Prograf Oral Capsule 0.5Mg Drug Medication Dosage Information
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Prograf: Oral capsule (0.5mg)

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Drug Image file DrugItem_8953.JPG
Prograf 0.5mg Cap
Astellas Pharma US, Inc.
Pill Identification: 0.5mg LOGO 607 

What is this Medicine?

TACROLIMUS (ta KROE li mus) is used to decrease the immune system's response to a transplanted organ.

CVS Pharmacy Patient Statistics for Prograf: Oral capsule(0.5mg)
Generic vs. Brand Name Usage*
*Brand contains same active ingredient but may not represent FDA-approved generic equivalent
Usage By Strength
In-Depth Information

Prograf 0.5mg Capsule

NDC: 004690607
  • Prescription Required
  • Not a Controlled Drug
    (CSA Schedule)
  • FDA Approved




FDA approved for the following conditions:
Heart Transplant Rejection Prophylaxis, Liver Transplant Rejection Prophylaxis

Sometimes used for but not FDA approved for the following conditions:
Uveitis, Heart Transplant Rejection, Small Bowel Transplant Rejection Prophylaxis, Graft-versus-host Disease (GVHD), Graft-versus-host Disease (GVHD) Prophylaxis, Kidney Transplant Rejection, Kidney Transplant Rejection Prophylaxis, Psoriasis, Ulcerative Colitis, Pancreas Transplant Rejection Prophylaxis, Lung Transplant Rejection, Nephrotic Syndrome, Liver Transplant Rejection, Lung Transplant Rejection Prophylaxis, Lupus Nephritis

Storage Information
Store at 77 degrees F; excursions permitted to 59-86 degrees F
Prograf 0.5mg Capsule
Drug Image file DrugItem_8953.JPG
Astellas Pharma US, Inc.
Pill Identification: 0.5mg LOGO 607 
Shape: capsule
Color: yellow

