Due to limited clinical data on Diafer the mentioned undesirable effects are primarily based on safety data for other parenteral iron solutions.
More than 1% of patients may be expected to experience adverse reactions.
Acute, severe anaphylactoid reactions may occur with parenteral iron preparations, although they are uncommon. They usually occur within the first few minutes of administration and are generally characterised by the sudden onset of respiratory difficulty and / or cardiovascular collapse; fatalities have been reported. Other less severe manifestations of immediate hypersensitivity are also uncommon and include urticaria, rashes, itching, nausea and shivering. Administration must be stopped immediately if signs of an anaphylactoid reaction are observed.
Delayed reactions may also occur with parenteral iron preparations and can be severe. They are characterised by arthralgia, myalgia and sometimes fever. The onset varies from several hours up to four days after administration. Symptoms usually last two to four days and settle spontaneously or following the use of simple analgesics. In addition, exacerbation of joint pain in rheumatoid arthritis can occur and local reactions may cause pain and inflammation at or near injection site and a local phlebitic reaction.
Very common (≥ 1/10)
Common (≥ 1/100 to <1/10)
Uncommon (≥ 1/1,000 to <1/100)
Rare (≥ 1/10,000 to <1/1,000)
Very Rare (<1/10,000)
Not known (cannot be estimated with the available data)
Cardiac disorders
Rare: Arrhythmia, tachycardia
Very rare: Foetal bradycardia, palpitations
Not known: Kounis syndrome
Blood and lymphatic system disorders
Very rare: Haemolysis
Nervous system disorders
Uncommon: Blurred vision, numbness, dysphonia
Rare: Loss of consciousness, seizure, dizziness, restlessness, tremor, fatigue, altered mental status
Very rare: Headache, paresthesia
Ear and labyrinth disorders
Very rare: Transient deafness
Respiratory, thoracic and mediastinal disorders
Uncommon: Dyspnoea
Rare: Chest pain
Gastrointestinal disorders
Uncommon: Nausea, emesis, abdominal pain, constipation
Rare: Diarrhoea
Skin and subcutaneous tissue disorders
Uncommon: Flushing, pruritus, rash
Rare: Angioedema, sweating
Musculoskeletal and connective tissue disorders
Uncommon: Cramps
Rare: Myalgias, arthralgia
Vascular disorders
Rare: Hypotension
Very rare: Hypertension
General disorders and administration site conditions
Uncommon: Anaphylactoid reactions, feeling hot, fever, soreness, inflammation near the injection site, local phlebitic reaction
Rare: Fatigue
Very rare: Acute severe anaphylactic reactions
Not known: Influenza like illness whose onset may vary from a few hours to several days
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
or search for MHRA Yellow Card in the Google Play or Apple App Store.