Active substance
Amitriptyline
- SFDA 8
- US FDA 141
- Health Canada 15
- US price lines 6
- NHS prices 6
- WHO EML 2
- Safety 11
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| Alatript | 75 mg | Film-coated tablet · Oral use | 30 Blister | SAR 65.25 | Generic · Prescription | Saudi Amarox | Valid |
| Alatript | 50 mg | Film-coated tablet · Oral use | 30 Blister | SAR 43.50 | Generic · Prescription | Saudi Amarox | Valid |
| Alatript | 25 mg | Film-coated tablet · Oral use | 30 Blister | SAR 21.75 | Generic · Prescription | Saudi Amarox | Valid |
| Alatript | 10 mg | Film-coated tablet · Oral use | 30 Blister | SAR 17.90 | Generic · OTC | Saudi Amarox | Valid |
| SAROTEN RETARD 25MG CAPS | 25 mg | Capsule · Oral use | 100 Tablet Container | SAR 43.35 | NCE · Prescription | H. LUNDBECK | Withdrawn by MAH · Not Marketed |
| SAROTEN RETARD 25MG CAPS | 25 mg | Capsule · Oral use | 30 Blister | SAR 16.60 | NCE · Prescription | H. LUNDBECK | Withdrawn by MAH · Not Marketed |
| SAROTEN RETARD 50MG CAPS | 50 mg | Capsule · Oral use | 30 Blister | SAR 20.65 | NCE · Prescription | H. LUNDBECK | Withdrawn by MAH · Not Marketed |
| SAROTEN RETARD 50MG CAPS | 50 mg | Capsule · Oral use | 100 Tablet Container | SAR 68.80 | NCE · Prescription | H. LUNDBECK | Withdrawn by MAH · Not Marketed |
Indications — CHI Daman Drug Formulary
IRRITABLE BOWEL SYNDROME
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| AMITRIPTYLINE HYDROCHLORIDE | 150MG | tablet · oral | SANDOZ | Prescription | 21 Nov 1977 |
| AMITRIPTYLINE HYDROCHLORIDE | 50MG; 25MG; 100MG; 10MG; 150MG; 75MG | tablet · oral | SANDOZ | Prescription | 29 Nov 1977 |
| AMITRIPTYLINE HYDROCHLORIDE | 50MG; 10MG; 25MG; 75MG; 100MG; 150MG | tablet · oral | AUROBINDO PHARMA USA | Prescription | 10 Apr 1978 |
| AMITRIPTYLINE HYDROCHLORIDE | 25MG | tablet · oral | MYLAN | Prescription | 10 Apr 1978 |
| AMITRIPTYLINE HYDROCHLORIDE | 75MG | tablet · oral | MYLAN | Prescription | 10 Apr 1978 |
| AMITRIPTYLINE HYDROCHLORIDE | 150MG | tablet · oral | MYLAN | Prescription | 26 Apr 1978 |
| AMITRIPTYLINE HYDROCHLORIDE | 10MG | tablet · oral | MYLAN | Prescription | 26 Apr 1978 |
| AMITRIPTYLINE HYDROCHLORIDE | 100MG | tablet · oral | MYLAN | Prescription | 26 Apr 1978 |
| AMITRIPTYLINE HYDROCHLORIDE | 25MG; 10MG; 50MG; 75MG; 100MG; 150MG | tablet · oral | SUN PHARM INDS INC | Prescription | 14 Jul 1987 |
| AMITRIPTYLINE HYDROCHLORIDE | 50MG | tablet · oral | MUTUAL PHARM | Prescription | 14 Jul 1987 |
| AMITRIPTYLINE HYDROCHLORIDE | 100MG | tablet · oral | MUTUAL PHARM | Prescription | 14 Jul 1987 |
| AMITRIPTYLINE HYDROCHLORIDE | 10MG; 25MG; 50MG; 75MG; 100MG; 150MG | tablet · oral | ACCORD HLTHCARE | Prescription | 4 Jun 2014 |
| AMITRIPTYLINE HYDROCHLORIDE | 10MG; 25MG; 50MG; 75MG; 100MG; 150MG | tablet · oral | ZYDUS PHARMS | Prescription | 6 Oct 2017 |
