Is Vardenafil registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 12 valid registrations of Vardenafil, including DEVARIN 10 MG F.C.TABLET (10 mg, Film-coated tablet, SAR 53.95); DEVARIN 10MG ORODISPERSIBLE TABLET (10 mg, Orodispersible tablet, SAR 53.95); DEVARIN 20 MG F.C.TABLET (20 mg, Film-coated tablet, SAR 68.70); EREVARD 10MG Film-Coated Tablet (10 mg, Film-coated tablet, SAR 59.95); EREVARD 20MG Film-Coated Tablet (20 mg, Film-coated tablet, SAR 76.35).

Is Vardenafil approved by the US FDA?

Drugs@FDA lists 10 application product lines for Vardenafil, including VARDENAFIL HYDROCHLORIDE (Prescription); VARDENAFIL HYDROCHLORIDE (Prescription); VARDENAFIL HYDROCHLORIDE (Prescription); VARDENAFIL HYDROCHLORIDE (Prescription); VARDENAFIL HYDROCHLORIDE (Prescription).

Is Vardenafil authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Vardenafil: Levitra.

Are there safety signals or safety updates for Vardenafil?

US FDA: 2 entries (latest 2023-04-24).

Active substance

Vardenafil

SFDA 13
US FDA 10
EMA 2
Health Canada 12
US price lines 4
NHS prices 3
Safety 2

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
DEVARIN 10 MG F.C.TABLET	10 mg	Film-coated tablet · Oral use	4 Blister	SAR 53.95	Generic · Prescription	LABORATORIOS CINFA SA	Valid
DEVARIN 10MG ORODISPERSIBLE TABLET	10 mg	Orodispersible tablet · Ocular use	4 Blister	SAR 53.95	Generic · Prescription	LABORATORIOS CINFA SA	Valid
DEVARIN 20 MG F.C.TABLET	20 mg	Film-coated tablet · Oral use	4 Blister	SAR 68.70	Generic · Prescription	LABORATORIOS CINFA SA	Valid
EREVARD 10MG Film-Coated Tablet	10 mg	Film-coated tablet · Oral use	4 Blister	SAR 59.95	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
EREVARD 20MG Film-Coated Tablet	20 mg	Film-coated tablet · Oral use	4 Blister	SAR 76.35	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
FANVIL	10 mg	Orodispersible tablet · Oral use	4 Blister	SAR 41.95	Generic · Prescription	AJA PHARMACEUTICAL INDUSTRIES	Valid
LEVITRA 10MG TABLET	10 mg	Film-coated tablet · Oral use	4 Blister	SAR 64.35	NCE · Prescription	BAYER AG	Valid
LEVITRA 20MG TABLET	20 mg	Film-coated tablet · Oral use	4 Blister	SAR 93.95	NCE · Prescription	BAYER AG	Valid
LEVITRA 5MG TABLET	5 mg	Film-coated tablet · Oral use	4 Blister	SAR 48.30	NCE · Prescription	BAYER AG	Valid
Penetro	10 mg	Orodispersible tablet · Oral use	4 Blister	SAR 53.95	Generic · Prescription	Jamjoom Pharmaceuticals Factory Company	Valid
Penetro	20 mg	Tablet · Oral use	4 Blister	SAR 68.70	Generic · Prescription	Jamjoom Pharmaceuticals Factory Company	Valid
Vardenafil Eva	20 mg	Film-coated tablet · Oral use	4 Blister	SAR 68.70	Generic · Prescription	Eva pharma for Industry	Valid
LEVITRA 10 mg orodispersible tablet	10 mg	Orodispersible tablet · Oral use	4 Blister	SAR 73.75	NCE · Prescription	BAYER SCHERING PHARMA	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

