Adagen
How to Report an Adverse Reaction to a Medication »
"Potential drug treatments are tested on paper, in laboratories and eventually in thousands of people. But every drug that goes through this cycle – every drug that FDA approves – carries some risk. One of the first lines of defense against "...
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Adagen
Adagen Side Effects Center
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Adagen in Detail - Patient Information: Side Effects
If you experience any of the following serious side effects, stop using the pegademase bovine and seek emergency medical treatment or contact your doctor immediately:
- an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); or
- signs of infection such as sore throat, fever or congestion.
Other, less serious side effects may be more likely to occur. Continue to use the pegademase bovine and talk to your doctor if you experience:
- headache;
- swelling, redness, or pain at the injection site.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Adagen (Pegademase Bovine) »
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Adagen FDA Prescribing Information: Side Effects
(Adverse Reactions)
SIDE EFFECTS
Clinical experience with ADAGEN® (pegademase bovine) (pegademase bovine) Injection has been limited. The following adverse reactions were reported during clinical trials: 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
Read the entire FDA prescribing information for Adagen (Pegademase Bovine) »
Additional Adagen Information
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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