The following events have been reported during therapy for HIV disease with 3TC alone and in combination with other anti-retroviral agents. With many it is unclear whether they are related to the medicinal products or are as a result of the underlying disease process.
The following convention has been utilised for the classification of undesirable effects: very common (>1/10), common (>1/100, <1/10), uncommon (>1/1,000, <1/100), rare (>1/10,000, <1/1,000) very rare (<1/10,000).
Blood and lymphatic systems disorders: Uncommon: Neutropenia, anaemia, thrombocytopenia. Very rare: Pure red cell aplasia.
Metabolism and nutrition disorders: Common: Hyperlactataemia. Rare: Lactic acidosis (see Precautions).
Nervous system disorders: Common: Headache. Very rare: Paraesthesia. Peripheral neuropathy has been reported although a causal relationship to treatment is uncertain.
Gastrointestinal disorders: Common: Nausea, vomiting, upper abdominal pain, diarrhoea. Rare: Pancreatitis, although a causal relationship to treatment is uncertain. Rises in serum amylase.
Hepatobiliary disorders: Uncommon: Transient rises in liver enzymes (AST, ALT).
Skin and subcutaneous tissue disorders: Common: Rash, alopecia.
Musculoskeletal and connective tissue disorders: Common: Arthralgia, muscle disorders. Rare: Rhabdomyolysis.
General disorders and administration site conditions: Common: Fatigue, malaise, fever.
Paediatric population: The safety database to support lamivudine once daily dosing in paediatric patients comes from the ARROW Trial (COL105677) in which 669 HIV-1 infected paediatric subjects received abacavir and lamivudine either once or twice daily (see Pharmacology: Pharmacodynamics: Clinical Studies under Actions). No additional safety issues have been identified in paediatric subjects receiving either once or twice daily dosing compared to adults.