Significant: Hypomagnesaemia, vitamin B12 deficiency, fundic gland polyps (long-term use); cutaneous lupus erythematosus, subacute cutaneous lupus erythematosus (SCLE), SLE; osteoporosis-related fractures of the hip, wrist or spine (long term use or high doses); Clostridium difficile-associated diarrhoea (CDAD), gastrointestinal infections (e.g. Salmonella, Campylobacter). Rarely, acute interstitial nephritis, hypersensitivity reactions (e.g. urticaria, angioedema, anaphylaxis, maculopapular rash).
Ear and labyrinth disorders: Vertigo.
Gastrointestinal disorders: Nausea, vomiting, diarrhoea, constipation, flatulence, abdominal pain.
General disorders and administration site conditions: Asthenia, malaise.
Investigations: Increased liver enzymes.
Metabolism and nutrition disorders: Peripheral oedema.
Musculoskeletal and connective tissue disorders: Back pain.
Nervous system disorders: Headache, dizziness, somnolence, paraesthesia.
Psychiatric disorders: Insomnia.
Respiratory, thoracic and mediastinal disorders: Cough, URTI.
Potentially Fatal: Very rarely, severe cutaneous adverse reactions (e.g. acute generalised exanthematous pustulosis, drug reaction with eosinophilia and systemic symptoms, Stevens-Johnson syndrome, toxic epidermal necrolysis).