This grade answers one narrow question: how strong is the public evidence and safety record behind this drug, and how clean is its money trail and court record? It is not a verdict on whether the drug is right for you.
WARNING: MALIGNANCIES AND SERIOUS INFECTIONS Increased risk for developing serious infections and malignancies with PROGRAF or other immunosuppressants that may lead to hospitalization or death. ( 5.1 , 5.2 ) WARNING: MALIGNANCIES AND SERIOUS INFECTIONS See full prescribing information for complete boxed warning. Increased risk for developing serious infections and malignancies with PROGRAF or other immunosuppressants that may lead to hospitalization or death. ( 5.1 , 5.2 )
This verdict covers topical tacrolimus, not every form of the drug, so it does not affect the grade.
Topical pimecrolimus and topical tacrolimus, two immunosuppressants used in atopic eczema, can cause skin cancer and lymphoma. These adverse effects are disproportionate, as the drugs’ efficacy is barely different from that of high-potency topical corticosteroids (Prescrire Int n° 71, 101, 110, 118, 131, 224; Rev Prescrire n° 311, 331, 343, 367 , 428) ( c). Judicious use of a topical corticosteroid to treat flare-ups is a better option in this situation. There are almost no comparative evaluation data available on pimecrolimus or tacrolimus in patients in whom a topical corticosteroid has fail...
Prescrire is a French independent review funded only by subscribers, with no industry money. Its annual "drugs to avoid" list (2026 edition, section: Allergy) names drugs it judges more harmful than useful in every authorised indication. Its view is one expert opinion, reached without a conflict of interest.
Listed on the WHO Model List of Essential Medicines: a global expert panel judged it among the medicines a health system should always have, on evidence of value, not marketing.
is a calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric patients receiving allogeneic liver, kidney, heart, or lung transplants, in combination with other immunosuppressants. ( 1.1 ) 1.1 Prophylaxis of Organ Rejection in Kidney, Liver, Heart, or Lung Transplant PROGRAF ® is indicated for the prophylaxis of organ rejection, in adult and pediatric patients receiving allogeneic kidney transplant [see Clinical Studies ( 14.1 )], liver transplant [see Clinical Studies ( 14.2 )], heart transplant [see Clinical Studies ( 14.3 )], or lung transplant [see Clinical Studies ( 14.4 )] in combination with other immunosuppressants.
is contraindicated in patients with a hypersensitivity to tacrolimus. PROGRAF injection is contraindicated in patients with a hypersensitivity to HCO-60 (polyoxyl 60 hydrogenated castor oil). Hypersensitivity symptoms reported include dyspnea, rash, pruritus, and acute respiratory distress syndrome [see Adverse Reactions ( 6 )] . • Hypersensitivity to tacrolimus or HCO-60 (polyoxyl 60 hydrogenated castor oil). ( 4 )
• Not Interchangeable with Extended-Release Tacrolimus Products - Medication Errors: Instruct patients or caregivers to recognize the appearance of PROGRAF capsules. ( 5.3 ) • New Onset Diabetes After Transplant: Monitor blood glucose. ( 5.4 ) • Nephrotoxicity (acute and/or chronic): Reduce the dose; use caution with other nephrotoxic drugs. ( 5.5 ) • Neurotoxicity: Including risk of Posterior Reversible Encephalopathy Syndrome (PRES); monitor for neurologic abnormalities; reduce or discontinue PROGRAF. ( 5.6 ) • Hyperkalemia: Monitor serum potassium levels. Consider carefully before using with other agents also associated with hyperkalemia. ( 5.7 ) • Hypertension: May require antihypertensive therapy. Monitor relevant drug-drug interactions. ( 5.8 ) • Anaphylactic Reactions with IV formulation: Observe patients receiving PROGRAF injection for signs and symptoms of anaphylaxis. ( 5.9 ) • Not recommended for use with sirolimus: Not recommended in liver and heart transplant due to increased risk of serious adverse reactions. ( 5.10 ) • Myocardial Hypertrophy: Consider dose reduction/discontinuation. ( 5.13 ) • Immunizations: Avoid live vaccines. ( 5.14 ) • Pure Red Cell Aplasia: Cons...
