of 1,191 adverse event reports submitted to the FDA from 2004 to 2025.

Total Reports

1,191

Death-Related

123

10.3% of reports

Hospitalizations

394

33.1% of reports

Top Indication

Hypertension

Most Reported Adverse Reactions

NAUSEA
88
DRUG INEFFECTIVE
79
DIZZINESS
77
HEADACHE
76
FATIGUE
74
RENAL FAILURE
65
PAIN
64
DYSPNOEA
63
ASTHENIA
62
DIARRHOEA
59
ANXIETY
54
MYOCARDIAL INFARCTION
54
OEDEMA PERIPHERAL
54
HYPERTENSION
50
PRURITUS
49
CHRONIC KIDNEY DISEASE
46
PAIN IN EXTREMITY
44
BACK PAIN
42
CEREBROVASCULAR ACCIDENT
42
BLOOD PRESSURE INCREASED
41

Who Reports Side Effects

Gender Distribution

Female 723 (62%)
Male 439 (38%)

Age Distribution

18-44 51 (7%)
45-64 264 (35%)
65-74 189 (25%)
75+ 242 (32%)

Reporting Trend by Year

2004 2025

Reactions in Death Reports

Top reactions reported in 123 reports where death was an outcome. These are voluntarily reported and do not establish causation.

Reaction Reports
DEATH 39
RENAL FAILURE 21
MYOCARDIAL INFARCTION 19
COMPLETED SUICIDE 17
INJURY 14
ASTHENIA 13
CARDIAC FAILURE CONGESTIVE 12
PAIN 12
PNEUMONIA 12
ANXIETY 11
DYSPNOEA 10
RESPIRATORY FAILURE 9
CHRONIC KIDNEY DISEASE 8
DIARRHOEA 8
NAUSEA 8
WEIGHT DECREASED 8
ANHEDONIA 7
ATRIAL FIBRILLATION 7
DIZZINESS 7
END STAGE RENAL DISEASE 7

Reactions in Hospitalization Reports

Top reactions in 394 reports where hospitalization was an outcome.

Reaction Reports
DYSPNOEA 43
MYOCARDIAL INFARCTION 39
CARDIAC FAILURE CONGESTIVE 35
RENAL FAILURE 35
ASTHENIA 34
NAUSEA 33
PAIN 33
ANXIETY 31
CEREBROVASCULAR ACCIDENT 31
PNEUMONIA 31
DIARRHOEA 29
DIZZINESS 27
FATIGUE 26
CORONARY ARTERY DISEASE 25
HEADACHE 24
HYPERTENSION 24
BACK PAIN 23
CHEST PAIN 23
ATRIAL FIBRILLATION 22
INJURY 22

Nearby — Related Medications

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What the FAERS Data Reveals About nisoldipine Side Effects

The FDA Adverse Event Reporting System (FAERS) contains 1,191 voluntary reports linked to nisoldipine and its brand equivalents (Sular), spanning 2004 through 2025. Of those, 123 (10.3%) listed death as an outcome and 394 (33.1%) 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, 62% were female and 38% male; age distribution skews toward 45-64, with 264 reports in that bracket. The single most reported reaction is nausea with 88 submissions, followed by drug ineffective and dizziness.

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.