Is Tacrolimus registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 32 valid registrations of Tacrolimus, including ADVAGRAF 0.5MG PROLONGED RELEASE CAPSULE (0.5 mg, Prolonged-release capsule, hard, SAR 347.90); ADVAGRAF 1MG PROLONGED RELEASE CAPSULE (1 mg, Prolonged-release capsule, hard, SAR 695.75); ADVAGRAF 3MG PROLONGED RELEASE CAPSULE (3 mg, Prolonged-release capsule, hard, SAR 2087.25); ADVAGRAF 5MG PROLONGED RELEASE CAPSULE (5 mg, Prolonged-release capsule, hard, SAR 3478.75); ARNALTEM (0.5 mg, Capsule, hard, SAR 200.95).

Is Tacrolimus approved by the US FDA?

Drugs@FDA lists 26 application product lines for Tacrolimus, including PROGRAF (Prescription); PROGRAF (Prescription); PROTOPIC (Prescription); TACROLIMUS (Prescription); TACROLIMUS (Prescription).

Is Tacrolimus authorised in the European Union?

EMA lists 5 centrally authorised medicines containing Tacrolimus: Protopic, Advagraf, Modigraf, Envarsus, Tacforius.

Is Tacrolimus on the WHO Model List of Essential Medicines?

Yes — 8.1. Immunomodulators for non-malignant disease (complementary list): Failure or rejection of transplanted organs or tissues.

Are there safety signals or safety updates for Tacrolimus?

EMA PRAC: 4 entries; US FDA: 5 entries (latest 2024-04-08).

Active substance

Tacrolimus

SFDA 35
US FDA 26
EMA 6
Health Canada 23
US price lines 13
NHS prices 19
WHO EML 1
Safety 9

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
ADVAGRAF 0.5MG PROLONGED RELEASE CAPSULE	0.5 mg	Prolonged-release capsule, hard · Oral use	100 Blister	SAR 347.90	NCE · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
ADVAGRAF 1MG PROLONGED RELEASE CAPSULE	1 mg	Prolonged-release capsule, hard · Oral use	100 Blister	SAR 695.75	NCE · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
ADVAGRAF 3MG PROLONGED RELEASE CAPSULE	3 mg	Prolonged-release capsule, hard · Oral use	100 Blister	SAR 2087.25	NCE · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
ADVAGRAF 5MG PROLONGED RELEASE CAPSULE	5 mg	Prolonged-release capsule, hard · Oral use	100 Blister	SAR 3478.75	NCE · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
ARNALTEM	0.5 mg	Capsule, hard · Oral use	100 Blister	SAR 200.95	Generic · Prescription	ALPHA PHARMA INDUSTRY	Valid
ARNALTEM	5 mg	Capsule, hard · Oral use	100 Blister	SAR 2009.90	Generic · Prescription	ALPHA PHARMA INDUSTRY	Valid
