Adverse reactions : תופעות לוואי

4.8. Undesirable effects


Data from large clinical studies were used to determine the frequency of adverse reactions classified as very common to rare. The frequencies assigned to all other reactions (i.e. those occurring in < 1/1000) were mainly determined using post-marketing data and refer to a reporting rate rather than a true frequency.

The following convention (or agreement) has been used for the classification of frequency: Very common            ≥1/10
Common                 ≥1/100 and <1/10
Uncommon               ≥ 1/1000 and < 1/100
Rare                   ≥ 1/10,000 and < 1/1000
Very rare              < 1/10,000


Use in systemic helminth infections:
Blood and lymphatic system disorders
Uncommon:            leukopenia
Very rare:           pancytopenia, aplastic anemia, agranulocytosis

Leukopenia has been associated with albendazole when treating patients with echinococcosis.

Patients with hepatic disease, including hepatic echinococcosis, appear to be more susceptible to bone marrow suppression (see sections 4.2 and 4.8).

Immune system disorders
Uncommon:           hypersensitivity reactions including rash, pruritus and urticaria 
Nervous system disorders
Very common: headache
Common:              dizziness

Gastrointestinal disorders
Common:                gastrointestinal disturbances (abdominal pain, nausea, vomiting) 
Gastrointestinal disturbances have been associated with albendazole when treating patients with echinococcosis.

Hepatobiliary disorders
Very common:          mild to moderate elevation of hepatic enzymes.
Uncommon:             hepatitis

Skin and subcutaneous tissue disorders
Common:              reversible alopecia (thinning of hair and moderate hair loss) Very rare:           erythema multiforme, Stevens-Johnson syndrome

General disorders and administration site conditions
Common:              fever

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).