| AMITRIPTYLINE HYDROCHLORIDE | 25MG; 10MG; 50MG; 75MG; 100MG; 150MG | tablet · oral | AIPING PHARM INC | Prescription | 7 Apr 2020 |
| AMITRIPTYLINE HYDROCHLORIDE | 10MG; 25MG; 50MG; 75MG; 100MG; 150MG | tablet · oral | MANKIND PHARMA | Prescription | 19 Feb 2021 |
| AMITRIPTYLINE HYDROCHLORIDE | 10MG; 25MG; 50MG; 75MG; 100MG; 150MG | tablet · oral | UNICHEM | Prescription | 19 May 2021 |
| AMITRIPTYLINE HYDROCHLORIDE | 10MG; 25MG; 50MG; 75MG; 100MG; 150MG | tablet · oral | RUBICON RESEARCH | Prescription | 1 May 2023 |
| AMITRIPTYLINE HYDROCHLORIDE | 10MG; 25MG; 50MG; 75MG; 100MG; 150MG | tablet · oral | RISING | Prescription | 19 May 2023 |
| AMITRIPTYLINE HYDROCHLORIDE | 10MG; 25MG; 50MG; 75MG; 100MG; 150MG | tablet · oral | UNIQUE PHARM | Prescription | 23 Jun 2025 |
| ELAVIL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | tablet · oral | ASTRAZENECA | Discontinued | 7 Apr 1961 |
| ELAVIL | 10MG/ML | injectable · injection | ASTRAZENECA | Discontinued | 11 Apr 1961 |
| AMITRIPTYLINE HYDROCHLORIDE | 25MG; 10MG; 50MG; 75MG | tablet · oral | ANI PHARMS | Discontinued | 16 Nov 1976 |
| AMITRIPTYLINE HYDROCHLORIDE | 50MG | tablet · oral | ANI PHARMS INC | Discontinued | 19 Nov 1976 |
| ENDEP | 150MG | tablet · oral | ROCHE | Discontinued | 27 Dec 1976 |
| AMITRIPTYLINE HYDROCHLORIDE | 25MG | tablet · oral | MUTUAL PHARM | Discontinued | 10 May 1977 |
116 more — full table
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| JAMP-AMITRIPTYLINE | 02457660 | 75 MG | TABLET · ORAL | JAMP PHARMA CORPORATION |
| JAMP-AMITRIPTYLINE | 02457679 | 10 MG | TABLET · ORAL | JAMP PHARMA CORPORATION |
| JAMP-AMITRIPTYLINE | 02457687 | 50 MG | TABLET · ORAL | JAMP PHARMA CORPORATION |
| JAMP-AMITRIPTYLINE | 02457695 | 25 MG | TABLET · ORAL | JAMP PHARMA CORPORATION |
| MAR-AMITRIPTYLINE | 02429861 | 10 MG | TABLET · ORAL | MARCAN PHARMACEUTICALS INC |
| MAR-AMITRIPTYLINE | 02429888 | 25 MG | TABLET · ORAL | MARCAN PHARMACEUTICALS INC |
| MAR-AMITRIPTYLINE | 02429896 | 50 MG | TABLET · ORAL | MARCAN PHARMACEUTICALS INC |
| MAR-AMITRIPTYLINE | 02429918 | 75 MG | TABLET · ORAL | MARCAN PHARMACEUTICALS INC |
| PMS-AMITRIPTYLINE | 00654507 | 50 MG | TABLET · ORAL | PHARMASCIENCE INC |
| PMS-AMITRIPTYLINE | 00654515 | 25 MG | TABLET · ORAL | PHARMASCIENCE INC |
| PMS-AMITRIPTYLINE | 00654523 | 10 MG | TABLET · ORAL | PHARMASCIENCE INC |
| PMS-AMITRIPTYLINE | 02468409 | 100 MG | TABLET · ORAL | PHARMASCIENCE INC |
| PRO-AMITRIPTYLINE | 00370991 | 10 MG | TABLET · ORAL | PRO DOC LIMITEE |
| PRO-AMITRIPTYLINE | 00371009 | 25 MG | TABLET · ORAL | PRO DOC LIMITEE |
| PRO-AMITRIPTYLINE | 00456349 | 50 MG | TABLET · ORAL | PRO DOC LIMITEE |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | AMITRIPTYLINE HCL 10 MG TAB | $0.02998 | per EA | 23 Sep 2026 |
