"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-"...
Koate Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Koate-DVI Antihemophilic Factor (Human) is a naturally occurring protein in the blood used to treat or prevent bleeding episodes in adults and children with hemophilia A. It is also used to control bleeding related to surgery or dentistry in a person with hemophilia. It is not for use in people with von Willebrand disease. Common side effects include nausea or stomach pain, tingly or jittery feeling, blurred vision, headache, or swelling, stinging, or irritation where the injection was given.
The dosage of Koate-DVI required for hemostasis must be individualized according to the needs of the patient, the severity of the deficiency, the severity of the hemorrhage, the presence of inhibitors, and the factor VIII level desired. Koate-DVI may interact with other drugs. Tell your doctor all medications and supplements you use. Koate-DVI 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 Koate-DVI Antihemophilic Factor (Human) 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.
Koate 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 Koate (Antihemophilic Factor) »
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Koate FDA Prescribing Information: Side Effects
Allergic-type reactions may result from the administration of Antihemophilic Factor (Human) preparations.10,11
Ten adverse reactions related to 7 infusions were observed during a total of 1053 infusions performed during the clinical study of Koate (antihemophilic factor) -DVI, for a frequency of 0.7% infusions associated with adverse reactions. All reactions were mild and included tingling in the arm, ear, and face, blurred vision, headache, nausea, stomach ache, and jittery feeling.2
Read the entire FDA prescribing information for Koate (Antihemophilic Factor) »
Additional Koate 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.