Drug side effects
atropine Side Effects
The reactions most often reported to the FDA for atropine (also sold as AtroPen), with demographics, serious outcomes, and reporting trends.
Data updated 2026-05-15
- 7,881
- FAERS reports
Data from the FDA Adverse Event Reporting System (FAERS), 2000 to 2025. A FAERS report records a temporal association, not proof of cause. See our methodology for how figures are compiled and de-duplicated.
The most commonly reported side effects of atropine come from 7,881 reports to the FDA, broken down here by frequency, patient demographics, and serious outcomes.
This page analyzes 7,881 reports to the FDA Adverse Event Reporting System (FAERS) for atropine (AtroPen): the reactions reported most often, who reported them, serious outcomes such as hospitalization, and year-over-year trends. A FAERS report does not prove the drug caused the effect, and report volume tracks how widely a drug is used, not how likely an effect is for any one person. Educational information, not medical advice.
Total Reports
7,881
Reports Mentioning Death
1,594
20.2% of reports — not proof the medicine caused the death
Hospitalizations
3,432
43.5% of reports
Top Indication
Product Used For Unknown Indication
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 1,594 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 443 |
| CARDIAC ARREST | 137 |
| DIARRHOEA | 128 |
| FATIGUE | 111 |
| NAUSEA | 106 |
| HYPOTENSION | 104 |
| VOMITING | 100 |
| PNEUMONIA | 96 |
| DYSPNOEA | 91 |
| RESPIRATORY FAILURE | 91 |
| ASTHENIA | 87 |
| DISEASE PROGRESSION | 85 |
| PAIN | 85 |
| RENAL FAILURE | 82 |
| TOXICITY TO VARIOUS AGENTS | 76 |
| BRADYCARDIA | 73 |
| CARDIO-RESPIRATORY ARREST | 73 |
| ANAEMIA | 62 |
Reactions in Hospitalization Reports
Top reactions in 3,432 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| HYPOTENSION | 348 |
| DIARRHOEA | 282 |
| DYSPNOEA | 251 |
| PAIN | 240 |
| BRADYCARDIA | 232 |
| TOXICITY TO VARIOUS AGENTS | 212 |
| PYREXIA | 206 |
| VOMITING | 196 |
| NAUSEA | 191 |
| FALL | 186 |
| CARDIAC ARREST | 162 |
| DRUG INTERACTION | 161 |
| PNEUMONIA | 154 |
| FEBRILE NEUTROPENIA | 148 |
| CONSTIPATION | 145 |
| FATIGUE | 143 |
| HYPERTENSION | 138 |
| TACHYCARDIA | 130 |
Nearby, Related Medications
What the FAERS Data Reveals About atropine Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 7,881 voluntary reports linked to atropine and its brand equivalents (AtroPen), spanning 2000 through 2025. Of those, 1,594 (20.2%) listed death as an outcome and 3,432 (43.5%) 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, 49% were female and 50% male; age distribution skews toward 45-64, with 1,884 reports in that bracket. The single most reported reaction is diarrhoea with 535 submissions, followed by hypotension and nausea.
How to read these numbers
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.
Drugs With a Similar FAERS Report Volume
Other medications with a total FDA adverse-event report count closest to atropine's 7,881.
Read our methodology - how this data is sourced, computed, and verified.