Is Sulfamethoxazole 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 Sulfamethoxazole.

Is Sulfamethoxazole approved by the US FDA?

Drugs@FDA lists 10 application product lines for Sulfamethoxazole, including GANTANOL (Discontinued); GANTANOL (Discontinued); GANTANOL-DS (Discontinued); SULFAMETHOXAZOLE (Discontinued); SULFAMETHOXAZOLE (Discontinued).

Are there safety signals or safety updates for Sulfamethoxazole?

US FDA: 7 entries (latest 2025-02-21).

Active substance

Sulfamethoxazole

SFDA 1
US FDA 10
Safety 7

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
SEPTRIN INJECTION	80, 16 mg/ml	Solution for injection · Intravenous use	10 Ampoule	SAR 86.05	NCE · Prescription	ASPEN PHARMA TRADING LIMITED (APTL)	Withdrawn by MAH · Not Marketed

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

Product	Strength	Form · route	Applicant	Status	First approved
GANTANOL	500MG/5ML	suspension · oral	ROCHE	Discontinued	1 Jul 1965
GANTANOL	500MG	tablet · oral	ROCHE	Discontinued	25 Aug 1965
GANTANOL-DS	1GM	tablet · oral	ROCHE	Discontinued	25 Aug 1965
SULFAMETHOXAZOLE	500MG	tablet · oral	RISING	Discontinued	23 Mar 1978
SULFAMETHOXAZOLE	500MG	tablet · oral	BARR	Discontinued	25 Jul 1983
SULFAMETHOXAZOLE	500MG	tablet · oral	WATSON LABS	Discontinued
SULFAMETHOXAZOLE	1GM	tablet · oral	WATSON LABS	Discontinued
SULFAMETHOXAZOLE	500MG	tablet · oral	HEATHER	Discontinued
UROBAK	500MG	tablet · oral	SHIONOGI	Discontinued
SULFAMETHOXAZOLE	500MG	tablet · oral	ASCOT	Discontinued

Safety signals and safety-related labeling changes

US FDA 21 Feb 2025 BACTRIM — 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 21 Feb 2025 BACTRIM DS — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions
US FDA 21 Feb 2025 BACTRIM PEDIATRIC — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations
US FDA 21 Feb 2025 SEPTRA — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions
US FDA 21 Feb 2025 SEPTRA DS — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions
US FDA 21 Feb 2025 SULFAMETHOXAZOLE AND TRIMETHOPRIM — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions
US FDA 21 Feb 2025 SULFATRIM — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions

All safety entries for sulfamethoxazole →

Combinations containing Sulfamethoxazole

Sulfamethoxazole + trimethoprim

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.