Is Tadalafil registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 87 valid registrations of Tadalafil, including AVIALIS 20 MG F.C.TABLET (20 mg, Film-coated tablet, SAR 64.00); AVIALIS 5 MG F.C.TABLET (5 mg, Film-coated tablet, SAR 136.15); Ascenta (20 mg, Film-coated tablet, SAR 64.84); Ascenta (5 mg, Film-coated tablet, SAR 136.15); Avialis (20 mg, Film-coated tablet, SAR 32.00).

Is Tadalafil approved by the US FDA?

Drugs@FDA lists 49 application product lines for Tadalafil, including CIALIS (Prescription); ADCIRCA (Prescription); TADALAFIL (Prescription); TADALAFIL (Prescription); TADALAFIL (Prescription).

Is Tadalafil authorised in the European Union?

EMA lists 5 centrally authorised medicines containing Tadalafil: Cialis, Adcirca (previously Tadalafil Lilly), Tadalafil Mylan, Talmanco (previously Tadalafil Generics), Tadalafil Lilly.

Are there safety signals or safety updates for Tadalafil?

US FDA: 3 entries (latest 2025-04-02).

Active substance

Tadalafil

SFDA 98
US FDA 49
EMA 5
Health Canada 71
US price lines 10
NHS prices 4
Safety 3

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
AVIALIS 20 MG F.C.TABLET	20 mg	Film-coated tablet · Oral use	4 Blister	SAR 64.00	Generic · Prescription	Middle East Pharmaceutical Industries Co Ltd Avalon Pharma	Valid
AVIALIS 20 MG F.C.TABLET	20 mg	Film-coated tablet · Oral use	1 Blister	SAR 16.00	Generic · Prescription	Middle East Pharmaceutical Industries Co Ltd Avalon Pharma	Valid
AVIALIS 5 MG F.C.TABLET	5 mg	Film-coated tablet · Oral use	28 Blister	SAR 136.15	Generic · Prescription	Middle East Pharmaceutical Industries Co Ltd Avalon Pharma	Valid
Ascenta	20 mg	Film-coated tablet · Oral use	4 Blister	SAR 64.84	Generic · Prescription	ALPHA PHARMA INDUSTRY	Valid
Ascenta	5 mg	Film-coated tablet · Oral use	30 Blister	SAR 136.15	Generic · Prescription	ALPHA PHARMA INDUSTRY	Valid
Avialis	20 mg	Film-coated tablet · Oral use	2 Blister	SAR 32.00	Generic · Prescription	Middle East Pharmaceutical Industries Co Ltd Avalon Pharma	Valid
CIALIS 20MG TAB	20 mg	Film-coated tablet · Oral use	4 Blister	SAR 109.50	NCE · Prescription	AJA PHARMACEUTICAL INDUSTRIES	Valid
CIALIS 20MG TAB	20 mg	Film-coated tablet · Oral use	12 Blister	SAR 314.15	NCE · Prescription	AJA PHARMACEUTICAL INDUSTRIES	Valid
