In general, anaphylactoid reactions are potentially the most serious adverse reactions.
In clinical trials, the following adverse drug reactions have been reported in temporal relationship with the administration of Iron sucrose Injection USP, 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): paresthesia.
Cardiovascular disorders: Uncommon (>1/1000, <1/100): hypotension and collapse; tachycardia and palpitations.
Respiratory, thoracic and mediastinal disorders: Uncommon (>1/1000, <1/100): bronchospasm, dyspnoea.
Gastrointestinal disorders: Uncommon (>1/1000, <1/100): nausea; vomiting; abdominal pain; diarrhea.
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): anaphylactoid reactions (rarely involving arthralgia); peripheral edema; fatigue, asthenia; malaise.
Moreover, in spontaneous reports the following adverse reactions have been reported: Isolated cases: reduced level of consciousness, light-headed feeling, confusion; angioedema; swelling of joints, hyperhidrosis, and back pain.
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