Is Amlodipine 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 Amlodipine, including AMEP 10 mg Tablet (10 mg, Tablet, SAR 27.20); AMEP 5 mg Tablet (5 mg, Tablet, SAR 13.00); AMLOCARD 10 mg tablets (10 mg, Tablet, SAR 43.35); AMLOCARD 5MG TABLETS (5 mg, Tablet, SAR 26.45); AMLOPHAR 5MG CAPSULES (5 mg, Capsule, hard, SAR 29.40).

Is Amlodipine approved by the US FDA?

Drugs@FDA lists 47 application product lines for Amlodipine, including NORVASC (Prescription); AMLODIPINE BESYLATE (Prescription); AMLODIPINE BESYLATE (Prescription); AMLODIPINE BESYLATE (Prescription); AMLODIPINE BESYLATE (Prescription).

Is Amlodipine on the WHO Model List of Essential Medicines?

Yes — 12.3. Antihypertensive medicines (core list): Essential hypertension.

Are there safety signals or safety updates for Amlodipine?

EMA PRAC: 2 entries; US FDA: 12 entries (latest 2025-09-04).

Active substance

Amlodipine

SFDA 44
US FDA 47
Health Canada 67
US price lines 8
NHS prices 8
WHO EML 1
Safety 14

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
AMEP 10 mg Tablet	10 mg	Tablet · Oral use	28 Blister	SAR 27.20	Generic · Prescription	Cooper Pharma Arabia	Valid
AMEP 5 mg Tablet	5 mg	Tablet · Oral use	28 Blister	SAR 13.00	Generic · Prescription	Cooper Pharma Arabia	Valid
AMLOCARD 10 mg tablets	10 mg	Tablet · Oral use	30 Blister	SAR 43.35	Generic · Prescription	BATTERJEE PHARMACETICAL FACTORY	Valid
AMLOCARD 5MG TABLETS	5 mg	Tablet · Oral use	30 Blister	SAR 26.45	Generic · Prescription	BATTERJEE PHARMACETICAL FACTORY	Valid
AMLOPHAR 5MG CAPSULES	5 mg	Capsule, hard · Oral use	30 Blister	SAR 29.40	Generic · Prescription	Gulf Pharmaceutical Industries (Julphar)	Valid
AMLOPINE 10MG CAPSULES	10 mg	Capsule · Oral use	30 Blister	SAR 64.40	Generic · Prescription	SPIMACO ADDWAEIH	Valid
AMLOPINE 5MG CAPSULE	5 mg	Capsule · Oral use	30 Blister	SAR 53.35	Generic · Prescription	SPIMACO ADDWAEIH	Valid
AMLOPRESS 5MG CAPSULES	5 mg	Capsule · Oral use	28 Blister	SAR 32.65	Generic · Prescription	SAJA-SAUDI ARABIAN JAPANESE PHARMACEUTICAL CO	Valid
AMLOR 10MG CAPSULES	10 mg	Capsule, hard · Oral use	30 Blister	SAR 64.40	NCE · Prescription	Viatris Arabia Limited	Valid
AMLOR CAPS 5MG	5 mg	Capsule, hard · Oral use	30 Blister	SAR 60.65	NCE · Prescription	Viatris Arabia Limited	Valid
AMODIP 5 mg capsule	5 mg	Capsule · Oral use	30 Blister	SAR 26.45	Generic · Prescription	Middle East Pharmaceutical Industries Co Ltd Avalon Pharma	Valid
AMOLAR 10MG CAPSULES	10 mg	Capsule · Oral use	28 Blister	SAR 29.15	Generic · Prescription	DAR ALDAWA	Valid
AMVASC 10MG CAPSULE	10 mg	Capsule · Oral use	30 Blister	SAR 64.40	Generic · Prescription	Jamjoom Pharmaceuticals Factory Company	Valid
AMVASC 2.5MG CAPSULE	2.5 mg	Capsule · Oral use	30 Blister	SAR 27.45	Generic · Prescription	Jamjoom Pharmaceuticals Factory Company	Valid
AMVASC 5MG CAPSULE	5 mg	Capsule · Oral use	30 Blister	SAR 53.35	Generic · Prescription	Jamjoom Pharmaceuticals Factory Company	Valid
Amlodipine Qo	1 mg/ml	Oral solution · Oral use	1 Bottle	SAR 529.60	Generic · Prescription	Qomel Co	Valid
Amlosol	1 mg/ml	Oral solution · Oral use	1 Bottle	SAR 462.55	Generic · Prescription	Syri Limited t/a SyriMed	Valid
BLOCAL 5 mg capsule	5 mg	Capsule, hard · Oral use	30 Blister	SAR 23.80	Generic · Prescription	DEEF PHARMACEUTICAL INDUSTRIES	Valid
GLODIP 5MG CAPSULE	5 mg	Capsule · Oral use	30 Blister	SAR 23.80	Generic · Prescription	GLOBAL PHARMA	Valid
HYPODIPINE 5MG CAPSULES	5 mg	Capsule · Oral use	28 Blister	SAR 21.80	Generic · Prescription	Middle East Pharmaceutical and Chemical Industries and Medical Appliances Co.	Valid
LODIPAM 10 mg Film-Coated Tablet	10 mg	Film-coated tablet · Oral use	30 Blister	SAR 45.95	Generic · Prescription	SAUDI PHARMACEUTICAL INDUSTRIES	Valid
LODIPAM 2.5 mg Film-Coated Tablet	2.5 mg	Film-coated tablet · Oral use	30 Blister	SAR 22.25	Generic · Prescription	SAUDI PHARMACEUTICAL INDUSTRIES	Valid
LODIPAM 5 mg Film-Coated Tablet	5 mg	Film-coated tablet · Oral use	30 Blister	SAR 23.80	Generic · Prescription	SAUDI PHARMACEUTICAL INDUSTRIES	Valid
LOFRAL 10MG TABLETS	10 mg	Tablet · Oral use	30 Blister	SAR 26.60	Generic · Prescription	ACINO PHARMA AG	Valid
LOFRAL 5MG TABLETS	5 mg	Tablet · Oral use	30 Blister	SAR 16.20	Generic · Prescription	ACINO PHARMA AG	Valid