CIALIS ONCE-A-DAY 5MG TABLETS	5 mg	Film-coated tablet · Oral use	28 Blister	SAR 229.90	NCE · Prescription	AJA PHARMACEUTICAL INDUSTRIES	Valid
Cialis	20 mg	Film-coated tablet · Oral use	1 Blister	SAR 27.40	NCE · Prescription	AJA PHARMACEUTICAL INDUSTRIES	Valid
Coduro	5 mg	Film-coated tablet · Oral use	28 Blister	SAR 127.05	Generic · Prescription	LABORATORIOS CINFA SA	Valid
Coduro	20 mg	Film-coated tablet · Oral use	4 Blister	SAR 64.85	Generic · Prescription	LABORATORIOS CINFA SA	Valid
Coduro	20 mg	Film-coated tablet · Oral use	12 Blister	SAR 181.25	Generic · Prescription	LABORATORIOS CINFA SA	Valid
DANDAXA	20 mg	Film-coated tablet · Oral use	12 Blister	SAR 192.00	Generic · Prescription	Gulf Pharmaceutical Industries (Julphar)	Valid
DANDAXA	20 mg	Film-coated tablet · Oral use	4 Blister	SAR 64.00	Generic · Prescription	Gulf Pharmaceutical Industries (Julphar)	Valid
Dandaxa	20 mg	Film-coated tablet · Oral use	1 Blister	SAR 15.85	Generic · Prescription	GULF PHARMACEUTICAL INDUSTIRES- JULPHAR	Valid
Dandaxa	5 mg	Coated tablet · Oral use	28 Blister	SAR 120.00	Generic · Prescription	Gulf Pharmaceutical Industries (Julphar)	Valid
EDYST 20 MG F.C.TABLET	20 mg	Film-coated tablet · Oral use	4 Blister	SAR 50.55	Generic · Prescription	UNITED PHARMACEUTICAL COMPANY	Valid
Esqua	5 mg	Film-coated tablet · Oral use	28 Blister	SAR 131.55	Generic · Prescription	Galenicum Health S.L	Valid
FONTAX	5 mg	Film-coated tablet · Oral use	30 Blister	SAR 136.15	Generic · Prescription	AJA PHARMACEUTICAL INDUSTRIES	Valid
FONTAX 20 mg film-coated tablet	20 mg	Film-coated tablet · Oral use	4 Blister	SAR 64.85	Generic · Prescription	AJA PHARMACEUTICAL INDUSTRIES	Valid
Falofil	20 mg	Film-coated tablet · Oral use	4 Blister	SAR 63.45	Generic · Prescription	Pharma Pharmaceutical Industries & Biological Products	Valid
Falofil	5 mg	Tablet · Oral use	4 Blister	SAR 17.15	Generic · Prescription	Pharma Pharmaceutical Industries & Biological Products	Valid
GLOFEL 20 mg Film-coated Tablet	20 mg	Film-coated tablet · Oral use	2 Blister	SAR 32.00	Generic · Prescription	GLOBAL PHARMA	Valid
GLOFEL 20 mg Film-coated Tablet	20 mg	Film-coated tablet · Oral use	4 Blister	SAR 64.00	Generic · Prescription	GLOBAL PHARMA	Valid