Reported Side Effects for Prograf 0.5mg Capsule

Cholestasis Incidence:
<15.0%*
Severity: MODERATE
Onset: DELAYED
Liver Infection Incidence:
<15.0%*
Severity: MODERATE
Onset: DELAYED
High White Blood Cells Incidence:
<32.0%*
Severity: MILD
Onset: DELAYED
Fluid Retention Incidence:
<36.0%*
Severity: MODERATE
Onset: DELAYED
Nerve Pain Incidence:
<15.0%*
Severity: MODERATE
Onset: DELAYED
Inability To Urinate Incidence:
<15.0%*
Severity: SEVERE
Onset: DELAYED
Convulsions Incidence:
<15.0%*
Severity: SEVERE
Onset: DELAYED
Increased Body Fluid Incidence:
<15.0%*
Severity: SEVERE
Onset: DELAYED
Mouth Ulcers Incidence:
<15.0%*
Severity: MODERATE
Onset: DELAYED
Osteoporosis Incidence:
<15.0%*
Severity: MODERATE
Onset: DELAYED
Protein In The Urine Incidence:
<15.0%*
Severity: MODERATE
Onset: DELAYED
Itching Incidence:
<46.0%*
Severity: MILD
Onset: RAPID
Fluid In Lungs Incidence:
<15.0%*
Severity: SEVERE
Onset: EARLY
Weakness Incidence:
<52.0%*
Severity: MILD
Onset: DELAYED
Low Platelet Count Incidence:
<24.0%*
Severity: MODERATE
Onset: DELAYED
Ringing In Ears Incidence:
<15.0%*
Severity: MILD
Onset: DELAYED
Vaginal Infection Incidence:
<15.0%*
Severity: MODERATE
Onset: DELAYED
Stomach Pain Incidence:
<59.0%*
Severity: MILD
Onset: EARLY
Rapid Heart Rate Incidence:
<15.0%*
Severity: MODERATE
Onset: RAPID
Osteopenia Incidence:
<15.0%*
Severity: MODERATE
Onset: DELAYED
Ear Pain Incidence:
<14.9%*
Severity: MILD
Onset: EARLY
Paresthesias Incidence:
<40.0%*
Severity: MILD
Onset: DELAYED
Skin Rash Incidence:
<24.0%*
Severity: MILD
Onset: EARLY
Kidney Failure Incidence:
<15.0%*
Severity: SEVERE
Onset: DELAYED
Kidney Damage Incidence:
<15.0%*
Severity: SEVERE
Onset: DELAYED
Nightmares Incidence:
<15.0%*
Severity: MILD
Onset: EARLY
Neurotoxicity Incidence:
<15.0%*
Severity: MODERATE
Onset: EARLY
Heartburn Incidence:
<15.0%*
Severity: MILD
Onset: DELAYED
Blurred Vision Incidence:
<15.0%*
Severity: MODERATE
Onset: EARLY
Confusion Incidence:
<15.0%*
Severity: MODERATE
Onset: EARLY
Conjunctivitis Incidence:
<15.0%*
Severity: MODERATE
Onset: DELAYED
Cushingoid Features Incidence:
<15.0%*
Severity: MILD
Onset: DELAYED
Lightheadedness Incidence:
<19.0%*
Severity: MILD
Onset: EARLY
Elevated Hepatic Enzymes Incidence:
<37.0%*
Severity: MODERATE
Onset: DELAYED
Flushing Incidence:
<15.0%*
Severity: MILD
Onset: RAPID
Acute Lung Injury Incidence:
<15.0%*
Severity: SEVERE
Onset: EARLY
Hallucinations Incidence:
<15.0%*
Severity: MODERATE
Onset: EARLY
Hypoesthesia Incidence:
<15.0%*
Severity: MILD
Onset: DELAYED
Decreased Healing Incidence:
<15.0%*
Severity: MODERATE
Onset: DELAYED
High Blood Pressure Incidence:
<89.0%*
Severity: MODERATE
Onset: EARLY
High Phosphate Levels Incidence:
<15.0%*
Severity: MODERATE
Onset: DELAYED
High Potassium Level Incidence:
<45.0%*
Severity: SEVERE
Onset: DELAYED
Excessive Sweating Incidence:
<15.0%*
Severity: MILD
Onset: DELAYED
Hemolytic Anemia Incidence:
<15.0%*
Severity: SEVERE
Onset: DELAYED
Inflamed Stomach Incidence:
<15.0%*
Severity: MODERATE
Onset: DELAYED
Gas Incidence:
<15.0%*
Severity: MILD
Onset: EARLY
Exfoliative Dermatitis Incidence:
<14.9%*
Severity: SEVERE
Onset: DELAYED
Throat Inflammation Incidence:
<15.0%*
Severity: MODERATE
Onset: DELAYED
Shortness Of Breath Incidence:
<29.0%*
Severity: MODERATE
Onset: EARLY
Upset Stomach Incidence:
<28.0%*
Severity: MILD
Onset: EARLY
Decreased Urination Incidence:
<19.0%*
Severity: SEVERE
Onset: EARLY
Depression Incidence:
<15.0%*
Severity: MODERATE
Onset: DELAYED
Cough Incidence:
<18.0%*
Severity: MILD
Onset: DELAYED
Heart Muscle Disease Incidence:
<1.0%*
Severity: SEVERE
Onset: DELAYED
Irregular Heart Rate Incidence:
<15.0%*
Severity: SEVERE
Onset: EARLY
Irregular Heart Beat Incidence:
<15.0%*
Severity: SEVERE
Onset: EARLY
Joint Pain Incidence:
<25.0%*
Severity: MILD
Onset: DELAYED
Nervousness Incidence:
<15.0%*
Severity: MILD
