Tacrolimus is a calcineurin inhibitor immunosuppressant sold in the U.S. under 5 brand and generic names, for atopic dermatitis and graft vs host disease. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Astagraf XL (application NDA204096). Other tacrolimus products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Capsules must be taken whole. ( 2.1 ) • Take consistently every morning at the same time on an empty stomach at least 1 hour before a meal or at least 2 hours after a meal. ( 2.1 ) • Avoid eating grapefruit or drinking grapefruit juice or alcohol. ( 2.1 ) • African-American patients and patients with severe hepatic impairment may require dosing adjustments. ( 2.3 ) • Frequent monitoring of trough concentrations is recommended. ( 2.4 ) • For complete dosing information, see Full Prescribing Information. MMF = Mycophenolate mofetil Recommended ASTAGRAF XL Initial Dosage Patient Population Initial Oral Dosage Whole Blood Trough Concentration Range ADULT With basiliximab, MMF and steroids 0.15 to 0.2 mg/kg once daily prior to reperfusion or within 48 hours of completion of transplant • Month 1: 7‑15 ng/mL • Months 2-6: 5‑15 ng/mL • > 6 Months: 5‑10 ng/mL With MMF and steroids, without basiliximab induction • First dose (pre-operative): 0.1 mg/kg, within 12 hours prior to reperfusion • Subsequent doses (post-operative): 0.2 mg/kg once daily at least 4 hours after pre-operative dose and within 12 hours after reperfusion • Month 1: 10‑15 ng/mL • Months 2-6: 5‑15 ng/mL • > 6 Months: 5‑10 ng/mL PEDIATRIC With basiliximab, MMF and steroids 0.3 mg/kg once daily, administered within 24 hours following reperfusion • Month 1: 10‑20 ng/mL • > Month 1: 5‑15 ng/mL…
The following clinically significant adverse drug reactions are discussed in greater detail in other sections of labeling: • Lymphoma and Other Malignancies [see Warnings and Precautions ( 5.1 )] • Serious Infections [see Warnings and Precautions ( 5.2 )] • Increased Mortality in Female Liver Transplant Patients [see Warnings and Precautions ( 5.3 )] • New Onset Diabetes after Transplant [see Warnings and Precautions ( 5.5 )] • Nephrotoxicity due to ASTAGRAF XL and Drug Interactions [see Warnings and Precautions ( 5.6 )] • Neurotoxicity [see Warnings and Precautions ( 5.7 )] • Hyperkalemia [see Warnings and Precautions ( 5.8 )] • Hypertension [see Warnings and Precautions ( 5.9 )] • QT Prolongation [see Warnings and Precautions ( 5.11 )] • Pure Red Cell Aplasia [see Warnings and Precautions ( 5.13 )] • Thrombotic Microangiopathy, Including Hemolytic Uremic Syndrome and Thrombotic Thrombocytopenic Purpura [see Warnings and Precautions ( 5.14 )] The most common adverse reactions (≥ 30%) are: diarrhea, constipation, nausea, peripheral edema, tremor and anemia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Astellas Pharma US, Inc. at 1-800-727-7003 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot…
Grapefruit & grapefruit juice
Avoid grapefruit and grapefruit juice with this medicine unless your pharmacist or the label says it's fine — check, because not every drug in a class is affected the same way.
Grapefruit Juice and Some Drugs Don't Mix — U.S. FDA ↗Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | 72/100 | Prescription | Capsule | Generic | $1 | View → | |
| 2 |
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| G;686 | 1 mg | white, white | capsule | — |
| 0;5MG;RDY525 | 0.5 mg | yellow | capsule | — |
| 5MG;RDY527 | 5 mg | red | capsule | — |
| G;685 | 0.5 mg | yellow, yellow | capsule | — |
| G;686 | 1 mg | white, white | capsule | — |
| Biocon;logo;T;0;5 | 0.5 mg |
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
Prograf (tacrolimus) capsules
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Astellas Pharma US Inc. · Dec 23, 2024
Astagraf XL (tacrolimus extended-release capsules) 0.5 mg
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Astellas Pharma US Inc. · Dec 23, 2024
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
ASTAGRAF XL is contraindicated in patients with known hypersensitivity to tacrolimus [see Adverse Reactions ( 6.2 )] . Known hypersensitivity to tacrolimus. ( 4 )
Risk of rejection with strong CYP3A inducers and risk of serious adverse reactions with strong CYP3A inhibitors: Adjust dose and monitor tacrolimus concentrations. ( 2.4 , 5.10 , 7.2 ) • Therapeutic drug monitoring and dose reduction for ASTAGRAF XL should be considered when ASTAGRAF XL is co-administered with cannabidiol ( 2.4 , 5.15 , 7.3 ). • See Full Prescribing Information for clinically significant drug interactions. ( 7.1 , 7.2 , 7.3 ) 7.1 Mycophenolic Acid When ASTAGRAF XL is prescribed with a given dose of a mycophenolic acid (MPA) product, exposure to MPA is higher with ASTAGRAF XL co-administration than with cyclosporine co-administration with MPA, because cyclosporine interrupts the enterohepatic recirculation of MPA while tacrolimus does not. Monitor for MPA-associated adverse reactions and reduce the dose of concomitantly administered mycophenolic acid products as needed. 7.2 Effects of Other Drugs on ASTAGRAF XL Table 5 displays the effects of other drugs on ASTAGRAF XL. Table 5: Effects of Other Drugs/Substances on ASTAGRAF XL a Drug/Substance Class or Name Drug Interaction Effect Recommendations a ASTAGRAF XL dosage adjustment recommendation based on observed effect of co-administered drug on tacrolimus exposures [see Clinical Pharmacology ( 12.3 )] , literature reports of altered tacrolimus exposures, or the other drug’s known CYP3A…
| 72/100 |
| Prescription |
| Capsule |
| Generic |
| $1 |
| View → |
| 3 | Not yet rated | Prescription | Tablet | Generic | $1 | View → |
| 4 | Not yet rated | Prescription | Topical | Generic | $1 | View → |
| 5 | Not yet rated | Prescription | Capsule | Generic | $1 | View → |
| yellow |
| capsule |
| — |
| Bioconlogo;T;1 | 1 mg | white | capsule | — |
|---|
| Biocon;logo;T;5 | 5 mg | gray | capsule | — |
|---|
| SAL;720 | 0.5 mg | red | capsule | — |
|---|
| SAL;721 | 1 mg | green | capsule | — |
|---|
| SAL;722 | 5 mg | blue | capsule | — |
|---|
| G;687 | 5 mg | red, red | capsule | — |
|---|