Astagraf Xl Oral Capsule, Extended Release 0.5Mg Drug Medication Dosage Information
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ASTAGRAF XL: Oral capsule, extended release (0.5mg)

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Drug Image file DrugItem_17389.JPG
Astagraf XL 0.5mg ER Cap
Astellas Pharma US, Inc.
Pill Identification: 0.5mg LOGO 647 

What is this Medicine?

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

In-Depth Information

Astagraf XL 0.5mg Extended-Release Capsule

NDC: 004690647
  • Prescription Required
  • Not a Controlled Drug
    (CSA Schedule)
  • FDA Approved




FDA approved for the following conditions:
Kidney Transplant Rejection Prophylaxis

Storage Information
Store at 77 degrees F; excursions permitted to 59-86 degrees F
Astagraf XL 0.5mg Extended-Release Capsule
Drug Image file DrugItem_17389.JPG
Astellas Pharma US, Inc.
Pill Identification: 0.5mg LOGO 647 
Shape: capsule
Color: orange,yellow

Reported Side Effects for Astagraf XL 0.5mg Extended-Release Capsule

Uncontrolled Urination Incidence:
<15.0%*
Severity: MODERATE
Onset: EARLY
Retaining Urine Incidence:
<15.0%*
Severity: MODERATE
Onset: EARLY
Vaginal Infection Incidence:
<1.0%*
Severity: MODERATE
Onset: DELAYED
Stomach Pain Incidence:
<59.0%*
Severity: MILD
Onset: EARLY
Cholestasis Incidence:
<15.0%*
Severity: MODERATE
Onset: DELAYED
Nighttime Urination Incidence:
<15.0%*
Severity: MILD
Onset: EARLY
Increased Urination Incidence:
<15.0%*
Severity: MILD
Onset: EARLY
Blood In The Urine Incidence:
<15.0%*
Severity: MODERATE
Onset: DELAYED
Inflamed Pancreas Incidence:
<15.0%*
Severity: SEVERE
Onset: DELAYED
Heartburn Incidence:
<15.0%*
Severity: MILD
Onset: DELAYED
Extra Abdominal Fluid Incidence:
<15.0%*
Severity: MODERATE
Onset: DELAYED
Bladder Spasm Incidence:
<15.0%*
Severity: MODERATE
Onset: EARLY
Bladder Infection Incidence:
<1.0%*
Severity: MODERATE
Onset: DELAYED
Dehydration Incidence:
<15.0%*
Severity: MODERATE
Onset: DELAYED
Kidney Damage Incidence:
<15.0%*
Severity: SEVERE
Onset: DELAYED
Painful Urination Incidence:
<15.0%*
Severity: MODERATE
Onset: EARLY
Pus In Urine Incidence:
<15.0%*
Severity: MODERATE
Onset: DELAYED
Stomach Ulcer Incidence:
<15.0%*
Severity: SEVERE
Onset: DELAYED
Mouth Sores Incidence:
0.2-1.0%*
Severity: MODERATE
Onset: DELAYED
Dry Mouth Incidence:
0.2-1.0%*
Severity: MILD
Onset: EARLY
Inflamed Stomach Incidence:
0.2-15.0%*
Severity: MODERATE
Onset: DELAYED
Constipation Incidence:
0.2-40.0%*
Severity: MODERATE
Onset: DELAYED
Inflamed Colon Incidence:
0.2-15.0%*
Severity: MODERATE
Onset: DELAYED
High Bilirubin Level Incidence:
0.2-15.0%*
Severity: MODERATE
Onset: DELAYED
Mouth Ulcers Incidence:
0.2-15.0%*
Severity: MODERATE
Onset: DELAYED
Metallic Taste Incidence:
0.2-1.0%*
Severity: MILD
Onset: EARLY
Decreased Appetite Incidence:
0.2-34.0%*
Severity: MILD
Onset: DELAYED
Upset Stomach Incidence:
1.0-46.0%*
Severity: MILD
Onset: EARLY
Vomiting Incidence:
1.0-29.0%*
Severity: MILD
Onset: EARLY
Menstrual Cramps Incidence:
1.0-4.0%*
Severity: MILD
Onset: DELAYED
Upset Stomach Incidence:
1.0-28.0%*
Severity: MILD
Onset: EARLY
Cholangitis Incidence:
3.0-15.0%*
Severity: MODERATE
Onset: DELAYED
Loose Stools Incidence:
3.0-72.0%*
Severity: MILD
Onset: EARLY
Weight Gain Incidence:
3.0-15.0%*
Severity: MILD
Onset: DELAYED
Throat Inflammation Incidence:
3.0-15.0%*
Severity: MODERATE
Onset: DELAYED
Gas Incidence:
3.0-15.0%*
Severity: MILD
Onset: EARLY
Bowel Obstruction Incidence:
3.0-15.0%*
Severity: SEVERE
Onset: DELAYED
Difficulty Swallowing Incidence:
3.0-15.0%*
Severity: MODERATE
Onset: DELAYED
Intestinal Bleeding Incidence:
3.0-15.0%*
Severity: SEVERE
Onset: DELAYED
Hole In Intestines Incidence:
3.0-15.0%*
Severity: SEVERE
Onset: DELAYED
Liver Infection Incidence:
3.0-15.0%*
Severity: MODERATE
Onset: DELAYED
Yellow Skin Incidence:
3.0-15.0%*
Severity: MODERATE
Onset: DELAYED
Throat Ulcers Incidence:
3.0-15.0%*
Severity: SEVERE
Onset: DELAYED
Elevated Hepatic Enzymes Incidence:
3.0-36.0%*
Severity: MODERATE
Onset: DELAYED
Causing To Be Hungry Incidence:
3.0-15.0%*
Severity: MILD
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 Astagraf XL 0.5mg Extended-Release 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 Astagraf XL 0.5mg Extended-Release 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 Astagraf XL 0.5mg Extended-Release 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 Astagraf XL 0.5mg Extended-Release 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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