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carvedilol Side Effects

Also known as: Coreg

Analysis of 130,791 adverse event reports submitted to the FDA from 2003 to 2025.

Total Reports

130,791

Death-Related

15,919

12.2% of reports

Hospitalizations

53,070

40.6% of reports

Top Indication

Product Used For Unknown Indication

Most Reported Adverse Reactions

FATIGUE
8,669
DYSPNOEA
8,178
DIARRHOEA
6,867
DIZZINESS
6,776
NAUSEA
6,492
DRUG INEFFECTIVE
5,676
DEATH
5,632
HYPOTENSION
5,601
ASTHENIA
5,344
CARDIAC FAILURE CONGESTIVE
4,427
ACUTE KIDNEY INJURY
4,408
OFF LABEL USE
4,392
PAIN
4,341
FALL
4,335
HEADACHE
4,197
RENAL FAILURE
4,183
CHRONIC KIDNEY DISEASE
4,025
PNEUMONIA
4,012
VOMITING
3,684
MYOCARDIAL INFARCTION
3,647

Who Reports Side Effects

Gender Distribution

Female 57,183 (47%)
Male 65,450 (53%)
Unknown 135

Age Distribution

0-17 900 (1%)
18-44 5,607 (6%)
45-64 28,089 (32%)
65-74 26,227 (30%)
75+ 26,948 (31%)

Reporting Trend by Year

2003 2025

Reactions in Death Reports

Top reactions reported in 15,919 reports where death was an outcome. These are voluntarily reported and do not establish causation.

Reaction Reports
DEATH 5,616
COMPLETED SUICIDE 1,202
RENAL FAILURE 1,049
CARDIAC FAILURE CONGESTIVE 1,030
DYSPNOEA 869
PNEUMONIA 868
CARDIAC ARREST 855
ACUTE KIDNEY INJURY 799
CARDIAC FAILURE 735
HYPOTENSION 710
CHRONIC KIDNEY DISEASE 665
MYOCARDIAL INFARCTION 659
ASTHENIA 596
CARDIO-RESPIRATORY ARREST 585
RESPIRATORY FAILURE 571
FATIGUE 560
GASTROINTESTINAL HAEMORRHAGE 535
SEPSIS 533
FALL 532
TOXICITY TO VARIOUS AGENTS 520

Reactions in Hospitalization Reports

Top reactions in 53,070 reports where hospitalization was an outcome.

Reaction Reports
DYSPNOEA 4,434
CARDIAC FAILURE CONGESTIVE 3,622
PNEUMONIA 3,344
HYPOTENSION 3,313
FATIGUE 3,000
FALL 2,876
ASTHENIA 2,781
MYOCARDIAL INFARCTION 2,733
NAUSEA 2,666
DIARRHOEA 2,663
ACUTE KIDNEY INJURY 2,525
DIZZINESS 2,511
ANAEMIA 2,290
GASTROINTESTINAL HAEMORRHAGE 2,252
RENAL FAILURE 2,097
VOMITING 2,050
CARDIAC FAILURE 1,953
CHEST PAIN 1,835
HYPERTENSION 1,776
PAIN 1,763

Nearby — Related Medications

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What the FAERS Data Reveals About carvedilol Side Effects

The FDA Adverse Event Reporting System (FAERS) contains 130,791 voluntary reports linked to carvedilol and its brand equivalents (Coreg), spanning 2003 through 2025. Of those, 15,919 (12.2%) listed death as an outcome and 53,070 (40.6%) 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, 47% were female and 53% male; age distribution skews toward 45-64, with 28,089 reports in that bracket. The single most reported reaction is fatigue with 8,669 submissions, followed by dyspnoea and diarrhoea.

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.