Ceprotin
Ceprotin 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 Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Ceprotin FDA Prescribing Information: Side Effects
(Adverse Reactions)
SIDE EFFECTS
Clinical Studies Experience
The most serious and common adverse reactions related to CEPROTIN (protein c concentrate) treatment observed were hypersensitivity or allergic reactions (itching and rash) and lightheadedness.
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in one clinical study of a drug cannot be directly compared with rates in the clinical studies of the same drug or another drug and may not reflect the rates observed in practice.
The safety profile of CEPROTIN (protein c concentrate) was based on 121 patients from clinical studies and compassionate use in severe congenital Protein C deficiency. Duration of exposure ranged from 1 day to 8 years. One patient experienced hypersensitivity/allergic reactions (itching and rash) and lightheadedness which were determined by the investigator to be related to CEPROTIN (protein c concentrate) .
No inhibiting antibodies to CEPROTIN (protein c concentrate) have been observed in clinical studies. However, the potential for developing antibodies cannot be ruled out.
Post-marketing Experience
The following adverse reactions have been identified during postapproval use of CEPROTIN (protein c concentrate) : hemothorax, hypotension, hyperhydrosis, fever and restlessness. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Read the entire FDA prescribing information for Ceprotin (Protein C Concentrate) »
Additional Ceprotin 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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