19 more — full table

Indications — CHI Daman Drug Formulary

CHRONIC KIDNEY DISEASE; CORONARY ARTERY DISEASE; HYPERTENSION; PULMONARY ARTERIAL HYPERTENSION; RAYNAUD'S PHENOMENON; SYSTEMIC LUPUS ERYTHEMATOSUS

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

Product	Strength	Form · route	Applicant	Status	First approved
NORVASC	EQ 2.5MG BASE; EQ 5MG BASE; EQ 10MG BASE	tablet · oral	VIATRIS	Prescription	31 Jul 1992
AMLODIPINE BESYLATE	EQ 2.5MG BASE; EQ 5MG BASE; EQ 10MG BASE	tablet · oral	COREPHARMA	Prescription	23 May 2007
AMLODIPINE BESYLATE	EQ 2.5MG BASE; EQ 5MG BASE; EQ 10MG BASE	tablet · oral	TEVA	Prescription	28 Jun 2007
AMLODIPINE BESYLATE	EQ 2.5MG BASE; EQ 5MG BASE; EQ 10MG BASE	tablet · oral	ZYDUS PHARMS USA	Prescription	9 Jul 2007
AMLODIPINE BESYLATE	EQ 2.5MG BASE; EQ 5MG BASE; EQ 10MG BASE	tablet · oral	LUPIN	Prescription	12 Jul 2007
AMLODIPINE BESYLATE	EQ 2.5MG BASE; EQ 5MG BASE; EQ 10MG BASE	tablet · oral	AUROBINDO PHARMA	Prescription	17 Jul 2007
AMLODIPINE BESYLATE	EQ 2.5MG BASE; EQ 5MG BASE; EQ 10MG BASE	tablet · oral	CHARTWELL RX	Prescription	20 Jul 2007
AMLODIPINE BESYLATE	EQ 2.5MG BASE; EQ 5MG BASE; EQ 10MG BASE	tablet · oral	INVAGEN PHARMS	Prescription	28 Aug 2007
AMLODIPINE BESYLATE	EQ 2.5MG BASE; EQ 5MG BASE; EQ 10MG BASE	tablet · oral	CIPLA	Prescription	26 Sep 2007
AMLODIPINE BESYLATE	EQ 2.5MG BASE; EQ 5MG BASE; EQ 10MG BASE	tablet · oral	EPIC PHARMA LLC	Prescription	8 Apr 2009
AMLODIPINE BESYLATE	EQ 2.5MG BASE; EQ 5MG BASE; EQ 10MG BASE	tablet · oral	ALKEM	Prescription	4 May 2009
AMLODIPINE BESYLATE	EQ 2.5MG BASE; EQ 5MG BASE; EQ 10MG BASE	tablet · oral	ORBION PHARMS	Prescription	2 Jul 2009
AMLODIPINE BESYLATE	EQ 2.5MG BASE; EQ 5MG BASE; EQ 10MG BASE	tablet · oral	OXFORD PHARMS	Prescription	7 Apr 2010
AMLODIPINE BESYLATE	EQ 5MG BASE; EQ 10MG BASE; EQ 2.5MG BASE	tablet · oral	CHINA RESOURCES	Prescription	15 Apr 2011
AMLODIPINE BESYLATE	EQ 5MG BASE; EQ 10MG BASE; EQ 2.5MG BASE	tablet · oral	GRAVITI PHARMS	Prescription	13 Apr 2012
AMLODIPINE BESYLATE	EQ 2.5MG BASE; EQ 5MG BASE; EQ 10MG BASE	tablet · oral	ACCORD HLTHCARE	Prescription	29 Apr 2013
AMLODIPINE BESYLATE	EQ 2.5MG BASE; EQ 5MG BASE; EQ 10MG BASE	tablet · oral	UNICHEM	Prescription	21 Oct 2013
AMLODIPINE BESYLATE	EQ 2.5MG BASE; EQ 5MG BASE; EQ 10MG BASE	tablet · oral	INVAGEN PHARMS	Prescription	10 Dec 2015
