Is Sildenafil registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 57 valid registrations of Sildenafil, including ALADIN 25 mg film-coated tablets (25 mg, Film-coated tablet, SAR 36.30); ALADIN 50 mg film-coated tablets (50 mg, Film-coated tablet, SAR 43.70); APHRODIL 50 mg Film coated tablet (50 mg, Film-coated tablet, SAR 43.70); Aladin (50 mg, Tablet, SAR 3713.35); Aladin (25 mg, Tablet, SAR 3084.15).

Is Sildenafil approved by the US FDA?

Drugs@FDA lists 55 application product lines for Sildenafil, including VIAGRA (Prescription); REVATIO (Prescription); REVATIO (Prescription); SILDENAFIL CITRATE (Prescription); SILDENAFIL CITRATE (Prescription).

Is Sildenafil authorised in the European Union?

EMA lists 8 centrally authorised medicines containing Sildenafil: Viagra, Revatio, Vizarsin, Sildenafil Teva, Sildenafil Actavis, Sildenafil ratiopharm, Mysildecard, Granpidam.

Are there safety signals or safety updates for Sildenafil?

EMA PRAC: 6 entries; US FDA: 4 entries; MHRA: 1 entry (latest 2023-03-03).

Active substance

Sildenafil

SFDA 65
US FDA 55
EMA 10
Health Canada 47
US price lines 6
NHS prices 6
Safety 11

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
ALADIN 25 mg film-coated tablets	25 mg	Film-coated tablet · Oral use	4 Blister	SAR 36.30	Generic · Prescription	National Pharmaceutical Industries Co. (SAOG)	Valid
ALADIN 50 mg film-coated tablets	50 mg	Film-coated tablet · Oral use	4 Blister	SAR 43.70	Generic · Prescription	National Pharmaceutical Industries Co. (SAOG)	Valid
APHRODIL 50 mg Film coated tablet	50 mg	Film-coated tablet · Oral use	4 Blister	SAR 43.70	Generic · Prescription	DAR ALDAWA	Valid
Aladin	50 mg	Tablet · Oral use	400 Blister	SAR 3713.35	Generic · Prescription	National Pharmaceutical Industries Co. (SAOG)	Valid
Aladin	25 mg	Tablet · Oral use	400 Blister	SAR 3084.15	Generic · Prescription	National Pharmaceutical Industries Co. (SAOG)	Valid
CAVERTA 100MG F.C.TABLET	100 mg	Film-coated tablet · Oral use	4 Blister	SAR 13.10	Generic · Prescription	Sun Pharmaceutical Industries Limited	Valid
CAVERTA 50 MG F.C.TABLET	50 mg	Film-coated tablet · Oral use	4 Blister	SAR 6.30	Generic · Prescription	Sun Pharmaceutical Industries Limited	Valid
ERECTA 100 mg film-coated tablets	100 mg	Film-coated tablet · Oral use	4 Blister	SAR 48.55	Generic · Prescription	Jamjoom Pharmaceuticals Factory Company	Valid
ERECTA 50 mg film-coated tablets	50 mg	Film-coated tablet · Oral use	4 Blister	SAR 48.55	Generic · Prescription	Jamjoom Pharmaceuticals Factory Company	Valid
ESSERA 100 mg film-coated tablet	100 mg	Film-coated tablet · Oral use	4 Blister	SAR 43.70	Generic · Prescription	DAMMAM PHARMA	Valid
ESSERA 50 mg film-coated tablet	50 mg	Film-coated tablet · Oral use	4 Blister	SAR 43.70	Generic · Prescription	DAMMAM PHARMA	Valid
EXTEMENT 100 mg Chewable Tablet	100 mg	Chewable tablet · Oral use	4 Blister	SAR 39.35	NCE · Prescription	GENEPHARM S.A.	Valid
EXTEMENT 25 mg Chewable Tablet	25 mg	Chewable tablet · Oral use	4 Blister	SAR 36.30	NCE · Prescription	GENEPHARM S.A.	Valid
EXTEMENT 50 mg Chewable Tablet	50 mg	Chewable tablet · Oral use	4 Blister	SAR 39.35	NCE · Prescription	GENEPHARM S.A.	Valid
FALLAH 100 mg film-coated tablets	100 mg	Film-coated tablet · Oral use	4 Blister	SAR 43.70	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
FALLAH 25 mg film-coated tablets	25 mg	Film-coated tablet · Oral use	4 Blister	SAR 40.35	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
FALLAH 50 mg film-coated tablets	50 mg	Film-coated tablet · Oral use	4 Blister	SAR 43.70	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
GIAD 50 mg film-coated tablets	50 mg	Film-coated tablet · Oral use	4 Blister	SAR 43.70	Generic · Prescription	DEEF PHARMACEUTICAL INDUSTRIES	Valid
Kamagra	50 mg	Tablet · Oral use	4 Blister	SAR 39.35	Generic · Prescription	Pharma Pharmaceutical Industries & Biological Products	Valid
Kamagra	100 mg	Tablet · Oral use	4 Blister	SAR 39.35	Generic · Prescription	Pharma Pharmaceutical Industries & Biological Products	Valid
Kamagra	25 mg	Tablet · Oral use	4 Blister	SAR 36.30	Generic · Prescription	Pharma Pharmaceutical Industries & Biological Products	Valid
Sildenafil	10 mg/ml	Powder for oral suspension · Oral use	1 Bottle	SAR 1315.20	Generic · Prescription	Novitium pharma LLC	Valid
Sildenafil Amarox	10 mg/ml	Powder for oral suspension · Oral use	125 Bottle	SAR 1315.20	Generic · Prescription	Saudi Amarox	Valid
Sildenafil OHRE Pharma	20 mg	Film-coated tablet · Oral use	90 Blister	SAR 1327.50	NCE · Prescription	STRAGEN FRANCE	Valid
Tqmint	25 mg	Chewable tablet · Oral use	30 Blister	SAR 59.60	Generic · Prescription	Al-Taqaddom pharmaceutical Industries	Valid