ARNALTEM	1 mg	Capsule, hard · Oral use	100 Blister	SAR 402.00	Generic · Prescription	ALPHA PHARMA INDUSTRY	Valid
CROTAL 1MG CAPSULE	1 mg	Capsule · Oral use	100 Blister	SAR 423.15	Generic · Prescription	SPIMACO ADDWAEIH	Valid
CROTAL 5MG CAPSULE	5 mg	Capsule · Oral use	100 Blister	SAR 2115.70	Generic · Prescription	SPIMACO ADDWAEIH	Valid
Crotal	0.5 mg	Capsule · Oral use	100 Bottle	SAR 211.55	Generic · Prescription	SPIMACO ADDWAEIH	Valid
PROGRAF 1 mg capsule	1 mg	Capsule, hard · Oral use	100 Tablet Container	SAR 884.20	NCE · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
PROGRAF 5 mg capsule	5 mg	Capsule, hard · Oral use	100 Tablet Container	SAR 4033.60	NCE · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
PROTOPIC 0.03% OINTMENT	0.03 %	Ointment · Topical	1 Tube	SAR 176.60	NCE · Prescription	LEO Pharma A/S Denmark	Valid
PROTOPIC 0.1% OINTMENT	0.1 %	Ointment · Topical	1 Tube	SAR 188.80	NCE · Prescription	LEO Pharma A/S Denmark	Valid
Prograf	0.5 mg	Capsule, hard · Oral use	100 Bottle	SAR 442.10	NCE · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
ROLITAC 0.5 mg Capsule	0.5 mg	Capsule, hard · Oral use	100 Blister	SAR 235.05	Generic · Prescription	SANDOZ	Valid
ROLITAC 1 mg Capsule	1 mg	Capsule, hard · Oral use	100 Blister	SAR 470.15	Generic · Prescription	SANDOZ	Valid
ROLITAC 5 mg Capsule	5 mg	Capsule, hard · Oral use	100 Blister	SAR 2350.81	Generic · Prescription	SANDOZ	Valid
Rolitac XL	0.5 mg	Prolonged-release capsule, hard · Oral use	100 Blister	SAR 253.30	Generic · Prescription	HEXAL AG	Valid
Rolitac XL	1 mg	Prolonged-release capsule, hard · Oral use	100 Blister	SAR 509.45	Generic · Prescription	HEXAL AG	Valid
Rolitac XL	3 mg	Prolonged-release capsule, hard · Oral use	100 Blister	SAR 1324.05	Generic · Prescription	HEXAL AG	Valid
Rolitac XL	5 mg	Prolonged-release capsule, hard · Oral use	100 Blister	SAR 2147.30	Generic · Prescription	HEXAL AG	Valid
TACROZ 0.03% OINTMENT	0.03 %	Ointment · Topical	1 Tube	SAR 26.50	Generic · Prescription	Glenmark Pharmaceuticals Limited	Valid
TACROZ FORTE OINTMENT	0.1 %	Ointment · Topical	1 Tube	SAR 29.40	Generic · Prescription	Glenmark Pharmaceuticals Limited	Valid
TACROZ Forte	0.1 %	Ointment · Topical	1 Tube	SAR 70.70	Generic · Prescription	Glenmark Pharmaceuticals Limited	Valid