Onset: DELAYED
Decreased Appetite Incidence:
<34.0%*
Severity: MILD
Onset: DELAYED
Hair Loss Incidence:
<15.0%*
Severity: MILD
Onset: DELAYED
Distressed Incidence:
<15.0%*
Severity: MILD
Onset: EARLY
Acne Incidence:
<15.0%*
Severity: MILD
Onset: DELAYED
Low Potassium Levels Incidence:
<29.0%*
Severity: MODERATE
Onset: DELAYED
Electrolyte Imbalance Incidence:
<15.0%*
Severity: MODERATE
Onset: DELAYED
Muscle Pain Incidence:
<14.9%*
Severity: MILD
Onset: EARLY
High Uric Acid Level Incidence:
<15.0%*
Severity: MODERATE
Onset: DELAYED
Low Blood Sodium Levels Incidence:
<15.0%*
Severity: MODERATE
Onset: DELAYED
Low White Blood Cells Incidence:
<15.0%*
Severity: MODERATE
Onset: DELAYED
Chills Incidence:
0.2-14.9%*
Severity: MILD
Onset: RAPID
Photosensitivity Incidence:
0.2-14.9%*
Severity: MILD
Onset: DELAYED
Balance Problems Incidence:
0.2-14.9%*
Severity: MILD
Onset: EARLY
Peripheral Vasodilation Incidence:
0.2-14.9%*
Severity: MODERATE
Onset: RAPID
Inflamed Colon Incidence:
0.2-0.9%*
Severity: MODERATE
Onset: DELAYED
Stiff Heart Vavle Incidence:
0.2-0.9%*
Severity: SEVERE
Onset: DELAYED
Chest Pain Incidence:
0.2-19.0%*
Severity: MODERATE
Onset: EARLY
Fainting Incidence:
0.2-14.9%*
Severity: MILD
Onset: EARLY
Swelling Incidence:
0.2-18.0%*
Severity: MODERATE
Onset: DELAYED
Constipation Incidence:
0.2-40.0%*
Severity: MODERATE
Onset: DELAYED
Diaphoresis Incidence:
0.2-14.9%*
Severity: MILD
Onset: EARLY
Inflamed Vocal Cords Incidence:
0.2-0.9%*
Severity: MILD
Onset: DELAYED
Bruise Incidence:
0.2-14.9%*
Severity: MILD
Onset: DELAYED
Underactive Thyroid Incidence:
0.2-0.9%*
Severity: MODERATE
Onset: DELAYED
Dehydration Incidence:
0.2-14.9%*
Severity: MODERATE
Onset: DELAYED
High Bilirubin Level Incidence:
0.2-14.9%*
Severity: MODERATE
Onset: DELAYED
Anemia Incidence:
0.2-65.0%*
Severity: MODERATE
Onset: DELAYED
Skin Ulcer Incidence:
0.2-14.9%*
Severity: MODERATE
Onset: DELAYED
Skin Discoloration Incidence:
0.2-14.9%*
Severity: MILD
Onset: DELAYED
Dry Mouth Incidence:
0.2-0.9%*
Severity: MILD
Onset: EARLY
Muscle Cramps Incidence:
0.2-0.9%*
Severity: MILD
Onset: DELAYED
Migraine Incidence:
0.2-0.9%*
Severity: MODERATE
Onset: EARLY
High Cholesterol Incidence:
0.2-57.0%*
Severity: MODERATE
Onset: DELAYED
Upset Stomach Incidence:
1.0-46.0%*
Severity: MILD
Onset: EARLY
Back Pain Incidence:
1.0-30.0%*
Severity: MILD
Onset: DELAYED
Vomiting Incidence:
1.0-29.0%*
Severity: MILD
Onset: EARLY
Inability To Sleep Incidence:
1.0-64.0%*
Severity: MILD
Onset: EARLY
Hives Incidence:
1.0-6.0%*
Severity: MILD
Onset: RAPID
Infection Incidence:
1.0-69.0%*
Severity: MILD
Onset: DELAYED
Fever Incidence:
1.0-46.0%*
Severity: MILD
Onset: EARLY
Viral Kidney Damage Incidence:
1.2-14.9%*
Severity: MODERATE
Onset: DELAYED
Rhinitis Incidence:
2.0-14.9%*
Severity: MILD
Onset: EARLY
Sinus Infection Incidence:
2.0-14.9%*
Severity: MILD
Onset: DELAYED
Sore Throat Incidence:
3.0-14.9%*
Severity: MILD
Onset: DELAYED
Loose Stools Incidence:
3.0-72.0%*
Severity: MILD
Onset: EARLY
Lazy Eye Incidence:
3.1-14.9%*
Severity: MODERATE
Onset: DELAYED
Weight Gain Incidence:
3.1-14.9%*
Severity: MILD
Onset: DELAYED
Abnormal Dreams Incidence:
3.1-14.9%*
Severity: MILD
Onset: EARLY
Bladder Infection Incidence:
3.1-14.9%*
Severity: MODERATE
Onset: DELAYED
Unable To Stop Crying Incidence:
3.1-14.9%*
Severity: MILD
Onset: DELAYED
Cushing's Syndrome Incidence:
3.1-14.9%*
Severity: MODERATE
Onset: DELAYED
Hiccups Incidence:
3.1-14.9%*
Severity: MILD
Onset: EARLY
Muscle Weakness Incidence:
3.1-14.9%*
Severity: MODERATE
Onset: DELAYED
Chest Pain Incidence:
3.1-14.9%*
Severity: MODERATE
Onset: EARLY
Blood Clot Incidence:
3.1-14.9%*
Severity: SEVERE
Onset: DELAYED
Rapid Muscle Twitches Incidence:
3.1-14.9%*
Severity: MODERATE
Onset: DELAYED
Nighttime Urination Incidence:
3.1-14.9%*
Severity: MILD
Onset: EARLY
Cholangitis Incidence:
3.1-14.9%*