40 more — full table

Indications — CHI Daman Drug Formulary

BENIGN PROSTATIC HYPERTROPHY; 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
VIAGRA	EQ 25MG BASE; EQ 50MG BASE; EQ 100MG BASE	tablet · oral	VIATRIS	Prescription	27 Mar 1998
REVATIO	EQ 20MG BASE	tablet · oral	VIATRIS	Prescription	3 Jun 2005
REVATIO	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	solution · intravenous	VIATRIS	Prescription	18 Nov 2009
SILDENAFIL CITRATE	EQ 20MG BASE	tablet · oral	TORRENT PHARMS LTD	Prescription	6 Nov 2012
SILDENAFIL CITRATE	EQ 20MG BASE	tablet · oral	WATSON LABS INC	Prescription	6 Nov 2012
SILDENAFIL CITRATE	EQ 20MG BASE	tablet · oral	CHARTWELL RX	Prescription	6 Nov 2012
SILDENAFIL CITRATE	EQ 20MG BASE	tablet · oral	AMNEAL PHARMS	Prescription	28 Feb 2013
SILDENAFIL CITRATE	EQ 20MG BASE	tablet · oral	MACLEODS PHARMS	Prescription	17 Dec 2013
SILDENAFIL CITRATE	EQ 20MG BASE	tablet · oral	HETERO LABS LTD V	Prescription	26 Nov 2014
SILDENAFIL CITRATE	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	solution · intravenous	EUGIA PHARMA	Prescription	1 Apr 2015
SILDENAFIL CITRATE	EQ 20MG BASE	tablet · oral	AUROBINDO PHARMA LTD	Prescription	18 Nov 2015
SILDENAFIL CITRATE	EQ 25MG BASE; EQ 50MG BASE; EQ 100MG BASE	tablet · oral	TEVA	Prescription	9 Mar 2016
SILDENAFIL CITRATE	EQ 20MG BASE	tablet · oral	RUBICON RESEARCH	Prescription	20 Jun 2016
SILDENAFIL CITRATE	EQ 20MG BASE	tablet · oral	AJANTA PHARMA LTD	Prescription	4 May 2018
SILDENAFIL CITRATE	EQ 25MG BASE; EQ 50MG BASE; EQ 100MG BASE	tablet · oral	TORRENT	Prescription	11 Jun 2018
SILDENAFIL CITRATE	EQ 25MG BASE; EQ 50MG BASE; EQ 100MG BASE	tablet · oral	HETERO LABS LTD V	Prescription	11 Jun 2018
SILDENAFIL CITRATE	EQ 25MG BASE; EQ 50MG BASE; EQ 100MG BASE	tablet · oral	AUROBINDO PHARMA LTD	Prescription	11 Jun 2018
SILDENAFIL CITRATE	EQ 25MG BASE; EQ 50MG BASE; EQ 100MG BASE	tablet · oral	RUBICON RESEARCH	Prescription	11 Jun 2018
SILDENAFIL CITRATE	EQ 25MG BASE; EQ 50MG BASE; EQ 100MG BASE	tablet · oral	AMNEAL PHARMS NY	Prescription	27 Jun 2018
SILDENAFIL CITRATE	EQ 25MG BASE; EQ 50MG BASE; EQ 100MG BASE	tablet · oral	AJANTA PHARMA LTD	Prescription	12 Oct 2018
SILDENAFIL CITRATE	EQ 25MG BASE; EQ 50MG BASE; EQ 100MG BASE	tablet · oral	CHARTWELL RX	Prescription	22 Mar 2019
SILDENAFIL CITRATE	EQ 10MG BASE/ML	for suspension · oral	NOVITIUM PHARMA	Prescription	31 May 2019