| US NADAC | AMITRIPTYLINE HCL 100 MG TAB | $0.14274 | per EA | 23 Sep 2026 |
| US NADAC | AMITRIPTYLINE HCL 150 MG TAB | $0.28986 | per EA | 23 Sep 2026 |
| US NADAC | AMITRIPTYLINE HCL 25 MG TAB | $0.05221 | per EA | 23 Sep 2026 |
| US NADAC | AMITRIPTYLINE HCL 50 MG TAB | $0.09628 | per EA | 23 Sep 2026 |
| US NADAC | AMITRIPTYLINE HCL 75 MG TAB | $0.1225 | per EA | 23 Sep 2026 |
| NHS Drug Tariff | Amitriptyline 10mg tablets | £0.61 | 28 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Amitriptyline 10mg/5ml oral solution sugar free | £25.27 | 150 ml | 1 Oct 2026 |
| NHS Drug Tariff | Amitriptyline 25mg tablets | £0.67 | 28 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Amitriptyline 25mg/5ml oral solution sugar free | £9.46 | 150 ml | 1 Oct 2026 |
| NHS Drug Tariff | Amitriptyline 50mg tablets | £0.74 | 28 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Amitriptyline 50mg/5ml oral solution sugar free | £12.16 | 150 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)
- 2.3. Medicines for other common symptoms in palliative care · core
Palliative care
Oral > Liquid: 25 mg per 5 mL (EMLc) | Oral > Solid > tablet: 25 mg; 10 mg; 75 mg (EML) - 24.2.1. Medicines for depressive disorders · core
Depressive disorders
Oral > Solid: 25 mg; 75 mg
Safety signals and safety-related labeling changes
- EMA PRAC 7 May 2026 PRAC signal: Miscarriage associated with in utero exposure to benzodiazepines (including fixed-dose combinations)
Action for MAH: update of the product information: No - EMA PRAC 7 May 2026 PRAC signal: Miscarriage associated with in utero exposure to benzodiazepines (including fixed-dose combinations)
Action for MAH: update of the product information: No - US FDA 24 Jun 2025 LIMBITROL — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - EMA PRAC 1 Oct 2020 PRAC signal: Postpartum haemorrhage
Action for MAH: update of the product information: Yes - EMA PRAC 11 Jun 2020 PRAC signal: Postpartum haemorrhage
Action for MAH: update of the product information: No - EMA PRAC 12 Mar 2020 PRAC signal: Postpartum haemorrhage
Action for MAH: update of the product information: No - EMA PRAC 12 Jul 2018 PRAC signal: Dementia
Action for MAH: update of the product information: No - EMA PRAC 12 Apr 2018 PRAC signal: Dry eye
Action for MAH: update of the product information: Yes - EMA PRAC 8 Mar 2018 PRAC signal: Dry eye
Action for MAH: update of the product information: No - EMA PRAC 26 Oct 2017 PRAC signal: Risk of drug induced liver injury (DILI) and hepatocellular injury
Action for MAH: update of the product information: No - EMA PRAC 9 Jun 2017 PRAC signal: Risk of drug induced liver injury (DILI) and hepatocellular injury
Action for MAH: update of the product information: No
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.