Adverse Reactions
Frequencies of adverse reactions for Zometa 4 mg are mainly based on data collection from chronic treatment. Adverse reactions to Zometa are similar to those reported for other bisphosphonates and can be expected to occur in approximately one third of patients. Intravenous administration has been most commonly associated with a flu-like syndrome in about 9% of patients, including bone pain (9.1%), fever (7.2%), fatigue (4.1%) and rigors (2.9%). Occasionally cases of arthralgia and myalgia in approximately 3% have been reported. No information is available on the reversibility of these adverse effects.Frequently, the reduction in renal calcium excretion is accompanied by a fall in serum phosphate levels (in approximately 20% of patients), which is asymptomatic not requiring treatment. The serum calcium may fall to asymptomatic hypocalcaemic levels in approximately 3% of patients.Gastrointestinal reactions, such as nausea (5.8%) and vomiting (2.6%) have been reported following intravenous infusion of Zometa. Occasionally local reactions at the infusion site such as redness or swelling and/or pain were also observed in less than 1% of the patients.Anorexia was reported in 1.5% of patients treated with Zometa 4 mg.Few cases of rash or pruritus have been observed (below 1%).As with other bisphosphonates, cases of conjunctivitis in approximately 1% have been reported.There have been some reports of impaired renal function (2.3%), although the aetiology appears to be multifactorial in many cases.Based on pooled analysis of placebo-controlled studies, severe anaemia (Hb < 8.0 g/dl) was reported in 5.2% of patients receiving Zometa 4 mg versus 4.2% on placebo.The following adverse drug reactions, listed in Table 1, have been accumulated from clinical studies following predominantly chronic treatment with zoledronic acid:Adverse reactions are ranked under headings of frequency, the most frequent first, using the following convention: 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), including isolated reports.Blood and lymphatic system disordersCommon: AnaemiaUncommon: Thrombocytopenia, leukopeniaRare: PancytopeniaNervous system disordersCommon: HeadacheUncommon: Dizziness, paraesthesia, taste disturbance, hypoaesthesia, hyperaesthesia, tremorPsychiatric disordersUncommon: Anxiety, sleep disturbanceRare: ConfusionEye disordersCommon: ConjunctivitisUncommon: Blurred visionVery rare: Uveitis, episcleritisGastrointestinal disordersCommon: Nausea, vomiting, anorexiaUncommon: Diarrhoea, constipation, abdominal pain, dyspepsia, stomatitis, dry mouthRespiratory, thoracic and mediastinal disordersUncommon: Dyspnoea, coughSkin and subcutaneous tissue disordersUncommon: Pruritus, rash (including erythematous and macular rash), increased sweatingMusculoskeletal, connective tissue and bone disordersCommon: Bone pain, myalgia, arthralgia, generalised painUncommon: Muscle crampsCardiovascul