3TC Adverse Reactions

The following adverse reactions have been reported during therapy for HIV disease with 3TC.
The adverse reactions considered at least possibly related to the treatment are listed as follows by body system, organ class and absolute frequency. Frequencies are defined as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Blood and lymphatic systems disorders: Uncommon: Neutropenia and anaemia (both occasionally severe), thrombocytopenia.
Very rare: Pure red cell aplasia.
Metabolism and nutrition disorders: Very rare: Lactic acidosis.
Nervous system disorders: Common: Headache, insomnia.
Very rare: Peripheral neuropathy (or paraesthesia).
Respiratory, Thoracic and mediastinal disorders: Common: Cough, nasal symptoms.
Gastrointestinal disorders: Common: Nausea, vomiting, abdominal pain or cramps, diarrhoea.
Rare: Pancreatitis, elevations in serum amylase.
Hepatobiliary disorders: Uncommon: Transient elevations in liver enzymes (AST, ALT).
Rare: Hepatitis.
Skin and subcutaneous tissue disorders: Common: Rash, alopecia.
Rare: Angioedema.
Musculoskeletal and connective tissue disorders: Common: Arthralgia, muscle disorders.
Rare: Rhabdomyolysis.
General disorders and administration site conditions: Common: Fatigue, malaise, fever.
Weight and levels of blood lipids and glucose may increase during antiretroviral therapy (see Precautions).
In HIV-infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic infections may arise. Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment (see Precautions).
Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term combined antiretroviral exposure (CART). The frequency of which is unknown (see Precautions).
Paediatric population: 1206 HIV-infected paediatric patients aged 3 months to 17 years were enrolled in the ARROW Trial (COL105677), 669 of whom received abacavir and lamivudine either once or twice daily (see Pharmacology: Pharmacodynamics under Actions). No additional safety issues have been identified in paediatric subjects receiving either once or twice daily dosing compared to adults.
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.