73 more — full table

Indications — CHI Daman Drug Formulary

PULMONARY ARTERIAL HYPERTENSION; RAYNAUD'S PHENOMENON; SICKLE CELL DISEASE - PRIAPISM; TREATMENT OF ALTITUDE SICKNESS

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

Product	Strength	Form · route	Applicant	Status	First approved
CIALIS	5MG; 10MG; 20MG	tablet · oral	LILLY	Prescription	21 Nov 2003
ADCIRCA	20MG	tablet · oral	ELI LILLY CO	Prescription	22 May 2009
TADALAFIL	2.5MG; 5MG; 10MG; 20MG	tablet · oral	TEVA PHARMS USA	Prescription	22 May 2018
TADALAFIL	20MG	tablet · oral	AUROBINDO PHARMA LTD	Prescription	5 Feb 2019
TADALAFIL	20MG	tablet · oral	HETERO LABS LTD III	Prescription	5 Feb 2019
ALYQ	20MG	tablet · oral	TEVA PHARMS USA	Prescription	5 Feb 2019
TADALAFIL	20MG	tablet · oral	DR REDDYS	Prescription	5 Feb 2019
TADALAFIL	20MG	tablet · oral	CIPLA	Prescription	5 Feb 2019
TADALAFIL	20MG	tablet · oral	AJANTA PHARMA LTD	Prescription	5 Feb 2019
TADALAFIL	20MG	tablet · oral	CHARTWELL RX	Prescription	5 Feb 2019
TADALAFIL	2.5MG; 5MG; 10MG; 20MG	tablet · oral	ALEMBIC	Prescription	26 Mar 2019
TADALAFIL	2.5MG; 5MG; 10MG; 20MG	tablet · oral	AUROBINDO PHARMA LTD	Prescription	26 Mar 2019
TADALAFIL	2.5MG; 5MG; 10MG; 20MG	tablet · oral	ZYDUS PHARMS	Prescription	26 Mar 2019
TADALAFIL	2.5MG; 5MG; 10MG; 20MG	tablet · oral	SUN PHARM	Prescription	26 Mar 2019
TADALAFIL	2.5MG; 5MG; 10MG; 20MG	tablet · oral	ACCORD HLTHCARE	Prescription	26 Mar 2019
TADALAFIL	2.5MG; 5MG; 10MG; 20MG	tablet · oral	UNICHEM	Prescription	26 Mar 2019
TADALAFIL	2.5MG; 5MG; 10MG; 20MG	tablet · oral	CIPLA	Prescription	26 Mar 2019
TADALAFIL	2.5MG; 5MG; 10MG; 20MG	tablet · oral	AJANTA PHARMA LTD	Prescription	26 Mar 2019
TADALAFIL	2.5MG; 5MG; 10MG; 20MG	tablet · oral	AMNEAL PHARMS CO	Prescription	26 Mar 2019
TADALAFIL	2.5MG; 5MG; 10MG; 20MG	tablet · oral	HETERO LABS LTD III	Prescription	26 Mar 2019
TADALAFIL	2.5MG; 5MG; 10MG; 20MG	tablet · oral	DR REDDYS	Prescription	26 Mar 2019
TADALAFIL	2.5MG; 5MG; 10MG; 20MG	tablet · oral	QILU PHARM HAINAN	Prescription	26 Mar 2019
TADALAFIL	2.5MG; 5MG; 10MG; 20MG	tablet · oral	LUPIN	Prescription	26 Mar 2019
TADALAFIL	2.5MG; 5MG; 10MG; 20MG	tablet · oral	SUNSHINE	Prescription	26 Mar 2019
TADALAFIL	2.5MG; 5MG; 10MG; 20MG	tablet · oral	TORRENT	Prescription	26 Mar 2019

24 more — full table

EMA European Union — centrally authorised medicines

Cialis Eli Lilly Nederland B.V. · Authorised · authorised 12 Nov 2002 · ATC G04BE08

Therapeutic indication (EMA)

Treatment of erectile dysfunction. In order for tadalafil to be effective, sexual stimulation is required. Cialis is not indicated for use by women.

Adcirca (previously Tadalafil Lilly) Eli Lilly Nederland B.V. · Authorised · authorised 1 Oct 2008 · ATC G04BE08

Therapeutic indication (EMA)

AdultsTreatment of pulmonary arterial hypertension (PAH) classified as WHO functional class II and III, to improve exercise capacity (see section 5.1). Efficacy has been shown in idiopathic PAH (IPAH) and in PAH related to collagen vascular disease. Paediatric populationTreatment of paediatric patients aged 2 years and above with pulmonary arterial hypertension (PAH) classified as WHO functional class II and III.

Tadalafil Mylan Mylan Pharmaceuticals Limited · Authorised · authorised 21 Nov 2014 · ATC G04BE08

Therapeutic indication (EMA)

Treatment of erectile dysfunction in adult males. In order for tadalafil to be effective, sexual stimulation is required. Tadalafil Mylan is not indicated for use by women.

Talmanco (previously Tadalafil Generics) Viatris Limited · Authorised · authorised 9 Jan 2017 · ATC G04BE08

Therapeutic indication (EMA)

Talmanco is indicated in adults for the treatment of pulmonary arterial hypertension (PAH) classified as WHO functional class II and III, to improve exercise capacity. Efficacy has been shown in idiopathic PAH (IPAH) and in PAH related to collagen vascular disease.

