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Adverse reactions reported are listed according to the following frequency: Very common: ≥ 1/10; Common: ≥ 1/100 and <1/10; Uncommon: ≥ 1/1000 and <1/100; Rare: ≥ 1/10000 and <1/1000; Very rare: < 1/10000.
Clinical trial data: Adults and adolescents of 16 years of age and above: The safety profile presented as follows is based on data from more than 6,000 subjects who received either the standard 0, 1, 6 month schedule or the accelerated 0, 7, 21 days schedule. In a comparative study it was noted that the frequency of solicited adverse events following the administration of Twinrix is not different from the frequency of solicited adverse events following the administration of the monovalent vaccines.
Infections and infestations: Uncommon: upper respiratory tract infection.
Blood and lymphatic system disorders: Rare: lymphadenopathy.
Metabolism and nutrition disorders: Rare: decreased appetite.
Nervous system disorders: Very common: headache. Uncommon: dizziness. Rare: hypoaesthesia, paraesthesia.
Vascular disorders: Rare: hypotension.
Gastrointestinal disorders: Common: gastrointestinal symptoms (such as diarrhoea, nausea, vomiting).
Skin and subcutaneous tissue disorders: Rare: rash, pruritus. Very rare: urticaria.
Musculoskeletal and connective tissue disorders: Uncommon: myalgia. Rare: arthralgia.
General disorders and administration site conditions: Very common: pain and redness at the injection site, fatigue. Common: swelling at the injection site, injection site reaction, malaise. Uncommon: fever (≥37.5°C). Rare: influenza like illness, chills.
In a clinical trial where Twinrix was administered at 0, 7, 21 days, solicited general symptoms were reported with the same categories of frequency as defined previously. After a fourth dose given at month 12, the incidence of systemic adverse reactions was comparable to that seen after vaccination at 0, 7, 21 days.
Children and adolescents of 1 to 15 years of age inclusive: Clinical trials involved the administration of 1537 doses of Twinrix as a two doses schedule to 778 subjects from 1 year up to and including 15 years of age.
Nervous system disorders: Very common: headache. Common: drowsiness.
Gastrointestinal disorders: Common: gastrointestinal symptoms.
Metabolism and nutrition disorders: Very common: appetite lost.
General disorders and administration site conditions: Very common: fatigue, pain and redness at the injection site. Common: fever, swelling at the injection site.
Psychiatric disorders: Very common: irritability.
Post marketing data: Adults and adolescents of 16 years of age and above: The following adverse reactions have been reported with either Twinrix (given as a 0, 1, 6 month schedule or a 0, 7, 21 days schedule) or with GlaxoSmithKline monovalent hepatitis A or B vaccines.
Infections and infestations: Meningitis.
Blood and lymphatic system disorders: Thrombocytopenia, thrombocytopenic purpura.
Immune system disorders: Anaphylaxis, allergic reactions including anaphylactoid reactions and mimicking serum sickness.
Nervous system disorders: Encephalitis, encephalopathy, neuritis, neuropathy, paralysis, convulsions.
Vascular disorders: Vasculitis.
Skin and subcutaneous tissue disorders: Angioneurotic oedema, lichen planus, erythema multiforme.
Musculoskeletal and connective tissue disorders: Arthritis, muscular weakness.
General disorders and administration site conditions: Immediate injection site pain, stinging and burning sensation.
Children and adolescents of 1 to 15 years of age inclusive: The following adverse reactions were reported during the post-marketing surveillance following vaccination with Twinrix given as a 2 dose schedule.
Immune system disorders: Very rare: allergic reactions including anaphylactic and anaphylactoid reactions.
Nervous system disorders: Very rare: syncope or vasovagal responses to injection, hypoesthesia.
General disorders and administration site conditions: Immediate injection site pain, stinging and burning sensation.
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