Sandronic Adverse Reactions

The most serious adverse drug reactions in patients receiving Zoledronic Acid Monohydrate indication are anaphylactic reaction, ocular adverse events, osteonecrosis of the jaw, atypical femoral fracture, atrial fibrillation, renal function impairment, acute phase reaction and hypocalcemia.
Adverse reactions to Zoledronic Acid Monohydrate are usually mild and transient and similar to those reported for other bisphosphonate. Those reactions can be expected to occur in approximately one third of patients treated with Zoledronic Acid Monohydrate. Within three days after Zoledronic Acid Monohydrate administration, an acute phase reaction has commonly been reported, with symptoms including pyrexia, fatigue, bone pain, chills, influenza-like illness, arthritis with subsequent joint swelling; these symptoms usually resolve within few days. Case of arthralgia and myalgia have commonly been reported.
Very commonly, the reduction in renal calcium excretion is accompanied by a fall in serum phosphate levels, which is asymptomatic not requiring treatment. Commonly, the serum calcium may fall to asymptomatic hypocalcemic levels. Gastrointestinal reactions, such as nausea and vomiting have been commonly reported following intravenous infusion of Zoledronic Acid Monohydrate. Uncommonly local reactions at the infusion site such as redness or swelling and/or pain were also observed.
Anorexia was commonly reported in patients treated with Zoledronic Acid Monohydrate 4 mg.
Rash or pruritus have been uncommonly observed. As with other bisphosphonates, cases of conjunctivitis have been commonly reported. Severe anemia (Hb < 8.0 g/dL) was commonly reported in patients receiving Zoledronic Acid Monohydrate 4 mg. (See Table 3.)


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Adverse drug reactions from spontaneous reports and literature cases (frequency not known): The following adverse reactions have been reported during post marketing experience with Zoledronic Acid Monohydrate via spontaneous case reports and literature cases. Because these reactions are reported voluntarily from a population of uncertain size and are subject to confounding factors, it is not possible to reliably estimate their frequency (which is therefore categorized as not known) or established a causal relationship to drug exposure.
Immune system disorders: Anaphylactic reaction/shock.
Nervous system disorders: Somnolence.
Eye disorders: Episcleritis, scleritis and orbital inflammation.
Cardiac disorders: Atrial fibrillation.
Vascular disorders: Hypotension leading to syncope or circulatory collapse, primarily in patients with underlying risk factors.
Respiratory, thoracic and mediastinal disorders: Bronchospasm.
Skin and subcutaneous tissue disorders: Urticaria.
Musculoskeletal and connective tissue disorders: Severe and occasionally incapacitating bone, joint and/or muscle pain, atypical subtrochanteric and diaphyseal femoral fractures (adverse reaction, including Zoledronic Acid Monohydrate).