The following serious and otherwise important 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 )] • New Onset Diabetes After Transplant [see Warnings and Precautions ( 5.4 )] • Nephrotoxicity [see Warnings and Precautions ( 5.5 )] • Neurotoxicity [see Warnings and Precautions ( 5.6 )] • Hyperkalemia [see Warnings and Precautions ( 5.7 )] • Hypertension [see Warnings and Precautions ( 5.8 )] • Anaphylactic Reactions with PROGRAF Injection [see Warnings and Precautions ( 5.9 )] • Myocardial Hypertrophy [see Warnings and Precautions ( 5.13 )] • Pure Red Cell Aplasia [see Warnings and Precautions ( 5.15 )] • Thrombotic Microangiopathy, Including Hemolytic Uremic Syndrome and Thrombotic Thrombocytopenic Purpura [see Warnings and Precautions ( 5.16 )] The most common adverse reactions (≥ 15%) were abnormal renal function, hypertension, diabetes mellitus, fever, CMV infection, tremor, hyperglycemia, leukopenia, infection, anemia, bronchitis, pericardial effusion, urinary tract infection, constipation, diarrhea, headache, abd...
Warnings and Precautions ( 5.5 , 5.10 , 5.16 ) 11/2022 Warnings and Precautions, Cannabidiol Drug Interactions ( 5.17 ) 08/2023
Source: FDA SPL label for Prograf (Astellas Pharma US, Inc.), effective 20230825. Full label on DailyMed.
These are counts of reports people filed, not rates of harm. Anyone can file one, and nobody checks whether the drug was the cause. Millions of doses are taken for every report sent, so the useful part is how this drug compares with the average across all drugs.
| 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | 2026 |
|---|---|---|---|---|---|---|---|
| 12,194 | 14,373 | 13,058 | 12,400 | 13,762 | 14,871 | 14,737 | 6,775 |
52,910 reports blaming this drug for every million Medicare prescriptions filled, which is 19.1× the typical drug on this site. (35,501 reports in 2024–2026, against 670,966 Medicare fills in one year. This is the one number here that accounts for how many people take the drug.)
Source: the FDA's Adverse Event Reporting System (FAERS). Reports are voluntary and unverified. Drugs that are prescribed a lot, in the news, or in lawsuits attract more reports, so the percentages are compared with the whole database to correct for that partly, not fully.
| Date | Class | Firm | Reason |
|---|---|---|---|
| 12/2024 | Class I | Astellas Pharma US Inc. | Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules |
| 12/2023 | Class II | Dr. Reddy's Laboratories, Inc. | Presence of Foreign Tablets/Capsules: One 0.5 mg Tacrolimus capsule found in a bottle of 1 mg Tacrolimus capsules. |
| 02/2023 | Class II | Dr. Reddy's Laboratories, Inc. | 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. |
| 07/2022 | Class III | Glenmark Pharmaceuticals Inc., USA | Defective Container: Tube split from side seam |
| 12/2020 | Class III | Strides Pharma Inc. | Failed Moisture Limits |
| 03/2020 | Class III | Mylan Pharmaceuticals Inc. | Presence of foreign tablet/capsule - Potential presence of commingled one Tacrolimus 1 mg capsule in 5 mg bottles. |
| 06/2012 | Class II | Mylan LLC. | Failed USP Content Uniformity Requirements: OOS result reported on retained samples. |
Class I = reasonable probability of serious harm. Class II = temporary or reversible harm. Class III = unlikely to harm. Most generic recalls are manufacturing or labeling defects for one lot, not a verdict on the molecule.
Counts measure how much evidence exists and how transparent it is, not how big the benefit is. For that, ask your prescriber: if 100 people like me took this, how many would get better because of it, and how many would be harmed? (Doctors call these the "number needed to treat" and "number needed to harm.") It differs by condition and is the number drug ads leave out. Sources: PubMed, ClinicalTrials.gov.
In 2024, drug companies reported $80,959 in payments to US physicians and hospitals tied to this drug across 660 transactions (Envarsus $80,959).
No pending federal MDL names this drug or its brands.
Not named in any federal pharmaceutical settlement of $100M or more on record.
Sources: CMS Open Payments (Sunshine Act); Judicial Panel on Multidistrict Litigation pending docket list; DOJ settlements as tabulated on Wikipedia with links to the primary record. State-court and individual suits are not included.
| Product | Fills | $/fill |
|---|---|---|
| Tacrolimus | 646,614 | $133 |
| Envarsus XR | 19,015 | $887 |
| Prograf | 4,634 | $863 |
| Astagraf XL | 703 | $708 |
2 drugs in the same class grade a letter or more higher than tacrolimus on this site. Worth asking whether one of them would do the same job for you.
Same ATC pharmacological class, graded ones first, best grade at the top. Being in the same class does not make them interchangeable for your condition; it makes them worth asking about.