Is Escitalopram registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 27 valid registrations of Escitalopram, including CIPRALEX 10 MG F.C. TABLETS (10 mg, Film-coated tablet, SAR 88.50); CIPRALEX 20MG F.C. TABLETS (20 mg, Film-coated tablet, SAR 129.23); CITOXAL 10 mg film-coated tablet (10 mg, Film-coated tablet, SAR 46.60); CITOXAL 20 mg film-coated tablet (20 mg, Film-coated tablet, SAR 83.90); CITOXAL 5 mg film-coated tablet (5 mg, Film-coated tablet, SAR 32.60).

Is Escitalopram approved by the US FDA?

Drugs@FDA lists 29 application product lines for Escitalopram, including LEXAPRO (Prescription); LEXAPRO (Prescription); ESCITALOPRAM OXALATE (Prescription); ESCITALOPRAM OXALATE (Prescription); ESCITALOPRAM OXALATE (Prescription).

Is Escitalopram on the WHO Model List of Essential Medicines?

Yes — 24.3. Medicines for anxiety disorders (core (EML); complementary (EMLc) list): Therapeutic equivalent to fluoxetine for Generalised anxiety disorder.

Are there safety signals or safety updates for Escitalopram?

EMA PRAC: 13 entries; US FDA: 2 entries (latest 2024-04-19).

Active substance

Escitalopram

SFDA 33
US FDA 29
Health Canada 48
US price lines 8
NHS prices 5
WHO EML 1
Safety 15

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
CIPRALEX 10 MG F.C. TABLETS	10 mg	Film-coated tablet · Oral use	28 Blister	SAR 88.50	NCE · Prescription	AJA PHARMACEUTICAL INDUSTRIES	Valid
CIPRALEX 10 MG F.C. TABLETS	10 mg	Film-coated tablet · Oral use	98 Blister	SAR 384.35	Generic · Prescription	AJA PHARMACEUTICAL INDUSTRIES	Valid
CIPRALEX 20MG F.C. TABLETS	20 mg	Film-coated tablet · Oral use	28 Blister	SAR 129.23	Generic · Prescription	AJA PHARMACEUTICAL INDUSTRIES	Valid
CITOXAL 10 mg film-coated tablet	10 mg	Film-coated tablet · Oral use	30 Blister	SAR 46.60	Generic · Prescription	SAUDI PHARMACEUTICAL INDUSTRIES	Valid
CITOXAL 20 mg film-coated tablet	20 mg	Film-coated tablet · Oral use	30 Blister	SAR 83.90	Generic · Prescription	SAUDI PHARMACEUTICAL INDUSTRIES	Valid
CITOXAL 5 mg film-coated tablet	5 mg	Film-coated tablet · Oral use	30 Blister	SAR 32.60	Generic · Prescription	SAUDI PHARMACEUTICAL INDUSTRIES	Valid
DAMESTA 10MG F.C.TABLET	10 mg	Film-coated tablet · Oral use	30 Blister	SAR 46.60	Generic · Prescription	DAMMAM PHARMA	Valid
DAMESTA 20MG F.C.TABLET	20 mg	Film-coated tablet · Oral use	30 Blister	SAR 83.90	Generic · Prescription	DAMMAM PHARMA	Valid
DEPRALEX 10MG FILM COATED TABLET	10 mg	Film-coated tablet · Oral use	28 Blister	SAR 63.20	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
DEPRALEX 20MG FILM COATED TABLET	20 mg	Film-coated tablet · Oral use	28 Blister	SAR 103.60	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
ENTAPRO 10MG FILM COATED TABLETS	10 mg	Film-coated tablet · Oral use	30 Blister	SAR 75.20	Generic · Prescription	SPIMACO ADDWAEIH	Valid
ENTAPRO 20MG FILM COATED TABLETS	20 mg	Film-coated tablet · Oral use	30 Blister	SAR 123.35	Generic · Prescription	SPIMACO ADDWAEIH	Valid
ESCIPRA 10MG FILM COATED TABLET	10 mg	Film-coated tablet · Oral use	28 Blister	SAR 43.50	Generic · Prescription	Middle East Pharmaceutical Industries Co Ltd Avalon Pharma	Valid
ESCIPRA 20MG FILM COATED TABLET	20 mg	Film-coated tablet · Oral use	28 Blister	SAR 78.30	Generic · Prescription	Middle East Pharmaceutical Industries Co Ltd Avalon Pharma	Valid
ESCITALAX 10MG FILM COATED TABLET	10 mg	Film-coated tablet · Oral use	28 Blister	SAR 32.65	Generic · Prescription	LABORATORIOS CINFA SA	Valid
ESCITALAX 15MG FILM COATED TABLET	15 mg	Film-coated tablet · Oral use	28 Blister	SAR 49.05	Generic · Prescription	LABORATORIOS CINFA SA	Valid
ESCITALAX 20MG FILM COATED TABLET	20 mg	Film-coated tablet · Oral use	28 Blister	SAR 65.40	Generic · Prescription	LABORATORIOS CINFA SA	Valid
ESCITAM 10 mg film-coated tablet	10 mg	Film-coated tablet · Oral use	30 Blister	SAR 46.60	Generic · Prescription	AJA PHARMACEUTICAL INDUSTRIES	Valid
ESCITAM 20 mg film-coated tablet	20 mg	Film-coated tablet · Oral use	30 Blister	SAR 83.90	Generic · Prescription	AJA PHARMACEUTICAL INDUSTRIES	Valid
Exopex	10 mg	Film-coated tablet · Oral use	30 Blister	SAR 23.20	Generic · Prescription	Al-Taqaddom pharmaceutical Industries	Valid
Exopex	20 mg	Film-coated tablet · Oral use	30 Blister	SAR 23.20	Generic · Prescription	Al-Taqaddom pharmaceutical Industries	Valid
Inment	20 mg	Film-coated tablet · Oral use	28 Blister	SAR 78.30	Generic · Prescription	AL RAZI PHARMA INDUSTRIES	Valid
Inment	10 mg	Film-coated tablet · Oral use	28 Blister	SAR 43.50	Generic · Prescription	AL RAZI PHARMA INDUSTRIES	Valid
SETAPRO 10 mg film-coated tablet	10 mg	Film-coated tablet · Oral use	30 Blister	SAR 46.60	Generic · Prescription	Jamjoom Pharmaceuticals Factory Company	Valid
SETAPRO 20 mg film-coated tablet	20 mg	Film-coated tablet · Oral use	30 Blister	SAR 93.25	Generic · Prescription	Jamjoom Pharmaceuticals Factory Company	Valid

