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Drug ReportsCaffeine citrate
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
Therapeutic Area
MeSH
respiratory tract diseasesD012140
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
No data
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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Labels
FDA
EMA
Brand Name
Status
Last Update
cafcitNew Drug Application2024-04-08
caffeine citrateANDA2025-04-19
caffeine citrate oral solutionANDA2023-07-31
excedrin pm triple action caplets and excedrin extra strength pain relieverC2002632024-03-14
excedrin pm triple action caplets and excedrin tension headacheC2002632024-03-14
fioricetANDA2021-01-01
fioricet with codeineANDA2021-03-01
norgesicANDA2024-01-08
norgesic forteANDA2024-01-27
orphenadrine citrate aspirin caffeineANDA2024-07-25
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Indications
FDA
EMA
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Agency Specific
FDA
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Clinical
Clinical Trials
64 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
ApneaD001049—R06.811155820
Premature birthD047928EFO_0003917O601163717
Respiratory distress syndromeD012128EFO_1000637J801——113
Newborn respiratory distress syndromeD012127—P221——113
Bronchopulmonary dysplasiaD001997—P27.8—11113
Respiratory insufficiencyD012131—J96.9———123
AnesthesiaD000758—————2—2
SyndromeD013577———1—1—2
IntubationD007440—————1—1
HemorrhageD006470MP_0001914R58———1—1
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HypoxiaD000860—R09.023—2——5
Brain diseasesD001927—G93.403—1——4
Brain ischemiaD002545EFO_0003883I67.823—1——4
Brain hypoxia-ischemiaD020925EFO_1000846P91.63—1——4
IschemiaD007511EFO_0000556—2—1——3
Atrial fibrillationD001281EFO_0000275I48.0——1——1
Migraine disordersD008881EFO_0003821G43——1——1
Respiratory tract diseasesD012140———11——1
Respiration disordersD012120—J00-J99—11——1
LeiomyomaD007889—D25——1——1
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Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
IleusD045823—K56.7—1———1
NarcolepsyD009290EFO_0000614G47.411———1
Retinopathy of prematurityD012178EFO_1001158H35.1—1———1
Parkinson diseaseD010300EFO_0002508G20—1———1
Neurobehavioral manifestationsD019954EFO_0004364—11———1
Alcoholic intoxicationD000435——11———1
Laparoscopic cholecystectomyD017081———1———1
DepressionD003863—F33.9—1———1
Postoperative cognitive complicationsD000079690———1———1
DeliriumD003693—R41.0—1———1
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———1———12
Postoperative painD010149—G89.181————1
Liver diseasesD008107EFO_0001421K70-K771————1
Acute kidney injuryD058186—N171————1
HypothermiaD007035—T681————1
Atopic dermatitisD003876EFO_0000274L201————1
EczemaD004485—L30.91————1
DermatitisD003872—L30.91————1
Necrotizing enterocolitisD020345EFO_0003928K55.31————1
EnterocolitisD004760EFO_1001481—1————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
WheelchairsD014910——————11
Dietary supplementsD019587——————11
BronchiolitisD001988——————11
ExerciseD015444EFO_0000483—————11
Nutritional physiological phenomenaD009747——————11
Newborn infant diseasesD007232——————11
RecurrenceD012008——————11
AnorexiaD000855—R63.0————11
Anorexia nervosaD000856EFO_0004215F50.0————11
StrokeD020521EFO_0000712I63.9————11
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameCaffeine 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—
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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-ID2097117-68-3
RxCUI—
ChEMBL IDCHEMBL1200569
ChEBI ID—
PubChem CID6241
DrugBank—
UNII ID—
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
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â‚£
Migergot – Horizon Therapeutics Public
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Estimated US medical usage
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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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