Overview
Metamizole (dipyrone) is a pyrazolone derivative that belongs to the group of nonacid nonopioids. It is considered a potent analgesic and antipyretic with favourable gastrointestinal tolerability. Metamizole was formerly marketed in the US as Dimethone tablets and injection, Protemp oral liquid, and other drug products, and was withdrawn due to its association with potentially fatal agranulocytosis. Approvals of the NDA's for metamizole drug products were withdrawn on June 27, 1977 (see the Federal Register of June 17, 1977, 42 FR 30893). In 1963, metamizole was withdrawn from the Canadian market and banned in the UK, France, Sweden, Norway and Australia. Metamizole is still used in certain countries in Europe, Asia and South America.
Indication
Metamizole is banned in several countries, where it was previously used as a powerful analgesic and fever reducer. In countries where it is still available, metamizole is indicated for acute severe pain after injuries or surgeries, colic, tumor pain, and acute or severe pain symptoms, as well as high fever if other treatments are unsuccessful.
Associated Conditions
- Severe Pain
- Severe Fever
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/04/30 | Phase 4 | Not yet recruiting | |||
2024/02/01 | Phase 3 | Not yet recruiting | EMS | ||
2023/06/23 | Not Applicable | Recruiting | Universidade Estadual Paulista Júlio de Mesquita Filho | ||
2023/06/23 | Not Applicable | Recruiting | Universidade Estadual Paulista Júlio de Mesquita Filho | ||
2021/11/18 | Phase 2 | Withdrawn | EMS | ||
2021/01/22 | N/A | Completed | Dr. Negrin University Hospital | ||
2021/01/11 | Not Applicable | Completed | Jessa Hospital | ||
2020/12/31 | Phase 4 | Completed | Łukasz Krzych | ||
2020/11/23 | Phase 3 | Completed | Brazilian Clinical Research Institute | ||
2020/11/09 | Phase 1 | Completed | University Hospital, Basel, Switzerland |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
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 |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Metamizole Sodium Tablets | 国药准字H62020245 | 化学药品 | 片剂 | 4/10/2020 | |
| Metamizole Sodium Tablets | 国药准字H41024002 | 化学药品 | 片剂 | 2/16/2023 | |
| Metamizole Sodium Tablets | 国药准字H42020787 | 化学药品 | 片剂 | 6/17/2020 | |
| Metamizole Sodium Tablets | 国药准字H63020133 | 化学药品 | 片剂 | 3/20/2020 | |
| Metamizole Sodium Tablets | 国药准字H22021200 | 化学药品 | 片剂 | 4/8/2020 | |
| Metamizole Sodium Tablets | 国药准字H13020549 | 化学药品 | 片剂 | 5/6/2020 | |
| Metamizole Sodium Tablets | 国药准字H45020459 | 化学药品 | 片剂 | 8/20/2020 | |
| Metamizole Sodium Tablets | 国药准字H50020154 | 化学药品 | 片剂 | 9/15/2020 | |
| Metamizole Sodium Tablets | 国药准字H22022655 | 化学药品 | 片剂 | 3/18/2020 | |
| Metamizole Sodium Tablets | 国药准字H62020081 | 化学药品 | 片剂 | 4/14/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Help Us Improve
Your feedback helps us provide better drug information and insights.