8 more — full table

Indications — CHI Daman Drug Formulary

ACUTE BIPOLAR I DEPRESSION; ALZHEIMER / DEMENTIA; ANXIETY DISORDERS; ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD); AUTISM SPECTRUM DISORDER; BIPOLAR II DISORDER; DEPRESSION; HUNTINGTON'S DISEASE-TICS; MENOPAUSE; MENSTRUAL DISORDERS; NEUROPATHIC PAIN; PAIN MANAGEMENT IN CANCER PATIENTS

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

Product	Strength	Form · route	Applicant	Status	First approved
LEXAPRO	EQ 5MG BASE; EQ 10MG BASE; EQ 20MG BASE	tablet · oral	ABBVIE	Prescription	14 Aug 2002
LEXAPRO	EQ 5MG BASE; EQ 10MG BASE; EQ 20MG BASE	tablet · oral	FOREST LABS	Prescription	29 Aug 2002
ESCITALOPRAM OXALATE	EQ 5MG BASE/5ML	solution · oral	AMNEAL PHARMS	Prescription	14 Mar 2012
ESCITALOPRAM OXALATE	EQ 5MG BASE/5ML	solution · oral	AUROBINDO PHARMA LTD	Prescription	2 Apr 2012
ESCITALOPRAM OXALATE	EQ 5MG BASE/5ML	solution · oral	HETERO LABS LTD III	Prescription	12 Jun 2012
ESCITALOPRAM OXALATE	EQ 5MG BASE; EQ 10MG BASE; EQ 20MG BASE	tablet · oral	ZYDUS LIFESCIENCES	Prescription	11 Sep 2012
ESCITALOPRAM OXALATE	EQ 5MG BASE; EQ 10MG BASE; EQ 20MG BASE	tablet · oral	CHARTWELL RX	Prescription	11 Sep 2012
ESCITALOPRAM OXALATE	EQ 5MG BASE; EQ 10MG BASE; EQ 20MG BASE	tablet · oral	INVAGEN PHARMS	Prescription	11 Sep 2012
ESCITALOPRAM OXALATE	EQ 5MG BASE; EQ 10MG BASE; EQ 20MG BASE	tablet · oral	GRAVITI PHARMS	Prescription	11 Sep 2012
ESCITALOPRAM OXALATE	EQ 5MG BASE; EQ 10MG BASE; EQ 20MG BASE	tablet · oral	AUROBINDO PHARMA LTD	Prescription	11 Sep 2012
ESCITALOPRAM OXALATE	EQ 5MG BASE; EQ 10MG BASE; EQ 20MG BASE	tablet · oral	TORRENT PHARMS LTD	Prescription	11 Sep 2012
ESCITALOPRAM OXALATE	EQ 5MG BASE; EQ 10MG BASE; EQ 20MG BASE	tablet · oral	MACLEODS PHARMS LTD	Prescription	11 Sep 2012
ESCITALOPRAM OXALATE	EQ 5MG BASE; EQ 10MG BASE; EQ 20MG BASE	tablet · oral	ACCORD HLTHCARE	Prescription	11 Sep 2012
ESCITALOPRAM OXALATE	EQ 5MG BASE; EQ 10MG BASE; EQ 20MG BASE	tablet · oral	JUBILANT CADISTA	Prescription	12 Sep 2012
ESCITALOPRAM OXALATE	EQ 5MG BASE/5ML	solution · oral	CHARTWELL MOLECULAR	Prescription	12 Jun 2013
ESCITALOPRAM OXALATE	EQ 5MG BASE; EQ 10MG BASE; EQ 20MG BASE	tablet · oral	PRINSTON INC	Prescription	28 Aug 2015
ESCITALOPRAM OXALATE	EQ 5MG BASE/5ML	solution · oral	MACLEODS PHARMS LTD	Prescription	31 Mar 2016
ESCITALOPRAM OXALATE	EQ 5MG BASE; EQ 10MG BASE; EQ 20MG BASE	tablet · oral	AMNEAL PHARMS	Prescription	17 May 2017
