capsaicin topical (OTC)

>10%

Transient increased pain at application site (dissipates w/ continued use)

Application site erythema (63%)

Pain (42%)

1-10%

Nausea (5%)

Vomiting (3%)

Hypertension (2%)

Dryness (2%)

Swelling (2%)

Pruritus (6%)

Papules (6%)

Edema (4%)

Sinusitis (3%)

Bronchitis (2%)

<1%

Exfoliation

Dizziness

Cough

Skin odor

Headache

Dysguesia

Contraindications

Hypersensitivity

Self-medication: Use on wounds; concurrent use with other topical analgesics; damaged, irritated, broken skin or application into skin folds; within one our before or after bath, hot tub, sauna, or shower; do not cover with bandage; not for use with external heat source, including heating pad

Cautions

For external use only

Do not apply to face or scalp to avoid exposure to eyes or mucous membranes

Transient burn sensation may occur but generally disappears after several days

Not for use immediately before or after activities such as, swimming, showering, bathing, strenuous exercise, sunbathing, sauna, steam bath, or other types of heat, or exposure to sunlight to treated areas

Accidental exposure to eyes and mucous membranes can occur from touching drug product or items exposed to drug product and then touching eyes and mucous membranes

If irritation of eyes or mucous membranes occurs, flush eyes and mucous membranes with cool water

First, to third-degree chemical Burns may occur upon application; discontinue use and seek medical attention if signs of skin injury, including pain, blistering, or swelling occurs

Contact healthcare professional if excessive redness, blistering, burning or irritation develops, symptoms persist for >7 days, symptoms get worse, symptoms resolve and then recur, or if difficulty breathing or swallowing occurs

Do not handle contact lenses for at least 1 hr after handling drug product

Use caution in patients with uncontrolled hypertension, history of cerebrovascular events

Pregnancy Category: B

Lactation: Unknown whether distributed in breast milk; do not apply to nipple or areola

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

Mechanism of Action

Transient receptor potential vanilloid-1 (TRPV1) agonist; topical application causes initial TRPV1 stimulation that may cause pain, followed by pain relief by reduction in TRPV1-expressing nociceptive nerve endings