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chlorpheniramine Side Effects

Also known as: Chlor-Trimeton

Analysis of 6,221 adverse event reports submitted to the FDA from 2004 to 2025.

Total Reports

6,221

Death-Related

1,084

17.4% of reports

Hospitalizations

2,771

44.5% of reports

Top Indication

Product Used For Unknown Indication

Most Reported Adverse Reactions

NAUSEA
601
DIARRHOEA
568
OFF LABEL USE
506
FATIGUE
467
DYSPNOEA
416
PYREXIA
383
VOMITING
375
NEUTROPENIA
292
HEADACHE
274
PNEUMONIA
270
COUGH
259
NEUROPATHY PERIPHERAL
256
RASH
254
PRURITUS
246
DEATH
241
DIZZINESS
238
CONSTIPATION
231
FEBRILE NEUTROPENIA
226
DISEASE PROGRESSION
216
ABDOMINAL PAIN
192

Who Reports Side Effects

Gender Distribution

Female 3,329 (60%)
Male 2,262 (40%)
Unknown 3

Age Distribution

0-17 367 (8%)
18-44 862 (18%)
45-64 1,801 (38%)
65-74 938 (20%)
75+ 711 (15%)

Reporting Trend by Year

2004 2025

Reactions in Death Reports

Top reactions reported in 1,084 reports where death was an outcome. These are voluntarily reported and do not establish causation.

Reaction Reports
DEATH 240
OFF LABEL USE 161
NAUSEA 151
DISEASE PROGRESSION 136
DIARRHOEA 131
FATIGUE 125
PNEUMONIA 105
NEUTROPENIA 104
NEUROPATHY PERIPHERAL 96
SEIZURE 94
PYREXIA 85
DYSPNOEA 80
PLATELET COUNT DECREASED 80
MUCOSAL INFLAMMATION 79
OVERDOSE 75
VOMITING 74
DYSPEPSIA 73
ALOPECIA 71
COVID-19 68
TOXICITY TO VARIOUS AGENTS 68

Reactions in Hospitalization Reports

Top reactions in 2,771 reports where hospitalization was an outcome.

Reaction Reports
DIARRHOEA 372
NAUSEA 331
OFF LABEL USE 293
PYREXIA 263
VOMITING 260
FATIGUE 253
PNEUMONIA 208
DYSPNOEA 199
DISEASE PROGRESSION 195
FEBRILE NEUTROPENIA 193
NEUROPATHY PERIPHERAL 157
NEUTROPENIA 154
PLATELET COUNT DECREASED 145
COUGH 134
ABDOMINAL PAIN 132
MUCOSAL INFLAMMATION 130
ALOPECIA 126
ANAEMIA 124
CONSTIPATION 123
SEIZURE 122

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What the FAERS Data Reveals About chlorpheniramine Side Effects

The FDA Adverse Event Reporting System (FAERS) contains 6,221 voluntary reports linked to chlorpheniramine and its brand equivalents (Chlor-Trimeton), spanning 2004 through 2025. Of those, 1,084 (17.4%) listed death as an outcome and 2,771 (44.5%) 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, 60% were female and 40% male; age distribution skews toward 45-64, with 1,801 reports in that bracket. The single most reported reaction is nausea with 601 submissions, followed by diarrhoea 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.