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Antihemophilic Side Effects and Adverse Effects reported to US Food and Drug Administration (FDA)

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Showing 1-25 of 38 

Factor Viii Inhibition (8463875-5)
on Jun 20, 2012 Male from TURKEY , weighting 24.25 lb, was diagnosed with
  • factor viii deficiency
and was treated with Antihemophilic Factor (human). Directly after, patient experienced the unwanted or unexpected Antihemophilic side effects: factor viii inhibition. Antihemophilic Factor (human) dosage: 500 Iu, Weekly.

Nausea, Vertigo, Peripheral Vascular Disorder (8381088-2)
Patient was taking Antihemophilic Factor (human). Patient felt the following Antihemophilic side effects: nausea, vertigo, peripheral vascular disorder on May 01, 2012 from GERMANY Additional patient health information: Female , 17 years of age, was diagnosed with
  • von willebrand's disease
and. Antihemophilic Factor (human) dosage: 2000 Iu Prn Intravenous (not Otherwise Specified). Patient was hospitalized.

Von Willebrand's Disease (8255192-3)
Adverse event was reported on Mar 29, 2012 by a Female taking Antihemophilic Factor (human) (Dosage: N/A) . Location: JAPAN , weighting 6.61 lb, After Antihemophilic was administered, patient encountered several Antihemophilic side effects: von willebrand's disease.

Von Willebrand's Disease (8229029-2)
on Mar 14, 2012 Female from JAPAN , weighting 6.61 lb, was treated with Antihemophilic Factor (human). Directly after, patient experienced the unwanted or unexpected Antihemophilic side effects: von willebrand's disease. Antihemophilic Factor (human) dosage: N/A.


Caesarean Section, Maternal Exposure During Pregnancy (8214911-2)
on Mar 14, 2012 Female from JAPAN , 34 years of age, was treated with Antihemophilic Factor (human). Patient felt the following Antihemophilic side effects: caesarean section, maternal exposure during pregnancy. Antihemophilic Factor (human) dosage: Unk.

Factor Viii Inhibition (8139322-X)
Patient was taking Antihemophilic Factor Nos. After Antihemophilic was administered, patient encountered several Antihemophilic side effects: factor viii inhibition on Feb 09, 2012 from TURKEY Additional patient health information: Male , weighting 20.28 lb, was diagnosed with
  • factor viii deficiency
and. Antihemophilic Factor Nos dosage: 500 Unk, Unk.

(8104591-9)
Adverse event was reported on Jan 24, 2012 by a Male taking Antihemophilic Factor Nos (Dosage: N/A) . Location: UNITED STATES , 49 years of age, .

Maternal Exposure During Pregnancy, Caesarean Section, No Adverse Event (8104002-3)
on Jan 25, 2012 Female from JAPAN , 31 years of age, was diagnosed with
  • factor viii deficiency
  • factor v deficiency
and was treated with Antihemophilic Factor Viii (recombinant), Sucrose Formulated. Patient felt the following Antihemophilic side effects: maternal exposure during pregnancy, caesarean section, no adverse event. Antihemophilic Factor Viii (recombinant), Sucrose Formulated dosage: N/A.

Alanine Aminotransferase Increased, Anti Factor Viii Antibody Positive, Streptococcus Test Positive, Complement Factor C3 Decreased, Tachypnoea, Glomerulonephritis Rapidly Progressive, Lung Infiltration, Abdominal Distension (7941856-5)
on Nov 18, 2011 Male from UNITED STATES , child 9 years of age, was treated with Antihemophilic Factor (human). After Antihemophilic was administered, patient encountered several Antihemophilic side effects: alanine aminotransferase increased, anti factor viii antibody positive, streptococcus test positive, complement factor c3 decreased, tachypnoea, glomerulonephritis rapidly progressive, lung infiltration, abdominal distension. Antihemophilic Factor (human) dosage: 8 Iu/kg, Q1hr, During Hospital Admission.

Factor Viii Inhibition (7937989-X)
Patient was taking Antihemophilic Factor (human). Directly after, patient experienced the unwanted or unexpected Antihemophilic side effects: factor viii inhibition on Nov 18, 2011 from GERMANY Additional patient health information: Male , weighting 23.15 lb, . Antihemophilic Factor (human) dosage: 1250 Iu, 2x/day. Patient was hospitalized.

