Tacrolimus
Brand names: Astagraf Xl, Envarsus Xr, Prograf, Tacrolimus
At a glance
- Medicare prescriptions, 2024
- 474,022
- Medicare drug cost
- $74.0M
- Average cost per prescription
- $156
- Clinicians who prescribed it
- 13,093
Where it is prescribed
List the prescribers in any state, county, city or ZIP code →
What it is used for
ENVARSUS XR is a calcineurin-inhibitor immunosuppressant indicated for: The prophylaxis of organ rejection in de novo kidney transplant patients in combination with other immunosuppressants The prophylaxis of organ rejection in kidney transplant patients converted from tacrolimus immediate-release formulations in combination with other immunosuppressants
From the FDA-approved prescribing information (label dated February 2025). Full labels on DailyMed (opens in a new tab)
Boxed warning
WARNING: MALIGNANCIES AND SERIOUS INFECTIONS Increased risk for developing serious infections and malignancies with ENVARSUS XR or other immunosuppressants that may lead to hospitalization or death. WARNING: MALIGNANCIES AND SERIOUS INFECTIONS See full prescribing information for complete boxed warning. Increased risk for developing serious infections and malignancies with ENVARSUS XR or other immunosuppressants that may lead to hospitalization or death.
The FDA’s strongest warning on a label. It doesn’t mean the drug is unsafe for most people; talk to your doctor or pharmacist before stopping or changing any medicine.
Who prescribes it
- Dermatology 28.8%
- Nurse Practitioners 17.5%
- Physician Assistants 14.6%
- Nephrology (Kidney) 7.9%
- Gastroenterology 6.6%
- Hepatology 6.3%
- Internal Medicine 3.7%
- Heart Failure & Transplant Cardiology 3.5%
- Pulmonology 2.9%
- Family Medicine 1.5%
- Cardiology 1.3%
- Transplant Surgery 1.0%
All prescribers, by place, name or specialty →
Share of Medicare prescriptions written by each specialty. Select one to list its prescribers.
Trend, 2019–2024
Medicare prescriptions rose 72% from 2019 to 2024.
Biggest change by state since 2019
- Maryland +98%
- California +92%
- Georgia +90%
- North Carolina +88%
- Washington +81%
- Pennsylvania (smallest change) +46%
- Minnesota (smallest change) +49%
From CMS’s yearly state and national Part D summaries, which count every prescriber, including those CMS leaves out of its per-clinician data (fewer than 11 prescriptions). That is why these totals are higher than the count at the top of this page. Prescriptions include refills.
What it looks like
Pills from 5 makers on file. The same medicine can look different depending on who made it, so check the imprint (the letters and numbers on the pill) with your pharmacist if a refill looks different.
Biocon Pharma Inc.
| Strength | Looks like | Imprint |
|---|---|---|
| 0.5 mg | yellow capsule, 14 mm | BIOCON LOGO T 0 5 |
| 1 mg | white capsule, 14 mm | BIOCONLOGO T 1 |
| 5 mg | gray capsule, 14 mm | BIOCON LOGO T 5 |
Cardinal Health 107, LLC
| Strength | Looks like | Imprint |
|---|---|---|
| 1 mg | green capsule, 11 mm | SAL 721 |
Jubilant Cadista Pharmaceuticals Inc.
| Strength | Looks like | Imprint |
|---|---|---|
| 0.5 mg | yellow capsule, 5 mm | PBT 0 5 |
| 1 mg | white capsule, 5 mm | PBT 1 0 |
| 5 mg | pink capsule, 4 mm | PBT 5 0 |
Panacea Biotec Limited
| Strength | Looks like | Imprint |
|---|---|---|
| 0.5 mg | yellow capsule, 5 mm | PBT 0 5 |
| 1 mg | white capsule, 5 mm | PBT 1 0 |
| 5 mg | pink capsule, 4 mm | PBT 5 0 |
Veloxis Pharmaceuticals, Inc
| Strength | Looks like | Imprint |
|---|---|---|
| 0.75 mg | white oval tablet, 11 mm | 075 TCS |
| 1 mg | white oval tablet, 11 mm | 1 TCS |
| 4 mg | white oval tablet, 16 mm | 4 TCS |
Source: DailyMed (U.S. National Library of Medicine), from each maker’s FDA drug listing. A few makers are shown, not every one. Never take a pill you can’t identify; ask a pharmacist.
Industry payments about this drug
Drug makers reported $120,182 in payments to clinicians that named this drug in 2025 (meals, speaking, consulting and similar).
- Veloxis Pharmaceuticals, Inc. $120,037
- Astellas Pharma US Inc $144
Source: CMS Open Payments, general payments (not research), program year 2025. A payment is not evidence of wrongdoing. Payments by doctor
Recalls and shortages
Not on the FDA drug shortage list.
6 recalls since 2020
- Dec 2024 · Astellas Pharma US Inc. · Class I
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules - Dec 2023 · Dr. Reddy's Laboratories, Inc. · Class II
Presence of Foreign Tablets/Capsules: One 0.5 mg Tacrolimus capsule found in a bottle of 1 mg Tacrolimus capsules. - Feb 2023 · Dr. Reddy's Laboratories, Inc. · Class II
Presence of Foreign Tablets/Capsules: Presence of one Tacrolimus 1 mg capsule co-mingled in a bottle containing and labeled as Tacrolimus 0.5 mg capsules. - Jul 2022 · Glenmark Pharmaceuticals Inc., USA · Class III
Defective Container: Tube split from side seam - Dec 2020 · Strides Pharma Inc. · Class III
Failed Moisture Limits - Mar 2020 · Mylan Pharmaceuticals Inc. · Class III
Presence of foreign tablet/capsule - Potential presence of commingled one Tacrolimus 1 mg capsule in 5 mg bottles.
Recalls usually affect specific lots from one maker, not every version of a drug. Class I is the most serious; most drug recalls are Class II. FDA recalls (opens in a new tab)
Sources: CMS Medicare Part D Prescribers by Provider and Drug (2024; prescriptions include refills, and CMS hides counts under 11 per prescriber); U.S. Food and Drug Administration, openFDA (drug labels, NDC directory, enforcement reports, drug shortages); CMS Open Payments 2025; ClinicalTrials.gov. General information only, not medical advice; not yet reviewed by our medical reviewer.