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Hepatitis Side Effects

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Common Hepatitis Side Effects


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

Anaemia (3)
Rash (2)
Urticaria (2)
Hypersensitivity (2)
Dermatitis Diaper (1)
Anaemia Of Pregnancy (1)
Diarrhoea (1)
Myofascitis (1)
Muscle Disorder (1)
Arthralgia (1)
Oxygen Saturation Decreased (1)
Post Procedural Complication (1)
Cognitive Disorder (1)
Death (1)
Tachycardia (1)
Cyanosis (1)
Cough (1)
Cholestasis Of Pregnancy (1)
Complications Of Transplanted Liver (1)
Asthenia (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.

Hepatitis Side Effects Reported to FDA



Hepatitis Side Effect Report#9276404
Anaemia, Rash, Live Birth, Exposure During Pregnancy, Maternal Exposure Before Pregnancy, Anaemia Of Pregnancy
This is a report of a 26-year-old female patient (weight: NA) from GB, suffering from the following health symptoms/conditions: prophylaxis, who was treated with Hepatitis A Vaccine Nos (dosage: 1inj Single Dose, start time: 201007), combined with:
  • Tetanus Vaccine (1inj Single Dose)
and developed a serious reaction and side effect(s): Anaemia, Rash, Live Birth, Exposure During Pregnancy, Maternal Exposure Before Pregnancy, Anaemia Of Pregnancy after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Hepatitis A Vaccine Nos treatment in female patients, resulting in Anaemia side effect.
Hepatitis Side Effect Report#7647118-8
Dermatitis Diaper, Testicular Haemorrhage, Diarrhoea
This report suggests a potential Hepatitis B Vaccine Death side effect(s) that can have serious consequences. A male patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: NA and used Hepatitis B Vaccine (dosage: NA) starting
Feb 18, 2011. After starting Hepatitis B Vaccine the patient began experiencing various side effects, including: Dermatitis Diaper, Testicular Haemorrhage, DiarrhoeaAdditional drugs used concurrently:
  • Polio Vaccine
Although Hepatitis B Vaccine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Death, may still occur.
Hepatitis Side Effect Report#7318051-6
Cyanosis
This Cyanosis problem was reported by a consumer or non-health professional from United States. A male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Jan 27, 2009 this consumer started treatment with Hepatitis B Vaccine (dosage: NA). The following drugs were being taken at the same time:
  • Tysabri
  • Poly-vi-sol
When using Hepatitis B Vaccine, the patient experienced the following unwanted symptoms/side effects: CyanosisThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Cyanosis, may become evident only after a product is in use by the general population.
Hepatitis Side Effect Report#7227158-3
Cholestasis Of Pregnancy
This Cholestasis Of Pregnancy side effect was reported by a physician from France. A 26-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Hepatitis B Vaccine (drug dosage: NA), which was initiated on
Feb 20, 1996. Concurrently used drugs:
  • Yellow Fever Vaccine
  • Paludrine
  • Chloroquine Phosphate
  • Typhim Vi
  • Duphaston
  • Lariam (Frequency: Weekly)
  • Havrix
.After starting to take Hepatitis B Vaccine the consumer reported adverse symptoms, such as: Cholestasis Of PregnancyThese side effects may potentially be related to Hepatitis B Vaccine.
Hepatitis Side Effect Report#7072931-8
Hypersensitivity, Urticaria
This is a report of a 12-year-old female patient (weight: NA) from United States, suffering from the following health symptoms/conditions: prophylaxis, who was treated with Hepatitis A Vaccine (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Hypersensitivity, Urticaria after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Hepatitis A Vaccine treatment in female patients, resulting in Hypersensitivity side effect.
Hepatitis Side Effect Report#6817489-0
Anaemia, Rash
This report suggests a potential Hepatitis A Vaccine Anaemia side effect(s) that can have serious consequences. A female patient (weight: NA) from United Kingdom was diagnosed with the following symptoms/conditions: prophylaxis and used Hepatitis A Vaccine (dosage: NA) starting
Feb 17, 2010. After starting Hepatitis A Vaccine the patient began experiencing various side effects, including: Anaemia, RashAdditional drugs used concurrently:
  • Tetanus Vaccine
Although Hepatitis A Vaccine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Anaemia, may still occur.
Hepatitis Side Effect Report#6744118-7
Anaemia
This Anaemia problem was reported by a physician from United Kingdom. A female patient (weight: NA) was diagnosed with the following symptoms/conditions: prophylaxis. On
Feb 17, 2010 this consumer started treatment with Hepatitis A Vaccine (dosage: NA). The following drugs were being taken at the same time:
  • Tetanus Vaccine
When using Hepatitis A Vaccine, the patient experienced the following unwanted symptoms/side effects: AnaemiaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Anaemia, may become evident only after a product is in use by the general population.
Hepatitis Side Effect Report#6446592-2
Arthralgia, Asthenia, Cognitive Disorder, Muscle Disorder, Myofascitis
This Arthralgia side effect was reported by a health professional from France. A 43-year-old female patient (weight:NA) experienced the following symptoms/conditions: prophylaxis.The patient was prescribed Hepatitis B Vaccine (drug dosage: NA), which was initiated on
Jan 01, 1989. Concurrently used drugs:
  • Modafinil
.After starting to take Hepatitis B Vaccine the consumer reported adverse symptoms, such as: Arthralgia, Asthenia, Cognitive Disorder, Muscle Disorder, MyofascitisThese side effects may potentially be related to Hepatitis B Vaccine.
Hepatitis Side Effect Report#6220305-1
Hepatitis C Antibody Positive
This is a report of a 55-year-old male patient (weight: NA) from Canada, suffering from the following health symptoms/conditions: liver disorder, who was treated with Hepatitis B Immune Globulin (human) (dosage: 10 Ml; Total; Iv, start time:
Jul 15, 2005), combined with:
  • Albumin 25% Cbs/hq - Telcris (albumin (human)) (25 Pct) (2400 Ml; Total; Iv)
  • Blood Transfusion, Auxiliary Products (blood Transfusion, Auxiliary Pr
  • Blood Transfusion, Auxiliary Products (blood Transfusion, Auxiliary Pr
and developed a serious reaction and side effect(s): Hepatitis C Antibody Positive after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Hepatitis B Immune Globulin (human) treatment in male patients, resulting in Hepatitis C Antibody Positive side effect.
Hepatitis Side Effect Report#6220304-X
Cough, Dyspnoea, Erythema, Face Oedema, Hypersensitivity, Oxygen Saturation Decreased, Tachycardia, Urticaria
This report suggests a potential Hepatitis B Immune Globulin (human) Cough side effect(s) that can have serious consequences. A 23-year-old female patient (weight: NA) from Canada was diagnosed with the following symptoms/conditions: antiviral prophylaxis and used Hepatitis B Immune Globulin (human) (dosage: 3.48 Ml; Total; Im) starting
Jan 28, 2007. After starting Hepatitis B Immune Globulin (human) the patient began experiencing various side effects, including: Cough, Dyspnoea, Erythema, Face Oedema, Hypersensitivity, Oxygen Saturation Decreased, Tachycardia, UrticariaAdditional drugs used concurrently:
  • Antidepressants
  • Muscle Relaxants
Although Hepatitis B Immune Globulin (human) demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Cough, may still occur.
Hepatitis Side Effect Report#5408004-7
Complications Of Transplanted Liver, Hepatitis C, Liver Transplant, Post Procedural Complication
This Complications Of Transplanted Liver problem was reported by a consumer or non-health professional from Canada. A 55-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: liver disorder. On
Jul 15, 2005 this consumer started treatment with Hepatitis B Immune Globulin (human) (dosage: 10 Ml; Total; Iv). The following drugs were being taken at the same time:
  • Albuminar-25 (2400 Ml; Total; Iv)
  • Blood Transfusion, Auxiliary Products (blood Transfusion, Auxiliary Pr (Iv)
  • Blood Transfusion, Auxiliary Products (blood Transfusion, Auxiliary Pr
When using Hepatitis B Immune Globulin (human), the patient experienced the following unwanted symptoms/side effects: Complications Of Transplanted Liver, Hepatitis C, Liver Transplant, Post Procedural ComplicationAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Complications Of Transplanted Liver, may become evident only after a product is in use by the general population.