Renal Impairment (7799222-1)
Adverse event was reported on Sep 28, 2011 by a Male taking Antihemophilic Factor (human) (Dosage: Daily Dose 2000 U) was diagnosed with
  • factor viii deficiency
and. Location: JAPAN , 42 years of age, Patient felt the following Antihemophilic side effects: renal impairment.
Multiple prescriptions taken:
  • Nafamostat (Unk)


Haemorrhagic Diathesis, Therapeutic Response Decreased (7646789-X)
on Jul 27, 2011 Male from UNITED STATES , child 8 years of age, weighting 72.97 lb, was diagnosed with
  • factor viii deficiency
and was treated with Antihemophilic Factor (recombinant), Sucrose Formulated Fs. After Antihemophilic was administered, patient encountered several Antihemophilic side effects: haemorrhagic diathesis, therapeutic response decreased. Antihemophilic Factor (recombinant), Sucrose Formulated Fs dosage: 40 Iu/kg, Qod.

Haemorrhage, Therapeutic Response Decreased (7646788-8)
on Jul 27, 2011 Male from UNITED STATES , child 6 years of age, weighting 51.81 lb, was diagnosed with
  • factor viii deficiency
and was treated with Antihemophilic Factor (recombinant), Sucrose Formulated Fs. Directly after, patient experienced the unwanted or unexpected Antihemophilic side effects: haemorrhage, therapeutic response decreased. Antihemophilic Factor (recombinant), Sucrose Formulated Fs dosage: 50 Iu/kg, Qod.

Anti Factor Viii Antibody Positive, Haematoma (7646787-6)
Patient was taking Antihemophilic Factor (recombinant), Sucrose Formulated Fs. Patient felt the following Antihemophilic side effects: anti factor viii antibody positive, haematoma on Jul 27, 2011 from MEXICO Additional patient health information: Male , child 10 years of age, weighting 70.55 lb, was diagnosed with
  • factor viii deficiency
and. Antihemophilic Factor (recombinant), Sucrose Formulated Fs dosage: N/A.

Factor Viii Inhibition (7629349-6)
Adverse event was reported on Jul 13, 2011 by a Male taking Antihemophilic Factor (human) (Dosage: 3549.0iu Given For Initial Recovery) was diagnosed with
  • factor viii deficiency
and. Location: CHINA , 32 years of age, weighting 169.8 lb, After Antihemophilic was administered, patient encountered several Antihemophilic side effects: factor viii inhibition.

Factor Viii Inhibition (7629348-4)
on Jul 15, 2011 Male from CHINA , 29 years of age, weighting 143.3 lb, was diagnosed with
  • factor viii deficiency
and was treated with Antihemophilic Factor (human). Directly after, patient experienced the unwanted or unexpected Antihemophilic side effects: factor viii inhibition. Antihemophilic Factor (human) dosage: 3000iu Given For Initial Recovery.

Factor Viii Inhibition (7629344-7)
on Jul 15, 2011 Male from CHINA , 20 years of age, weighting 88.18 lb, was treated with Antihemophilic Factor (human). Patient felt the following Antihemophilic side effects: factor viii inhibition. Antihemophilic Factor (human) dosage: 1000.0iu Given On Demand.

No Adverse Event (7607560-8)
Patient was taking Antihemophilic Factor Nos. After Antihemophilic was administered, patient encountered several Antihemophilic side effects: no adverse event on Jun 29, 2011 from UNITED STATES Additional patient health information: Male , 29 years of age, weighting 155.2 lb, . Antihemophilic Factor Nos dosage: 1775 U, Tiw.

Hepatitis C, Hepatic Cirrhosis, Hepatic Neoplasm Malignant (7596336-6)
Adverse event was reported on Jun 29, 2011 by a Male taking Antihemophilic Factor (human) (Dosage: N/A) was diagnosed with
  • factor viii deficiency
and. Location: UNITED STATES , weighting 83.78 lb, Directly after, patient experienced the unwanted or unexpected Antihemophilic side effects: hepatitis c, hepatic cirrhosis, hepatic neoplasm malignant.
Associated medications used:
  • Hemofil M
  • Advate
  • Amicar
  • Abilify


Headache, Nausea, Hypersensitivity (7383678-2)
on Mar 21, 2011 Male from UNITED STATES , 50 years of age, was diagnosed with
  • factor viii deficiency
and was treated with Antihemophilic Factor (recombinant), Sucrose Formulated Fs. Patient felt the following Antihemophilic side effects: headache, nausea, hypersensitivity. Antihemophilic Factor (recombinant), Sucrose Formulated Fs dosage: N/A.

