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

Summary

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. Continue reading for a comprehensive list of adverse effects.

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

• intravenous solution

Serious side effects of Prograf

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:

More common

• Abnormal dreams
• agitation
• chills
• blurred vision
• confusion
• cough
• diarrhea
• dizziness
• dry mouth
• fever
• flushed, dry skin
• frequent urination
• fruit-like breath odor
• general feeling of discomfort or illness
• headache
• increased hunger
• increased thirst
• increased urination
• itching, skin rash
• joint pain
• loss of appetite
• loss of consciousness
• loss of energy or weakness
• mental depression
• muscle pains, trembling, or twitching
• nausea
• pale skin
• runny nose
• seeing or hearing things that are not there
• seizures
• shivering
• sore throat
• stomach pain
• sweating
• swelling of the feet or lower legs
• tingling
• trembling and shaking of the hands
• trouble breathing
• trouble sleeping
• unexplained weight loss
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting

Less common

• Chest pain
• increased sensitivity to pain
• muscle cramps
• numbness or pain in the legs
• ringing in the ears

Rare

• Enlarged heart
• flushing of the face or neck
• weight loss

Incidence not known

• Black, tarry stools
• blistering, peeling, or loosening of the skin
• bloating
• bloody nose
• bloody urine
• change in mental status
• constipation
• drowsiness
• fainting
• fast, slow, or irregular heartbeat
• heartburn
• heavier menstrual periods
• indigestion
• joint pain
• lightheadedness
• lower back or side pain
• pain and fullness in the right upper stomach
• 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

Other side effects of Prograf

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

• Belching
• difficulty with moving
• lack or loss of strength
• muscle stiffness

Less common

• Body aches or pain
• burning or stinging of the skin
• cracks in the skin
• crying
• dysphoria
• excessive muscle tone
• false beliefs that cannot be changed by facts
• false or unusual sense of well-being
• feeling of constant movement of self or surroundings
• feeling of unreality
• 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
• 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
• poor insight and judgment
• problems with memory or speech
• quick to react or overreact emotionally
• rapidly changing moods
• redness or other discoloration of the skin
• restlessness
• scaly skin
• sensation of spinning
• sense of detachment from self or body
• 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
• trouble recognizing objects
• trouble thinking and planning
• trouble walking
• 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

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]