10 more — full table

Indications — CHI Daman Drug Formulary

AUTOIMMUNE HEPATITIS; CROHN'S DISEASE; GLOMERULAR DISEASE; GRAFT VERSUS HOST DISEASE; MYASTHENIA GRAVIS; MYOSITIS; NON-INFECTIOUS UVEITIS; RENAL TRANSPLANT; SJOGREN'S SYNDROME; SYSTEMIC LUPUS ERYTHEMATOSUS; ULCERATIVE COLITIS

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
PROGRAF	EQ 1MG BASE; EQ 5MG BASE; EQ 0.5MG BASE	capsule · oral	ASTELLAS	Prescription	8 Apr 1994
PROGRAF	EQ 5MG BASE/ML	injectable · injection	ASTELLAS	Prescription	8 Apr 1994
PROTOPIC	0.03%; 0.1%	ointment · topical	LEO PHARMA AS	Prescription	8 Dec 2000
TACROLIMUS	EQ 0.5MG BASE; EQ 1MG BASE; EQ 5MG BASE	capsule · oral	SANDOZ	Prescription	10 Aug 2009
TACROLIMUS	EQ 0.5MG BASE; EQ 1MG BASE; EQ 5MG BASE	capsule · oral	DR REDDYS LABS LTD	Prescription	12 May 2010
TACROLIMUS	EQ 0.5MG BASE; EQ 1MG BASE; EQ 5MG BASE	capsule · oral	MYLAN	Prescription	17 Sep 2010
TACROLIMUS	EQ 0.5MG BASE; EQ 1MG BASE; EQ 5MG BASE	capsule · oral	ACCORD HLTHCARE	Prescription	31 Aug 2011
TACROLIMUS	EQ 0.5MG BASE; EQ 1MG BASE; EQ 5MG BASE	capsule · oral	PANACEA	Prescription	28 Sep 2012
ASTAGRAF XL	EQ 0.5MG BASE; EQ 1MG BASE; EQ 5MG BASE	capsule, extended release · oral	ASTELLAS	Prescription	19 Jul 2013
TACROLIMUS	EQ 0.5MG BASE; EQ 1MG BASE; EQ 5MG BASE	capsule · oral	STRIDES PHARMA	Prescription	22 Jul 2014
TACROLIMUS	0.03%; 0.1%	ointment · topical	FOUGERA PHARMS INC	Prescription	9 Sep 2014
ENVARSUS XR	EQ 0.75MG BASE; EQ 1MG BASE; EQ 4MG BASE	tablet, extended release · oral	VELOXIS PHARMS INC	Prescription	10 Jul 2015
TACROLIMUS	EQ 0.5MG BASE; EQ 1MG BASE; EQ 5MG BASE	capsule · oral	AJENAT PHARMS	Prescription	30 Nov 2017
TACROLIMUS	0.1%; 0.03%	ointment · topical	GLENMARK PHARMS LTD	Prescription	16 Apr 2018
PROGRAF	EQ 0.2MG BASE/PACKET; EQ 1MG BASE/PACKET	for suspension · oral	ASTELLAS	Prescription	24 May 2018
TACROLIMUS	0.03%; 0.1%	ointment · topical	ACCORD HLTHCARE	Prescription	31 Jan 2019
TACROLIMUS	EQ 0.5MG BASE; EQ 1MG BASE; EQ 5MG BASE	capsule · oral	GLENMARK PHARMS LTD	Prescription	10 Nov 2020
TACROLIMUS	EQ 0.5MG BASE; EQ 1MG BASE; EQ 5MG BASE	capsule · oral	BIOCON PHARMA	Prescription	10 Nov 2020
TACROLIMUS	EQ 0.5MG BASE; EQ 1MG BASE; EQ 5MG BASE	capsule · oral	CONCORD BIOTECH LTD	Prescription	10 Nov 2020
TACROLIMUS	EQ 0.5MG BASE; EQ 1MG BASE; EQ 5MG BASE	capsule · oral	ALKEM LABS LTD	Prescription	12 Nov 2020
TACROLIMUS	0.1%	ointment · topical	ENCUBE	Prescription	10 Oct 2023
TACROLIMUS	EQ 0.5MG BASE; EQ 1MG BASE; EQ 5MG BASE	capsule, extended release · oral	CHENGDU	Prescription	25 Jan 2024
TACROLIMUS	EQ 5MG BASE/ML	injectable · injection	NEXUS	Prescription	12 Feb 2025
TACROLIMUS	EQ 5MG BASE	capsule · oral	HERITAGE PHARMA AVET	Discontinued	1 Jul 2010
TACROLIMUS	EQ 5MG BASE/ML	injectable · injection	HOSPIRA	Discontinued	25 Aug 2017

1 more — full table

EMA European Union — centrally authorised medicines

Protopic LEO Pharma A/S · Authorised · authorised 27 Feb 2002 · ATC D11AH01

Therapeutic indication (EMA)

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 (two years of age and above) Treatment of moderate to severe atopic dermatitis in children (two years of age and above) who failed to respond adequately to conventional therapies such as topical corticosteroids. Maintenance treatment Maintenance treatment of moderate to severe atopic dermatitis for the prevention of flares and the prolongation of flare-free intervals in patients experiencing a high frequency of disease exacerbations (i.e. occurring four or more times per year) who have had an initial response to a maximum of six weeks treatment of twice daily tacrolimus ointment (lesions cleared, almost cleared or mildly affected).

Advagraf Astellas Pharma Europe BV · Authorised · authorised 23 Apr 2007 · ATC L04AD02

Therapeutic indication (EMA)

Prophylaxis of transplant rejection in adult kidney or liver allograft recipients. Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult patients.

Modigraf Astellas Pharma Europe B.V. · Authorised · authorised 15 May 2009 · ATC L04AD02

Therapeutic indication (EMA)

Prophylaxis of transplant rejection in adult and paediatric, kidney, liver or heart allograft recipients. Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult and paediatric patients.

