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Antihemophilic Side Effects

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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.

Antihemophilic Side Effects Reported to FDA



Antihemophilic Side Effect Report#9838920
Anti Factor Viii Antibody Positive, Haematemesis, Shock Haemorrhagic, Haematemesis, Hepatic Failure
This is a report of a 56-year-old male patient (weight: NA) from JP, suffering from the following health symptoms/conditions: factor viii deficiency, who was treated with Antihemophilic Factor Viii (recombinant), Sucrose Formulated (dosage: 8000 U, Bolus, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Anti Factor Viii Antibody Positive, Haematemesis, Shock Haemorrhagic, Haematemesis, Hepatic Failure after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Antihemophilic Factor Viii (recombinant), Sucrose Formulated treatment in male patients, resulting in Anti Factor Viii Antibody Positive side effect. The patient was hospitalized.
Antihemophilic Side Effect Report#9541903
Anti Factor Viii Antibody Positive
This report suggests a potential Antihemophilic Factor Viii (recombinant), Sucrose Formulated Anti Factor Viii Antibody Positive side effect(s) that can have serious consequences. A 15-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: immune tolerance induction,factor viii deficiency and used Antihemophilic Factor Viii (recombinant), Sucrose Formulated (dosage: 100 Iu/kg, Qd) starting NS. After starting Antihemophilic Factor Viii (recombinant), Sucrose Formulated the patient began experiencing various side effects, including: Anti Factor Viii Antibody PositiveAdditional drugs used concurrently: NA. Although Antihemophilic Factor Viii (recombinant), Sucrose Formulated demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Anti Factor Viii Antibody Positive, may still occur.
Antihemophilic Side Effect Report#9452262
Hypersensitivity, Feeling Abnormal, Product Quality Issue
This Hypersensitivity problem was reported by a consumer or non-health professional from US. A 32-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Aug 03, 2013 this consumer started treatment with Antihemophilic Factor (dosage: 12,000 Ius Once Daily Into A Vein). The following drugs were being taken at the same time: NA. When using Antihemophilic Factor, the patient experienced the following unwanted symptoms/side effects: Hypersensitivity, Feeling Abnormal, Product Quality IssueAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Hypersensitivity, may become evident only after a product is in use by the general population.
Antihemophilic Side Effect Report#9036864
No Therapeutic Response
This No Therapeutic Response side effect was reported by a physician from US. A 3-year-old male patient (weight:NA) experienced the following symptoms/conditions: factor viii deficiency.The patient was prescribed Antihemophilic Factor, Human Recombinant (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Antihemophilic Factor, Human Recombinant the consumer reported adverse symptoms, such as: No Therapeutic ResponseThese side effects may potentially be related to Antihemophilic Factor, Human Recombinant.
Antihemophilic Side Effect Report#8961554
Factor Viii Inhibition, Mass, Wound Secretion, Gastrointestinal Haemorrhage
This is a report of a 20-year-old male patient (weight: NA) from DE, suffering from the following health symptoms/conditions: hemophilia a,traumatic bleeding, who was treated with Antihemophilic Factor Viii (recombinant), Sucrose Formulated (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Factor Viii Inhibition, Mass, Wound Secretion, Gastrointestinal Haemorrhage after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Antihemophilic Factor Viii (recombinant), Sucrose Formulated treatment in male patients, resulting in Factor Viii Inhibition side effect. The patient was hospitalized.
Antihemophilic Side Effect Report#8956291
Hypothermia, Pyrexia, Body Temperature Fluctuation
This report suggests a potential Antihemophilic Factor (recombinant), Sucrose Formulated Fs Hypothermia side effect(s) that can have serious consequences. A 6-year-old male patient (weight: NA) from GT was diagnosed with the following symptoms/conditions: NA and used Antihemophilic Factor (recombinant), Sucrose Formulated Fs (dosage: Unk) starting NS. After starting Antihemophilic Factor (recombinant), Sucrose Formulated Fs the patient began experiencing various side effects, including: Hypothermia, Pyrexia, Body Temperature FluctuationAdditional drugs used concurrently: NA.The patient was hospitalized. Although Antihemophilic Factor (recombinant), Sucrose Formulated Fs demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hypothermia, may still occur.