The appearance of Hepatitis 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.

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health 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

    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.

    Hepatitis 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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    Hepatitis Safety Alerts, Active Ingredients, Usage Information

    NDC43772-0029
    TypeHUMAN OTC DRUG
    Proprietary NameHEPATITIS-SODE Triticum Aestivum, Berberis Vulgaris, Chelidonium Majus, Taraxacum Officinale, Arsenicum Album, Glut
    NameLIQUID
    Dosage FormORAL
    Route20150119
    On market sinceSynergy Formulas, Inc.
    LabelerARSENIC TRIOXIDE; BERBERIS VULGARIS ROOT BARK; CHELIDONIUM MAJUS; CHELONE GLABRA; GERMANIUM SESQUIOX
    Active Ingredient(s)6; 3; 3; 6; 8; 6; 18; 33; 18; 6; 6; 6; 6; 3; 1
    Strength(s)[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [
    Unit(s)
    Pharma Class

    More About Hepatitis

    Side Effects reported to FDA: 11

    Hepatitis safety alerts: 2014 2012 2001

    Reported deaths: 1

    Reported hospitalizations: 1

    Statins and HIV or Hepatitis C Drugs: Drug Safety Communication - Interaction Increases Risk of Muscle Injury

    [Posted 03/01/2012]

    AUDIENCEInfectious Disease, Family Practice, Patients

    ISSUE: FDA notified healthcare professionals  of updates to the prescribing information concerning interactions between  protease inhibitors and certain statin  drugs. Protease inhibitors and statins taken together may raise the blood levels of statins and increase the risk for muscle injury (myopathy). The most serious form of myopathy, called rhabdomyolysis, can damage the kidneys and lead to kidney failure, which can be fatal.

    BACKGROUND: Statins are a class of prescription drugs used together with diet and exercise to reduce blood levels of low-density lipoprotein (LDL) cholesterol (“bad cholesterol”). HIV protease inhibitors are a class of prescription anti-viral drugs used to treat HIV. HCV protease inhibitors are a class of prescription anti-viral drugs used to treat hepatitis C infection.

    RECOMMENDATION: Healthcare professionals should follow the recommendations in the  prescribing information ( drug labels )  when prescribing HIV or HCV protease inhibitors with statins. See the FDA Drug Safety Communication for additional information, including a data summary.

    Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

    • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
    • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
     
    [03/01/2012 - Drug Safety Communication - FDA]

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