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Envarsus XR Side Effects

Generic Name: tacrolimus

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 Envarsus XR.

In Summary

Common side effects of Envarsus XR include: 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.

For the Consumer

Applies to tacrolimus: oral capsule, oral capsule extended release, oral tablet extended release

Other dosage forms:

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
  • Abdominal or stomach pain
  • abnormal dreams
  • agitation
  • chills
  • confusion
  • convulsions (seizures)
  • diarrhea
  • dizziness
  • fever and sore throat
  • flu-like symptoms
  • frequent urination
  • headache
  • itching
  • loss of appetite
  • loss of energy or weakness
  • mental depression
  • muscle trembling or twitching
  • nausea
  • pale skin
  • seeing or hearing things that are not there
  • shortness of breath
  • skin rash
  • swelling of the feet or lower legs
  • tingling
  • trembling and shaking of the hands
  • trouble sleeping
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • vomiting
Less common
  • Blurred vision
  • chest pain
  • increased sensitivity to pain
  • muscle cramps
  • numbness or pain in the legs
  • ringing in the ears
  • sweating
Rare
  • Enlarged heart
  • flushing of the face or neck
  • general feeling of discomfort or illness
  • weight loss
Incidence not known
  • Black, tarry stools
  • blistering, peeling, loosening of the skin
  • bloating
  • bloody urine
  • constipation
  • cough
  • drowsiness
  • fainting
  • fast, slow, or irregular heartbeat
  • heartburn
  • increased thirst
  • indigestion
  • joint or muscle pain
  • lightheadedness
  • lower back or side pain
  • pinpoint red spots on the skin
  • pounding or rapid pulse
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • skin sores
  • ulcers or white spots in the mouth or on the lips
  • weakness
  • weight gain
  • yellow eyes or skin

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
  • Acid or sour stomach
  • belching
  • difficulty with moving
  • lack or loss of strength
  • muscle pain or stiffness
Less common
  • Body aches or pain
  • burning or stinging of the skin
  • cracks in the skin
  • crying
  • delusions
  • dementia
  • depersonalization
  • dysphoria
  • euphoria
  • excessive muscle tone
  • feeling of constant movement of self or surroundings
  • feeling that others are watching you or controlling your behavior
  • feeling that others can hear your thoughts
  • increased sensitivity of the skin to sunlight
  • large, flat, blue or purplish patches in the skin
  • loss of strength or energy
  • muscle tension or tightness
  • painful blisters on the trunk of the body
  • painful cold sores or blisters on the lips, nose, eyes, or genitals
  • paranoia
  • quick to react or overreact emotionally
  • rapidly changing moods
  • redness or other discoloration of the skin
  • restlessness
  • scaly skin
  • sensation of spinning
  • severe mood or mental changes
  • severe sunburn
  • sleepiness or unusual drowsiness
  • sore mouth or tongue
  • sores on the skin
  • swelling or inflammation of the mouth
  • tender, swollen glands in the neck
  • unusual behavior
  • white patches in the mouth, tongue, or throat
Incidence not known
  • Change in color vision
  • decreased weight
  • difficulty seeing at night
  • feeling hot and cold
  • hearing loss
  • sudden sweating

For Healthcare Professionals

Applies to tacrolimus: intravenous solution, oral capsule, oral capsule extended release, 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 (up to 89%), peripheral edema (up to 36%), chest pain (up to 19%), pericardial effusion (up to 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, QT prolongation, tachycardia, thrombosis, Torsade de Pointes, vasodilation[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (up to 72%), nausea (up to 46%), constipation (up to 36%), vomiting (up to 29%), dyspepsia (up to 28%)
Frequency not reported: Abdomen enlarged, duodenitis, dysphagia, esophagitis, flatulence, gastritis, gastroesophagitis, gastrointestinal (GI) hemorrhage, GI perforation, ileus, oral moniliasis, pancreatic pseudocyst, peritonitis, rectal disorder, stomatitis, ulcerative esophagitis[Ref]

Metabolic

Very common (10% or more): Hyperglycemia (up to 70%), hypophosphatemia (up to 49%), hypomagnesemia (up to 48%), hyperkalemia (up to 45%), anorexia (up to 34%), hyperlipidemia (up to 34%), hypokalemia (up to 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 (up to 65%), leukopenia (up to 48%), leukocytosis (up to 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 (up to 64%), tremor (up to 56%), paresthesia (up to 40%), dizziness (up to 19%), fatigue (up to 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)[Ref]

Psychiatric

Very common (10% or more): Insomnia (up to 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 (up to 63%), asthenia (up to 54%), fever (up to 48%)
Frequency not reported: Abscess, accidental injury, chills, ear pain, fall, feeling abnormal, generalized edema, hernia, otitis media, sepsis, temperature intolerance, tinnitus, ulcer[Ref]

Renal

Very common (10% or more): Serum creatinine increased (up to 45%), BUN increased (up to 30%)
Frequency not reported: BK nephropathy, hydronephrosis, renal failure, toxic nephropathy, tubular necrosis[Ref]

Respiratory

Very common (10% or more): Pleural effusion (up to 36%), dyspnea (up to 29%), atelectasis (up to 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[Ref]

Hepatic

Very common (10% or more): Liver function tests abnormal (up to 36%)
Frequency not reported: Cholangitis, cholestatic jaundice, GGT increased, granulomatous hepatitis, hepatitis, jaundice[Ref]

Dermatologic

Very common (10% or more): Pruritus (up to 36%), rash (up to 24%)
Frequency not reported: Alopecia, cellulitis, hirsutism, photosensitivity, sweating[Ref]

Genitourinary

Very common (10% or more): Urinary tract infection (up to 34%), oliguria (up to 19%)
Frequency not reported: Albuminuria, bladder spasm, cystitis, dysuria, hematuria, nocturia, pyuria, urge incontinence, urinary frequency, urinary incontinence, urinary retention, vaginitis[Ref]

Immunologic

Very common (10% or more): Cytomegalovirus infection (up to 12%)
Frequency not reported: Flu syndrome[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[Ref]

Hypersensitivity

Frequency not reported: Allergic reaction[Ref]

Ocular

Frequency not reported: Abnormal vision, amblyopia[Ref]

References

1. Cerner Multum, Inc. "Australian Product Information." O 0

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. "Product Information. Prograf (tacrolimus)." Fujisawa, Deerfield, IL.

Some side effects of Envarsus XR may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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