Drug side effects
imipramine Side Effects
The reactions most often reported to the FDA for imipramine (also sold as Tofranil), with demographics, serious outcomes, and reporting trends.
Data updated 2026-05-15
- 537
- FAERS reports
Data from the FDA Adverse Event Reporting System (FAERS), 2004 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 imipramine come from 537 reports to the FDA, broken down here by frequency, patient demographics, and serious outcomes.
This page analyzes 537 reports to the FDA Adverse Event Reporting System (FAERS) for imipramine (Tofranil): 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
537
Reports Mentioning Death
30
5.6% of reports — not proof the medicine caused the death
Hospitalizations
198
36.9% 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 30 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 8 |
| COMPLETED SUICIDE | 7 |
| TOXICITY TO VARIOUS AGENTS | 6 |
| DEPRESSED LEVEL OF CONSCIOUSNESS | 4 |
| OVERDOSE | 4 |
| ASPHYXIA | 3 |
| PNEUMONIA | 3 |
| RESPIRATORY DISORDER | 3 |
| SOMNOLENCE | 3 |
| ARTHRALGIA | 2 |
| ARTHROPATHY | 2 |
| ASPIRATION | 2 |
| B-CELL SMALL LYMPHOCYTIC LYMPHOMA | 2 |
| CARDIAC ARREST | 2 |
| CERUMEN IMPACTION | 2 |
| CERVICAL RADICULOPATHY | 2 |
| CHRONIC KIDNEY DISEASE | 2 |
| CHRONIC LYMPHOCYTIC LEUKAEMIA | 2 |
| CYANOSIS | 2 |
| DIFFUSE LARGE B-CELL LYMPHOMA | 2 |
Reactions in Hospitalization Reports
Top reactions in 198 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| HALLUCINATION, AUDITORY | 25 |
| PSYCHOTIC DISORDER | 25 |
| PARANOIA | 24 |
| COLITIS | 18 |
| COLITIS ULCERATIVE | 17 |
| DECREASED ACTIVITY | 16 |
| FREQUENT BOWEL MOVEMENTS | 16 |
| RECTAL HAEMORRHAGE | 16 |
| DIZZINESS | 15 |
| DEPRESSION | 14 |
| FATIGUE | 14 |
| PNEUMONIA | 14 |
| ARTHRALGIA | 13 |
| DYSPNOEA | 13 |
| HYPERTENSION | 13 |
| NAUSEA | 13 |
| URINARY TRACT INFECTION | 13 |
| ANXIETY | 12 |
| CHEST PAIN | 12 |
| PYREXIA | 12 |
Nearby, Related Medications
What the FAERS Data Reveals About imipramine Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 537 voluntary reports linked to imipramine and its brand equivalents (Tofranil), spanning 2004 through 2025. Of those, 30 (5.6%) listed death as an outcome and 198 (36.9%) 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, 68% were female and 31% male; age distribution skews toward 45-64, with 132 reports in that bracket. The single most reported reaction is dizziness with 35 submissions, followed by fatigue and hypertension.
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 imipramine's 537.
Read our methodology - how this data is sourced, computed, and verified.