Over-the-counter medication · Topical Analgesic
capsaicin
Also sold as Zostrix, Qutenza. This medicine can help with minor muscle and joint pain.
Data updated 2026-05-15
- 3,030
- FDA reportsLightly reported
- 4
- Recall records
What the data shows
capsaicin (Zostrix) is an over-the-counter Topical Analgesic, among the least-reported drugs the FDA tracks (3,030 FDA reports).
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
capsaicin (Zostrix) is an over-the-counter Topical Analgesic. This medicine can help with minor muscle and joint pain.
Capsaicin cream is a medicine that helps relieve minor aches and pains. It comes in different brand names like Zostrix and Qutenza.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Generic Price
$0.07/unit
Generic Available
Yes (0 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
This medicine can help with minor muscle and joint pain.
Common side effects
Burning sensation, Pain at application site, Redness at application site
Key warnings
No specific warnings noted. Always follow your prescriber's instructions.
The sections below are summarized in plain English from capsaicin's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Capsaicin works by affecting nerve endings in the skin. It reduces the feeling of pain in the area where you put the cream. This provides temporary relief.
Side Effects (from patient reports)
Based on 3,030 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for capsaicin, by number of reports
- Application Site Pain
Application Site Pain
475 reports
- Pain
Pain
404 reports
- Burning Sensation
Burning Sensation
291 reports
- Pain In Extremity 178
Pain In Extremity
178 reports
- Fatigue 162
Fatigue
162 reports
- Application Site Erythema 137
Application Site Erythema
137 reports
- Insomnia 101
Insomnia
101 reports
- Weight Increased 100
Weight Increased
100 reports
- Dyspnoea 99
Dyspnoea
99 reports
- Nausea 91
Nausea
91 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for capsaicin each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where capsaicin sits
capsaicin has more FDA adverse-event reports than 18% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is capsaicin; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 3,030 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2004–2025.
Total Reports
3,030
Reports Mentioning Death
147
4.9% of reports — not proof of cause
Hospitalization Reports
602
Top Indication
Diabetic Neuropathy
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | APPLICATION SITE PAIN | 475 |
| 2 | PAIN | 404 |
| 4 | BURNING SENSATION | 291 |
| 5 | PAIN IN EXTREMITY | 178 |
| 6 | FATIGUE | 162 |
| 8 | APPLICATION SITE ERYTHEMA | 137 |
| 9 | INSOMNIA | 101 |
| 10 | WEIGHT INCREASED | 100 |
| 11 | DYSPNOEA | 99 |
| 12 | NAUSEA | 91 |
| 13 | ERYTHEMA | 89 |
| 14 | PARAESTHESIA | 88 |
| 15 | HYPERTENSION | 85 |
| 16 | HYPOAESTHESIA | 82 |
| 17 | DIZZINESS | 78 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Common Questions
What is capsaicin cream used for?
How often should I apply the cream?
Can children use this cream?
What should I do if I get the cream in my eyes?
Is it okay to use a heating pad with this cream?
Can I use this cream for severe pain?
How long will it take to feel relief?
Can I use this with other pain relievers?
What should I do if my skin gets irritated?
Can I use this cream if I am allergic to peppers?
What are the common side effects of capsaicin?
What drug class is capsaicin?
What pregnancy or breastfeeding source fields are listed for capsaicin?
Has capsaicin been recalled?
Active Recalls
Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
ARG Laboratories, Inc.
Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
ARG Laboratories, Inc.
Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
ARG Laboratories, Inc.
Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
ARG Laboratories, Inc.
Related Medications in Topical Analgesic
Other drugs grouped near capsaicin - same-class peers and common alternatives.
abatacept
Orencia
Orencia is a medicine that helps to reduce inflammation.
Compare with capsaicin →
acetaminophen
Tylenol
Acetaminophen (Tylenol) is a medicine that can relieve pain and reduce fever.
Compare with capsaicin →
acetaminophen/hydrocodone
Vicodin, Norco
This medicine contains acetaminophen and hydrocodone.
Compare with capsaicin →
acetaminophen/oxycodone
Percocet
Percocet is a strong pain medicine.
Compare with capsaicin →
adalimumab
Humira
Idacio is a medicine that blocks a protein called TNF.
Compare with capsaicin →
Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for capsaicin: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 3,030.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 4.85%.
- montelukast Δ 0.03 pts · 78,359 reports · Leukotriene Receptor Antagonist 4.82%death share
- empagliflozin Δ 0.07 pts · 61,560 reports · SGLT2 Inhibitor 4.92%death share
- secukinumab Δ 0.08 pts · 157,236 reports · IL-17A Inhibitor (Biologic) 4.93%death share
- tofacitinib Δ 0.10 pts · 181,998 reports · JAK Inhibitor 4.76%death share
Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Pain Relievers Compared
NSAIDs vs acetaminophen, which OTC pain reliever to use
Narrow Therapeutic Index Drugs
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
What the FDA Data Shows for capsaicin
The FDA label for capsaicin (sold under brand names such as Zostrix, Qutenza) classifies it as an over-the-counter product in the Topical Analgesic class. This medicine can help with minor muscle and joint pain. Official labeling lists 3 commonly reported side effects, including Burning sensation, Pain at application site, Redness at application site.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 3,030 voluntary reports. Interaction data is drawn directly from FDA-approved prescribing information. NADAC pricing from CMS shows a generic unit cost of $0.07.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history (currently 4 recall records on file), and patent information are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. This registry does not provide medication decisions.
Last updated: December 6, 2024
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages