azelaic acid cream - topical, Azelex (cont.)
SIDE EFFECTS: Temporary stinging, burning, itching, or tingling of the skin may occur, usually at the beginning of treatment. These effects usually lessen as your body adjusts to this medication. However, if minor irritation continues, your doctor may instruct you to only use this product once daily. If any of these effects persist or worsen, stop using this medication and tell your doctor or pharmacist promptly.Tell your doctor immediately if any of these unlikely side effects occur: worsening of cold sores or fever blisters (oral herpes), unusual or unwanted hair growth.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Rarely, some people may experience lightening of skin color (hypopigmentation) after using this medication. This side effect may be more noticeable in people with dark skin color. Consult your doctor for more details and report any skin color changes.Tell your doctor immediately if any of these rare but serious side effects occur: worsening of asthma symptoms (such as shortness of breath, wheezing).A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: asthma, repeated episodes of cold sores or fever blisters (oral herpes).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.This medication may pass into breast milk. Consult your doctor before breast-feeding.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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