ESCITALOPRAM OXALATE	EQ 5MG BASE; EQ 10MG BASE; EQ 20MG BASE	tablet · oral	ASCENT PHARMS INC	Prescription	15 Jul 2025
ESCITALOPRAM	EQ 15MG BASE	capsule · oral	ALMATICA	Prescription	29 Aug 2025
LEXAPRO	EQ 5MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	solution · oral	ABBVIE	Discontinued	27 Nov 2002
ESCITALOPRAM OXALATE	EQ 5MG BASE; EQ 10MG BASE; EQ 20MG BASE	capsule · oral	RISING	Discontinued	31 Jul 2007
ESCITALOPRAM OXALATE	EQ 5MG BASE; EQ 10MG BASE; EQ 20MG BASE	tablet · oral	TEVA PHARMS USA	Discontinued	14 Mar 2012
ESCITALOPRAM OXALATE	EQ 5MG BASE/5ML	solution · oral	SUN PHARMA CANADA	Discontinued	3 May 2012
ESCITALOPRAM OXALATE	EQ 5MG BASE; EQ 10MG BASE; EQ 20MG BASE	tablet · oral	HIKMA PHARMS	Discontinued	11 Sep 2012

4 more — full table

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ACH-ESCITALOPRAM	02434652	10 MG	TABLET · ORAL	ACCORD HEALTHCARE INC
ACH-ESCITALOPRAM	02434660	20 MG	TABLET · ORAL	ACCORD HEALTHCARE INC
ACT ESCITALOPRAM ODT	02454297	10 MG	TABLET (ORALLY-DISINTEGRATING) · ORAL	TEVA CANADA LIMITED
ACT ESCITALOPRAM ODT	02454300	20 MG	TABLET (ORALLY-DISINTEGRATING) · ORAL	TEVA CANADA LIMITED
AG-ESCITALOPRAM	02477742	10 MG	TABLET · ORAL	ANGITA PHARMA INC.
AG-ESCITALOPRAM	02477769	20 MG	TABLET · ORAL	ANGITA PHARMA INC.
AG-ESCITALOPRAM TABLETS	02510944	10 MG	TABLET · ORAL	ANGITA PHARMA INC.
AG-ESCITALOPRAM TABLETS	02510952	20 MG	TABLET · ORAL	ANGITA PHARMA INC.
APO-ESCITALOPRAM	02295016	10 MG	TABLET · ORAL	APOTEX INC
APO-ESCITALOPRAM	02295024	20 MG	TABLET · ORAL	APOTEX INC
AURO-ESCITALOPRAM	02397358	10 MG	TABLET · ORAL	AURO PHARMA INC
AURO-ESCITALOPRAM	02397374	20 MG	TABLET · ORAL	AURO PHARMA INC
BALANSYA	02566354	2 MG / ML	SOLUTION · ORAL	ORIMED PHARMA INC
BIO-ESCITALOPRAM	02481154	10 MG	TABLET · ORAL	BIOMED PHARMA
BIO-ESCITALOPRAM	02481170	20 MG	TABLET · ORAL	BIOMED PHARMA
CIPRALEX -10MG	02263238	10 MG	TABLET · ORAL	LUNDBECK CANADA INC
CIPRALEX -20MG	02263254	20 MG	TABLET · ORAL	LUNDBECK CANADA INC
ESCITALOPRAM	02424401	10 MG	TABLET · ORAL	PRO DOC LIMITEE
ESCITALOPRAM	02424428	20 MG	TABLET · ORAL	PRO DOC LIMITEE
ESCITALOPRAM	02429039	10 MG	TABLET · ORAL	SIVEM PHARMACEUTICALS ULC
ESCITALOPRAM	02429047	20 MG	TABLET · ORAL	SIVEM PHARMACEUTICALS ULC
ESCITALOPRAM	02429780	10 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
ESCITALOPRAM	02429799	20 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
ESCITALOPRAM	02430118	10 MG	TABLET · ORAL	SANIS HEALTH INC
ESCITALOPRAM	02430126	20 MG	TABLET · ORAL	SANIS HEALTH INC