Antihemophilic Side Effect Report#8904660
Haemorrhage
This Haemorrhage problem was reported by a health professional from KR. A 0-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On 201209 this consumer started treatment with Antihemophilic Factor (recombinant) (dosage: Unk). The following drugs were being taken at the same time: NA. When using Antihemophilic Factor (recombinant), the patient experienced the following unwanted symptoms/side effects: HaemorrhageAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Haemorrhage, may become evident only after a product is in use by the general population.
Antihemophilic Side Effect Report#8837746
Contusion
This Contusion side effect was reported by a physician from RU. A 11-year-old male patient (weight:NA) experienced the following symptoms/conditions: prophylaxis,hemophilia a.The patient was prescribed Antihemophilic Factor (recombinant), Sucrose Formulated Fs (drug dosage: 500 Iu Twice A Week), which was initiated on
Dec 01, 2008. Concurrently used drugs: NA..After starting to take Antihemophilic Factor (recombinant), Sucrose Formulated Fs the consumer reported adverse symptoms, such as: ContusionThese side effects may potentially be related to Antihemophilic Factor (recombinant), Sucrose Formulated Fs. The patient was hospitalized.
Antihemophilic Side Effect Report#8836983
Anti Factor Viii Antibody Positive, Muscle Haemorrhage
This is a report of a 60-year-old male patient (weight: NA) from DE, suffering from the following health symptoms/conditions: colonoscopy,traumatic haematoma, who was treated with Antihemophilic Factor Viii (recombinant), Sucrose Formulated (dosage: 35 Iu/kg, Once, start time: 201103), combined with: NA. and developed a serious reaction and side effect(s): Anti Factor Viii Antibody Positive, Muscle Haemorrhage after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Antihemophilic Factor Viii (recombinant), Sucrose Formulated treatment in male patients, resulting in Anti Factor Viii Antibody Positive side effect. The patient was hospitalized.
Antihemophilic Side Effect Report#8834546
Haematoma
This report suggests a potential Antihemophilic Factor (recombinant), Sucrose Formulated Fs Haematoma side effect(s) that can have serious consequences. A male patient (weight: NA) from RU was diagnosed with the following symptoms/conditions: hemophilia a and used Antihemophilic Factor (recombinant), Sucrose Formulated Fs (dosage: Unk) starting
Mar 24, 2008. After starting Antihemophilic Factor (recombinant), Sucrose Formulated Fs the patient began experiencing various side effects, including: HaematomaAdditional drugs used concurrently:
  • Haemoctin Sdh
The patient was hospitalized. Although Antihemophilic Factor (recombinant), Sucrose Formulated Fs demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Haematoma, may still occur.
Antihemophilic Side Effect Report#8764298
Anti Factor Viii Antibody Positive, Haemarthrosis
This Anti Factor Viii Antibody Positive problem was reported by a health professional from Country Not Specified. A 15-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Antihemophilic Factor Viii (recombinant), Sucrose Formulated (dosage: 50 Iu/kg, Bid). The following drugs were being taken at the same time:
  • Vancomycin
  • Amikacin
When using Antihemophilic Factor Viii (recombinant), Sucrose Formulated, the patient experienced the following unwanted symptoms/side effects: Anti Factor Viii Antibody Positive, HaemarthrosisAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Anti Factor Viii Antibody Positive, may become evident only after a product is in use by the general population.
Antihemophilic Side Effect Report#8583061
Cardiovascular Disorder, Nausea, Vertigo
This Cardiovascular Disorder side effect was reported by a health professional from DE. A 17-year-old female patient (weight:NA) experienced the following symptoms/conditions: von willebrand^s disease.The patient was prescribed Antihemophilic Factor (human) Nos (drug dosage: 2000 Iu Prn Intravenous (not Otherwise Specified)), which was initiated on NS. Concurrently used drugs: NA..After starting to take Antihemophilic Factor (human) Nos the consumer reported adverse symptoms, such as: Cardiovascular Disorder, Nausea, VertigoThese side effects may potentially be related to Antihemophilic Factor (human) Nos. The patient was hospitalized.
Antihemophilic Side Effect Report#8463875-5
Factor Viii Inhibition
