Is Apraclonidine registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 0 valid registrations of Apraclonidine.

Is Apraclonidine approved by the US FDA?

Drugs@FDA lists 3 application product lines for Apraclonidine, including IOPIDINE (Prescription); IOPIDINE (Prescription); APRACLONIDINE HYDROCHLORIDE (Prescription).

Are there safety signals or safety updates for Apraclonidine?

US FDA: 2 entries (latest 2026-03-18).

Active substance

Apraclonidine

SFDA 1
US FDA 3
Health Canada 2
US price lines 2
NHS prices 1
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
IOPIDINE 0.5% OPTH.SOLN.	0.5 %	Eye drops · Ocular use	1 Dropper Container	SAR 38.35	NCE · Prescription	ALCON LABORATORIES	Withdrawn by MAH · Not Marketed

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

Product	Strength	Form · route	Applicant	Status	First approved
IOPIDINE	EQ 1% BASE	solution/drops · ophthalmic	HARROW EYE	Prescription	31 Dec 1987
IOPIDINE	EQ 0.5% BASE	solution/drops · ophthalmic	HARROW EYE	Prescription	30 Jul 1993
APRACLONIDINE HYDROCHLORIDE	EQ 0.5% BASE	solution/drops · ophthalmic	RISING	Prescription	12 Mar 2009

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
IOPIDINE	00888354	1 % / W/V	SOLUTION · OPHTHALMIC	ESSENTIAL PHARMA SWITZERLAND GMBH
IOPIDINE	02076306	0.5 % / W/V	SOLUTION · OPHTHALMIC	ESSENTIAL PHARMA SWITZERLAND GMBH

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	APRACLONIDINE HCL 0.5% DROPS	$9.15612	per ML	23 Sep 2026
US NADAC	APRACLONIDINE HCL 0.5% DROPS	$9.422	per ML	23 Sep 2026
NHS Drug Tariff	Apraclonidine 1% eye drops 0.25ml unit dose preservative free	£110.69	24 unit dose	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 18 Mar 2026 IOPIDINE — 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 18 Mar 2026 IOPIDINE — 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 apraclonidine →

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.