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Twinrix Side Effects

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Common Twinrix Side Effects


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

Headache (4)
Hepatic Steatosis (3)
Hepatomegaly (3)
Blood Triglycerides Increased (3)
Chills (2)
Cerebrovascular Accident (2)
Grand Mal Convulsion (2)
Fatigue (2)
Oedema Peripheral (2)
Subdural Haematoma (2)
Underdose (2)
Pyrexia (2)
Overdose (1)
Pruritus (1)
Nausea (1)
Rash (1)
Live Birth (1)
Jaundice (1)
Malaria (1)
Mitochondrial Myopathy (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.

Twinrix Side Effects Reported to FDA



Twinrix Side Effect Report#8445409-4
Cardiac Arrest
This is a report of a 50-year-old female patient (weight: NA) from Norway, suffering from the following health symptoms/conditions: immunisation,prophylaxis, who was treated with Twinrix (dosage: Single Dose, start time:
Jun 21, 2011), combined with:
  • Zithromax (500 Mg, 1x/day For 3 Days)
and developed a serious reaction and side effect(s): Cardiac Arrest after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Twinrix treatment in female patients, resulting in Cardiac Arrest side effect. The patient was hospitalized and became disabled.
Twinrix Side Effect Report#7562713-2
Jaundice, Bronchitis, Vomiting, Hepatosplenomegaly, Brain Oedema, Malaria, Asthenia, Cholestasis, Nausea
This report suggests a potential Twinrix Injection (twinrix) Jaundice side effect(s) that can have serious consequences. A 32-year-old female patient (weight: NA) from Czech Republic was diagnosed with the following symptoms/conditions: prophylaxis and used Twinrix Injection (twinrix) (dosage: Single Dose) starting NS. After starting Twinrix Injection (twinrix) the patient began experiencing various side effects, including: Jaundice, Bronchitis, Vomiting, Hepatosplenomegaly, Brain Oedema, Malaria, Asthenia, Cholestasis, NauseaAdditional drugs used concurrently:
  • Yellow Fever Vac (nongsk) Injection (yellow Fever Vac (nongsk)) (Single Dose)
  • Atovaquone/proguanil Hydrochloride
  • Berodual
The patient was hospitalized. Although Twinrix Injection (twinrix) demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Jaundice, may still occur.
Twinrix Side Effect Report#6581513-3
Mitochondrial Myopathy, Rhabdomyolysis
This Mitochondrial Myopathy problem was reported by a pharmacist from Germany. A 33-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: prophylaxis. On
Aug 01, 2009 this consumer started treatment with Twinrix (dosage: NA). The following drugs were being taken at the same time:
  • Malarone
When using Twinrix, the patient experienced the following unwanted symptoms/side effects: Mitochondrial Myopathy, RhabdomyolysisAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Mitochondrial Myopathy, may become evident only after a product is in use by the general population.
Twinrix Side Effect Report#6423466-4
Anaemia Postoperative, Beta Haemolytic Streptococcal Infection, Live Birth
This Anaemia Postoperative side effect was reported by a health professional from Germany. A female patient (weight:NA) experienced the following symptoms/conditions: prophylaxis.The patient was prescribed Twinrix (drug dosage: 1ml Single Dose), which was initiated on
Dec 04, 2008. Concurrently used drugs:
  • Kaletra
  • Combivir
  • Retrovir
  • Fraxiparin
.After starting to take Twinrix the consumer reported adverse symptoms, such as: Anaemia Postoperative, Beta Haemolytic Streptococcal Infection, Live BirthThese side effects may potentially be related to Twinrix.
Twinrix Side Effect Report#6361320-7
Cerebrovascular Accident, Chills, Fatigue, Headache, Subdural Haematoma
This is a report of a 70-year-old male patient (weight: NA) from United States, suffering from the following health symptoms/conditions: prophylaxis, who was treated with Twinrix (dosage: NA, start time:
Jul 23, 2007), combined with:
  • Coreg (3.25mg Twice Per Day)
  • Warfarin Sodium
  • Coumadin
  • Prinivil
  • Ascorbic Acid
and developed a serious reaction and side effect(s): Cerebrovascular Accident, Chills, Fatigue, Headache, Subdural Haematoma after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Twinrix treatment in male patients, resulting in Cerebrovascular Accident side effect. The patient was hospitalized.
Twinrix Side Effect Report#6273749-6
Cerebrovascular Accident, Chills, Fatigue, Headache, Subdural Haematoma
This report suggests a potential Twinrix Cerebrovascular Accident side effect(s) that can have serious consequences. A 70-year-old male patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: prophylaxis and used Twinrix (dosage: NA) starting
Jul 23, 2007. After starting Twinrix the patient began experiencing various side effects, including: Cerebrovascular Accident, Chills, Fatigue, Headache, Subdural HaematomaAdditional drugs used concurrently:
  • Coreg (3.25mg Twice Per Day)
  • Coumadin
  • Prinivil
  • Ascorbic Acid
The patient was hospitalized. Although Twinrix demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Cerebrovascular Accident, may still occur.
Twinrix Side Effect Report#6035944-0
Grand Mal Convulsion, Headache, Injection Site Reaction, Injection Site Swelling, Injection Site Warmth, Oedema Peripheral, Pyrexia, Underdose
This Grand Mal Convulsion problem was reported by a physician from Germany. A 28-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: prophylaxis,epilepsy. On
Oct 01, 2008 this consumer started treatment with Twinrix Adult (dosage: 1ml Single Dose). The following drugs were being taken at the same time:
  • Lamictal (100mg Twice Per Day)
  • Vitamin B-12
When using Twinrix Adult, the patient experienced the following unwanted symptoms/side effects: Grand Mal Convulsion, Headache, Injection Site Reaction, Injection Site Swelling, Injection Site Warmth, Oedema Peripheral, Pyrexia, UnderdoseAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Grand Mal Convulsion, may become evident only after a product is in use by the general population.
Twinrix Side Effect Report#6021422-1
Grand Mal Convulsion, Headache, Oedema Peripheral, Pyrexia, Underdose
This Grand Mal Convulsion side effect was reported by a consumer or non-health professional from Germany. A 28-year-old female patient (weight:NA) experienced the following symptoms/conditions: prophylaxis,epilepsy.The patient was prescribed Twinrix Adult (drug dosage: 1ml Single Dose), which was initiated on
Oct 01, 2008. Concurrently used drugs:
  • Lamictal (100mg Twice Per Day)
  • Vitamin B-12
.After starting to take Twinrix Adult the consumer reported adverse symptoms, such as: Grand Mal Convulsion, Headache, Oedema Peripheral, Pyrexia, UnderdoseThese side effects may potentially be related to Twinrix Adult.
Twinrix Side Effect Report#5731865-9
Overdose, Suicide Attempt
This is a report of a 44-year-old male patient (weight: NA) from Germany, suffering from the following health symptoms/conditions: prophylaxis, who was treated with Twinrix (dosage: NA, start time:
May 02, 2008), combined with:
  • Aerius (100mg Per Day)
  • Decortin (200mg Per Day)
  • Dulcolax
  • Ketotifen Fumarate (20mg Per Day)
  • Acetaminophen (15000mg Per Day)
and developed a serious reaction and side effect(s): Overdose, Suicide Attempt after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Twinrix treatment in male patients, resulting in Overdose side effect.
Twinrix Side Effect Report#4944282-6
Blood Triglycerides Increased, Hepatic Steatosis, Hepatomegaly
This report suggests a potential Twinrix Blood Triglycerides Increased side effect(s) that can have serious consequences. A 29-year-old male patient (weight: NA) from Spain was diagnosed with the following symptoms/conditions: prophylaxis and used Twinrix (dosage: NA) starting
Jul 01, 2005. After starting Twinrix the patient began experiencing various side effects, including: Blood Triglycerides Increased, Hepatic Steatosis, HepatomegalyAdditional drugs used concurrently:
  • Malarone
Although Twinrix demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Blood Triglycerides Increased, may still occur.
Twinrix Side Effect Report#4920298-0
Hepatic Enzyme Increased, Pruritus, Rash
This Hepatic Enzyme Increased problem was reported by a physician from Germany. A 59-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: prophylaxis,bronchitis. On
Jun 01, 2005 this consumer started treatment with Twinrix Adult (dosage: NA). The following drugs were being taken at the same time:
  • Amoxicillin (700mg Three Times Per Day)
  • Sortis
When using Twinrix Adult, the patient experienced the following unwanted symptoms/side effects: Hepatic Enzyme Increased, Pruritus, RashAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Hepatic Enzyme Increased, may become evident only after a product is in use by the general population.
Twinrix Side Effect Report#4889630-0
Blood Triglycerides Increased, Hepatic Steatosis, Hepatomegaly
This Blood Triglycerides Increased side effect was reported by a pharmacist from Spain. A 29-year-old male patient (weight:NA) experienced the following symptoms/conditions: prophylaxis.The patient was prescribed Twinrix (drug dosage: NA), which was initiated on
Jul 01, 2005. Concurrently used drugs:
  • Malarone
.After starting to take Twinrix the consumer reported adverse symptoms, such as: Blood Triglycerides Increased, Hepatic Steatosis, HepatomegalyThese side effects may potentially be related to Twinrix.
Twinrix Side Effect Report#4881528-7
Blood Triglycerides Increased, Hepatic Steatosis, Hepatomegaly
This is a report of a 29-year-old male patient (weight: NA) from Spain, suffering from the following health symptoms/conditions: prophylaxis, who was treated with Twinrix (dosage: NA, start time:
Jul 01, 2005), combined with:
  • Malarone
and developed a serious reaction and side effect(s): Blood Triglycerides Increased, Hepatic Steatosis, Hepatomegaly after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Twinrix treatment in male patients, resulting in Blood Triglycerides Increased side effect.



The appearance of Twinrix 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.

    Twinrix 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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    Twinrix Safety Alerts, Active Ingredients, Usage Information

    NDC58160-815
    TypeVACCINE
    Proprietary NameTWINRIX
    NameHepatitis A and Hepatitis B (Recombinant) Vaccine
    Dosage FormINJECTION, SUSPENSION
    RouteINTRAMUSCULAR
    On market since20070607
    LabelerGlaxoSmithKline Biologicals SA
    Active Ingredient(s)HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED); HEPATITIS B VIRUS SUBTYPE ADW2 HB
    Strength(s)720; 20
    Unit(s)[iU]/mL; ug/mL
    Pharma ClassInactivated Hepatitis A Virus Vaccine [EPC],Actively Acquired Immunity [PE],Hepatitis A Vaccines [Ch

    More About Twinrix

    Side Effects reported to FDA: 13

    Twinrix safety alerts: No

    Reported deaths: 2

    Reported hospitalizations: 5

    Latest Twinrix clinical trials