Active substance
Gentamicin
- SFDA 16
- US FDA 61
- Health Canada 6
- US price lines 6
- NHS prices 4
- WHO EML 3
- Safety 3
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| APIGEN 0.3% E-E DROPS | 0.3 % | Ear/eye drops, solution · Ophthalmic use | 1 Dropper Container | SAR 3.40 | Generic · Prescription | Amman Pharmaceutical Industries (API) | Valid |
| APIGEN 0.3% EYE OINTEMENT | 0.3 % | Eye ointment · Topical | 1 Tube | SAR 3.25 | Generic · Prescription | Amman Pharmaceutical Industries (API) | Valid |
| BAGENTA | 40 mg/ml | Solution for injection · Intramuscular and intravenous use | 5 Ampoule | SAR 60.90 | Generic · Prescription | BATTERJEE PHARMACETICAL FACTORY | Valid |
| GENTACIN | 0.3 % | Ear/eye drops, solution · Ophthalmic use | 1 Bottle | SAR 12.00 | Generic · Prescription | RIYADH PHARMA | Valid |
| GENTACIN | 0.3 % | Ear/eye drops, solution · Topical | 1 Tube | SAR 8.10 | Generic · Prescription | RIYADH PHARMA | Valid |
| GENTAM 20MG-2ML AMP | 10 mg/ml | Solution for injection · Intravenous use | 5 Ampoule | SAR 26.10 | Generic · Prescription | SPIMACO ADDWAEIH | Valid |
| GENTAM 80MG-2ML AMP | 40 mg/ml | Solution for injection · Intravenous use | 5 Ampoule | SAR 67.70 | Generic · Prescription | SPIMACO ADDWAEIH | Valid |
| ALCOMICIN 0.3% EYE DROPS | 0.3 % | Ear/eye drops, solution · Topical | 1 Dropper Container | SAR 17.65 | Generic · Prescription | ALCON COUVREUR | Withdrawn by MAH · Not Marketed |
| COLIRCUSI GENTAMYCIN 0.3% | 0.3 % | Ear/eye drops, solution · Topical | 1 Dropper Container | SAR 4.60 | NCE · Prescription | ALCON CUSI | Withdrawn by MAH · Not Marketed |
| GARAMYCIN 0.3% E-E DROPS | 0.3 % | Ear/eye drops, solution · Topical | 1 Dropper Container | SAR 9.80 | Generic · Prescription | SCHERING-PLOUGH | Withdrawn by MAH · Not Marketed |
| GENTA 20MG-2ML AMPOULE | 10 mg/ml | Injection · Intravenous use | 5 Ampoule | SAR 5.15 | Generic · Prescription | SHIFA PHARMACEUTICAL INDUSTRIES | Invalid · Not Marketed |
| GENTA 40MG-2ML AMPOULE | 20 mg/ml | Injection · Intravenous use | 5 Ampoule | SAR 5.85 | Generic · Prescription | SHIFA PHARMACEUTICAL INDUSTRIES | Invalid · Not Marketed |
| GENTA 80MG-2ML AMPOULE | 40 mg/ml | Injection · Intravenous use | 5 Ampoule | SAR 7.25 | Generic · Prescription | SHIFA PHARMACEUTICAL INDUSTRIES | Invalid · Not Marketed |
| GENTAM 0.3% EYE OINT. | 0.3 % | Ointment · Ocular use | 1 Tube | SAR 7.20 | Generic · Prescription | SPIMACO ADDWAEIH | Withdrawn by MAH · Not Marketed |
| GENTAM E-E DROPS 0.3% | 0.3 % | Ear/eye drops, solution · Topical | 1 Dropper Container | SAR 13.35 | Generic · Prescription | SPIMACO ADDWAEIH | Withdrawn by MAH · Not Marketed |
| OFTALMOLOSA CUSI GENTAMYCIN 0.3%OINTMENT | 0.3 % | Ointment · Topical | 1 Tube | SAR 3.85 | Generic · Prescription | ALCON CUSI | Withdrawn by MAH · Not Marketed |
Indications — CHI Daman Drug Formulary
MUCOPURULENT CONJUCTIVITIS - GONOCOCCAL INFECTION OF THE EYE - CHLAMYDIAL CONJUNCTIVITIS; OTITIS EXTERNA
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| GENTAMICIN SULFATE | EQ 40MG BASE/ML; EQ 10MG BASE/ML | injectable · injection | HIKMA PHARMS | Prescription | 5 Jun 1980 |
| GENTAMICIN SULFATE | EQ 0.3% BASE | solution/drops · ophthalmic | SANDOZ | Prescription | 2 Jul 1980 |
| GENTAMICIN SULFATE | EQ 0.1% BASE | cream · topical | PADAGIS US | Prescription | 15 May 1981 |
| GENTAMICIN SULFATE | EQ 0.1% BASE | ointment · topical | PADAGIS US | Prescription | 18 Feb 1982 |
| GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 80MG BASE/100ML; EQ 100MG BASE/100ML; EQ 120MG BASE/100ML; EQ 1.2MG BASE/ML; EQ 1.6MG BASE/ML; EQ 2MG BASE/ML | injectable · injection | BAXTER HLTHCARE | Prescription | 7 Sep 1982 |
| GENTAMICIN SULFATE | EQ 40MG BASE/ML; EQ 10MG BASE/ML | injectable · injection | FRESENIUS KABI USA | Prescription | 4 Aug 1983 |
| GENTAMICIN SULFATE | EQ 10MG BASE/ML; EQ 40MG BASE/ML | injectable · injection | HOSPIRA | Prescription | 15 Aug 1983 |
| GENTAMICIN SULFATE | EQ 0.1% BASE | ointment · topical | FOUGERA PHARMS INC | Prescription | 5 Oct 1984 |
| GENTAMICIN SULFATE | EQ 0.1% BASE | ointment · topical | COSETTE PHARMS NC | Prescription | 29 Apr 1994 |
| GENTAMICIN SULFATE | EQ 0.1% BASE | cream · topical | COSETTE PHARMS NC | Prescription | 29 Apr 1994 |
| GENTAMICIN SULFATE | EQ 0.3% BASE | solution/drops · ophthalmic | BAUSCH AND LOMB INC | Prescription | 11 May 1994 |
| GENTAMICIN SULFATE | EQ 0.3% BASE | ointment · ophthalmic | SCIEGEN PHARMS | Prescription | 30 Jul 2004 |
| GENTAMICIN SULFATE | EQ 40MG BASE/ML | injectable · injection | EUGIA PHARMA | Prescription | 8 Jan 2024 |
| GARAMYCIN | EQ 0.1% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | cream · topical | SCHERING | Discontinued | 15 Mar 1966 |
| GARAMYCIN | EQ 0.1% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ointment · topical | SCHERING | Discontinued | 15 Mar 1966 |
| GARAMYCIN | EQ 0.3% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | solution/drops · ophthalmic | SCHERING | Discontinued | 19 Jun 1970 |
| GARAMYCIN | EQ 0.3% BASE | ointment · ophthalmic | SCHERING | Discontinued | 25 Nov 1970 |
| GARAMYCIN | EQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | injectable · injection | SCHERING | Discontinued | 3 May 1973 |
| GARAMYCIN | EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | injectable · intrathecal | SCHERING | Discontinued | 1 Oct 1979 |
| U-GENCIN | EQ 10MG BASE/ML; EQ 40MG BASE/ML | injectable · injection | PHARMACIA AND UPJOHN | Discontinued | 2 May 1980 |
| GARAMYCIN | EQ 40MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | injectable · injection | SCHERING | Discontinued | 3 Mar 1981 |
| GENTAMICIN SULFATE | EQ 40MG BASE/ML; EQ 10MG BASE/ML | injectable · injection | WATSON LABS | Discontinued | 20 Aug 1981 |
| GENTAMICIN SULFATE | EQ 10MG BASE/ML; EQ 40MG BASE/ML | injectable · injection | FRESENIUS KABI USA | Discontinued | 4 Mar 1982 |
| GENTAMICIN SULFATE | EQ 40MG BASE/ML | injectable · injection | KALAPHARM | Discontinued | 5 Apr 1982 |
| GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 0.8MG BASE/ML; EQ 40MG BASE/100ML; EQ 60MG BASE/100ML; EQ 2.4MG BASE/ML | injectable · injection | BAXTER HLTHCARE | Discontinued | 7 Sep 1982 |
36 more — full table
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| GENTAMICIN INJECTION USP | 02242652 | 40 MG / ML | SOLUTION · INTRAVENOUS; INTRAMUSCULAR | SANDOZ CANADA INCORPORATED |
| GENTAMICIN INJECTION USP | 02268531 | 10 MG / ML | SOLUTION · INTRAMUSCULAR; INTRAVENOUS | SANDOZ CANADA INCORPORATED |
| GENTAMICIN INJECTION USP | 02457008 | 40 MG / ML | SOLUTION · INTRAMUSCULAR; INTRAVENOUS | HIKMA CANADA LIMITED |
| GENTAMICIN INJECTION USP | 02470462 | 10 MG / ML | SOLUTION · INTRAMUSCULAR; INTRAVENOUS | HIKMA CANADA LIMITED |
| GENTAMICIN(E) | 02082136 | 1 MG / ML | SOLUTION · INTRAVENOUS | BAXTER CORPORATION |
