Is Paromomycin 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 Paromomycin.

Is Paromomycin approved by the US FDA?

Drugs@FDA lists 5 application product lines for Paromomycin, including PAROMOMYCIN SULFATE (Prescription); HUMATIN (Discontinued); HUMATIN (Discontinued); PAROMOMYCIN SULFATE (Discontinued); HUMATIN (Discontinued).

Is Paromomycin on the WHO Model List of Essential Medicines?

Yes — 6.5.2. Antileishmaniasis medicines (core list): Visceral leishmaniasis.

Active substance

Paromomycin

SFDA 2
US FDA 5
Health Canada 1
WHO EML 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
GABBRORAL SYRUP	125 mg/ml	Syrup · Oral use	1 Bottle	SAR 7.55	NCE · Prescription	PFIZER	Withdrawn by MAH · Not Marketed
GABBRORAL TAB 250MG	250 mg	Tablet · Oral use	12 Blister	SAR 9.70	NCE · Prescription	PFIZER	Withdrawn by MAH · Not Marketed

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

Product	Strength	Form · route	Applicant	Status	First approved
PAROMOMYCIN SULFATE	EQ 250MG BASE	capsule · oral	HERITAGE	Prescription	14 Dec 2007
HUMATIN	EQ 250MG BASE	capsule · oral	PARKEDALE	Discontinued	24 Mar 1969
HUMATIN	EQ 250MG BASE	capsule · oral	KING PFIZER	Discontinued	5 Jan 1981
PAROMOMYCIN SULFATE	EQ 250MG BASE	capsule · oral	SUN PHARM INDS INC	Discontinued	30 Jun 1997
HUMATIN	EQ 125MG BASE/5ML	syrup · oral	PARKE DAVIS	Discontinued

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
HUMATIN	02078759	250 MG	CAPSULE · ORAL	SEARCHLIGHT PHARMA INC

WHO WHO Model List of Essential Medicines (2025)

6.5.2. Antileishmaniasis medicines · core
Visceral leishmaniasis
Parenteral > General injections > IM: 750 mg paromomycin base (as sulfate)

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.