Severity: MODERATE
Onset: DELAYED
Slow Heart Beat Incidence:
3.1-14.9%*
Severity: SEVERE
Onset: RAPID
Bladder Spasm Incidence:
3.1-14.9%*
Severity: MODERATE
Onset: EARLY
Postural Low Blood Pressure Incidence:
3.1-14.9%*
Severity: MODERATE
Onset: DELAYED
Irritated Blood Vessels Incidence:
3.1-14.9%*
Severity: MODERATE
Onset: RAPID
Psychomotor Impairment Incidence:
3.1-14.9%*
Severity: MILD
Onset: EARLY
Pus In Urine Incidence:
3.1-14.9%*
Severity: MODERATE
Onset: DELAYED
Electrolyte Imbalance Incidence:
3.1-14.9%*
Severity: MODERATE
Onset: DELAYED
Flu Incidence:
3.1-14.9%*
Severity: MILD
Onset: DELAYED
Heart Failure Incidence:
3.1-14.9%*
Severity: SEVERE
Onset: DELAYED
Psychosis Incidence:
3.1-14.9%*
Severity: MODERATE
Onset: EARLY
High Red Blood Cells Incidence:
3.1-14.9%*
Severity: MODERATE
Onset: DELAYED
Collapsed Lung Incidence:
3.1-14.9%*
Severity: SEVERE
Onset: EARLY
Hirsutism Incidence:
3.1-14.9%*
Severity: MILD
Onset: DELAYED
High Calcium Levels Incidence:
3.1-14.9%*
Severity: MODERATE
Onset: DELAYED
Low Blood Sugar Incidence:
3.1-14.9%*
Severity: MODERATE
Onset: EARLY
Yellow Skin Incidence:
3.1-14.9%*
Severity: MODERATE
Onset: DELAYED
Bowel Obstruction Incidence:
3.1-14.9%*
Severity: SEVERE
Onset: DELAYED
Low Calcium Levels Incidence:
3.1-14.9%*
Severity: MODERATE
Onset: DELAYED
Increased Blood Volume Incidence:
3.1-14.9%*
Severity: MODERATE
Onset: DELAYED
Blood In The Urine Incidence:
3.1-14.9%*
Severity: MODERATE
Onset: DELAYED
Hole In Intestines Incidence:
3.1-14.9%*
Severity: SEVERE
Onset: DELAYED
Intestinal Bleeding Incidence:
3.1-14.9%*
Severity: SEVERE
Onset: DELAYED
Brain Dysfunction Incidence:
3.1-14.9%*
Severity: MODERATE
Onset: DELAYED
Difficulty Swallowing Incidence:
3.1-14.9%*
Severity: MODERATE
Onset: DELAYED
Coagulopathy Incidence:
3.1-14.9%*
Severity: SEVERE
Onset: DELAYED
Retaining Urine Incidence:
3.1-14.9%*
Severity: MODERATE
Onset: EARLY
Throat Ulcers Incidence:
3.1-14.9%*
Severity: SEVERE
Onset: DELAYED
Emotional Lability Incidence:
3.1-14.9%*
Severity: MILD
Onset: EARLY
Drowsiness Incidence:
3.1-14.9%*
Severity: MILD
Onset: EARLY
Low Blood Pressure Incidence:
3.1-14.9%*
Severity: MODERATE
Onset: RAPID
Brain Attack Incidence:
3.1-14.9%*
Severity: SEVERE
Onset: EARLY
Painful Urination Incidence:
3.1-14.9%*
Severity: MODERATE
Onset: EARLY
Heat Intolerance Incidence:
3.1-14.9%*
Severity: MODERATE
Onset: EARLY
Causing To Be Hungry Incidence:
3.1-14.9%*
Severity: MILD
Onset: DELAYED
Urinary Urgency Incidence:
3.1-14.9%*
Severity: MILD
Onset: EARLY
Loss Of Memory Incidence:
3.1-14.9%*
Severity: MODERATE
Onset: DELAYED
Gout Incidence:
3.1-14.9%*
Severity: MODERATE
Onset: DELAYED
Extra Abdominal Fluid Incidence:
7.0-27.0%*
Severity: MODERATE
Onset: DELAYED
Headache Incidence:
9.0-64.0%*
Severity: MILD
Onset: EARLY
Diabetes Incidence:
10.0-75.0%*
Severity: MODERATE
Onset: DELAYED
Increased Blood Fats Incidence:
10.0-34.0%*
Severity: MODERATE
Onset: DELAYED
Nephrotoxicity Incidence:
>10.0%*
Severity: SEVERE
Onset: DELAYED
Low White Blood Cell Counts Incidence:
13.0-48.0%*
Severity: MODERATE
Onset: DELAYED
Fluid Around The Heart Incidence:
15.0%*
Severity: SEVERE
Onset: DELAYED
Shaking Incidence:
15.0-56.0%*
Severity: MILD
Onset: EARLY
Increased Blood Sugar Incidence:
16.0-47.0%*
Severity: MODERATE
Onset: DELAYED
Tired Incidence:
16.0%*
Severity: MILD
Onset: EARLY
Low Magnesium Levels Incidence:
16.0-48.0%*
Severity: MODERATE
Onset: DELAYED
Fluid Around The Lungs Incidence:
22.0-36.0%*
Severity: SEVERE
Onset: DELAYED
Low Phosphate Level Incidence:
23.0-49.0%*
Severity: MODERATE
Onset: DELAYED
High Triglycerides Incidence:
65.0%*
Severity: MODERATE
Onset: DELAYED
*This is an approximate aggregated range of reported side effects from clinical studies performed on this drug. Your experience with this drug may be different.
Daily Life Interactions for Prograf 0.5mg Capsule