Envarsus Chiesi Farmaceutici S.p.A. · Authorised · authorised 18 Jul 2014 · ATC L04AD02

Therapeutic indication (EMA)

Tacforius Teva B.V. · Authorised · authorised 8 Dec 2017 · ATC L04AD02

Therapeutic indication (EMA)

Protopy Astellas Pharma GmbH · Withdrawn · authorised 28 Feb 2002 · ATC D11AX14

Therapeutic indication (EMA)

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. Treatment of moderate to severe atopic dermatitis in children (2 years of age and above) who failed to respond adequately to conventional therapies such as topical corticosteroids. Maintenance treatment of moderate to severe atopic dermatitis for the prevention of flares and the prolongation of flare-free intervals in patients experiencing a high frequency of disease exacerbations (i.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).

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ACH-TACROLIMUS	02454068	0.5 MG	CAPSULE (IMMEDIATE-RELEASE) · ORAL	ACCORD HEALTHCARE INC
ACH-TACROLIMUS	02456095	1 MG	CAPSULE (IMMEDIATE-RELEASE) · ORAL	ACCORD HEALTHCARE INC
ACH-TACROLIMUS	02456109	5 MG	CAPSULE (IMMEDIATE-RELEASE) · ORAL	ACCORD HEALTHCARE INC
ADVAGRAF	02296462	0.5 MG	CAPSULE (EXTENDED-RELEASE) · ORAL	ASTELLAS PHARMA CANADA INC
ADVAGRAF	02296470	1 MG	CAPSULE (EXTENDED-RELEASE) · ORAL	ASTELLAS PHARMA CANADA INC
ADVAGRAF	02296489	5 MG	CAPSULE (EXTENDED-RELEASE) · ORAL	ASTELLAS PHARMA CANADA INC
ADVAGRAF	02331667	3 MG	CAPSULE (EXTENDED-RELEASE) · ORAL	ASTELLAS PHARMA CANADA INC
ENVARSUS PA	02485877	0.75 MG	TABLET (EXTENDED-RELEASE) · ORAL	KNIGHT THERAPEUTICS INC.
ENVARSUS PA	02485885	1 MG	TABLET (EXTENDED-RELEASE) · ORAL	KNIGHT THERAPEUTICS INC.
ENVARSUS PA	02485893	4 MG	TABLET (EXTENDED-RELEASE) · ORAL	KNIGHT THERAPEUTICS INC.
PROGRAF	02175983	5 MG	CAPSULE · ORAL	ASTELLAS PHARMA CANADA INC
PROGRAF	02175991	1 MG	CAPSULE · ORAL	ASTELLAS PHARMA CANADA INC
PROGRAF	02176009	5 MG / ML	SOLUTION · INTRAVENOUS	ASTELLAS PHARMA CANADA INC
PROGRAF	02243144	0.5 MG	CAPSULE · ORAL	ASTELLAS PHARMA CANADA INC
PROTOPIC	02244148	0.1 % / W/W	OINTMENT · TOPICAL	LEO PHARMA INC
PROTOPIC	02244149	0.03 % / W/W	OINTMENT · TOPICAL	LEO PHARMA INC
SANDOZ TACROLIMUS	02416816	0.5 MG	CAPSULE (IMMEDIATE-RELEASE) · ORAL	SANDOZ CANADA INCORPORATED
SANDOZ TACROLIMUS	02416824	1 MG	CAPSULE (IMMEDIATE-RELEASE) · ORAL	SANDOZ CANADA INCORPORATED
SANDOZ TACROLIMUS	02416832	5 MG	CAPSULE (IMMEDIATE-RELEASE) · ORAL	SANDOZ CANADA INCORPORATED
SANDOZ TACROLIMUS XR	02528592	0.5 MG	CAPSULE (EXTENDED-RELEASE) · ORAL	SANDOZ CANADA INCORPORATED
SANDOZ TACROLIMUS XR	02528606	1 MG	CAPSULE (EXTENDED-RELEASE) · ORAL	SANDOZ CANADA INCORPORATED
SANDOZ TACROLIMUS XR	02528622	3 MG	CAPSULE (EXTENDED-RELEASE) · ORAL	SANDOZ CANADA INCORPORATED
SANDOZ TACROLIMUS XR	02528630	5 MG	CAPSULE (EXTENDED-RELEASE) · ORAL	SANDOZ CANADA INCORPORATED

