Drug side effects
protriptyline Side Effects
The reactions most often reported to the FDA for protriptyline (also sold as Vivactil), with demographics, serious outcomes, and reporting trends.
Data updated 2026-05-15
- 96
- FAERS reports
Data from the FDA Adverse Event Reporting System (FAERS), 2012 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 protriptyline come from 96 reports to the FDA, broken down here by frequency, patient demographics, and serious outcomes.
This page analyzes 96 reports to the FDA Adverse Event Reporting System (FAERS) for protriptyline (Vivactil): 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
96
Hospitalizations
24
25.0% 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 Hospitalization Reports
Top reactions in 24 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| FALL | 5 |
| HOSPITALISATION | 4 |
| ILLNESS | 3 |
| PRODUCT ADMINISTRATION INTERRUPTED | 3 |
| ABDOMINAL DISCOMFORT | 2 |
| ANXIETY | 2 |
| CONDITION AGGRAVATED | 2 |
| DIZZINESS | 2 |
| DYSPNOEA | 2 |
| HEAD INJURY | 2 |
| HYPERTENSION | 2 |
| HYPOGLYCAEMIA | 2 |
| INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION | 2 |
| LOSS OF CONSCIOUSNESS | 2 |
| MUSCLE SPASMS | 2 |
| OSTEOARTHRITIS | 2 |
| PAIN | 2 |
| SEIZURE | 2 |
| VOMITING | 2 |
| WITHDRAWAL SYNDROME | 2 |
Nearby, Related Medications
What the FAERS Data Reveals About protriptyline Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 96 voluntary reports linked to protriptyline and its brand equivalents (Vivactil), spanning 2012 through 2025. No reports in this dataset listed death as an outcome and 24 (25.0%) 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, 68% were female and 32% male; age distribution skews toward 18-44, with 14 reports in that bracket. The single most reported reaction is fall with 12 submissions, followed by product administration interrupted and sleep apnoea syndrome.
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 protriptyline's 96.
Read our methodology - how this data is sourced, computed, and verified.