Zostrix Sports

Zostrix Sports is part of the drug classes:

• Capsaicin and similar agents

• Other local anesthetics

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Very bad skin irritation.
• Very bad burning or burning that does not go away.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Review Date: October 4, 2017

Applies to capsaicin topical: topical cream, topical film, topical gel/jelly, topical liquid, topical lotion, topical ointment, topical pad, topical patch extended release, topical solution, topical stick

Along with its needed effects, capsaicin topical (the active ingredient contained in Zostrix Sports) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking capsaicin topical:

• Burning, itching, dryness, pain, redness, swelling, or soreness at the application site

• Cough
• cough-producing mucus
• difficulty with breathing
• shortness of breath or troubled breathing
• sore throat
• stuffy or runny nose
• tightness in the chest or wheezing

• Blurred vision
• dizziness
• headache
• nervousness
• pounding in the ears
• slow or fast heartbeat

• Bloating or swelling of the face, arms, hands, lower legs, or feet
• increased sensitivity to pain
• increased sensitivity to touch
• rapid weight gain
• tingling in the hands and feet
• unsteadiness or awkwardness
• unusual weight gain or loss
• weakness in the arms, hands, legs, or feet

Some side effects of capsaicin topical may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Fever
• muscle aches
• nausea
• pain or tenderness around the eyes and cheekbones
• unusual tiredness or weakness
• vomiting

• Abnormal skin color
• change in taste
• loss of taste

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 Zostrix Sports may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.