DIRA 1.0: Atlas of Drug-induced Rhabdomyolysis

TACROLIMUS EXTENDED-RELEASE CAPSULES

DIR Classification Postmarketing Surveillance Drug Property Information Reference

DIR Classification

Classification:Less-DIR concern

Severity Score:1

Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF

ADVERSE REACTIONS
Postmarketing Experience
The following adverse reactions have been reported from marketing experience with tacrolimus in the U.S. and outside the U.S. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Blood and Lymphatic System Disorders: Agranulocytosis, disseminated intravascular coagulation, hemolytic uremic syndrome, pancytopenia, pure red cell aplasia [see WARNINGS AND PRECAUTIONS (5.13)], coagulopathy, thrombotic thrombocytopenic purpura, prolonged activated partial thromboplastin time, decreased blood fibrinogen
Cardiac Disorders: Cardiac arrest, myocardial infarction, ventricular fibrillation, congestive cardiac failure, hypertrophic cardiomyopathy, pericardial effusion, angina pectoris, supraventricular extrasystoles, supraventricular tachycardia, bradycardia, Torsade de Pointes, QT prolongation
Ear Disorders: Hearing loss
Eye Disorders: Blindness, optic atrophy, photophobia
Gastrointestinal Disorders: Gastrointestinal hemorrhage, gastrointestinal perforation, pancreatitis, peritonitis, stomach ulcer, intestinal obstruction, ascites, colitis, ileus, impaired gastric emptying, dysphagia
Hepatobiliary Disorders: Hepatic failure, hepatic necrosis, cirrhosis, cholangitis, venoocclusive liver disease, bile duct stenosis, hepatic steatosis, jaundice
Hypersensitivity Reactions: Hypersensitivity, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria.
Immune System Disorders: Graft versus host disease (acute and chronic)
Investigations: Increased international normalized ratio
Metabolism and Nutrition Disorders: Hypoproteinaemia
Musculoskeletal and Connective Tissue Disorders: Rhabdomyolysis, myalgia, polyarthritis
Neoplasms: Lymphoma including EBV-associated lymphoproliferative disorder, hepatosplenic T-cell lymphoma, PTLD [see WARNINGS AND PRECAUTIONS (5.1)], leukemia, melanoma
Nervous System Disorders: Cerebral infarction, progressive multifocal leukoencephalopathy (PML) sometimes fatal [see WARNINGS AND PRECAUTIONS (5.2)], posterior reversible encephalopathy syndrome (PRES) [see WARNINGS AND PRECAUTIONS (5.7)], coma, status epilepticus, quadriplegia, flaccid paralysis, hemiparesis, aphasia, syncope, carpal tunnel syndrome, nerve compression, mutism, dysarthria, somnolence
Psychiatric Disorders: Mental status changes
Renal and Urinary Disorders: Hemorrhagic cystitis, hematuria, urinary retention, urinary incontinence
Respiratory, Thoracic and Mediastinal Disorders: Interstitial lung disease, pulmonary hypertension, lung infiltration, rhinitis allergic, hiccups
Skin and Subcutaneous Tissue Disorders: Hyperpigmentation, photosensitivity
Vascular Disorders: Hemorrhage

Postmarketing Surveillance

Contingency Table:

Current Drug

Other Drugs

Rhabdomyolysis

42820

Other ADRs

30634

14086645

Odds Ratio = 0.988

Drug Property Information

ATC Code(s): N/A

Active Ingredient:tacrolimus

Active Ingredient UNII:WM0HAQ4WNM

Drugbank ID:-

PubChem Compound:N/A

CAS Number:-

Dosage Form(s):capsule, coated, extended release

Route(s) Of Administrator:oral

Daily Dose:

5.0 mg/day L04AD02

Chemical Structure:

SMILE Code:
-

Reference

COHORT STUDY:

N/A

OTHER REFERENCE(S):

N/A

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