Active substance
Tinidazole
- SFDA 3
- US FDA 7
- US price lines 2
- WHO EML 1
- Safety 1
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| PROTOGYN | 500 mg | Film-coated tablet · Oral use | 4 Blister | SAR 10.45 | Generic · Prescription | HAYAT PHARMACEUTICAL INDUSTRIES | Valid |
| FASIGYN 500MG TABLET | 500 mg | Film-coated tablet · Oral use | 4 Blister | SAR 14.95 | Generic · Prescription | PFIZER | Withdrawn by MAH · Not Marketed |
| FASIGYN 500MG TABLET | 500 mg | Film-coated tablet · Oral use | 4 Blister | SAR 14.95 | Generic · Prescription | PFIZER | Withdrawn by MAH · Not Marketed |
Indications — CHI Daman Drug Formulary
BACTRIAL INFECTIONS OF THE GASTROINTESTINAL TRACT- H-PYLORI ERADICATION-EVIDENCE BASED FIRST LINE TREATMENT STRATEGY; ENTAMOEBA HISTOLYTICA INFECTION; GIARDIA LAMBLIA INFECTION; TRAVELLER'S DIARRHEA; TRICHOMONAS VAGINALIS
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| TINDAMAX | 250MG; 500MG | tablet · oral | MISSION PHARMA | Prescription | 17 May 2004 |
| TINDAMAX | 250MG; 500MG | tablet · oral | MISSION PHARMA | Prescription | 17 May 2004 |
| TINDAMAX | 250MG; 500MG | tablet · oral | MISSION PHARMA | Prescription | 17 May 2004 |
| TINIDAZOLE | 250MG; 500MG | tablet · oral | CHARTWELL RX | Prescription | 30 Apr 2012 |
| TINIDAZOLE | 250MG; 500MG | tablet · oral | UNIQUE | Prescription | 9 Oct 2013 |
| TINIDAZOLE | 250MG; 500MG | tablet · oral | EDENBRIDGE PHARMS | Prescription | 4 Aug 2015 |
| TINIDAZOLE | 250MG; 500MG | tablet · oral | HIKMA PHARMS | Discontinued | 30 Apr 2012 |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | TINIDAZOLE 250 MG TABLET | $1.50324 | per EA | 23 Sep 2026 |
| US NADAC | TINIDAZOLE 500 MG TABLET | $2.35434 | per EA | 23 Sep 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)
- 6.5.1. Antiamoebic and antigiardiasis medicines · core
Therapeutic equivalent to metronidazole for Amoebiasis
Safety signals and safety-related labeling changes
- US FDA 15 Dec 2021 TINDAMAX — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
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.