Drug · FAERS side-effect profile with label screen
Capsaicin side effects: what 3,274 FDA adverse event reports show
Drug class
Trpv1 channel agonist
FDA label, Indications wording
Brand names
Qutenza
openFDA label
Who reports
3,274 reports · 58% serious · 158 with death outcome · 55% female
openFDA FAERS counts, all years, deduplication not applied
Used for
QUTENZA is indicated in adults for the treatment of neuropathic pain associated with postherpetic neuralgia (PHN) and for neuropathic pain associated with diabetic peripheral neuropathy (DPN) of the feet. QUTENZA is a TRPV1 channel agonist indicated for the treatment of neuropathic pain associated with postherpetic neuralgia (PHN) and neuropathic pain associated with diabetic peripheral neuropathy (DPN) of the feet.
FDA label, Indications and Usage
What it is
QUTENZA (capsaicin) 8% topical system contains capsaicin in a localized dermal delivery system. The capsaicin in QUTENZA is a synthetic equivalent of the naturally occurring compound found in chili peppers. Capsaicin is soluble in alcohol, acetone, and ethyl acetate and very slightly soluble in water.
FDA label, Description section
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Labeled adverse reaction 8Labeled (related wording) 3Likely indication confounding 2Reporting / coding artifact 6Lab value / disease marker 1Not in label — unassessed 20
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 65 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Application site pain | 547 | 163.3 151.1–176.5ROR 195.9 · χ² 85,970 / p <1e-300 | 158.4 EB05 147.6 · IC025 +7.0 3/3 methods agree | Labeled adverse reaction exact term | serious n=209 | no trial data cached |
| Application site erythema | 149 | 36.5 31.2–42.7ROR 38.2 · χ² 5,086 / p <1e-300 | 36.1 EB05 31.5 · IC025 +4.7 3/3 methods agree | Labeled adverse reaction exact term | serious n=96 | no trial data cached |
| Hyperlipidaemia | 63 | 33.9 26.5–43.3ROR 34.5 · χ² 1,967 / p <1e-300 | 33.4 EB05 27.0 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 36.8 · ♀ 93% (drug 55%) · 92% clinician | no trial data cached |
| Impaired quality of life | 68 | 30.4 24.0–38.5ROR 31.1 · χ² 1,899 / p <1e-300 | 30.1 EB05 24.5 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 43.9 · ♀ 100% (drug 55%) · 95% clinician | no trial data cached |
| Burning sensation | 329 | 30.2 27.3–33.5ROR 33.5 · χ² 9,251 / p <1e-300 | 30.0 EB05 27.4 · IC025 +4.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 15.1 | no trial data cached |
| Poor quality sleep | 77 | 23.1 18.6–28.9ROR 23.7 · χ² 1,605 / p <1e-300 | 23.0 EB05 19.0 · IC025 +4.0 3/3 methods agree | Reporting / coding artifact | serious PRR 40.5 · ♀ 99% (drug 55%) · 93% clinician | no trial data cached |
| Impaired work ability | 68 | 20.4 16.1–25.8ROR 20.8 · χ² 1,232 / p 4e-270 | 20.2 EB05 16.5 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 25.8 · ♀ 93% (drug 55%) · 96% clinician | no trial data cached |
| Oral herpes | 57 | 18.8 14.6–24.4ROR 19.2 · χ² 943 / p 2e-207 | 18.7 EB05 14.9 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 43.7 · ♀ 100% (drug 55%) · 93% clinician | no trial data cached |
| Neuralgia | 50 | 13.2 10.1–17.4ROR 13.4 · χ² 553 / p 1e-122 | 13.0 EB05 10.1 · IC025 +3.1 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 8.2 | no trial data cached |
| Bone density decreased | 62 | 12.6 9.8–16.1ROR 12.8 · χ² 648 / p 3e-143 | 12.4 EB05 9.9 · IC025 +3.1 3/3 methods agree | Lab value / disease marker | serious PRR 15.5 · ♀ 93% (drug 55%) · 91% clinician | no trial data cached |
| Skin disorder | 61 | 11.8 9.2–15.1ROR 12.0 · χ² 590 / p 1e-130 | 11.5 EB05 9.2 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 19.8 · ♀ 95% (drug 55%) | no trial data cached |
| Cellulitis (skin infection) | 65 | 8.3 6.5–10.5ROR 8.4 · χ² 409 / p 4e-91 | 7.9 EB05 6.4 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 8.9 · ♀ 88% (drug 55%) | no trial data cached |
| Herpes zoster (shingles) | 74 | 8.3 6.6–10.3ROR 8.4 · χ² 465 / p 2e-103 | 8.0 EB05 6.5 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 11.9 · ♀ 92% (drug 55%) | no trial data cached |
| Quality of life decreased | 17 | 8.1 5.1–13.0ROR 8.2 · χ² 99 / p 1e-23 | 7.0 EB05 4.5 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 8.7 | no trial data cached |
