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propranolol Side Effects

Also known as: Inderal

Analysis of 68,257 adverse event reports submitted to the FDA from 2002 to 2025.

Total Reports

68,257

Death-Related

6,894

10.1% of reports

Hospitalizations

21,161

31.0% of reports

Top Indication

Product Used For Unknown Indication

Most Reported Adverse Reactions

OFF LABEL USE
7,261
DRUG INEFFECTIVE
5,333
NAUSEA
4,279
HEADACHE
3,785
FATIGUE
3,752
DIARRHOEA
3,119
DIZZINESS
3,102
PRODUCT USE IN UNAPPROVED INDICATION
2,837
VOMITING
2,650
DYSPNOEA
2,561
PRODUCT USE ISSUE
2,488
PAIN
2,324
TOXICITY TO VARIOUS AGENTS
2,275
ANXIETY
2,188
INSOMNIA
2,172
FALL
2,137
ASTHENIA
2,039
SOMNOLENCE
1,920
MALAISE
1,905
HYPOTENSION
1,890

Who Reports Side Effects

Gender Distribution

Female 41,046 (66%)
Male 20,503 (33%)
Unknown 201

Age Distribution

0-17 3,426 (8%)
18-44 13,336 (29%)
45-64 16,287 (36%)
65-74 7,308 (16%)
75+ 5,276 (12%)

Reporting Trend by Year

2002 2025

Reactions in Death Reports

Top reactions reported in 6,894 reports where death was an outcome. These are voluntarily reported and do not establish causation.

Reaction Reports
COMPLETED SUICIDE 1,787
TOXICITY TO VARIOUS AGENTS 1,214
DEATH 1,185
CARDIO-RESPIRATORY ARREST 731
CARDIAC ARREST 587
SEPSIS 392
OVERDOSE 348
DYSPNOEA 342
DIARRHOEA 334
ASTHENIA 321
COMA 320
NAUSEA 319
FALL 315
OFF LABEL USE 297
FATIGUE 295
DRUG INTERACTION 290
ASCITES 287
MALAISE 278
ABDOMINAL PAIN 274
PYREXIA 274

Reactions in Hospitalization Reports

Top reactions in 21,161 reports where hospitalization was an outcome.

Reaction Reports
OFF LABEL USE 1,435
NAUSEA 1,220
HYPOTENSION 1,174
VOMITING 1,126
DRUG INEFFECTIVE 1,125
TOXICITY TO VARIOUS AGENTS 1,083
FALL 1,078
DIARRHOEA 1,062
FATIGUE 998
DYSPNOEA 962
HEADACHE 953
ASTHENIA 882
PNEUMONIA 879
BRADYCARDIA 864
PAIN 854
DRUG INTERACTION 820
DIZZINESS 805
OVERDOSE 762
ABDOMINAL PAIN 747
INTENTIONAL OVERDOSE 715

Nearby — Related Medications

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What the FAERS Data Reveals About propranolol Side Effects

The FDA Adverse Event Reporting System (FAERS) contains 68,257 voluntary reports linked to propranolol and its brand equivalents (Inderal), spanning 2002 through 2025. Of those, 6,894 (10.1%) listed death as an outcome and 21,161 (31.0%) 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, 66% were female and 33% male; age distribution skews toward 45-64, with 16,287 reports in that bracket. The single most reported reaction is off label use with 7,261 submissions, followed by drug ineffective 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.