Raised bilirubin, liver enzymes and clinical jaundice are considered to be common. These undesirable effects are usually reversible on discontinuation of the drug.

Undesirable effects are listed below, by MedDRA System Organ Class, in decreasing order of frequency within each class. Where frequencies are given, these are based on the clinical trial data, using the stated frequency classification. Where the term 'Not known' is given, these effects are derived from spontaneous reports.

Frequency classification:

Very common
 >1/10
 
Common
 >1/100 and <1/10
 
Uncommon
 >1/1,000 and <1/100
 
Rare
 >1/10,000 and <1/1,000
 
Very rare
 <1/10,000
 

• Blood and lymphatic system disorders
 
Not known:
 Pancytopenia
 
 
 Leukopenia*
 
 
 Thrombocytopenia
 
 
 
Anaemia
 
 
 *Haematological disorders affecting the white cell line (neutropenia, granulocytopenia, agranulocytosis) and, more rarely, disorders affecting the other two cell lines have been reported, either as isolated events or associated. These abnormalities have been observed especially with treatment of more than 15 days and are reversible upon drug withdrawal.

 
• Immune system disorders
 
Rare:
 Allergic reaction
 
Not known:
 Anaphylactic reaction

 
• Metabolism and nutrition disorders
 
Uncommon:
 Anorexia

 
• Nervous system disorders
 
Common:
 Drowsiness
 
 
 Dizziness
 
Uncommon:
 Headache

 
• Hepatobiliary disorders
 
Common:
 Hyperbilirubinaemia
 
   Jaundice (see section 4.4)
 
 
 Hepatic enzymes increased (see section 4.4)
 
Not known:
 Hepatorenal syndrome
 
 
 Liver function abnormalities like hyperbilirubinaemia with or without jaundice and increase in hepatic enzymes such as alkaline phosphatase and transaminases should lead to withdrawal of treatment. Return of laboratory parameters to normal is usual and generally rapid.

 
• Skin and subcutaneous tissue disorders
 
Uncommon:
 Rash*
 
 
 Urticaria
 
 
 Pruritus
 
 
 *Rash includes various types of reactions such as erythematous, maculo-papular and pustular.

 
• Musculoskeletal and connective tissue disorders
 
Not known:
 Rhabdomyolysis (see Section 4.4 and 4.5)
 
 
 Rhabdomyolysis may be fatal. Examples of signs and symptoms are: muscle weakness, muscle swelling and muscle pain, dark urine, myoglobinuria, elevated serum creatine kinase, acute renal failure, cardiac arrhythmia.

 
• Renal and urinary disorders
 
Not known:
 Renal failure
 
 
 Acute renal failu