Drug side effects
capsaicin Side Effects
The reactions most often reported to the FDA for capsaicin (also sold as Zostrix, Qutenza), with demographics, serious outcomes, and reporting trends.
Data updated 2026-05-15
- 3,030
- 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 capsaicin come from 3,030 reports to the FDA, broken down here by frequency, patient demographics, and serious outcomes.
This page analyzes 3,030 reports to the FDA Adverse Event Reporting System (FAERS) for capsaicin (Zostrix): 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
3,030
Reports Mentioning Death
147
4.9% of reports — not proof the medicine caused the death
Hospitalizations
602
19.9% of reports
Top Indication
Diabetic Neuropathy
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 147 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 57 |
| PNEUMONIA | 15 |
| NEOPLASM MALIGNANT | 13 |
| ACUTE KIDNEY INJURY | 10 |
| MALIGNANT NEOPLASM PROGRESSION | 9 |
| ACUTE RESPIRATORY DISTRESS SYNDROME | 8 |
| ASTHENIA | 8 |
| DRUG INTERACTION | 8 |
| DYSPNOEA | 7 |
| PAIN | 7 |
| SPINAL CORD INJURY | 7 |
| TORSADE DE POINTES | 7 |
| RENAL FAILURE | 6 |
| CARDIAC ARREST | 5 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 5 |
| MULTIPLE ORGAN DYSFUNCTION SYNDROME | 5 |
| MYOCARDIAL INFARCTION | 5 |
| BACK PAIN | 4 |
| CHRONIC KIDNEY DISEASE | 4 |
| GASTROENTERITIS | 4 |
Reactions in Hospitalization Reports
Top reactions in 602 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| FATIGUE | 101 |
| POOR QUALITY SLEEP | 71 |
| IMPAIRED WORK ABILITY | 65 |
| INSOMNIA | 64 |
| HYPERTENSION | 63 |
| IMPAIRED QUALITY OF LIFE | 62 |
| WEIGHT INCREASED | 62 |
| CELLULITIS | 61 |
| HYPERLIPIDAEMIA | 59 |
| HERPES ZOSTER | 58 |
| CONTUSION | 56 |
| SKIN DISORDER | 56 |
| BONE DENSITY DECREASED | 55 |
| CATARACT | 55 |
| BODY TINEA | 54 |
| GLUCOSE TOLERANCE IMPAIRED | 54 |
| INFECTION SUSCEPTIBILITY INCREASED | 54 |
| ORAL HERPES | 54 |
| PURPURA | 54 |
Nearby, Related Medications
What the FAERS Data Reveals About capsaicin Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 3,030 voluntary reports linked to capsaicin and its brand equivalents (Zostrix, Qutenza), spanning 2004 through 2025. Of those, 147 (4.9%) listed death as an outcome and 602 (19.9%) involved hospitalization. The most common indication reported alongside adverse events was Diabetic Neuropathy.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 55% were female and 45% male; age distribution skews toward 45-64, with 838 reports in that bracket. The single most reported reaction is application site pain with 475 submissions, followed by pain and burning sensation.
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 capsaicin's 3,030.
Read our methodology - how this data is sourced, computed, and verified.