Is Trimethoprim 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 Trimethoprim.

Is Trimethoprim approved by the US FDA?

Drugs@FDA lists 12 application product lines for Trimethoprim, including TRIMETHOPRIM (Prescription); TRIMETHOPRIM (Prescription); TRIMETHOPRIM (Prescription); TRIMETHOPRIM (Prescription); PROLOPRIM (Discontinued).

Is Trimethoprim on the WHO Model List of Essential Medicines?

Yes — 6.2.1. Access group antibiotics (core list): First choice: Infectious cystitis.

Are there safety signals or safety updates for Trimethoprim?

US FDA: 8 entries (latest 2025-08-04).

Active substance

Trimethoprim

SFDA 1
US FDA 12
Health Canada 2
US price lines 1
NHS prices 4
WHO EML 1
Safety 8

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
TRIMIDAR TAB 100MG	100 mg	Tablet · Oral use	50 Blister	SAR 7.30	NCE · Prescription	DAR ALDAWA	Withdrawn by MAH · Not Marketed

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

Product	Strength	Form · route	Applicant	Status	First approved
TRIMETHOPRIM	100MG	tablet · oral	DR REDDYS LABS SA	Prescription	30 Jul 1982
TRIMETHOPRIM	100MG	tablet · oral	WATSON LABS	Prescription	6 Jun 1985
TRIMETHOPRIM	100MG	tablet · oral	NOVEL LABS INC	Prescription	15 Jun 2011
TRIMETHOPRIM	100MG	tablet · oral	NOVITIUM PHARMA	Prescription	28 Oct 2022
PROLOPRIM	100MG; 200MG	tablet · oral	MONARCH PHARMS	Discontinued	30 May 1980
TRIMPEX	100MG	tablet · oral	ROCHE	Discontinued	30 May 1980
TRIMPEX 200	200MG	tablet · oral	ROCHE	Discontinued	30 May 1980
TRIMETHOPRIM	100MG	tablet · oral	SUN PHARM INDUSTRIES	Discontinued	23 Jan 1986
TRIMETHOPRIM	200MG	tablet · oral	SUN PHARM INDUSTRIES	Discontinued	14 Mar 1986
TRIMETHOPRIM	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	tablet · oral	TEVA	Discontinued	18 Jun 1987
PRIMSOL	EQ 25MG BASE/5ML	solution · oral	PANGEA	Discontinued	23 Jun 1995
PRIMSOL	EQ 50MG BASE/5ML	solution · oral	PANGEA	Discontinued	24 Jan 2000

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
TRIMETHOPRIM TABLETS	02243116	100 MG	TABLET · ORAL	AA PHARMA INC
TRIMETHOPRIM TABLETS	02243117	200 MG	TABLET · ORAL	AA PHARMA INC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	TRIMETHOPRIM 100 MG TABLET	$1.30681	per EA	23 Sep 2026
NHS Drug Tariff	Trimethoprim 100mg tablets	£4.32	28 tablet	1 Oct 2026
NHS Drug Tariff	Trimethoprim 200mg tablets	£1.04	6 tablet	1 Oct 2026
NHS Drug Tariff	Trimethoprim 200mg tablets	£2.43	14 tablet	1 Oct 2026
NHS Drug Tariff	Trimethoprim 50mg/5ml oral suspension sugar free	£13.65	100 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)

6.2.1. Access group antibiotics · core
First choice: Infectious cystitis
Oral > Liquid: 50 mg per mL (EMLc) | Oral > Solid: 100 mg; 200 mg

Safety signals and safety-related labeling changes

US FDA 4 Aug 2025 POLYTRIM — safety-related labeling change
Labeling sections changed: Adverse Reactions
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 trimethoprim →

Combinations containing 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.