This is a report of a male patient (weight: NA) from Turkey, suffering from the following health symptoms/conditions: factor viii deficiency, who was treated with Antihemophilic Factor (human) (dosage: 500 Iu, Weekly, start time:
Sep 19, 2011), combined with: NA. and developed a serious reaction and side effect(s): Factor Viii Inhibition after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Antihemophilic Factor (human) treatment in male patients, resulting in Factor Viii Inhibition side effect.
Antihemophilic Side Effect Report#8381088-2
Nausea, Vertigo, Peripheral Vascular Disorder
This report suggests a potential Antihemophilic Factor (human) Nausea side effect(s) that can have serious consequences. A 17-year-old female patient (weight: NA) from Germany was diagnosed with the following symptoms/conditions: von willebrand's disease and used Antihemophilic Factor (human) (dosage: 2000 Iu Prn Intravenous (not Otherwise Specified)) starting NS. After starting Antihemophilic Factor (human) the patient began experiencing various side effects, including: Nausea, Vertigo, Peripheral Vascular DisorderAdditional drugs used concurrently: NA.The patient was hospitalized. Although Antihemophilic Factor (human) demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Nausea, may still occur.
Antihemophilic Side Effect Report#8255192-3
Von Willebrand's Disease
This Von Willebrand's Disease problem was reported by a physician from Japan. A female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Antihemophilic Factor (human) (dosage: NA). The following drugs were being taken at the same time: NA. When using Antihemophilic Factor (human), the patient experienced the following unwanted symptoms/side effects: Von Willebrand's DiseaseAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Von Willebrand's Disease, may become evident only after a product is in use by the general population.
Antihemophilic Side Effect Report#8229029-2
Von Willebrand's Disease
This Von Willebrand's Disease side effect was reported by a physician from Japan. A female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Antihemophilic Factor (human) (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Antihemophilic Factor (human) the consumer reported adverse symptoms, such as: Von Willebrand's DiseaseThese side effects may potentially be related to Antihemophilic Factor (human).
Antihemophilic Side Effect Report#8214911-2
Caesarean Section, Maternal Exposure During Pregnancy
This is a report of a 34-year-old female patient (weight: NA) from Japan, suffering from the following health symptoms/conditions: NA, who was treated with Antihemophilic Factor (human) (dosage: Unk, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Caesarean Section, Maternal Exposure During Pregnancy after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Antihemophilic Factor (human) treatment in female patients, resulting in Caesarean Section side effect.
Antihemophilic Side Effect Report#8139322-X
Factor Viii Inhibition
This report suggests a potential Antihemophilic Factor Nos Factor Viii Inhibition side effect(s) that can have serious consequences. A male patient (weight: NA) from Turkey was diagnosed with the following symptoms/conditions: factor viii deficiency and used Antihemophilic Factor Nos (dosage: 500 Unk, Unk) starting
Jan 09, 2012. After starting Antihemophilic Factor Nos the patient began experiencing various side effects, including: Factor Viii InhibitionAdditional drugs used concurrently: NA. Although Antihemophilic Factor Nos demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Factor Viii Inhibition, may still occur.
Antihemophilic Side Effect Report#8104591-9
This Death problem was reported by a consumer or non-health professional from United States. A 49-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Antihemophilic Factor Nos (dosage: NA). The following drugs were being taken at the same time: NA. When using Antihemophilic Factor Nos, the patient experienced the following unwanted symptoms/side effects:Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Death, may become evident only after a product is in use by the general population.
Antihemophilic Side Effect Report#8104002-3
Maternal Exposure During Pregnancy, Caesarean Section, No Adverse Event
This Maternal Exposure During Pregnancy side effect was reported by a physician from Japan. A 31-year-old female patient (weight:NA) experienced the following symptoms/conditions: factor viii deficiency,factor v deficiency.The patient was prescribed Antihemophilic Factor Viii (recombinant), Sucrose Formulated (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Antihemophilic Factor Viii (recombinant), Sucrose Formulated the consumer reported adverse symptoms, such as: Maternal Exposure During Pregnancy, Caesarean Section, No Adverse EventThese side effects may potentially be related to Antihemophilic Factor Viii (recombinant), Sucrose Formulated.