Tadalafil Lilly Eli Lilly Nederland B.V. · Authorised · authorised 22 Mar 2017 · ATC G04BE08

Therapeutic indication (EMA)

Treatment of erectile dysfunction in adult males.In order for tadalafil to be effective, sexual stimulation is required. Tadalafil Lilly is not indicated for use by women. Treatment of the signs and symptoms of benign prostatic hyperplasia in adult males.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ACH-TADALAFIL	02515989	5 MG	TABLET · ORAL	ACCORD HEALTHCARE INC
ACH-TADALAFIL	02515997	10 MG	TABLET · ORAL	ACCORD HEALTHCARE INC
ACH-TADALAFIL	02516004	20 MG	TABLET · ORAL	ACCORD HEALTHCARE INC
AG-TADALAFIL	02481405	5 MG	TABLET · ORAL	ANGITA PHARMA INC.
AG-TADALAFIL	02481421	20 MG	TABLET · ORAL	ANGITA PHARMA INC.
APO-TADALAFIL	02422085	2.5 MG	TABLET · ORAL	APOTEX INC
APO-TADALAFIL	02422093	5 MG	TABLET · ORAL	APOTEX INC
APO-TADALAFIL	02422107	10 MG	TABLET · ORAL	APOTEX INC
APO-TADALAFIL	02422115	20 MG	TABLET · ORAL	APOTEX INC
APO-TADALAFIL PAH	02421933	20 MG	TABLET · ORAL	APOTEX INC
AURO-TADALAFIL	02435896	2.5 MG	TABLET · ORAL	AURO PHARMA INC
AURO-TADALAFIL	02435926	5 MG	TABLET · ORAL	AURO PHARMA INC
AURO-TADALAFIL	02435934	10 MG	TABLET · ORAL	AURO PHARMA INC
AURO-TADALAFIL	02435942	20 MG	TABLET · ORAL	AURO PHARMA INC
BIO-TADALAFIL	02508702	5 MG	TABLET · ORAL	BIOMED PHARMA
BIO-TADALAFIL	02508710	10 MG	TABLET · ORAL	BIOMED PHARMA
BIO-TADALAFIL	02508729	20 MG	TABLET · ORAL	BIOMED PHARMA
CIALIS	02248088	10 MG	TABLET · ORAL	ELI LILLY CANADA INC
CIALIS	02248089	20 MG	TABLET · ORAL	ELI LILLY CANADA INC
CIALIS	02296888	2.5 MG	TABLET · ORAL	ELI LILLY CANADA INC
CIALIS	02296896	5 MG	TABLET · ORAL	ELI LILLY CANADA INC
JAMP-TADALAFIL	02451832	5 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
JAMP-TADALAFIL	02451840	10 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
JAMP-TADALAFIL	02451859	20 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
M-TADALAFIL	02512114	5 MG	TABLET · ORAL	MANTRA PHARMA INC

46 more — full table

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	ALYQ 20 MG TABLET	$0.14633	per EA	23 Sep 2026
US NADAC	CIALIS 10 MG TABLET	$53.6874	per EA	18 Mar 2026
US NADAC	CIALIS 20 MG TABLET	$53.82543	per EA	23 Sep 2026
US NADAC	CIALIS 5 MG TABLET	$9.20446	per EA	23 Sep 2026
US NADAC	TADALAFIL 10 MG TABLET	$0.15341	per EA	23 Sep 2026
US NADAC	TADALAFIL 2.5 MG TABLET	$0.11265	per EA	23 Sep 2026
US NADAC	TADALAFIL 20 MG TABLET	$0.16709	per EA	23 Sep 2026
US NADAC	TADALAFIL 20 MG TABLET	$0.14633	per EA	23 Sep 2026
US NADAC	TADALAFIL 5 MG TABLET	$0.10319	per EA	23 Sep 2026
US NADAC	TADLIQ 20 MG/5 ML SUSPENSION	$13.59311	per ML	1 Oct 2026
NHS Drug Tariff	Tadalafil 10mg tablets	£0.85	4 tablet	1 Oct 2026
NHS Drug Tariff	Tadalafil 2.5mg tablets	£16.26	28 tablet	1 Oct 2026
NHS Drug Tariff	Tadalafil 20mg tablets	£0.82	4 tablet	1 Oct 2026
NHS Drug Tariff	Tadalafil 5mg tablets	£2.08	28 tablet	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.

Safety signals and safety-related labeling changes

US FDA 2 Apr 2025 OPSYNVI — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 15 Sep 2020 ADCIRCA — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 15 Feb 2018 CIALIS — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for tadalafil →

Combinations containing Tadalafil

Macitentan + tadalafil

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.