Adverse reactions : תופעות לוואי

4.8   Undesirable effects
Summary of the safety profile


The safety profile presented below is based on data from 5329 subjects followed in 23 studies.


The current formulation of Engerix B does not contain thiomersal (an organomercuric compound). The following undesirable effects have been reported following the use of the thiomersal containing formulations as well as the thiomersal free formulation.


In one clinical study conducted in adults with the current formulation (thiomersal free formulation), the incidence of pain, redness, swelling, fatigue, gastro-enteritis, headache and fever was comparable to the incidence observed in the clinical studies conducted with former thiomersal containing vaccine formulations.

In one clinical study conducted in children with the current formulation (thiomersal free formulation), the incidence of pain, redness, swelling, drowsiness, irritability, loss of appetite and fever was comparable to the incidence observed in the clinical studies conducted with former thiomersal containing vaccine formulations.

Tabulated summary of adverse reactions

Frequencies per dose are defined as follows:

Very common: >1/10
Common:     >1/100 to <1/10
Uncommon: >1/1000 to <1/100
Rare;       >1/10,000 to <1/1000
Very rare:  1/10,000

System Organ Class                        Frequency      Adverse reactions Clinical trials
Blood and lymphatic system                Rare           Lymphadenopathy disorders
Metabolism and nutrition disorders        Common         Appetite lost Psychiatric disorders                     Very           Irritability common
Nervous system disorders                  Very           Headache (paediatric use) common
Common         Drowsiness, headache (adult use)
Uncommon       Dizziness
Rare           Paraesthesia
Gastrointestinal disorders                Common         Gastrointestinal symptoms (such as nausea, vomiting, diarrhoea,
abdominal pain)
Skin and subcutaneous tissue              Rare           Urticaria, pruritus, rash disorders
Musculoskeletal and connective            Uncommon       Myalgia tissue disorders
Rare           Arthralgia

General disorders and administration   Very           Pain and redness at injection site, site conditions                        common         fatigue
Common         Fever (37.5°C), malaise, swelling at injection site, injection site reaction (such as induration)
Uncommon       Influenza-like illness
Post-marketing surveillance
Infections and infestations            Not known      Meningitis
(cannot be estimated from the available data)

Blood and lymphatic system             Not known      Thrombocytopenia disorders                              (cannot be estimated from the available data)
Immune system disorders                Not known      Anaphylaxis, allergic reactions (cannot be     including anaphylactoid reactions estimated      and mimicking serum sickness from the available data)
Nervous system disorders               Not known      Encephalitis, encephalopathy, (cannot be     convulsions, paralysis, neuritis estimated      (including Guillain-Barré from the       syndrome, optic neuritis and available      multiple sclerosis), neuropathy,
data)          hypoaesthesia
Vascular disorders                     Not known      Vasculitis, hypotension (cannot be estimated from the available data)
Respiratory thoracic and mediastinal   Not known      Apnoea in very premature infants disorders                              (cannot be     (≤ 28 weeks of gestation) (see estimated      section 4.4) from the available data)
Skin and subcutaneous tissue           Not known      Erythema multiforme, disorders                              (cannot be     angioneurotic oedema, lichen estimated      planus from the


available data)
Musculoskeletal and connective        Not known       Arthritis, muscular weakness tissue disorders                      (cannot be estimated from the available data)


In a comparative trial in subjects from 11 years up to and including 15 years of age, the incidence of local and general solicited symptoms reported after a two-dose regimen of Engerix B 20 µg/1 ml was similar overall to that reported after the standard three-dose regimen of Engerix B 10 µg/0.5 ml.

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il.
Additionally, you should also report to GSK Israel (il.safety@gsk.com)