Limast Adverse Reactions

Infections and infestations: As is well known for other potent immunosuppressive agents, patients receiving tacrolimus are frequently at increased risk for infections (viral, bacterial, fungal, protozoal). The course of pre-existing infections may be aggravated. Both generalised and localised infections can occur.
Cases of BK virus associated nephropathy, as well as cases of JC virus associated progressive multifocal leukoencephalopathy (PML), have been reported in patients treated with immunosuppressants, including Tacrolimus Capsule.
Neoplasms benign, malignant and unspecified (incl. cysts and polyps): Patients receiving immunosuppressive therapy are at increased risk of developing malignancies. Benign as well as malignant neoplasms including EBV-associated lymphoproliferative disorders and skin malignancies have been reported in association with tacrolimus treatment.
Blood and lymphatic system disorders: Common: anaemia, leukopenia, thrombocytopenia, leukocytosis, red blood cell analyses abnormal. Uncommon: coagulopathies, coagulation and bleeding analyses abnormal, pancytopenia, neutropenia. Rare: thrombotic thrombocytopenic purpura, hypoprothrombinaemia, thrombotic microangiopathy. Not known: pure red cell aplasia, agranulocytosis, haemolytic anaemia.
Immune system disorders: Allergic and anaphylactoid reactions have been observed in patients receiving tacrolimus.
Endocrine disorders: Rare: hirsutism.
Metabolism and nutrition disorders: Very common: hyperglycaemic conditions, diabetes mellitus, hyperkalaemia. Common: hypomagnesaemia, hypophosphataemia, hypokalaemia, hypocalcaemia, hyponatraemia, fluid overload, hyperuricaema appetite decreased, metabolic acidoses, hyperlipidaemia, hypercholesterolaemia, hypertriglyceridaemia, other electrolyte abnormalities. Uncommon: dehydration, hypoproteinaemia, hyperphosphataemia, hypoglycaemia.
Psychiatric disorders: Very common: insomnia. Common: anxiety symptoms, confusion and disorientation, depression, depressed mood, mood disorders and disturbances, nightmare, hallucination, mental disorders. Uncommon: psychotic disorder.
Nervous system disorders: Very common: tremor, headache. Common: seizures, disturbances in consciousness, paraesthesias and dysaesthesias, peripheral neuropathies, dizziness, writing impaired, nervous system disorders. Uncommon: coma, central nervous system, haemorrhages and cerebrovascular accidents, paralysis and paresis, encephalopathy, speech and language abnormalities, amnesia. Rare: hypertonia. Very rare: myasthenia.
Eye disorders: Common: vision blurred, photophobia, eye disorders. Uncommon: cataract. Rare: blindness. Not known: optic neuropathy.
Ear and labyrinth disorders: Common: tinnitus. Uncommon: hypoacusis. Rare: deafness neurosensory. Very rare: hearing impaired.
Cardiac disorders: Common: ischaemic coronary artery disorders, tachycardia. Uncommon: ventricular arrhythmias and cardiac arrest, heart failures, cardiomyopathies, ventricular hypertrophy, supraventricular arrhythmias, palpitations. Rare: pericardial effusion. Very rare: Torsades de Pointes.
Vascular disorders: Very common: hypertension. Common: haemorrhage, thrombembolic and ischaemic events, peripheral vascular disorders, vascular hypotensive disorders. Uncommon: infarction, venous thrombosis deep limb, shock.
Respiratory, thoracic and mediastinal disorders: Common: dyspnoea, parenchymal lung disorders, pleural effusion, pharyngitis, cough, nasal congestion and inflammations. Uncommon: respiratory failures, respiratory tract disorders, asthma. Rare: acute respiratory distress syndrome.
Gastrointestinal disorders: Very common: diarrhoea, nausea. Common: gastrointestinal inflammatory conditions, gastrointestinal ulceration and perforation, gastrointestinal haemorrhages, stomatitis and ulceration, ascites, vomiting, gastrointestinal and abdominal pains, dyspeptic signs and symptoms, constipation, flatulence, bloating and distension, loose stools, gastrointestinal signs and symptoms. Uncommon: ileus paralytic, acute and chronic pancreatitis, gastrooesophageal reflux disease, impaired gastric emptying. Rare: subileus, pancreatic pseudocyst.
Hepatobiliary disorders: Common: cholestasis and jaundice, hepatocellular damage and hepatitis, cholangitis. Rare: hepatitic artery thrombosis, veno occlusive liver disease. Very rare: hepatic failure, bile duct stenosis.
Skin and subcutaneous tissue disorders: Common: pruritus, rash, 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, muscle spasms, pain in extremity, back pain. Uncommon: joint disorders. Rare: mobility decreased.
Renal and urinary disorders: Very common: renal impairment. Common: renal failure, renal failure acute, oliguria, renal tubular necrosis, nephropathy toxic, urinary abnormalities, bladder and urethral symptoms. Uncommon: anuria, haemolytic uraemic syndrome. Very rare: nephropathy, cystitis haemorrhagic.
Reproductive system and breast disorders: Uncommon: dysmenorrhoea and uterine bleeding.
General disorders and administration site conditions: Common: asthenic conditions, febrile disorders, oedema, pain and discomfort, body temperature perception disturbed. Uncommon: multi-organ failure, influenza like illness, temperature intolerance, chest pressure sensation, feeling jittery, feeling abnormal. Rare: thirst, fall, chest tightness, ulcer. 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.