| GENTAMICIN(E) | 02082152 | 1.6 MG / ML | SOLUTION · INTRAVENOUS | BAXTER CORPORATION |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | GENTAMICIN 0.1% CREAM | $0.88433 | per GM | 23 Sep 2026 |
| US NADAC | GENTAMICIN 0.1% CREAM | $0.88707 | per GM | 23 Sep 2026 |
| US NADAC | GENTAMICIN 0.1% OINTMENT | $0.94071 | per GM | 23 Sep 2026 |
| US NADAC | GENTAMICIN 0.1% OINTMENT | $0.77054 | per GM | 23 Sep 2026 |
| US NADAC | GENTAMICIN 0.3% EYE DROP | $0.79003 | per ML | 23 Sep 2026 |
| US NADAC | GENTAMICIN 80 MG/2 ML VIAL | $1.3026 | per ML | 23 Sep 2026 |
| NHS Drug Tariff | Gentamicin 0.3% ear/eye drops | £27.44 | 10 ml | 1 Oct 2026 |
| NHS Drug Tariff | Gentamicin 20mg/2ml solution for injection ampoules | £11.25 | 5 ampoule | 1 Oct 2026 |
| NHS Drug Tariff | Gentamicin 80mg/2ml solution for injection ampoules | £6.88 | 5 ampoule | 1 Oct 2026 |
| NHS Drug Tariff | Gentamicin 80mg/2ml solution for injection vials | £6.88 | 5 vial | 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: Neonatal meningitis; First choice: Sepsis without septic shock; First choice: Bacterial pneumonia (Community-acquired pneumonia - severe) [children] (co-prescribed with amoxicillin); First choice: Acute malnutrition in infants, children or adolescents (complicated) [children] (co-prescribed with ampicillin); First choice: Bacterial pneumonia (Community-acquired pneumonia - severe) [children] (co-prescribed with ampicillin); First choice: Peritoneal abscess (mild-moderate) (co-prescribed with ampicillin); First choice: Peritoneal abscess (severe) (co-prescribed with ampicillin); First choice: Peritonitis (mild-moderate) (co-prescribed with ampicillin); First choice: Peritonitis (severe) (co-prescribed with ampicillin); First choice: Acute malnutrition in infants, children or adolescents (complicated) [children] (co-prescribed with benzylpenicillin); First choice: Bacterial pneumonia (Community-acquired pneumonia - severe) [children] (co-prescribed with benzylpenicillin); Second choice: Other specified prophylactic measures; Second choice: Gonococcal infection
Parenteral > General injections > unspecified: 10 mg per mL in 2 mL vial (as sulfate) (EMLc); 40 mg per mL in 2 mL vial (as sulfate) (EMLc) | Parenteral > General injections > unspecified: 10 mg per mL in 2 mL vial (as sulfate); 40 mg per mL in 2 mL vial (as sulfate) - 21.1. Ophthalmological preparations > Anti-infective agents · core
Other specified conjunctivitis; Infectious blepharitis
Local > Ophthalmological > Solution (eye drops): 0.3% (gentamicin sulfate) - 5.1.6.1. Medicines for bacterial central nervous system infections · core
First choice: Neonatal meningitis
Parenteral > General injections > unspecified: 10 mg per mL in 2 mL vial (as sulfate) (EMLc); 40 mg per mL in 2 mL vial (as sulfate) (EMLc)
Safety signals and safety-related labeling changes
- US FDA 7 Jun 2018 PRED-G — safety-related labeling change
Labeling sections changed: Adverse Reactions - US FDA 7 Jun 2018 PRED-G — safety-related labeling change
Labeling sections changed: Adverse Reactions - MHRA 24 Nov 2017 Gentamicin: potential for histamine-related adverse drug reactions with some batches
Some batches of gentamicin sulphate active pharmaceutical ingredient (API) used to manufacture gentamicin may contain higher than expected levels of histamine, which is a residual from the manufacturing process. Monitor patients for signs of histamine-related adverse reactions.
Combinations containing Gentamicin
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.