Report Adverse Events

Report an Adverse Event

IF YOU HAVE A MEDICAL EMERGENCY, CALL 911 IMMEDIATELY.

If you need to report an adverse event that occurred while taking one of our drug products, please call (800) 298-1087.

A trained professional will be available to assist you Monday through Wednesday from 7:00 a.m. to 5:30 p.m. CST, and Thursday from 7:00 a.m. to 5:00 p.m. CST.

You can also contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch to report an adverse event.

Reports of adverse events should not be left on e-mail, but should be called into the telephone number above. Mission Pharmacal Company cannot be held responsible for reports of adverse events submitted by e-mail. Your cooperation is appreciated.

Important Safety Information

AVAR products are not for everyone. You should not use AVAR products if you:

are allergic to any ingredient in AVAR products. Ask your doctor if you are not sure.

have had a severe allergic reaction (e.g., severe rash, hives, difficulty breathing, swelling) to sulfonamide medicines or sulfur.

have kidney disease.

KEEP ALL AVAR PRODUCTS OUT OF THE REACH OF CHILDREN.

Before you use AVAR products, tell your doctor about all of your medical conditions, including if you:

are pregnant or planning to become pregnant. It is not known whether AVAR products can cause harm to the fetus.

are breastfeeding or plan to breastfeed. It is not known whether the ingredients in AVAR products can pass into breast milk.

have allergies to medicines, foods, or other substances.

AVAR PRODUCTS ARE FOR EXTERNAL USE ONLY. AVOID CONTACT WITH THE EYES. AVAR products should be used as directed by your doctor. Do not use them for other conditions. AVAR products should not be used in children younger than 12 years old; safety and effectiveness in these children have not been determined.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. You should tell your doctor if you are using silver-containing medicines, such as silver sulfadiazine.

AVAR products may cause serious side effects in some people, including:

severe allergic reactions. You should discontinue any AVAR product if the condition becomes worse, or if a rash develops in the area being treated or elsewhere. Seek medical attention right away if you develop signs or symptoms of a severe allergic reaction (rash, hives, itching, difficulty breathing, tightness in the chest, swelling of the mouth, face, lips, or tongue).

systemic lupus erythematosus. In one of these cases there was a fatal outcome. Discontinue the AVAR product immediately and contact your doctor right away if you experience arthritis (pain, stiffness or swelling in your joints), or fever or sores in your mouth develop.

Possible side effects of AVAR products include mild skin irritation or dryness. These are not all of the possible side effects of AVAR products. Tell your doctor if you have any side effect that bothers you or does not go away.

You may report negative side effects to Mission Pharmacal Company at 1-800-298-1087, or to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Report an Adverse Event

IF YOU HAVE A MEDICAL EMERGENCY, CALL 911 IMMEDIATELY.

Important Safety Information

ARE YOU A HEALTHCARE PROFESSIONAL?