SILDENAFIL CITRATE	EQ 10MG BASE/ML	for suspension · oral	AMNEAL PHARMS	Prescription	27 Nov 2019
SILDENAFIL CITRATE	EQ 10MG BASE/ML	for suspension · oral	ALKEM LABS LTD	Prescription	27 Nov 2019
SILDENAFIL CITRATE	EQ 10MG BASE/ML	for suspension · oral	AJANTA PHARMA LTD	Prescription	27 Nov 2019

30 more — full table

EMA European Union — centrally authorised medicines

Viagra Upjohn EESV · Authorised · authorised 13 Sep 1998 · ATC G04BE03

Therapeutic indication (EMA)

Treatment of men with erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance. In order for Viagra to be effective, sexual stimulation is required.

Revatio Upjohn EESV · Authorised · authorised 28 Oct 2005 · ATC G04BE03

Therapeutic indication (EMA)

Treatment of adult patients with pulmonary arterial hypertension classified as World Health Organization (WHO) functional class II and III, to improve exercise capacity. Efficacy has been shown in primary pulmonary hypertension and pulmonary hypertension associated with connective tissue disease. Paediatric population Treatment of paediatric patients aged one year to 17 years old with pulmonary arterial hypertension. Efficacy in terms of improvement of exercise capacity or pulmonary haemodynamics has been shown in primary pulmonary hypertension and pulmonary hypertension associated with congenital heart disease. Revatio solution for injection is for the treatment of adult patients with pulmonary arterial hypertension who are currently prescribed oral Revatio and who are temporarily unable to take oral therapy, but are otherwise clinically and haemodynamically stable. Revatio (oral) is indicated for treatment of adult patients with pulmonary arterial hypertension classified as WHO functional class II and III, to improve exercise capacity. Efficacy has been shown in primary pulmonary hypertension and pulmonary hypertension associated with connective tissue disease.

Vizarsin Krka, d.d., Novo mesto · Authorised · authorised 21 Sep 2009 · ATC G04BE03

Therapeutic indication (EMA)

Treatment of men with erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance. In order for Vizarsin to be effective, sexual stimulation is required.

Sildenafil Teva Teva B.V. · Authorised · authorised 30 Nov 2009 · ATC G04BE03

Therapeutic indication (EMA)

Treatment of men with erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance. In order for Sildenafil Teva to be effective, sexual stimulation is required.