AMLODIPINE BESYLATE	EQ 2.5MG BASE; EQ 5MG BASE; EQ 10MG BASE	tablet · oral	PURACAP LABS BLU	Prescription	11 Jul 2016
KATERZIA	EQ 1MG BASE/ML	suspension · oral	AZURITY	Prescription	8 Jul 2019
NORLIQVA	EQ 1MG BASE/ML	solution · oral	CMP DEV LLC	Prescription	24 Feb 2022
SDAMLO	EQ 2.5MG BASE/BOT; EQ 5MG BASE/BOT; EQ 10MG BASE/BOT	for solution · oral	BRILLIAN PHARMA	Prescription	24 Jul 2025
AMLODIPINE BESYLATE	EQ 2.5MG BASE; EQ 5MG BASE; EQ 10MG BASE	tablet · oral	IPCA LABS LTD	Prescription	22 Sep 2026
AMVAZ	2.5MG; 5MG; 10MG	tablet · oral	DR REDDYS LABS INC	Discontinued	31 Oct 2003
AMLODIPINE BESYLATE	EQ 2.5MG BASE; EQ 5MG BASE; EQ 10MG BASE	tablet · oral	MYLAN	Discontinued	3 Oct 2005

22 more — full table

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ACH-AMLODIPINE	02419556	2.5 MG	TABLET · ORAL	ACCORD HEALTHCARE INC
ACH-AMLODIPINE	02419564	5 MG	TABLET · ORAL	ACCORD HEALTHCARE INC
ACH-AMLODIPINE	02419572	10 MG	TABLET · ORAL	ACCORD HEALTHCARE INC
AG-AMLODIPINE	02369222	2.5 MG	TABLET · ORAL	ANGITA PHARMA INC.
AG-AMLODIPINE	02369230	5 MG	TABLET · ORAL	ANGITA PHARMA INC.
AG-AMLODIPINE	02369249	10 MG	TABLET · ORAL	ANGITA PHARMA INC.
AMLODIPINE	02326795	2.5 MG	TABLET · ORAL	PRO DOC LIMITEE
AMLODIPINE	02326809	5 MG	TABLET · ORAL	PRO DOC LIMITEE
AMLODIPINE	02326817	10 MG	TABLET · ORAL	PRO DOC LIMITEE
AMLODIPINE	02331284	5 MG	TABLET · ORAL	SANIS HEALTH INC
AMLODIPINE	02331292	10 MG	TABLET · ORAL	SANIS HEALTH INC
AMLODIPINE	02385783	2.5 MG	TABLET · ORAL	SIVEM PHARMACEUTICALS ULC
AMLODIPINE	02385791	5 MG	TABLET · ORAL	SIVEM PHARMACEUTICALS ULC
AMLODIPINE	02385805	10 MG	TABLET · ORAL	SIVEM PHARMACEUTICALS ULC
AMLODIPINE	02429217	5 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
AMLODIPINE	02429225	10 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
AMLODIPINE	02478587	2.5 MG	TABLET · ORAL	SANIS HEALTH INC
AMLODIPINE	02490781	2.5 MG	TABLET · ORAL	ALTAMED PHARMA
AMLODIPINE	02490803	5 MG	TABLET · ORAL	ALTAMED PHARMA
AMLODIPINE	02490811	10 MG	TABLET · ORAL	ALTAMED PHARMA
AMLODIPINE	02492199	2.5 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
AMLODIPINE	02552868	2.5 MG	TABLET · ORAL	ANGITA PHARMA INC.
AMLODIPINE	02552876	5 MG	TABLET · ORAL	ANGITA PHARMA INC.
AMLODIPINE	02552884	10 MG	TABLET · ORAL	ANGITA PHARMA INC.
APO-AMLODIPINE	02273373	5 MG	TABLET · ORAL	APOTEX INC