BENIGN PROSTATIC HYPERTROPHY; PULMONARY ARTERIAL HYPERTENSION; RAYNAUD'S PHENOMENON

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

Product	Strength	Form · route	Applicant	Status	First approved
VARDENAFIL HYDROCHLORIDE	EQ 2.5MG BASE; EQ 5MG BASE; EQ 10MG BASE; EQ 20MG BASE	tablet · oral	TEVA PHARMS	Prescription	3 May 2012
VARDENAFIL HYDROCHLORIDE	EQ 2.5MG BASE; EQ 5MG BASE; EQ 10MG BASE; EQ 20MG BASE	tablet · oral	ZYDUS PHARMS	Prescription	31 Oct 2018
VARDENAFIL HYDROCHLORIDE	EQ 2.5MG BASE; EQ 5MG BASE; EQ 10MG BASE; EQ 20MG BASE	tablet · oral	CROSSMEDIKA SA	Prescription	31 Oct 2018
VARDENAFIL HYDROCHLORIDE	10MG	tablet, orally disintegrating · oral	ALEMBIC	Prescription	16 Nov 2018
VARDENAFIL HYDROCHLORIDE	EQ 2.5MG BASE; EQ 5MG BASE; EQ 10MG BASE; EQ 20MG BASE	tablet · oral	MACLEODS PHARMS	Prescription	22 Oct 2019
VARDENAFIL HYDROCHLORIDE	10MG	tablet, orally disintegrating · oral	MACLEODS PHARMS	Prescription	10 Mar 2020
VARDENAFIL HYDROCHLORIDE	EQ 2.5MG BASE; EQ 5MG BASE; EQ 10MG BASE; EQ 20MG BASE	tablet · oral	ALEMBIC	Prescription	4 Aug 2020
LEVITRA	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	tablet · oral	BAYER HLTHCARE	Discontinued	19 Aug 2003
STAXYN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	tablet, orally disintegrating · oral	BAYER HLTHCARE	Discontinued	17 Jun 2010
VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE; EQ 10MG BASE; EQ 20MG BASE	tablet · oral	STEVENS J	Discontinued	31 Oct 2018

EMA European Union — centrally authorised medicines

Levitra Bayer AG · Authorised · authorised 6 Mar 2003 · ATC G04BE09

Therapeutic indication (EMA)

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

Vivanza Bayer AG · Withdrawn · authorised 4 Mar 2003 · ATC G04BE09

Therapeutic indication (EMA)

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

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
APO-VARDENAFIL	02471647	5 MG	TABLET · ORAL	APOTEX INC
APO-VARDENAFIL	02471655	10 MG	TABLET · ORAL	APOTEX INC
APO-VARDENAFIL	02471663	20 MG	TABLET · ORAL	APOTEX INC
JAMP-VARDENAFIL	02475677	5 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
JAMP-VARDENAFIL	02475685	10 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
JAMP-VARDENAFIL	02475693	20 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
JAMP-VARDENAFIL ODT	02476088	10 MG	TABLET (ORALLY-DISINTEGRATING) · ORAL	JAMP PHARMA CORPORATION
MYLAN-VARDENAFIL	02464209	5 MG	TABLET · ORAL	MYLAN PHARMACEUTICALS ULC
MYLAN-VARDENAFIL	02464225	10 MG	TABLET · ORAL	MYLAN PHARMACEUTICALS ULC
MYLAN-VARDENAFIL	02464233	20 MG	TABLET · ORAL	MYLAN PHARMACEUTICALS ULC
VARDENAFIL	02520397	10 MG	TABLET · ORAL	SANIS HEALTH INC
VARDENAFIL	02520400	20 MG	TABLET · ORAL	SANIS HEALTH INC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	VARDENAFIL HCL 10 MG ODT	$23.327	per EA	23 Sep 2026
US NADAC	VARDENAFIL HCL 10 MG TABLET	$2.86665	per EA	23 Sep 2026
US NADAC	VARDENAFIL HCL 20 MG TABLET	$2.7928	per EA	23 Sep 2026
US NADAC	VARDENAFIL HCL 5 MG TABLET	$7.0998	per EA	18 Mar 2026
NHS Drug Tariff	Vardenafil 10mg tablets	£8.11	4 tablet	1 Oct 2026
NHS Drug Tariff	Vardenafil 20mg tablets	£9.19	4 tablet	1 Oct 2026
NHS Drug Tariff	Vardenafil 5mg tablets	£7.49	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 24 Apr 2023 STAXYN — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 15 Mar 2023 LEVITRA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for vardenafil →

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.