Depression, Nervousness, Multi-organ Failure, Renal Disorder, Emotional Distress, Anxiety, Renal Injury, Fear (7382410-6)
on Mar 09, 2011 Male from UNITED STATES , weighting 282.2 lb, was treated with Antihemophilic Factor (human). After Antihemophilic was administered, patient encountered several Antihemophilic side effects: depression, nervousness, multi-organ failure, renal disorder, emotional distress, anxiety, renal injury, fear. Antihemophilic Factor (human) dosage: 12,000 Units.
Multiple concurrent drugs taken:
  • Bentyl (10 Mg, Tid)
  • Insulin
  • Cordarone (Unk)
  • Platelets (36 Units)
  • Plasma (12 Units)
  • Cryoprecipitates (30 Units)
  • Lipitor (20 Mg, Qd)
  • Solu-medrol (500 Mg, Unk)


Factor Viii Inhibition, Haemorrhage (7236886-5)
Patient was taking Antihemophilic Factor (human). Directly after, patient experienced the unwanted or unexpected Antihemophilic side effects: factor viii inhibition, haemorrhage on Jan 12, 2011 from NETHERLANDS Additional patient health information: Patient , 18 years of age, was diagnosed with
  • factor viii deficiency
and. Antihemophilic Factor (human) dosage: N/A.

Haemorrhage, Factor Viii Inhibition (7236884-1)
Adverse event was reported on Jan 12, 2011 by a Patient taking Antihemophilic Factor (human) (Dosage: N/A) was diagnosed with
  • factor viii deficiency
and. Location: NETHERLANDS , 18 years of age, Patient felt the following Antihemophilic side effects: haemorrhage, factor viii inhibition.

Factor Viii Inhibition, Haemorrhage (7236716-1)
on Jan 12, 2011 Patient from NETHERLANDS , 63 years of age, was diagnosed with
  • factor viii deficiency
and was treated with Antihemophilic Factor (human). After Antihemophilic was administered, patient encountered several Antihemophilic side effects: factor viii inhibition, haemorrhage. Antihemophilic Factor (human) dosage: N/A.

Rash (7147807-8)
on Dec 07, 2010 Male from UNITED STATES , 54 years of age, weighting 173.5 lb, was diagnosed with
  • von willebrand's disease
and was treated with Antihemophilic Factor (human). Directly after, patient experienced the unwanted or unexpected Antihemophilic side effects: rash. Antihemophilic Factor (human) dosage: 2000 Units Once Iv.

Showing 1-25 of 38 

Antihemophilic Health Episodes

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Most drugs have a large list of nonsevere or mild adverse effects which do not rule out continued usage. These effects depend on individual sensitivity, and can include nausea, dizziness, diarrhea, malaise, vomiting, headache, dermatitis, dry mouth, etc. Check commonly reported side effects . These can be considered a form of pseudo-allergic reaction, as not all users experience these effects; many users experience none at all.

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.

Antihemophilic Information

More About Antihemophilic

Side Effects reported to FDA: 38. View Antihemophilic Adverse Reports

Antihemophilic safety alerts: 2000

Reported deaths: 4

Reported hospitalizations: 4

Helixate (antihemophilic factor [recombinant])

Voluntary withdrawal of Helixate lot number 670H071E. This lot of Helixate was tested for Factor VIII potency using a reagent known as FVIII-deficient plasma. During a routine quality assurance investigation of the testing procedure, Bayer learned that Lot 670H071 may not retain its labeled potency if held at room temperature (25° C) for 3 months. The product will remain stable if stored at 2-8° C. Further investigation has confirmed that the cause is not related to a stability issue with the product but is attributed to the reagent used during the initial testing. As of this date there have been no adverse events reported in association with this lot of Helixate.

[August 1, 2000 - Letter - Aventis Behring]

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