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capsaicin

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Brand names: Zostrix, Qutenza

Topical Analgesic OTC

Capsaicin cream is a medicine that helps relieve minor aches and pains. It comes in different brand names like Zostrix and Qutenza.

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

There are no boxed warnings for this medication.

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.

How to Take It

Adults and children 18 and older should apply a thin layer of cream to the painful area. Gently rub it in until it's fully absorbed, unless you are treating your hands. Wash your hands well with soap and water right after using it. Use it 3 to 4 times each day.

Pregnancy & Breastfeeding

It is not known if this medicine will harm an unborn baby. Talk to your doctor if you are pregnant or breastfeeding before using this medicine.

Missed Dose

Apply the cream as soon as you remember. Do not apply extra cream to make up for the missed dose.

Storage

Store at room temperature between 59°F and 86°F (15°C to 30°C).

Side Effects (from patient reports)

Based on 2,340 FDA adverse event reports.

Pain at application site
475
Pain
404
Medicine not working
351
Burning sensation
291
Pain in arm or leg
178
Tiredness
162
Using medicine for unapproved purpose
141
Redness at application site
137
Trouble sleeping
101
Weight gain
100

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

Death-Related Reports

147

Hospitalization Reports

602

Top Indication

Diabetic Neuropathy

Gender Distribution

Female 1,580 (55%)
Male 1,273 (45%)

Age Distribution

0–17 32
18–44 291
45–64 838
65–74 433
75+ 373

Most Reported Adverse Reactions (FAERS)

# Reaction Reports
1 APPLICATION SITE PAIN 475
2 PAIN 404
3 DRUG INEFFECTIVE 351
4 BURNING SENSATION 291
5 PAIN IN EXTREMITY 178
6 FATIGUE 162
7 OFF LABEL USE 141
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

Reactions in Death 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

Reactions in Hospitalization Reports

DRUG INEFFECTIVE 106
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

Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation

Serious Warnings

There are no boxed warnings for this medication.

Common Questions

What is capsaicin cream used for?
It is used to relieve minor aches and pains in muscles and joints.
How often should I apply the cream?
Apply it 3 to 4 times a day.
Can children use this cream?
Children under 18 should ask a doctor before using it.
What should I do if I get the cream in my eyes?
Rinse your eyes thoroughly with water.
Is it okay to use a heating pad with this cream?
Ask your doctor before using a heating pad.
Can I use this cream for severe pain?
This cream is for minor aches and pains. Talk to your doctor for severe pain.
How long will it take to feel relief?
It may take a few days to feel the full effect.
Can I use this with other pain relievers?
Ask your doctor before combining with other pain medicines.
What should I do if my skin gets irritated?
Stop using the cream and talk to your doctor.
Can I use this cream if I am allergic to peppers?
Ask your doctor before using this cream.
What are the common side effects of capsaicin?
The most commonly reported side effects of capsaicin include Burning sensation, Pain at application site, Redness at application site. Based on 2,340 FDA adverse event reports. Always consult your healthcare provider about potential side effects.
What drug class is capsaicin?
capsaicin belongs to the Topical Analgesic drug class. It is available over the counter (OTC). This medicine can help with minor muscle and joint pain.
Is capsaicin safe during pregnancy?
It is not known if this medicine will harm an unborn baby. Talk to your doctor if you are pregnant or breastfeeding before using this medicine. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.
Has capsaicin been recalled?
There are 4 recalls associated with capsaicin products. Out of Specification for active ingredient. Check the recalls section below for full details and affected products.

Active Recalls

Class II April 17, 2024

Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.

ARG Laboratories, Inc.

Class II April 17, 2024

Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.

ARG Laboratories, Inc.

Class II April 17, 2024

Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.

ARG Laboratories, Inc.

Class II April 17, 2024

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.

Compare capsaicin vs abatacept side-by-side →

Medication Guides

Related Health & Safety Data

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 2,340 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 further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.

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. Always consult a healthcare professional before making medication decisions.

Last updated: December 6, 2024

All federal data sources used on this page