42 more — full table

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	AMLODIPINE BESYLATE 10 MG TAB	$0.01479	per EA	23 Sep 2026
US NADAC	AMLODIPINE BESYLATE 2.5 MG TAB	$0.01061	per EA	23 Sep 2026
US NADAC	AMLODIPINE BESYLATE 5 MG TAB	$0.01018	per EA	23 Sep 2026
US NADAC	KATERZIA 1 MG/ML SUSPENSION	$4.20321	per ML	23 Sep 2026
US NADAC	NORLIQVA 1 MG/ML SOLUTION	$3.21723	per ML	23 Sep 2026
US NADAC	NORVASC 10 MG TABLET	$11.94157	per EA	23 Sep 2026
US NADAC	NORVASC 2.5 MG TABLET	$8.70379	per EA	1 Jan 2026
US NADAC	NORVASC 5 MG TABLET	$8.69312	per EA	23 Sep 2026
NHS Drug Tariff	Amlodipine 10mg orodispersible tablets sugar free	£9.93	28 tablet	1 Oct 2026
NHS Drug Tariff	Amlodipine 10mg tablets	£0.75	28 tablet	1 Oct 2026
NHS Drug Tariff	Amlodipine 10mg/5ml oral solution sugar free	£71.77	150 ml	1 Oct 2026
NHS Drug Tariff	Amlodipine 2.5mg tablets	£3.90	28 tablet	1 Oct 2026
NHS Drug Tariff	Amlodipine 5mg orodispersible tablets sugar free	£8.86	28 tablet	1 Oct 2026
NHS Drug Tariff	Amlodipine 5mg tablets	£0.67	28 tablet	1 Oct 2026
NHS Drug Tariff	Amlodipine 5mg/5ml oral solution sugar free	£49.39	150 ml	1 Oct 2026
NHS Drug Tariff	Amlodipine 5mg/5ml oral suspension sugar free	£70.00	150 ml	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)

12.3. Antihypertensive medicines · core
Essential hypertension
Oral > Solid: 5 mg (as maleate, mesylate or besylate)

Safety signals and safety-related labeling changes

EMA PRAC 4 Sep 2025 PRAC signal: Subacute cutaneous lupus erythematosus
Action for MAH: update of the product information: No
US FDA 4 Nov 2024 CADUET — 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 28 Apr 2021 CONSENSI — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 2 Oct 2020 TRIBENZOR — 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 2 Oct 2020 AZOR — 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 20 Aug 2020 EXFORGE HCT — 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 10 Feb 2020 LOTREL — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 12 Jun 2019 EXFORGE — 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 1 Feb 2018 TWYNSTA — safety-related labeling change
Labeling sections changed: Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 29 Sep 2017 PRESTALIA — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Drug Interactions; Use in Specific Populations
EMA PRAC 1 Sep 2017 PRAC signal: Drug interaction between amlopdine and rifamipicin leading to reduced antihypertensive effect of amlodipine
Action for MAH: update of the product information: No
US FDA 30 Mar 2017 NORVASC — safety-related labeling change
Labeling sections changed: Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 4 Nov 2016 AMTURNIDE — 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 4 Nov 2016 TEKAMLO — safety-related labeling change
Labeling sections changed: Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for amlodipine →

Combinations containing Amlodipine

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.