Capsagel Extra Strength

• It is used to ease muscle and joint aches and pain.
• It is used to help diabetic nerve pain.
• It may be given to you for other reasons. Talk with the doctor.

• If you have an allergy to Capsagel Extra Strength (capsaicin cream, gel, liquid, and lotion) or any part of this medicine.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you are using another drug like this one.

This is not a list of all drugs or health problems that interact with Capsagel Extra Strength.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Burning or stinging feeling. Most of the time, this will go away after a few days.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• Store at room temperature.
• Protect from heat or open flame.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

Applies to capsaicin topical: compounding powder, topical cream, topical film, topical gel, topical kit, topical liquid, topical lotion, topical stick

General

The most commonly reported side effects were application site erythema and application site pain.[Ref]

Local

Very common (10% or more): Application site erythema (63%), application site pain (42%)
Common (1% to 10%): Application site pruritus, application site papules, application site edema, application site swelling, application site dryness
Uncommon (0.1% to 1%): Application site urticaria, application site paresthesia, application site dermatitis, application site hyperesthesia, application site excoriation, application site warmth, application site anesthesia, application site bruising, application site inflammation, application site exfoliation[Ref]

Cardiovascular

Common (1% to 10%): Hypertension
Uncommon (0.1% to 1%): First degree atrio-ventricular (AV) block, tachycardia, palpitations, increased blood pressure[Ref]

Dermatologic

Uncommon (0.1% to 1%): Herpes zoster, pruritus
Frequency not reported: Abnormal skin odor, second degree burns[Ref]

Respiratory

Common (1% to 10%): Nasopharyngitis, bronchitis, sinusitis
Uncommon (0.1% to 1%): Cough, throat irritation
Frequency not reported: Sneezing, dyspnea, wheezing, exacerbation of asthma, irritation of the mucous membranes of the respiratory tract (such as nasal and throat irritation)[Ref]

Gastrointestinal

Common (1% to 10%): Nausea[Ref]

Musculoskeletal

Uncommon (0.1% to 1%): Pain in extremity, muscle spasms[Ref]

Nervous system

Uncommon (0.1% to 1%): Dysgeusia, hypoesthesia, burning sensation
Frequency not reported: Headache, peripheral sensory neuropathy, dizziness, dysgeusia, hyperesthesia[Ref]

Ocular

Uncommon (0.1% to 1%): Eye irritation
Frequency not reported: Irritation of the mucous membranes of the eyes, runny eyes[Ref]

Other

Frequency not reported: Peripheral edema[Ref]

Some side effects of Capsagel Extra Strength may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.