"A new consumer-friendly form ( is now available for making reports to MedWatch, the Food and Drug Administration's (FDA) on-line system for collecting information about serious problems with drugs, medical devices and other FDA-"...
Monoclate-P 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.
Monoclate-P in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; feeling light-headed, fainting; swelling of your face, lips, tongue, or throat.
Stop using this medication and call your doctor at once if you have any of these serious side effects:
- easy bruising, increased bleeding episodes;
- bleeding from a wound or where the medicine was injected;
- fever, chills, drowsiness, and runny nose followed by skin rash and joint pain 2 weeks later; or
- nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Less serious side effects may include:
- mild nausea or stomach pain.
- tingly or jittery feeling;
- blurred vision;
- headache; or
- swelling, stinging, or irritation where the injection was given.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Monoclate-P (Antihemophilic Factor) »
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Monoclate-P FDA Prescribing Information: Side Effects
Products of this type are known to cause allergic reactions, mild chills, nausea or stinging at the infusion site. In some cases, inhibitors of FVIII may occur.
Read the entire FDA prescribing information for Monoclate-P (Antihemophilic Factor) »
Additional Monoclate-P 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.
Find out what women really need.