Sildenafil Actavis Actavis Group PTC ehf · Authorised · authorised 10 Dec 2009 · ATC G04BE03

Therapeutic indication (EMA)

Treatment of men with erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance. In order for Sildenafil Actavis to be effective, sexual stimulation is required.

Sildenafil ratiopharm Ratiopharm GmbH · Authorised · authorised 23 Dec 2009 · ATC G04BE03

Therapeutic indication (EMA)

Treatment of men with erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance. In order for sildenafil to be effective, sexual stimulation is required.

Mysildecard Viatris Limited · Authorised · authorised 15 Sep 2016 · ATC G04BE03

Therapeutic indication (EMA)

AdultsTreatment of adult patients with pulmonary arterial hypertension classified as WHO functional class II and III, to improve exercise capacity. Efficacy has been shown in primary pulmonary hypertension and pulmonary hypertension associated with connective tissue disease. Paediatric populationTreatment of paediatric patients aged 1 year to 17 years old with pulmonary arterial hypertension. Efficacy in terms of improvement of exercise capacity or pulmonary haemodynamics has been shown in primary pulmonary hypertension and pulmonary hypertension associated with congenital heart disease (see section 5.1).

Granpidam Accord Healthcare S.L.U. · Authorised · authorised 14 Nov 2016 · ATC G04BE03

Therapeutic indication (EMA)

Adults Treatment of adult patients with pulmonary arterial hypertension classified as WHO functional class II and III, to improve exercise capacity. Efficacy has been shown in primary pulmonary hypertension and pulmonary hypertension associated with connective tissue disease. Paediatric population Treatment of paediatric patients aged 1 year to 17 years old with pulmonary arterial hypertension. Efficacy in terms of improvement of exercise capacity or pulmonary haemodynamics has been shown in primary pulmonary hypertension and pulmonary hypertension associated with congenital heart disease.

Sildenafil FGK FGK Representative Service GmbH · Application withdrawn · ATC G04BE03

Therapeutic indication (EMA)

Treatment of erectile dysfunction

Patrex Pfizer Limited · Withdrawn · authorised 15 Sep 1998 · ATC G04BE03

Therapeutic indication (EMA)

Treatment of men with erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance. In order for Patrex to be effective, sexual stimulation is required. Patrex is not indicated for use by women.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ACCEL-SILDENAFIL	02479796	25 MG	TABLET · ORAL	ACCEL PHARMA INC
ACCEL-SILDENAFIL	02479818	50 MG	TABLET · ORAL	ACCEL PHARMA INC
ACCEL-SILDENAFIL	02479826	100 MG	TABLET · ORAL	ACCEL PHARMA INC
AG-SILDENAFIL TABLETS	02503344	100 MG	TABLET · ORAL	ANGITA PHARMA INC.
APO-SILDENAFIL	02248201	25 MG	TABLET · ORAL	APOTEX INC
APO-SILDENAFIL	02248202	50 MG	TABLET · ORAL	APOTEX INC
APO-SILDENAFIL	02248203	100 MG	TABLET · ORAL	APOTEX INC
AURO-SILDENAFIL	02414368	25 MG	TABLET · ORAL	AURO PHARMA INC
AURO-SILDENAFIL	02414376	50 MG	TABLET · ORAL	AURO PHARMA INC
AURO-SILDENAFIL	02414384	100 MG	TABLET · ORAL	AURO PHARMA INC
BIO-SILDENAFIL	02480980	100 MG	TABLET · ORAL	BIOMED PHARMA
JAMP SILDENAFIL TABLETS	02503506	100 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
JAMP-SILDENAFIL R	02469669	20 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
M-SILDENAFIL	02430037	100 MG	TABLET · ORAL	MANTRA PHARMA INC
MAR-SILDENAFIL	02402548	100 MG	TABLET · ORAL	MARCAN PHARMACEUTICALS INC
MINT-SILDENAFIL	02393069	25 MG	TABLET · ORAL	MINT PHARMACEUTICALS INC
MINT-SILDENAFIL	02393077	50 MG	TABLET · ORAL	MINT PHARMACEUTICALS INC
MINT-SILDENAFIL	02393085	100 MG	TABLET · ORAL	MINT PHARMACEUTICALS INC
NRA-SILDENAFIL	02476819	100 MG	TABLET · ORAL	NORA PHARMA INC
PMS-SILDENAFIL R	02412179	20 MG	TABLET · ORAL	PHARMASCIENCE INC
PRZ-SILDENAFIL	02468557	100 MG	TABLET · ORAL	PHARMARIS CANADA INC
PRZ-SILDENAFIL	02505150	25 MG	TABLET · ORAL	PHARMARIS CANADA INC
PRZ-SILDENAFIL	02505169	50 MG	TABLET · ORAL	PHARMARIS CANADA INC
REVATIO	02279401	20 MG	TABLET · ORAL	BGP PHARMA ULC
REVATIO	02341611	0.8 MG / ML	SOLUTION · INTRAVENOUS	BGP PHARMA ULC

