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candesartan Side Effects

Also known as: Atacand

Analysis of 33,477 adverse event reports submitted to the FDA from 2004 to 2025.

Total Reports

33,477

Death-Related

4,308

12.9% of reports

Hospitalizations

17,659

52.7% of reports

Top Indication

Product Used For Unknown Indication

Most Reported Adverse Reactions

OFF LABEL USE
3,515
DYSPNOEA
3,169
FATIGUE
3,159
NAUSEA
2,989
DIARRHOEA
2,764
DIZZINESS
2,677
HEADACHE
2,506
PAIN
2,454
DRUG INEFFECTIVE
2,384
VOMITING
2,251
GENERAL PHYSICAL HEALTH DETERIORATION
2,177
ARTHRALGIA
2,146
ASTHENIA
1,979
MALAISE
1,951
HYPERTENSION
1,922
CONDITION AGGRAVATED
1,912
PNEUMONIA
1,781
PYREXIA
1,774
FALL
1,735
RASH
1,612

Who Reports Side Effects

Gender Distribution

Female 17,136 (57%)
Male 13,048 (43%)
Unknown 48

Age Distribution

0-17 288 (1%)
18-44 2,929 (11%)
45-64 7,143 (26%)
65-74 7,508 (28%)
75+ 9,109 (34%)

Reporting Trend by Year

2004 2025

Reactions in Death Reports

Top reactions reported in 4,308 reports where death was an outcome. These are voluntarily reported and do not establish causation.

Reaction Reports
OFF LABEL USE 1,190
GENERAL PHYSICAL HEALTH DETERIORATION 945
CONDITION AGGRAVATED 841
INTENTIONAL PRODUCT USE ISSUE 809
ASTHENIA 799
MATERNAL EXPOSURE DURING PREGNANCY 796
PEMPHIGUS 790
FOLLICULITIS 777
SYSTEMIC LUPUS ERYTHEMATOSUS 768
TYPE 2 DIABETES MELLITUS 766
BURSITIS 763
PAIN 763
PERICARDITIS 760
GLOSSODYNIA 758
SYNOVITIS 753
HYPOAESTHESIA 749
HYPERTENSION 747
PNEUMONIA 747
DIARRHOEA 745
CONFUSIONAL STATE 743

Reactions in Hospitalization Reports

Top reactions in 17,659 reports where hospitalization was an outcome.

Reaction Reports
DYSPNOEA 2,128
GENERAL PHYSICAL HEALTH DETERIORATION 1,987
NAUSEA 1,835
OFF LABEL USE 1,835
FATIGUE 1,815
DIARRHOEA 1,677
VOMITING 1,620
DIZZINESS 1,586
PAIN 1,548
ASTHENIA 1,474
PNEUMONIA 1,423
HEADACHE 1,411
FALL 1,403
CONDITION AGGRAVATED 1,296
HYPERTENSION 1,260
ACUTE KIDNEY INJURY 1,240
PYREXIA 1,231
DRUG INEFFECTIVE 1,229
MALAISE 1,227
ARTHRALGIA 1,181

Nearby — Related Medications

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What the FAERS Data Reveals About candesartan Side Effects

The FDA Adverse Event Reporting System (FAERS) contains 33,477 voluntary reports linked to candesartan and its brand equivalents (Atacand), spanning 2004 through 2025. Of those, 4,308 (12.9%) listed death as an outcome and 17,659 (52.7%) 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, 57% were female and 43% male; age distribution skews toward 75+, with 9,109 reports in that bracket. The single most reported reaction is off label use with 3,515 submissions, followed by dyspnoea and fatigue.

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.