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Monoclate-P Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 6/15/2016

Monoclate-P [Antihemophilic Factor (Human), Factor VIII: C Pasteurized, Monoclonal Antibody Purified] is a naturally occurring protein in the blood used to treat or prevent bleeding episodes in adults and children with hemophilia A. Monoclate-P is also used to control bleeding related to surgery or dentistry in a person with hemophilia. Monoclate-P is not for use in people with von Willebrand disease. Monoclate-P is available in generic form. Common side effects of Monoclate-P include:

  • mild nausea or stomach pain
  • tingly or jittery feeling
  • blurred vision
  • headache
  • chills
  • allergic reactions, or
  • injection site reactions (swelling, stinging, or irritation)

Dosage of Monoclate-P must be individualized according to the needs of the patient (weight, severity of hemorrhage, presence of inhibitors). Monoclate-P may interact with other drugs. Tell your doctor all medications and supplements you use. Monoclate-P may be harmful to a fetus. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is unknown if this drug passes into breast milk or if it could harm a nursing baby. Consult your doctor before breastfeeding.

Our Monoclate-P [Antihemophilic Factor (Human), Factor VIII:C Pasteurized, Monoclonal Antibody Purified] Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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 medicine and call your doctor at once if you have a serious side effect such as:

  • 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, upper stomach pain, itching, 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. Call your doctor for medical advice about side effects. 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
(Adverse Reactions)


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)

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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