Antihemophilic Side Effect Report#7941856-5
Alanine Aminotransferase Increased, Anti Factor Viii Antibody Positive, Streptococcus Test Positive, Complement Factor C3 Decreased, Tachypnoea, Glomerulonephritis Rapidly Progressive, Lung Infiltration, Abdominal Distension
This is a report of a 9-year-old male patient (weight: NA) from United States, suffering from the following health symptoms/conditions: NA, who was treated with Antihemophilic Factor (human) (dosage: 8 Iu/kg, Q1hr, During Hospital Admission, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Alanine Aminotransferase Increased, Anti Factor Viii Antibody Positive, Streptococcus Test Positive, Complement Factor C3 Decreased, Tachypnoea, Glomerulonephritis Rapidly Progressive, Lung Infiltration, Abdominal Distension after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Antihemophilic Factor (human) treatment in male patients, resulting in Alanine Aminotransferase Increased side effect.
Antihemophilic Side Effect Report#7937989-X
Factor Viii Inhibition
This report suggests a potential Antihemophilic Factor (human) Factor Viii Inhibition side effect(s) that can have serious consequences. A male patient (weight: NA) from Germany was diagnosed with the following symptoms/conditions: NA and used Antihemophilic Factor (human) (dosage: 1250 Iu, 2x/day) starting
Jul 16, 2010. After starting Antihemophilic Factor (human) the patient began experiencing various side effects, including: Factor Viii InhibitionAdditional drugs used concurrently: NA.The patient was hospitalized. Although Antihemophilic Factor (human) demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Factor Viii Inhibition, may still occur.
Antihemophilic Side Effect Report#7799222-1
Renal Impairment
This Renal Impairment problem was reported by a physician from Japan. A 42-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: factor viii deficiency. On NS this consumer started treatment with Antihemophilic Factor (human) (dosage: Daily Dose 2000 U). The following drugs were being taken at the same time:
  • Nafamostat (Unk)
When using Antihemophilic Factor (human), the patient experienced the following unwanted symptoms/side effects: Renal ImpairmentAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Renal Impairment, may become evident only after a product is in use by the general population.
Antihemophilic Side Effect Report#7646789-X
Haemorrhagic Diathesis, Therapeutic Response Decreased
This Haemorrhagic Diathesis side effect was reported by a physician from United States. A 8-year-old male patient (weight:NA) experienced the following symptoms/conditions: factor viii deficiency.The patient was prescribed Antihemophilic Factor (recombinant), Sucrose Formulated Fs (drug dosage: 40 Iu/kg, Qod), which was initiated on NS. Concurrently used drugs: NA..After starting to take Antihemophilic Factor (recombinant), Sucrose Formulated Fs the consumer reported adverse symptoms, such as: Haemorrhagic Diathesis, Therapeutic Response DecreasedThese side effects may potentially be related to Antihemophilic Factor (recombinant), Sucrose Formulated Fs.
Antihemophilic Side Effect Report#7646788-8
Haemorrhage, Therapeutic Response Decreased
This is a report of a 6-year-old male patient (weight: NA) from United States, suffering from the following health symptoms/conditions: factor viii deficiency, who was treated with Antihemophilic Factor (recombinant), Sucrose Formulated Fs (dosage: 50 Iu/kg, Qod, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Haemorrhage, Therapeutic Response Decreased after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Antihemophilic Factor (recombinant), Sucrose Formulated Fs treatment in male patients, resulting in Haemorrhage side effect.


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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.

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    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    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.

    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 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.

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    Antihemophilic 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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