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Antihemophilic Side Effects

Common Antihemophilic Side Effects

The most commonly reported Antihemophilic side effects (click to view or check a box to report):

Factor Viii Inhibition (18)
Haemorrhage (7)
Anti Factor Viii Antibody Positive (6)
Death (4)
Nausea (3)
Haematemesis (2)
Caesarean Section (2)
Maternal Exposure During Pregnancy (2)
No Adverse Event (2)
Hypersensitivity (2)
Haematoma (2)
White Blood Cell Count Decreased (2)
Therapeutic Response Decreased (2)
Shock (2)
Platelet Count Decreased (2)
Vertigo (2)
Von Willebrand's Disease (2)
Pulmonary Oedema (2)
Peripheral Vascular Disorder (1)
Portal Vein Thrombosis (1)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

Antihemophilic Side Effects Reported to FDA

The following Antihemophilic reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.


The appearance of Antihemophilic on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.
Anti Factor Viii Antibody Positive, Haematemesis, Shock Haemorrhagic, Hepatic Failure
on Feb 18, 2014 Male from JP , 56 years of age, weighting 123.5 lb, was diagnosed with and was treated with Antihemophilic Factor Viii (recombinant), Sucrose Formulated. Directly after, patient experienced the unwanted or unexpected Antihemophilic side effects: anti factor viii antibody positive, haematemesis, shock haemorrhagic, hepatic failure. Antihemophilic Factor Viii (recombinant), Sucrose Formulated dosage: 8000 U, Bolus. Patient was hospitalized.

Anti Factor Viii Antibody Positive
Patient was taking Antihemophilic Factor Viii (recombinant), Sucrose Formulated. Patient felt the following Antihemophilic side effects: anti factor viii antibody positive on Sep 16, 2013 from US Additional patient health information: Male , 15 years of age, was diagnosed with and. Antihemophilic Factor Viii (recombinant), Sucrose Formulated dosage: 100 Iu/kg, Qd.

Hypersensitivity, Feeling Abnormal, Product Quality Issue
Adverse event was reported on Aug 08, 2013 by a Male taking Antihemophilic Factor (Dosage: 12,000 Ius Once Daily Into A Vein) . Location: US , 32 years of age, weighting 204.0 lb, After Antihemophilic was administered, patient encountered several Antihemophilic side effects: hypersensitivity, feeling abnormal, product quality issue.

No Therapeutic Response
on Jan 22, 2013 Male from US , child 3 years of age, was diagnosed with and was treated with Antihemophilic Factor, Human Recombinant. Directly after, patient experienced the unwanted or unexpected Antihemophilic side effects: no therapeutic response. Antihemophilic Factor, Human Recombinant dosage: N/A.


Factor Viii Inhibition, Mass, Wound Secretion, Gastrointestinal Haemorrhage
on Dec 13, 2012 Male from DE , 20 years of age, was diagnosed with and was treated with Antihemophilic Factor Viii (recombinant), Sucrose Formulated. Patient felt the following Antihemophilic side effects: factor viii inhibition, mass, wound secretion, gastrointestinal haemorrhage. Antihemophilic Factor Viii (recombinant), Sucrose Formulated dosage: N/A. Patient was hospitalized.

Hypothermia, Pyrexia, Body Temperature Fluctuation
Patient was taking Antihemophilic Factor (recombinant), Sucrose Formulated Fs. After Antihemophilic was administered, patient encountered several Antihemophilic side effects: hypothermia, pyrexia, body temperature fluctuation on Jan 04, 2013 from GT Additional patient health information: Male , child 6 years of age, . Antihemophilic Factor (recombinant), Sucrose Formulated Fs dosage: Unk. Patient was hospitalized.

Haemorrhage
Adverse event was reported on Nov 13, 2012 by a Male taking Antihemophilic Factor (recombinant) (Dosage: Unk) . Location: KR , child 0 years of age, Directly after, patient experienced the unwanted or unexpected Antihemophilic side effects: haemorrhage.

Contusion
on Nov 28, 2012 Male from RU , child 11 years of age, weighting 55.12 lb, was diagnosed with and was treated with Antihemophilic Factor (recombinant), Sucrose Formulated Fs. Patient felt the following Antihemophilic side effects: contusion. Antihemophilic Factor (recombinant), Sucrose Formulated Fs dosage: 500 Iu Twice A Week. Patient was hospitalized.

Anti Factor Viii Antibody Positive, Muscle Haemorrhage
on Oct 12, 2012 Male from DE , 60 years of age, was diagnosed with and was treated with Antihemophilic Factor Viii (recombinant), Sucrose Formulated. After Antihemophilic was administered, patient encountered several Antihemophilic side effects: anti factor viii antibody positive, muscle haemorrhage. Antihemophilic Factor Viii (recombinant), Sucrose Formulated dosage: 35 Iu/kg, Once. Patient was hospitalized.

Haematoma
Patient was taking Antihemophilic Factor (recombinant), Sucrose Formulated Fs. Directly after, patient experienced the unwanted or unexpected Antihemophilic side effects: haematoma on Nov 26, 2012 from RU Additional patient health information: Male , weighting 44.09 lb, was diagnosed with and. Antihemophilic Factor (recombinant), Sucrose Formulated Fs dosage: Unk.
Associated medications used:
  • Haemoctin Sdh
Patient was hospitalized.

Anti Factor Viii Antibody Positive, Haemarthrosis
Adverse event was reported on Aug 31, 2012 by a Male taking Antihemophilic Factor Viii (recombinant), Sucrose Formulated (Dosage: 50 Iu/kg, Bid) . Location: COUNTRY NOT SPECIFIED , 15 years of age, Patient felt the following Antihemophilic side effects: anti factor viii antibody positive, haemarthrosis.
Multiple prescriptions taken:
  • Vancomycin
  • Amikacin


Cardiovascular Disorder, Nausea, Vertigo
on Jul 23, 2012 Female from DE , 17 years of age, was diagnosed with and was treated with Antihemophilic Factor (human) Nos. After Antihemophilic was administered, patient encountered several Antihemophilic side effects: cardiovascular disorder, nausea, vertigo. Antihemophilic Factor (human) Nos dosage: 2000 Iu Prn Intravenous (not Otherwise Specified). Patient was hospitalized.

Factor Viii Inhibition
on Jun 20, 2012 Male from TURKEY , weighting 24.25 lb, was diagnosed with 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
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 and. Antihemophilic Factor (human) dosage: 2000 Iu Prn Intravenous (not Otherwise Specified). Patient was hospitalized.

Von Willebrand's Disease
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
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
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
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 and. Antihemophilic Factor Nos dosage: 500 Unk, Unk.


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
on Jan 25, 2012 Female from JAPAN , 31 years of age, was diagnosed with 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
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
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
Adverse event was reported on Sep 28, 2011 by a Male taking Antihemophilic Factor (human) (Dosage: Daily Dose 2000 U) was diagnosed with 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
on Jul 27, 2011 Male from UNITED STATES , child 8 years of age, weighting 72.97 lb, was diagnosed with 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
on Jul 27, 2011 Male from UNITED STATES , child 6 years of age, weighting 51.81 lb, was diagnosed with 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.

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It is really important to keep of your symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:

     

    Side Effects

    Scale

    Date & Time

    Other Medicine(s) or Treatment(s)

     

     

     

     

    Scale: 1 = very mild to 10 = very bad


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    Safety Alerts, Active Ingredients, Usage Information

    More About Antihemophilic

    Side Effects reported to FDA: 51

    Antihemophilic safety alerts: 2000

    Reported deaths: 5

    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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