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Note: This document contains side effect information about tacrolimus. Some of the dosage forms listed on this page may not apply to the brand name Prograf.
Common side effects of Prograf include: opportunistic infection, diabetes mellitus, infection, headache, hyperglycemia, hyperkalemia, increased blood urea nitrogen, increased serum creatinine, mental status changes, nephrotoxicity, sensation disorder, and tremor. See below for a comprehensive list of adverse effects.
Applies to tacrolimus: oral capsule, oral capsule extended release, oral tablet extended release
Other dosage forms:
Oral route (Capsule, Extended Release; Capsule; Granule)
Increased risk for developing serious infections and malignancies with tacrolimus extended-release or other immunosuppressants that may lead to hospitalization or death. Increased mortality in female liver transplant patients with tacrolimus extended-release; not approved for use in liver transplantation.Increased risk for developing serious infections and malignancies with tacrolimus oral capsules, oral granules, or other immunosuppressants that may lead to hospitalization or death.
Oral route (Tablet, Extended Release)
Increased risk for developing serious infections and malignancies with tacrolimus extended-release tablets or other immunosuppressants that may lead to hospitalization or death.
Along with its needed effects, tacrolimus (the active ingredient contained in Prograf) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking tacrolimus:
Incidence not known
Some side effects of tacrolimus may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Incidence not known
Applies to tacrolimus: intravenous solution, oral capsule, oral capsule extended release, oral granule for reconstitution, oral tablet extended release
Some of the most commonly reported side effects include hypertension, diarrhea, hyperglycemia, anemia, headache, tremor, insomnia, pain, and asthenia.
Very common (10% or more): Hypertension (89%), peripheral edema (36%), chest pain (19%), pericardial effusion (15%)
Frequency not reported: Angina pectoris, bradycardia, cardiac fibrillation, cardiomyopathy, cardiopulmonary failure, deep thrombophlebitis, ECG abnormalities, echocardiogram abnormalities, heart rate decreased, hemorrhage, hypotension, myocardial hypertrophy, peripheral vascular disorder, phlebitis, tachycardia, thrombosis, vasodilation
Postmarketing reports: Cardiac arrest, myocardial infarction, ventricular fibrillation, congestive cardiac failure, pericardial effusion, supraventricular extrasystoles, supraventricular tachycardia, bradycardia, Torsade de Pointes, QT prolongation
Very common (10% or more): Diarrhea (72%), nausea (46%), constipation (36%), vomiting (29%), dyspepsia (28%)
Frequency not reported: Abdomen enlarged, duodenitis, dysphagia, esophagitis, flatulence, gastritis, gastroesophagitis, GI hemorrhage, GI perforation, ileus, oral moniliasis, pancreatic pseudocyst, peritonitis, rectal disorder, stomatitis, ulcerative esophagitis, ulcer
Very common (10% or more): Hyperglycemia (70%), hypophosphatemia (49%), hypomagnesemia (48%), hyperkalemia (45%), anorexia (34%), hyperlipidemia (34%), hypokalemia (29%)
Frequency not reported: Abnormal healing, acidosis, alkalosis, appetite increased, bicarbonate decreased, dehydration, gout, hypercalcemia, hypercholesterolemia, hyperphosphatemia, hyperuricemia, hypervolemia, hypocalcemia, hypoglycemia, hyponatremia, hypoproteinemia, lactic dehydrogenase increased, weight gain
Very common (10% or more): Anemia (65%), leukopenia (48%), leukocytosis (32%), thrombocytopenia (24%)
Frequency not reported: Coagulation disorder, ecchymosis, hematocrit increased, hemoglobin abnormal, hypochromic anemia, polycythemia, prothrombin decreased, serum iron decreased
Postmarketing reports: Agranulocytosis, disseminated intravascular coagulation, hemolytic anemia, hemolytic-uremic syndrome, neutropenia, pancytopenia, pure red cell aplasia, thrombocytopenic purpura, thrombotic thrombocytopenic purpura
Very common (10% or more): Headache (64%), tremor (56%), paresthesia (40%), dizziness (19%), fatigue (16%)
Frequency not reported: Amnesia, aphasia, convulsion, encephalopathy, hemorrhagic stroke, hypertonia, incoordination, monoparesis, myoclonus, nerve compression, nervousness, neuralgia, neuropathy, paralysis flaccid, psychomotor skills impaired, quadriparesis, seizures, somnolence, vertigo, writing impaired
Postmarketing reports: Coma, dysarthria, posterior reversible encephalopathy syndrome (PRES), progressive multifocal leukoencephalopathy (PML), status epilepticus, quadriplegia, flaccid paralysis, hemiparesis, aphasia, syncope, carpal tunnel syndrome, nerve compression, mutism, dysarthria
Very common (10% or more): Insomnia (64%)
Frequency not reported: Abnormal dreams, agitation, anxiety, confusion, crying, depression, emotional lability, hallucinations, mental status changes, mood elevated, nightmares, psychosis, thinking abnormal
Postmarketing reports: Mutism
Very common (10% or more): Pain (63%), asthenia (54%), fever (48%)
Frequency not reported: Abscess, accidental injury, chills, ear pain, fall, feeling abnormal, generalized edema, hernia, otitis media, sepsis, temperature intolerance, tinnitus
Very common (10% or more): Serum creatinine increased (45%), BUN increased (30%)
Frequency not reported: BK nephropathy, hydronephrosis, renal failure, toxic nephropathy, tubular necrosis
Very common (10% or more): Pleural effusion (36%), dyspnea (29%), atelectasis (28%), cough increased (18%), bronchitis (17%)
Frequency not reported: Asthma, emphysema, hiccups, lung disorder, pharyngitis, pneumonia, pneumothorax, pulmonary edema, rhinitis, sinusitis, voice changes
Postmarketing reports: Interstitial lung disease, pulmonary hypertension, lung infiltration, hiccups
Very common (10% or more): Liver function tests abnormal (36%)
Frequency not reported: Cholangitis, cholestatic jaundice, GGT increased, granulomatous hepatitis, hepatitis, jaundice
Very common (10% or more): Pruritus (36%), rash (24%)
Frequency not reported: Alopecia, cellulitis, hirsutism, photosensitivity, sweating
Postmarketing reports: Hyperpigmentation
Very common (10% or more): Urinary tract infection (34%), oliguria (19%)
Frequency not reported: Albuminuria, bladder spasm, cystitis, dysuria, hematuria, nocturia, pyuria, urge incontinence, urinary frequency, urinary incontinence, urinary retention, vaginitis, hemorrhagic cystitis, urinary retention
Very common (10% or more): Cytomegalovirus infection (12%)
Frequency not reported: Flu syndrome, graft versus host disease (acute and chronic)
Postmarketing reports: Epstein-Barr virus associated lymphoproliferative disorder, hepatosplenic T-cell lymphoma, leukemia, lymphoma, melanoma, post-transplant lymphoproliferative disorder (PTLD)
Frequency not reported: Arthralgia, generalized spasm, joint disorder, leg cramps, mobility decreased, myasthenia, myalgia, osteoporosis
Postmarketing reports: Rhabdomyolysis, polyarthritis, pain in extremity including Calcineurin-Inhibitor Induced Pain Syndrome (CIPS)
Frequency not reported: Hypersensitivity, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria
Frequency not reported: Abnormal vision, amblyopia, blindness, optic atrophy, photophobia