Elements of your daily lifestyle may have an effect on the medications you are taking. Drug interactions can result in unwanted side effects, reduce the effectiveness of your medicine or possibly increase the action of a particular medicine.

Severe Lifestyle Interaction
Grapefruit juice and Prograf 0.5mg Capsule(Tacrolimus)
Grapefruit juice and Tacrolimus(Tacrolimus)
Avoid grapefruit juice while taking Tacrolimus. Grapefruit and Grapefruit juice increase Tacrolimus blood levels significantly leading to side effects like abdominal pain, confusion, decreased urination, dizziness, headache, mood changes, nausea-vomiting, tremor, yellowing of skin or eyes, weakness, or other problems. An interaction with topical Tacrolimus is unlikely.
Severe Lifestyle Interaction
Food and Prograf 0.5mg Capsule(Tacrolimus)
Food and Tacrolimus (Oral)(Tacrolimus)
Tacrolimus may be taken with or without food, but it is critical that you always take tacrolimus consistently with or without food to maintain consistent blood levels of this drug. Avoid grapefruit juice while taking Tacrolimus. Grapefruit and Grapefruit juice increase Tacrolimus blood levels significantly leading to side effects like abdominal pain, confusion, decreased urination, dizziness, headache, mood changes, nausea-vomiting, tremor, yellowing of skin or eyes, weakness, or other problems. An interaction with topical Tacrolimus is unlikely.
Major Lifestyle Interaction
Alcohol and Prograf 0.5mg Capsule(Tacrolimus)
Alcohol and Tacrolimus(Tacrolimus)
Do not drink alcoholic beverages while taking Tacrolimus extended-release capsules (Astagraf XL). Alcohol may increase blood levels of Astagraf XL and increase the risk of serious side effects. In roughly 3 to 7 out of every 100 persons using topical tacrolimus (Protopic), drinking alcohol may cause the skin or face to become flushed or red and feel hot. Let your prescriber know if you notice such reactions, particularly if they are bothersome. In some cases, your prescriber can recommend a treatment that might lessen the reaction when you drink alcohol socially. If the reaction is particularly uncomfortable, it may be best to limit your alcohol intake.
Pregnancy & Lactation Information
First Trimester

Class C - Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women. OR No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women.

Second Trimester

Class C - Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women. OR No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women.

Third Trimester

Class C - Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women. OR No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women.

Lactation

Caution - Not enough information is available to rule out harm to infants when this drug is taken by nursing mothers.


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