| Feeling hot | 74 | 7.7 6.2–9.7ROR 7.9 · χ² 428 / p 2e-95 | 7.5 EB05 6.1 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 · 85% consumer | no trial data cached |
| Drug eruption | 21 | 7.6 5.0–11.7ROR 7.7 · χ² 115 / p 5e-27 | 6.7 EB05 4.6 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 8.3 · ♀ 15% (drug 55%) · 95% clinician | no trial data cached |
| Cataract | 70 | 7.6 6.0–9.6ROR 7.7 · χ² 394 / p 7e-88 | 7.3 EB05 5.9 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 8.3 · ♀ 94% (drug 55%) | no trial data cached |
| Sleep apnoea syndrome | 22 | 7.4 4.9–11.2ROR 7.4 · χ² 115 / p 4e-27 | 6.5 EB05 4.5 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 8.7 · ♀ 19% (drug 55%) | no trial data cached |
| Therapy non-responder | 50 | 7.2 5.5–9.5ROR 7.3 · χ² 261 / p 5e-59 | 6.8 EB05 5.3 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 11.2 · ♀ 76% (drug 55%) | no trial data cached |
| Blister | 58 | 6.6 5.1–8.6ROR 6.7 · χ² 273 / p 1e-61 | 6.3 EB05 5.1 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.7 | no trial data cached |
| Limb discomfort | 31 | 6.4 4.5–9.1ROR 6.5 · χ² 137 / p 7e-32 | 5.9 EB05 4.3 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 1.4 · 84% consumer | no trial data cached |
| Application site rash | 13 | 6.0 3.5–10.4ROR 6.1 · χ² 50 / p 9e-13 | 5.1 EB05 3.1 · IC025 +1.4 3/3 methods agree | Labeled (related wording) related wording | serious n=3 | no trial data cached |
| Application site pruritus | 21 | 5.9 3.9–9.1ROR 6.0 · χ² 81 / p 1e-19 | 5.3 EB05 3.7 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious n=12 | no trial data cached |
| Paraesthesia oral | 12 | 5.4 3.0–9.4ROR 5.4 · χ² 38 / p 3e-10 | 4.5 EB05 2.8 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 | no trial data cached |
| Glaucoma | 16 | 5.3 3.3–8.7ROR 5.3 · χ² 52 / p 3e-13 | 4.7 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 | no trial data cached |
| No therapeutic response | 10 | 5.2 2.8–9.6ROR 5.2 · χ² 30 / p 3e-8 | 4.3 EB05 2.5 · IC025 +1.0 3/3 methods agree | Reporting / coding artifact | serious PRR 7.2 | no trial data cached |
| Application site irritation | 10 | 5.2 2.8–9.6ROR 5.2 · χ² 29 / p 3e-8 | 4.3 EB05 2.5 · IC025 +1.0 3/3 methods agree | Labeled (related wording) related wording | serious n=6 | no trial data cached |
| Economic problem | 12 | 5.0 2.8–8.8ROR 5.0 · χ² 34 / p 2e-9 | 4.3 EB05 2.6 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 5.4 | no trial data cached |
| Paralysis | 11 | 4.9 2.7–8.9ROR 4.9 · χ² 30 / p 2e-8 | 4.1 EB05 2.5 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 | no trial data cached |
| Therapeutic product effect incomplete | 54 | 4.9 3.8–6.4ROR 5.0 · χ² 164 / p 7e-38 | 4.7 EB05 3.7 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 2.5 | no trial data cached |
| Liver function test increased | 16 | 4.8 3.0–7.8ROR 4.8 · χ² 45 / p 1e-11 | 4.3 EB05 2.8 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 7.4 | no trial data cached |
| Sensory disturbance | 12 | 4.8 2.7–8.4ROR 4.8 · χ² 32 / p 7e-9 | 4.1 EB05 2.5 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 2.4 | no trial data cached |
| Pain in extremity | 215 | 4.7 4.1–5.3ROR 4.9 · χ² 625 / p 3e-138 | 4.6 EB05 4.1 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.9 · 71% consumer | no trial data cached |
| Contusion | 69 | 4.6 3.6–5.8ROR 4.7 · χ² 192 / p 6e-44 | 4.5 EB05 3.7 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 7.4 · ♀ 94% (drug 55%) | no trial data cached |
| Throat irritation | 32 | 4.6 3.3–6.5ROR 4.6 · χ² 86 / p 7e-21 | 4.3 EB05 3.2 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.3 · ♀ 86% (drug 55%) | no trial data cached |
| Pain | 425 | 4.4 4.1–4.8ROR 4.9 · χ² 1,159 / p 3e-254 | 4.4 EB05 4.1 · IC025 +2.0 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 2.8 | no trial data cached |
| Product administered at inappropriate site | 12 | 4.2 2.4–7.5ROR 4.2 · χ² 27 / p 1e-7 | 3.7 EB05 2.3 · IC025 +0.9 3/3 methods agree | Reporting / coding artifact | serious n=4 | no trial data cached |
| Paraesthesia (tingling/numbness) | 101 | 4.1 3.4–5.0ROR 4.2 · χ² 236 / p 1e-53 | 4.0 EB05 3.4 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.7 | no trial data cached |
