The adverse event profile appears similar for adults and children. The following events have been reported in patients treated with RETROVIR.
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 system disorders: Common: Anaemia (which may require transfusions), neutropenia and leucopenia.
These occur more frequently at higher dosages (1200-1500mg/day) and in patients with advanced HIV disease (especially when there is poor bone marrow reserve prior to treatment), and particularly in patients with CD4 cell counts less than 100/mm3. Dosage reduction or cessation of therapy may become necessary (see Precautions). The incidence of neutropenia was also increased in those patients whose neutrophil counts, haemoglobin levels and serum vitamin B12 levels were low at the start of RETROVIR therapy.
Uncommon: Thrombocytopenia and pancytopenia (with marrow hypoplasia). Rare: Pure red cell aplasia. Very rare: Aplastic anaemia.
Metabolism and nutrition disorders: Common: Hyperlactataemia. Rare: Lactic acidosis (see Precautions), anorexia.
Treatment with zidovudine has been associated with loss of subcutaneous fat (see Precautions).
Psychiatric disorders: Rare: Anxiety and depression.
Nervous system disorders: Very common: Headache. Common: Dizziness. Rare: Insomnia, paraesthesia, somnolence, loss of mental acuity, convulsions.
Cardiac disorders: Rare: Cardiomyopathy.
Respiratory, thoracic and mediastinal disorders: Uncommon: Dyspnoea. Rare: Cough.
Gastrointestinal disorders: Very common: Nausea. Common: Vomiting, abdominal pain, and diarrhoea. Uncommon: Flatulence. Rare: Oral mucosa pigmentation, taste disturbance and dyspepsia. Pancreatitis.
Hepatobilary disorders: Common: Raised blood levels of liver enzymes and bilirubin. Rare: Liver disorders such as severe hepatomegaly with steatosis.
Skin and subcutaneous tissue disorders: Uncommon: Rash and pruritus. Rare: Nail and skin pigmentation, urticaria and sweating.
Musculoskeletal and connective tissue disorders: Common: Myalgia. Uncommon: Myopathy.
Renal and urinary disorders: Rare: Urinary frequency.
Reproductive system and breast disorders: Rare: Gynaecomastia.
General disorders and administration site conditions: Common: Malaise. Uncommon: Fever, generalised pain and asthenia. Rare: Chills, chest pain and influenza-like syndrome.
The available data from both placebo-controlled and open-labelled studies indicate that the incidence of nausea and other frequently reported clinical adverse events consistently decreases over time during the first few weeks of therapy with RETROVIR.
IV infusion: Experience with Retrovir IV for Infusion treatment for periods in excess of two weeks is limited, although some patients have received treatment for up to 12 weeks. The most frequent adverse events were anaemia, neutropenia and leucopenia. Local reactions were infrequent.
Adverse reactions with RETROVIR for the prevention of maternal-foetal transmission: In a placebo-controlled trial (ACTG 076), RETROVIR was well tolerated in pregnant women at the doses recommended for this indication. Clinical adverse events and laboratory test abnormalities were similar in the RETROVIR and placebo groups.
In the same trial, haemoglobin concentrations in infants exposed to RETROVIR for this indication were marginally lower than in infants in the placebo group, but transfusion was not required. Anaemia resolved within 6 weeks after completion of RETROVIR therapy. Other clinical adverse events and laboratory test abnormalities were similar in the RETROVIR and placebo groups. The long-term consequences of in utero and infant exposure to RETROVIR are unknown.