, nasal congestion and inflammations
uncommon: respiratory failures, respiratory tract disorders, asthma
rare: acute respiratory distress syndrome
Gastrointestinal disorders
very common: diarrhoea, nausea
common: gastrointestinal signs and symptoms, vomiting, gastrointestinal and abdominal pains, gastrointestinal inflammatory conditions, gastrointestinal haemorrhages, gastrointestinal ulceration and perforation, ascites, stomatitis and ulceration, constipation, dyspeptic signs and symptoms, flatulence, bloating and distension, loose stools
uncommon: acute and chronic pancreatitis, ileus paralytic, gastrooesophageal reflux disease, impaired gastric emptying
rare: pancreatic pseudocyst, subileus
Hepatobiliary disorders
common: bile duct disorders, hepatocellular damage and hepatitis, cholestasis and jaundice
rare: venoocclusive liver disease, hepatic artery thrombosis
very rare: hepatic failure
Skin and subcutaneous tissue disorders
common: rash, pruritus, alopecias, acne, sweating increased
uncommon: dermatitis, photosensitivity
rare: toxic epidermal necrolysis (Lyell's syndrome)
very rare: Stevens Johnson syndrome
Musculoskeletal and connective tissue disorders
common: arthralgia, back pain, muscle spasms, pain in limb
uncommon: joint disorders
rare: mobility decreased
Renal and urinary disorders
very common: renal impairment
common: renal failure, renal failure acute, nephropathy toxic, renal tubular necrosis, urinary abnormalities, oliguria, bladder and urethral symptoms
uncommon: haemolytic uraemic syndrome, anuria
very rare: nephropathy, cystitis haemorrhagic
Reproductive system and breast disorders
uncommon: dysmenorrhoea and uterine bleeding
General disorders and administration site conditions
common: febrile disorders, pain and discomfort, asthenic conditions, oedema, body temperature perception disturbed
uncommon: influenza like illness, feeling jittery, feeling abnormal, multi-organ failure, chest pressure sensation, temperature intolerance
rare: fall, ulcer, chest tightness, thirst
very rare: fat tissue increased
Investigations
very common: liver function tests abnormal
common: blood alkaline phosphatase increased, weight increased
uncommon: amylase increased, ECG investigations abnormal, heart rate and pulse investigations abnormal, weight decreased, blood lactate dehydrogenase increased
very rare: echocardiogram abnormal, electrocardiogram QT prolonged
Injury, poisoning and procedural complications
common: primary graft dysfunction
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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
4.9 Overdose
Several cases of accidental overdose have been reported with tacrolimus; symptoms have included tremor, headache, nausea and vomiting, infections, urticaria, lethargy and increases in blood urea nitrogen, serum creatinine concentrations and alanine aminotransferase levels.
No specific antidote to tacrolimus therapy is available. If overdose occurs, general supportive measures and s |