23 more — full table

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	ESCITALOPRAM 10 MG TABLET	$0.03945	per EA	23 Sep 2026
US NADAC	ESCITALOPRAM 15 MG CAPSULE	$5.45324	per EA	23 Sep 2026
US NADAC	ESCITALOPRAM 20 MG TABLET	$0.06316	per EA	23 Sep 2026
US NADAC	ESCITALOPRAM 5 MG TABLET	$0.04157	per EA	23 Sep 2026
US NADAC	ESCITALOPRAM OXALATE 5 MG/5 ML	$0.14255	per ML	23 Sep 2026
US NADAC	LEXAPRO 10 MG TABLET	$15.41264	per EA	23 Sep 2026
US NADAC	LEXAPRO 20 MG TABLET	$16.09413	per EA	23 Sep 2026
US NADAC	LEXAPRO 5 MG TABLET	$14.74325	per EA	2 Jan 2026
NHS Drug Tariff	Escitalopram 10mg tablets	£1.09	28 tablet	1 Oct 2026
NHS Drug Tariff	Escitalopram 15mg orodispersible tablets sugar free	£29.40	28 tablet	1 Oct 2026
NHS Drug Tariff	Escitalopram 20mg tablets	£1.18	28 tablet	1 Oct 2026
NHS Drug Tariff	Escitalopram 20mg/ml oral drops sugar free	£20.16	15 ml	1 Oct 2026
NHS Drug Tariff	Escitalopram 5mg tablets	£1.10	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.

WHO WHO Model List of Essential Medicines (2025)

24.3. Medicines for anxiety disorders · core (EML); complementary (EMLc)
Therapeutic equivalent to fluoxetine for Generalised anxiety disorder

Safety signals and safety-related labeling changes

US FDA 19 Apr 2024 LEXAPRO — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 19 Apr 2024 LEXAPRO — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 29 Sep 2022 PRAC signal: Pulmonary hypertension
Action for MAH: update of the product information: No
EMA PRAC 10 Mar 2022 PRAC signal: Pulmonary hypertension
Action for MAH: update of the product information: No
EMA PRAC 1 Oct 2020 PRAC signal: Postpartum haemorrhage
Action for MAH: update of the product information: Yes
EMA PRAC 11 Jun 2020 PRAC signal: Postpartum haemorrhage
Action for MAH: update of the product information: No
EMA PRAC 12 Mar 2020 PRAC signal: Postpartum haemorrhage
Action for MAH: update of the product information: No
EMA PRAC 16 May 2019 PRAC signal: Persistent sexual dysfunction after drug withdrawal
Action for MAH: update of the product information: Yes
EMA PRAC 11 Apr 2019 PRAC signal: Drug interaction with fluconazole
Action for MAH: update of the product information: Yes
EMA PRAC 29 Nov 2018 PRAC signal: Drug interaction with fluconazole
Action for MAH: update of the product information: No
EMA PRAC 31 Oct 2018 PRAC signal: Persistent sexual dysfunction after drug withdrawal
Action for MAH: update of the product information: No
EMA PRAC 6 Sep 2018 PRAC signal: Persistent sexual dysfunction after drug withdrawal
Action for MAH: update of the product information: No
EMA PRAC 2 Sep 2016 PRAC signal: Risk of autism spectrum disorders (ASD) after maternal use of SSRI/SNRI
Action for MAH: update of the product information: No
EMA PRAC 13 May 2016 PRAC signal: Risk of autism spectrum disorders (ASD) after maternal use of SSRI/SNRI
Action for MAH: update of the product information: No
EMA PRAC 6 Nov 2015 PRAC signal: New malformative risks in newborn and risk of autism spectrum disorders (ASD) after maternal use of SSRI/SNRI
Action for MAH: update of the product information: No

All safety entries for escitalopram →

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.