Ranofer

Ranofer Side Effects

iron sucrose

Manufacturer:

Duopharma (M)

Distributor:

DKSH
Full Prescribing Info
Side Effects
The most frequently reported adverse drug reaction (ADRs) was dysgeusia. Hypersensitivity reaction was the most significant serious adverse drug reaction associated with this product. The adverse drug reactions reported after administration are presented as follows.
Common (≥1/100, <1/10): Nervous system disorders: Dysgeusia.
Vascular disorders: Hypotension, hypertension.
Gastrointestinal Disorders: Nausea.
General disorders and administration site conditions: Injection/infusion site reaction (extravasation, -irritation, -reaction, -discolouration, -haematoma, -pruritus).
Uncommon (≥1/1,000, <1/100): Immune system disorders: Hypersensitivity.
Nervous system disorders: Headache, dizziness, paraesthesia, hypoaesthesia.
Vascular disorders: Flushing, phlebitis.
Respiratory, thoracic and mediastinal disorders: Dyspnoea.
Gastrointestinal Disorders: Vomiting, abdominal pain, diarrhoea, Constipation.
Skin and subcutaneous tissue disorders: Pruritus, rash.
Musculoskeletal and connective tissue disorders: Muscle spasm, myalgia, arthralgia, pain in extremity, back pain.
General disorders and administration site conditions: Chills, asthenia, fatigue, oedema peripheral, pain.
Investigations: Alanine aminotransferase increased, aspartate aminotransferase increased, gammaglutamyltransferase increased, serum ferritin increased.
Rare (≥1/10,000, <1/1,000): Nervous system disorders: Syncope, somnolence.
Cardiac disorders: Palpitations.
Renal and urinary disorders: Chromaturia.
General disorders and administration site conditions: Chest pain, hyperdrosis, pyrexia.
Investigations: Blood lactate dehydrogenase increased.
Frequency not known: Immune system disorders: Anaphylactoid reactions, Angioedema.
Nervous system disorders: Depressed level of consciousness, confusional state, loss of consciousness, anxiety, tremor.
Cardiac disorders: Bradycardia, tachycardia.
Vascular disorders: Circulatory collapse, thrombophlebitis.
Respiratory, thoracic and mediastinal disorders: Bronchospasm.
Skin and subcutaneous tissue disorders: Urticaria, erythema.
General disorders and administration site conditions: Cold sweat, malaise, pallor.
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