Adagen Side Effects

Please note - some side effects for Adagen may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Adagen - for the Consumer

Adagen

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Adagen:

Headache; pain or redness at the injection site.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); dark urine; severe or persistent tiredness or weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Adagen Side Effects - for the Professional

Adagen

Clinical experience with Adagen® (pegademase bovine) Injection has been limited. The following adverse reactions were reported: headache in one patient and pain at the injection site in two patients. The following adverse reactions have been identified during post-approval use of Adagen® (pegademase bovine) Injection. Because these reactions are reported voluntarily from a very small population, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Hematologic events: hemolytic anemia, auto-immune hemolytic anemia, thrombocythemia

Dermatological events: injection site erythema, urticaria

To report SUSPECTED ADVERSE REACTIONS, contact Sigma-Tau Pharmaceuticals, Inc. at 1-888-393-4584 or by email at drugsafety@sigmatau.com or contact the FDA at 1-800-FDA-1088 or www.fda.gov/safety/medwatch.

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