Cafcit, Gencebok(caffeine citrate)
Acetaminophen / Aspirin / Caffeine, Acetaminophen / Butalbital / Caffeine, Acetaminophen / Butalbital / Caffeine / Codeine, Aspirin / Butalbital / Caffeine, Aspirin / Butalbital / Caffeine / Codeine, Cafcit, Caffeine, Caffeine /, Darvon, Dhc, Excedrin (migraine Relief), Fioricet, Gencebok, Lanorinal, Migergot, Nymusa, Orphengesic, Peyona, Synalgos-dc, Synalgos-dc-a, Trezix (caffeine citrate) is a small molecule pharmaceutical. Caffeine citrate was first approved as Darvon w/ asa on 1982-01-01. It is used to treat apnea and fatigue in the USA. It has been approved in Europe to treat apnea.
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Commercial
Therapeutic Areas
Trade Name
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EMA
Cafcit, Caffeine (discontinued: Cafcit, Caffeine)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Caffeine citrate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| CAFCIT | Hikma Pharmaceuticals | N-020793 RX | 1999-09-21 | 1 products, RLD, RS |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| cafcit | New Drug Application | 2024-04-08 |
| caffeine citrate | ANDA | 2025-04-19 |
| caffeine citrate oral solution | ANDA | 2023-07-31 |
| excedrin pm triple action caplets and excedrin extra strength pain reliever | C200263 | 2024-03-14 |
| excedrin pm triple action caplets and excedrin tension headache | C200263 | 2024-03-14 |
| fioricet | ANDA | 2021-01-01 |
| fioricet with codeine | ANDA | 2021-03-01 |
| norgesic | ANDA | 2024-01-08 |
| norgesic forte | ANDA | 2024-01-27 |
| orphenadrine citrate aspirin caffeine | ANDA | 2024-07-25 |
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Agency Specific
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Clinical
Clinical Trials
1040 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pain | D010146 | EFO_0003843 | R52 | — | — | 1 | 1 | — | 2 |
| Common cold | D003139 | EFO_0007214 | J00 | — | — | 1 | 1 | — | 2 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Headache | D006261 | — | R51 | 1 | 1 | 2 | — | — | 3 |
| Tension-type headache | D018781 | — | G44.2 | 1 | 1 | 1 | — | — | 2 |
| Migraine disorders | D008881 | EFO_0003821 | G43 | — | — | 1 | — | — | 1 |
Indications Phases 2
No data
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Drug interactions | D004347 | — | — | 1 | — | — | — | — | 1 |
| Renal cell carcinoma | D002292 | EFO_0000376 | — | 1 | — | — | — | — | 1 |
| Anemia | D000740 | EFO_0004272 | D64.9 | 1 | — | — | — | — | 1 |
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | — | 1 |
| Substance-related disorders | D019966 | EFO_0003890 | F13 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Congenital abnormalities | D000013 | EFO_0003915 | Q89.9 | — | — | — | — | 1 | 1 |
| Depressive disorder | D003866 | EFO_1002014 | F32.A | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Caffeine citrate |
| INN | — |
| Description | Caffeine citrate, sold under the brand name Cafcit among others, is a medication used to treat a lack of breathing in premature babies. Specifically it is given to babies who are born at less than 35 weeks or weigh less than 2 kilograms (4.4 lb) once other causes are ruled out. It is given by mouth or slow injection into a vein.
|
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | Cn1c(=O)c2c(ncn2C)n(C)c1=O.O=C(O)CC(O)(CC(=O)O)C(=O)O |
Identifiers
| PDB | — |
| CAS-ID | 2097117-68-3 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1200569 |
| ChEBI ID | — |
| PubChem CID | 6241 |
| DrugBank | — |
| UNII ID | — |
Target
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Migergot – Horizon Therapeutics Public
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Estimated US medical usage
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Trends
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Safety
Black-box Warning
Black-box warning for: Fioricet, Fioricet with codeine, Trezix
Adverse Events
Top Adverse Reactions
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28,661 adverse events reported
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