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Envarsus XR Side Effects

Generic name: tacrolimus

Medically reviewed by Drugs.com. Last updated on Feb 12, 2024.

Note: This document contains side effect information about tacrolimus. Some dosage forms listed on this page may not apply to the brand name Envarsus XR.

Applies to tacrolimus: oral capsule, oral capsule extended release, oral granule, oral tablet extended release. Other dosage forms:

Warning

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.

Serious side effects of Envarsus XR

Along with its needed effects, tacrolimus (the active ingredient contained in Envarsus XR) 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:

More common

Less common

Rare

Incidence not known

Other side effects of Envarsus XR

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:

More common

Less common

Incidence not known

For Healthcare Professionals

Applies to tacrolimus: compounding powder, intravenous solution, oral capsule, oral capsule extended release, oral granule for reconstitution, oral tablet extended release.

General

Some of the most commonly reported side effects include hypertension, diarrhea, hyperglycemia, anemia, headache, tremor, insomnia, pain, and asthenia.[Ref]

Cardiovascular

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[Ref]

Gastrointestinal

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[Ref]

Metabolic

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[Ref]

Hematologic

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[Ref]

Nervous system

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[Ref]

Psychiatric

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[Ref]

Other

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[Ref]

Renal

Very common (10% or more): Serum creatinine increased (45%), BUN increased (30%)

Frequency not reported: BK nephropathy, hydronephrosis, renal failure, toxic nephropathy, tubular necrosis[Ref]

Respiratory

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[Ref]

Hepatic

Very common (10% or more): Liver function tests abnormal (36%)

Frequency not reported: Cholangitis, cholestatic jaundice, GGT increased, granulomatous hepatitis, hepatitis, jaundice[Ref]

Dermatologic

Very common (10% or more): Pruritus (36%), rash (24%)

Frequency not reported: Alopecia, cellulitis, hirsutism, photosensitivity, sweating

Postmarketing reports: Hyperpigmentation[Ref]

Genitourinary

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[Ref]

Immunologic

Very common (10% or more): Cytomegalovirus infection (12%)

Frequency not reported: Flu syndrome, graft versus host disease (acute and chronic)[Ref]

Oncologic

Postmarketing reports: Epstein-Barr virus associated lymphoproliferative disorder, hepatosplenic T-cell lymphoma, leukemia, lymphoma, melanoma, post-transplant lymphoproliferative disorder (PTLD)[Ref]

Musculoskeletal

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)[Ref]

Hypersensitivity

Frequency not reported: Hypersensitivity, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria[Ref]

Ocular

Frequency not reported: Abnormal vision, amblyopia, blindness, optic atrophy, photophobia[Ref]

References

1. Product Information. Prograf (tacrolimus). Fujisawa. 2001;PROD.

2. Cerner Multum, Inc. UK Summary of Product Characteristics.

3. Cerner Multum, Inc. Australian Product Information.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.