The following adverse reactions, listed in Table 2, have been accumulated from clinical studies and post-marketing reports following predominantly chronic treatment with 4 mg zoledronic acid:

Table 2

Adverse reactions are ranked under headings of frequency, the most frequent first, using the following convention: 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), not known (cannot be estimated from the available data).

Blood and lymphatic system disorders
 
  Common:
 Anaemia
 
  Uncommon:
 Thrombocytopenia, leukopenia
 
  Rare:
 Pancytopenia
 
Immune system disorders
 
  Uncommon:
 Hypersensitivity reaction
 
  Rare:
 Angioneurotic oedema
 
Psychiatric disorders
 
  Uncommon:
 Anxiety, sleep disturbance
 
  Rare:
 Confusion
 
Nervous system disorders
 
  Common:
 Headache
 
  Uncommon:
 Dizziness, paraesthesia, taste disturbance, hypoaesthesia, hyperaesthesia, tremor, somnolence
 
Eye disorders
 
  Common:
 Conjunctivitis
 
  Uncommon:
 Blurred vision, scleritis and orbital inflammation
 
  Very rare:
 Uveitis, episcleritis
 
Cardiac disorders
 
  Uncommon:
 Hypertension, hypotension, atrial fibrillation, hypotension leading to syncope or circulatory collapse
 
  Rare:
 Bradycardia
 
Respiratory, thoracic and mediastinal disorders
 
  Uncommon:
 Dyspnoea, cough, bronchoconstriction
 
Gastrointestinal disorders
 
  Common:
 Nausea, vomiting, anorexia
 
  Uncommon:
 Diarrhoea, constipation, abdominal pain, dyspepsia, stomatitis, dry mouth
 
Skin and subcutaneous tissue disorders
 
  Uncommon:
 Pruritus, rash (including erythematous and macular rash), increased sweating
 
Musculoskeletal and connective tissue disorders
 
  Common:
 Bone pain, myalgia, arthralgia, generalised pain
 
  Uncommon:
 Muscle cramps, osteonecrosis of the jaw*
 
Renal and urinary disorders
 
  Common:
 Renal impairment
 
  Uncommon:
 Acute renal failure, haematuria, proteinuria
 
General disorders and administration site conditions
 
 
 Common:
 Fever, flu-like syndrome (including fatigue, rigors, malaise and flushing)
 
 
 Uncommon:
 Asthenia, peripheral oedema, injection site reactions (including pain, irritation, swelling, induration), chest pain, weight increase, anaphylactic reaction/shock, urticaria
 
Investigations
 
 
 Very common:
 Hypophosphataemia
 
 
 Common:
 Blood creatinine and blood urea increased, hypocalcaemia
 
 
 Uncommon:
 Hypomagnesaemia, hypokalaemi