Overview
Morphine, the main alkaloid of opium, was first obtained from poppy seeds in 1805. It is a potent analgesic, though its use is limited due to tolerance, withdrawal, and the risk of abuse. Morphine is still routinely used today, though there are a number of semi-synthetic opioids of varying strength such as codeine, fentanyl, methadone, hydrocodone, hydromorphone, meperidine, and oxycodone. Morphine was granted FDA approval in 1941.
Indication
Morphine is used for the management of chronic, moderate to severe pain. Opiods, including morphine, are effective for the short term management of pain. Patients taking opioids long term may need to be monitored for the development of physical dependence, addiction disorder, and drug abuse.
Associated Conditions
- Chronic Pain
- Severe Pain
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/08/17 | Not Applicable | Not yet recruiting | Ondokuz Mayıs University | ||
2025/08/05 | Not Applicable | Not yet recruiting | Papa Giovanni XXIII Hospital | ||
2025/07/22 | Not Applicable | Not yet recruiting | GCS Ramsay Santé pour l'Enseignement et la Recherche | ||
2025/07/17 | Not Applicable | Recruiting | |||
2025/07/08 | Not Applicable | Recruiting | |||
2025/07/03 | Not Applicable | Recruiting | |||
2025/06/17 | Not Applicable | Recruiting | The Second Hospital of Anhui Medical University | ||
2025/06/17 | Not Applicable | Recruiting | |||
2025/06/10 | Not Applicable | Completed | |||
2025/06/04 | Not Applicable | Active, not recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Rhodes Pharmaceuticals L.P. | 42858-515 | ORAL | 15 mg in 1 1 | 12/27/2023 | |
Bryant Ranch Prepack | 63629-1091 | ORAL | 200 mg in 1 1 | 10/31/2019 | |
Quality Care Products LLC | 49999-848 | ORAL | 15 mg in 1 1 | 1/6/2020 | |
Cantrell Drug Company | 52533-059 | INTRAVENOUS | 1 mg in 1 mL | 10/20/2014 | |
Bryant Ranch Prepack | 71335-0707 | ORAL | 60 mg in 1 1 | 7/30/2025 | |
Hikma Pharmaceuticals USA Inc. | 0054-0235 | ORAL | 15 mg in 1 1 | 9/1/2018 | |
Hospira, Inc. | 0409-1890 | INTRAVENOUS | 2 mg in 1 mL | 7/30/2025 | |
STAT RX USA LLC | 16590-697 | ORAL | 20 mg in 1 1 | 6/15/2011 | |
Bryant Ranch Prepack | 63629-1965 | ORAL | 10 g in 1000 mL | 2/8/2021 | |
Upsher-Smith Laboratories, LLC | 0832-0225 | ORAL | 10 mg in 1 1 | 2/29/2024 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
MST CONTINUS TABLET 10 mg | SIN05506P | TABLET, FILM COATED | 10 mg | 3/4/1991 | |
MORPHINE SULFATE KALCEKS SOLUTION FOR INJECTION 10MG/ML | SIN16891P | INJECTION, SOLUTION | 10.00mg/mL | 10/20/2023 | |
DBL MORPHINE SULFATE INJECTION BP 10 mg/ml | SIN00757P | INJECTION | 10 mg/ml | 5/4/1988 | |
ORAMORPH SYRUP 2MG/ML | SIN16036P | SYRUP | 2MG/ML | 10/30/2020 | |
Morphine-hameln 10 mg/ml Injection | SIN13598P | INJECTION, SOLUTION | 10mg | 2/9/2009 | |
SOOV CREAM | SIN08901P | CREAM | 1.00% w/w | 9/4/1996 | |
MST CONTINUS TABLET 30 mg | SIN05508P | TABLET, FILM COATED | 30 mg | 3/4/1991 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
UNI-MORPHINE SYRUP (ALCOHOL FREE) 10MG/5ML | N/A | N/A | N/A | 11/12/2015 | |
UNI-MORPHINE SYRUP (ALCOHOL FREE) 50MG/5ML | N/A | N/A | N/A | 11/12/2015 | |
UNI-MORPHINE SYRUP (ALCOHOL FREE) 5MG/5ML | N/A | N/A | N/A | 11/12/2015 |
TGA Drug Approvals
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
SANDOZ MORPHINE SR | 02244791 | Tablet (Extended-Release) - Oral | 30 MG | 11/14/2001 | |
MORPHINE SULFATE INJECTION USP | 02242484 | Liquid - Intramuscular
,
Intravenous
,
Subcutaneous | 2 MG / ML | 12/12/2000 | |
PMS-MORPHINE SULFATE SR 100 MG | 02245287 | Tablet (Extended-Release) - Oral | 100 MG | 12/17/2007 | |
MORPHINE SULFATE INJECTION, USP | fresenius kabi canada ltd | 02488647 | Solution - Intramuscular
,
Intravenous
,
Subcutaneous | 10 MG / 1 ML | N/A |
DOLORAL SIROP | laboratoire atlas inc | 00614505 | Syrup - Oral | 5 MG / ML | 12/31/1991 |
KADIAN | BGP Pharma ULC | 02184451 | Capsule (Sustained-Release) - Oral | 100 MG | 10/25/1996 |
SANDOZ MORPHINE SR | 02478889 | Tablet (Extended-Release) - Oral | 100 MG | 12/19/2018 | |
PMS-MORPHINE SULFATE IR | 02549743 | Tablet (Immediate Release) - Oral | 5 MG | N/A | |
MORPHINE SULFATE INJECTION, USP | fresenius kabi canada ltd | 02488620 | Solution - Subcutaneous
,
Intramuscular
,
Intravenous | 2 MG / 1 ML | N/A |
MORPHINE SULFATE INJECTION BP | Sterimax Inc | 02474999 | Solution - Intramuscular
,
Intravenous
,
Subcutaneous | 15 MG / ML | N/A |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
MORFINA KALCEKS 10 MG/ML SOLUCION INYECTABLE EFG | Kalceks As | 82883 | SOLUCIÓN INYECTABLE | Medicamento Sujeto A Prescripción Médica. Estupefacientes | Not Commercialized |
MORFINA SERRA 20 MG/ML SOLUCION INYECTABLE | Laboratorios Serra Pamies S.A. | 37472 | SOLUCIÓN INYECTABLE | Medicamento Sujeto A Prescripción Médica. Estupefacientes | Commercialized |
MORFINA SERRA 10 MG/ML SOLUCION INYECTABLE | Laboratorios Serra Pamies S.A. | 37473 | SOLUCIÓN INYECTABLE | Medicamento Sujeto A Prescripción Médica. Estupefacientes | Commercialized |
DROPIZOL 10 MG/ML GOTAS ORALES EN SOLUCION | Pharmanovia A/S | 83323 | GOTAS ORALES EN SOLUCIÓN | Diagnóstico Hospitalario. Estupefacientes | Commercialized |
MARACEX 20 MG/ML SOLUCION INYECTABLE Y PARA PERFUSION | Kalceks As | 84129 | SOLUCIÓN INYECTABLE Y PARA PERFUSIÓN | Medicamento Sujeto A Prescripción Médica. Estupefacientes | Not Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
---|---|---|---|---|---|
No UK EMC drug information found for this drug. |
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