Avofer Side Effects

iron sucrose




Full Prescribing Info
Side Effects
The following data are based on the innovator product (Venofer 20mg iron/ml, solution for injection or concentrate for solution for infusion) summary of product characteristics from UK.
The most frequently reported adverse drug reactions (ADRs) of Iron (III) Hydroxide Sucrose Complex Injection were transient taste perversion, hypotension, fever and shivering, injection site reactions and nausea occurring in 0.5 to 1.5% of the patients. Non-serious anaphylactoid reactions occurred rarely.
In general anaphylactoid reactions are potentially the most serious adverse reactions.
The following adverse drug reactions have been reported with the administration of Iron (ID) Hydroxide Sucrose Complex Injection, with at least a possible causal relationship: Nervous system disorders: Common (≥ 1/100, < 1/10): transient taste perversions (in particular metallic taste). Uncommon (≥ 1/1000, < 1/100): headache, dizziness. Rare (≥ 1/10000, < 1/1000): paraesthesia, syncope, loss of consciousness, burning sensation.
Cardio-vascular disorders: Uncommon (≥ 1/1000, < 1/100): hypotension and collapse, tachycardia and palpitations. Rare (≥ 1/10000, < 1/1000): hypertension.
Respiratory, thoracic and mediastinal disorders: Uncommon (≥ 1/1000, < 1/100): bronchospasm, dyspnoea.
Gastrointestinal disorders: Uncommon (≥ 1/1000, < 1/100): nausea; vomiting, abdominal pain, diarrhoea.
Skin and subcutaneous tissue disorders: Uncommon (≥ 1/1000, < 1/100): pruritus, urticaria, rash, exanthema, erythema.
Musculoskeletal, connective tissue and bone disorders: Uncommon (≥ 1/1000, < 1/100): muscle cramps, myalgia.
General disorders and administration site disorders:
Uncommon (≥ 1/1000, < 1/100): fever, shivering, flushing, chest pain and tightness. Injection site disorders such as superficial phlebitis, burning, swelling. Rare (≥ 1/10000, < 1/1000): arthralgia, peripheral oedema, fatigue, asthenia, malaise, feeling hot, oedema.
Immune system disorders: Rare (≥ 1/10000, < 1/1000): anaphylactoid reactions.
Moreover, in spontaneous reports the following adverse reactions have been reported: Isolated cases: reduced level of consciousness, light-headed feeling, confusion, angio-oedema, swelling of joints, hyperhidrosis, back pain, bradycardia, chromaturia.
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