22 more — full table

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	SILDENAFIL 10 MG/ML ORAL SUSP	$0.26026	per ML	23 Sep 2026
US NADAC	SILDENAFIL 100 MG TABLET	$0.13192	per EA	30 Sep 2026
US NADAC	SILDENAFIL 20 MG TABLET	$0.05105	per EA	23 Sep 2026
US NADAC	SILDENAFIL 25 MG TABLET	$0.12199	per EA	7 Oct 2026
US NADAC	SILDENAFIL 50 MG TABLET	$0.10675	per EA	30 Sep 2026
US NADAC	VIAGRA 100 MG TABLET	$83.71647	per EA	23 Sep 2026
NHS Drug Tariff	Sildenafil 100mg tablets	£0.71	4 tablet	1 Oct 2026
NHS Drug Tariff	Sildenafil 10mg/ml oral suspension sugar free	£186.75	90 ml	1 Oct 2026
NHS Drug Tariff	Sildenafil 10mg/ml oral suspension sugar free	£186.75	122 ml	1 Oct 2026
NHS Drug Tariff	Sildenafil 20mg tablets	£446.33	90 tablet	1 Oct 2026
NHS Drug Tariff	Sildenafil 25mg tablets	£0.73	4 tablet	1 Oct 2026
NHS Drug Tariff	Sildenafil 50mg tablets	£0.66	4 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 3 Mar 2023 REVATIO — 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 3 Mar 2023 REVATIO — 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 31 Jan 2023 REVATIO — 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
MHRA 14 Nov 2018 Sildenafil (Revatio and Viagra): reports of persistent pulmonary hypertension of the newborn (PPHN) following in-utero exposure in a clinical trial on intrauterine growth restriction
Sildenafil is not authorised for use in pregnancy for the treatment of intrauterine growth restriction. The STRIDER clinical trial, which was studying the use of sildenafil in pregnancy for intrauterine growth restriction, has been prematurely discontinued due to a higher incidence of persistent pulmonary hypertension of the newborn (PPHN) and neonatal mortality in the sildenafil arm of the study.
EMA PRAC 6 Sep 2018 PRAC signal: Pulmonary hypertension and fatal cases associated with use in an off-label indication, early-onset intrauterine growth restriction
Action for MAH: update of the product information: No
US FDA 13 Dec 2017 VIAGRA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 7 May 2015 PRAC signal: Pulmonary haemorrhage in off label paediatric use
Action for MAH: update of the product information: No
EMA PRAC 10 Apr 2015 PRAC signal: Non-arteritic anterior ischaemic optic neuropathy (NAION)
Action for MAH: update of the product information: No
EMA PRAC 9 Jan 2015 PRAC signal: Pulmonary haemorrhage in off label paediatric use
Action for MAH: update of the product information: No
EMA PRAC 6 Nov 2014 PRAC signal: Increased risk of incident melanoma
Action for MAH: update of the product information: No
EMA PRAC 10 Jul 2014 PRAC signal: Increased risk of incident melanoma
Action for MAH: update of the product information: No

All safety entries for sildenafil →

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.