| Osteoarthritis | 27 | 4.1 2.8–5.9ROR 4.1 · χ² 60 / p 5e-15 | 3.8 EB05 2.8 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 · ♀ 28% (drug 55%) · 92% clinician | no trial data cached |
| Presyncope (near-fainting) | 15 | 4.0 2.4–6.6ROR 4.0 · χ² 31 / p 2e-8 | 3.6 EB05 2.3 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Application site pain | 547 | 163.3 151.1–176.5ROR 195.9 · χ² 85,970 / p <1e-300 | 158.4 EB05 147.6 · IC025 +7.0 3/3 methods agree | Labeled adverse reaction exact term | serious n=209 | no trial data cached |
| Pain | 425 | 4.4 4.1–4.8ROR 4.9 · χ² 1,159 / p 3e-254 | 4.4 EB05 4.1 · IC025 +2.0 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 2.8 | no trial data cached |
| Burning sensation | 329 | 30.2 27.3–33.5ROR 33.5 · χ² 9,251 / p <1e-300 | 30.0 EB05 27.4 · IC025 +4.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 15.1 | no trial data cached |
| Pain in extremity | 215 | 4.7 4.1–5.3ROR 4.9 · χ² 625 / p 3e-138 | 4.6 EB05 4.1 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.9 · 71% consumer | no trial data cached |
| Application site erythema | 149 | 36.5 31.2–42.7ROR 38.2 · χ² 5,086 / p <1e-300 | 36.1 EB05 31.5 · IC025 +4.7 3/3 methods agree | Labeled adverse reaction exact term | serious n=96 | no trial data cached |
| Weight increased (weight gain) | 102 | 2.9 2.4–3.6ROR 3.0 · χ² 130 / p 3e-30 | 2.9 EB05 2.5 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 · ♀ 93% (drug 55%) | no trial data cached |
| Paraesthesia (tingling/numbness) | 101 | 4.1 3.4–5.0ROR 4.2 · χ² 236 / p 1e-53 | 4.0 EB05 3.4 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.7 | no trial data cached |
| Erythema (skin redness) | 91 | 2.8 2.3–3.5ROR 2.9 · χ² 108 / p 1e-25 | 2.8 EB05 2.4 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.2 | no trial data cached |
| Hypoaesthesia (numbness) | 90 | 3.9 3.1–4.7ROR 3.9 · χ² 188 / p 4e-43 | 3.8 EB05 3.2 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 2.3 | no trial data cached |
| Poor quality sleep | 77 | 23.1 18.6–28.9ROR 23.7 · χ² 1,605 / p <1e-300 | 23.0 EB05 19.0 · IC025 +4.0 3/3 methods agree | Reporting / coding artifact | serious PRR 40.5 · ♀ 99% (drug 55%) · 93% clinician | no trial data cached |
| Feeling hot | 74 | 7.7 6.2–9.7ROR 7.9 · χ² 428 / p 2e-95 | 7.5 EB05 6.1 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 · 85% consumer | no trial data cached |
| Herpes zoster (shingles) | 74 | 8.3 6.6–10.3ROR 8.4 · χ² 465 / p 2e-103 | 8.0 EB05 6.5 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 11.9 · ♀ 92% (drug 55%) | no trial data cached |
| Cataract | 70 | 7.6 6.0–9.6ROR 7.7 · χ² 394 / p 7e-88 | 7.3 EB05 5.9 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 8.3 · ♀ 94% (drug 55%) | no trial data cached |
| Contusion | 69 | 4.6 3.6–5.8ROR 4.7 · χ² 192 / p 6e-44 | 4.5 EB05 3.7 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 7.4 · ♀ 94% (drug 55%) | no trial data cached |
| Impaired work ability | 68 | 20.4 16.1–25.8ROR 20.8 · χ² 1,232 / p 4e-270 | 20.2 EB05 16.5 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 25.8 · ♀ 93% (drug 55%) · 96% clinician | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Hyperlipidaemia — n=63, PRR 33.9
- Impaired quality of life — n=68, PRR 30.4
- Impaired work ability — n=68, PRR 20.4
- Oral herpes — n=57, PRR 18.8
- Cellulitis — n=65, PRR 8.3
- Herpes zoster — n=74, PRR 8.3
- Feeling hot — n=74, PRR 7.7
- Drug eruption — n=21, PRR 7.6
- Cataract — n=70, PRR 7.6
- Sleep apnoea syndrome — n=22, PRR 7.4
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Capsaicin?
In FDA FAERS, the most frequently co-reported reaction terms for Capsaicin are application site pain, pain, burning sensation, pain in extremity, application site erythema, weight increased. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Capsaicin have an FDA boxed warning?
No. The FDA label retrieved for Capsaicin has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Capsaicin causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 3ffbbcb0-ad93-4f15-bb38-5da76a71c735, effective 20260707; matched on
openfda.generic_name.exact:"CAPSAICIN" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 105 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.