ecchymosis, hot flush, flushing.
Uncommon:
Peripheral ischaemia, thrombophlebitis, haematoma.
Rare:
Circulatory failure, petechia, vasospasm.
Respiratory, thoracic and mediastinal disorders
Very common:
Common:
Upper respiratory tract inection, sinusitis.
Lower respiratory tract infection (e.g. bronchitis, pneumonia),dyspnoea, epistaxis.
Uncommon:
Pulmonary oedema, bronchospasm, pleurisy, pleural effusion.
Rare:
Interstitial lung disease (including rapidly progressive disease, lung fibrosis and pneumonitis).
Gastrointestinal disorders
Very common:
Common:
Abdominal pain, nausea.
Gastrointestinal haemorrhage, diarrhoea, dyspepsia, gastroesophageal reflux, constipation.
Uncommon:
Intestinal perforation, intestinal stenosis, diverticulitis, pancreatitis, cheilitis.
Hepatobiliary disorders
Common:
Hepatic function abnormal, transaminases increased.
Uncommon:
Hepatitis, hepatocellular damage, cholecystitis.
Rare:
Autoimmune hepatitis, jaundice.
Not known:
Liver failure.
Skin and subcutaneous tissue disorders
Common:
New onset or worsening psoriasis including pustular psoriasis (primarily palm & soles), urticaria, rash, pruritus, hyperhidrosis, dry skin, fungal dermatitis, eczema, alopecia.
Uncommon:
Rare:
Bullous eruption, onychomycosis, seborrhoea, rosacea, skin papilloma, hyperkeratosis, abnormal skin pigmentation.
Toxic epidermal necrolysis, Stevens-Johnson Syndrome, erythema multiforme, furunculosis.
Musculoskeletal and connective tissue disorders
Common:
Arthralgia, myalgia, back pain.
Renal and urinary disorders
Common:
Uncommon:
Urinary tract infection.
Pyelonephritis.
Reproductive system and breast disorders
Uncommon:
Vaginitis.
General disorders and administration site conditions
Very common:
Common:
Infusion-related reaction, pain.
Chest pain, fatigue, fever, injection site reaction, chills, oedema.
Uncommon:
Impaired healing.
Rare:
Granulomatous lesion.
Investigations
Uncommon:
Rare:
Autoantibody positive.
Complement factor abnormal.
Infusion-related reactions: An infusion-related reaction was defined in clinical studies as any adverse event occurring during an infusion or within 1 hour after an infusion. In phase 3 clinical studies, 18% of infliximab-treated patients compared with 5% of placebo-treated patients experienced an infusion-related reaction. Overall, a higher proportion of patients receiving infliximab monotherapy experienced an infusion-related reaction compared to patients receiving infliximab with concomitant immunomodulators. Approximately 3% of patients discontinued treatment due to infusion-related reactions and all patients recovered with or without medical therapy. Of infliximab-treated patients who had an infusion reaction during the induction period, through week 6, 27% experienced an infusion reaction during the maintenance period, week 7 through week 54. Of patients who did not have an infusion reaction during the induction period, 9% experienced an infusion reaction during the maintenance period.
In a clinical study of patients with rheumatoid arthritis (ASPIRE), infusions were to be administered over 2 hours for the first 3 infu |
