Tacrolimus
Active ingredient · 2 therapeutic classes
Sold as Protopy · Modigraf · Envarsus · Tacforius · PROGRAF
- Drug class
- Calcineurin Inhibitors
- Availability
- Prescription only
- Routes
- Oral, Topical, Intravenous
- Markets covered
- 4
- Products on record
- 181
- FDA reports (12 mo)
- 11,749
Overview
Tacrolimus is an active pharmaceutical ingredient in the Calcineurin Inhibitors group (L04AD). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 141 | May 22, 2026 |
| CA Canada | Health Canada | 31 | May 29, 2026 |
| EU European Union | EMA | 5 | December 3, 2025 |
| US United States | FDA | 4 | September 22, 2025 |
GBUnited Kingdom· MHRA
141 products
Uses
Prophylaxis of transplant rejection in liver, kidney or heart allograft recipients. Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products.
How to take
CACanada· Health Canada
31 products
Uses
Transplantation Prograf® (tacrolimus) is indicated for: • prophylaxis of organ rejection in patients receiving allogeneic liver, kidney or heart transplants. • treatment of refractory rejection in patients receiving allogeneic liver or kidney transplants.
Prograf is to be used concomitantly with adrenal corticosteroids and other immunosuppressive agents. The safety and efficacy of the use of Prograf with sirolimus has not been established. Only physicians experienced in immunosuppressive therapy and management of organ transplant should prescribe Prograf (tacrolimus).
Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient.
Rheumatoid Arthritis Prograf (tacrolimus immediate-release capsules, USP) is indicated for: • treatment of active rheumatoid arthritis in adult patients for whom disease modifying anti-rheumatic drug (DMARD) therapy is ineffective or inappropriate.
EUEuropean Union· EMA
5 products
Uses
03% ointment is indicated in adults, adolescents and children from the age of 2 years. Flare treatment Adults and adolescents (16 years of age and above) Treatment of moderate to severe atopic dermatitis in adults who are not adequately responsive to or are intolerant of conventional therapies such as topical corticosteroids.
Children (2 years of age and above) Treatment of moderate to severe atopic dermatitis in children who failed to respond adequately to conventional therapies such as topical corticosteroids. e. occurring 4 or more times per year) who have had an initial response to a maximum of 6 weeks treatment of twice daily tacrolimus ointment (lesions cleared, almost cleared or mildly affected).
How to take
USUnited States· FDA
4 products
Uses
2 )] . 's ASTAGRAF XL (tacrolimus extended-release capsules). 's marketing exclusivity rights, this drug product is not labeled with that information. Tacrolimus extended-release capsules is a calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in kidney transplant patients in combination with other immunosuppressants in adult patients who can swallow capsules intact.
2 )
How to take
Drug interactions
Known interactions involving Tacrolimus. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 600. Type above to find a specific drug.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PL002891620 · revised July 12, 2019
- [2]Health Canada (DPD) · 02175983 · revised January 22, 2026
- [3]European Medicines Agency · EMEA/H/C/000374 · revised December 3, 2025
- [4]FDA DailyMed · 08cf2861-2483-40… · revised February 7, 2024 [PDF]
- [5]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.