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	PROGRAF 0.2 MG GRANULE PACKET	$5.01513	per EA	23 Sep 2026
US NADAC	PROGRAF 0.5 MG CAPSULE	$3.65915	per EA	23 Sep 2026
US NADAC	PROGRAF 1 MG CAPSULE	$7.32732	per EA	23 Sep 2026
US NADAC	PROGRAF 1 MG GRANULE PACKET	$7.4446	per EA	23 Sep 2026
US NADAC	TACROLIMUS 0.03% OINTMENT	$0.92703	per GM	23 Sep 2026
US NADAC	TACROLIMUS 0.03% OINTMENT	$0.99827	per GM	23 Sep 2026
US NADAC	TACROLIMUS 0.03% OINTMENT	$0.88777	per GM	23 Sep 2026
US NADAC	TACROLIMUS 0.1% OINTMENT	$0.98159	per GM	23 Sep 2026
US NADAC	TACROLIMUS 0.1% OINTMENT	$0.94262	per GM	23 Sep 2026
US NADAC	TACROLIMUS 0.1% OINTMENT	$0.97006	per GM	23 Sep 2026
US NADAC	TACROLIMUS 0.5 MG CAPSULE (IMMEDIATE RELEASE)	$0.12274	per EA	23 Sep 2026
US NADAC	TACROLIMUS 1 MG CAPSULE (IMMEDIATE RELEASE)	$0.1535	per EA	23 Sep 2026
NHS Drug Tariff	Tacrolimus 0.03% ointment	£23.33	30 gram	1 Oct 2026
NHS Drug Tariff	Tacrolimus 0.03% ointment	£42.55	60 gram	1 Oct 2026
NHS Drug Tariff	Tacrolimus 0.1% ointment	£25.92	30 gram	1 Oct 2026
NHS Drug Tariff	Tacrolimus 0.1% ointment	£47.28	60 gram	1 Oct 2026
NHS Drug Tariff	Tacrolimus 1mg capsules	£80.28	50 capsule	1 Oct 2026
NHS Drug Tariff	Tacrolimus 1mg granules for oral suspension sachets sugar free	£356.65	50 sachet	1 Oct 2026
NHS Drug Tariff	Tacrolimus 1mg modified-release capsules	£71.59	50 capsule	1 Oct 2026
NHS Drug Tariff	Tacrolimus 1mg modified-release capsules	£143.17	100 capsule	1 Oct 2026
NHS Drug Tariff	Tacrolimus 1mg modified-release tablets	£59.10	30 tablet	1 Oct 2026
NHS Drug Tariff	Tacrolimus 200microgram granules for oral suspension sachets sugar free	£71.30	50 sachet	1 Oct 2026
NHS Drug Tariff	Tacrolimus 2mg capsules	£111.00	50 capsule	1 Oct 2026
NHS Drug Tariff	Tacrolimus 3mg modified-release capsules	£214.76	50 capsule	1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

WHO WHO Model List of Essential Medicines (2025)

8.1. Immunomodulators for non-malignant disease · complementary
Failure or rejection of transplanted organs or tissues
Parenteral > General injections > IV: 5 mg per mL in 1 mL vial | Oral > Liquid: 0.2 mg granules for oral suspension; 1 mg granules for oral suspension | Oral > Solid: 0.5 mg (immediate-release); 0.75 mg (immediate-release); 1 mg (immediate-release); 2 mg (immediate-release); 5 mg (immediate-release)

Safety signals and safety-related labeling changes

US FDA 8 Apr 2024 ENVARSUS XR — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 14 Sep 2023 PROGRAF — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 14 Sep 2023 ASTAGRAF XL — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 14 Sep 2023 PROGRAF — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 22 Nov 2022 PROGRAF — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 31 Oct 2018 PRAC signal: Hepatitis E infection
Action for MAH: update of the product information: Yes
EMA PRAC 14 Jun 2018 PRAC signal: Hepatitis E infection
Action for MAH: update of the product information: No
EMA PRAC 10 Jul 2014 PRAC signal: Potential drug-drug interaction between systemic tacrolimus and febuxostat
Action for MAH: update of the product information: No
EMA PRAC 6 Mar 2014 PRAC signal: Potential drug-drug interaction between systemic tacrolimus and febuxostat
Action for MAH: update of the product information: No

All safety entries for tacrolimus →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.