Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Caffeine
Drug ID BADD_D00332
Description Caffeine is a drug of the methylxanthine class used for a variety of purposes, including certain respiratory conditions of the premature newborn, pain relief, and to combat drowsiness. Caffeine is similar in chemical structure to [Theophylline] and [Theobromine].[A187691,L9851] It can be sourced from coffee beans, but also occurs naturally in various teas and cacao beans, which are different than coffee beans.[T716] Caffeine is also used in a variety of cosmetic products and can be administered topically, orally, by inhalation, or by injection.[T716] The caffeine citrate injection, used for apnea of the premature newborn, was initially approved by the FDA in 1999.[L9863] According to an article from 2017, more than 15 million babies are born prematurely worldwide. This correlates to about 1 in 10 births. Premature birth can lead to apnea and bronchopulmonary dysplasia, a condition that interferes with lung development and may eventually cause asthma or early onset emphysema in those born prematurely.[A187694] Caffeine is beneficial in preventing and treating apnea and bronchopulmonary dysplasia in newborns, improving the quality of life of premature infants.[T716]
Indications and Usage Caffeine is indicated for the short term treatment of apnea of prematurity in infants and off label for the prevention and treatment of bronchopulmonary dysplasia caused by premature birth.[T716,L9851] In addition, it is indicated in combination with sodium benzoate to treat respiratory depression resulting from an overdose with CNS depressant drugs.[L9899] Caffeine has a broad range of over the counter uses, and is found in energy supplements, athletic enhancement products, pain relief products, as well as cosmetic products.[T716,L9854,L9872]
Marketing Status approved
ATC Code D11AX26; N06BC01
DrugBank ID DB00201
KEGG ID D00528; D01453
MeSH ID D002110
PubChem ID 2519
TTD Drug ID D0B3HD
NDC Product Code 65724-4013; 15579-201; 21130-944; 52389-656; 53943-320; 57243-226; 70000-0409; 71179-018; 10267-5010; 58624-0316; 65724-4004; 65724-4008; 21130-226; 46122-457; 56062-030; 63868-114; 41163-226; 62011-0340; 0363-5009; 68998-076; 69842-500; 72036-020; 70677-1126; 41250-320; 55910-226; 56062-409; 69168-076; 69842-509; 70677-0021; 58624-0304; 11822-2260; 63083-1508; 66715-5930; 30142-726; 41163-434; 41520-708; 63941-020; 66715-5830; 68016-680; 80136-855; 51552-0200; 58624-0302; 67091-117; 58624-0308; 58624-0312; 58624-0534; 65724-4012; 68210-4030; 36800-844; 49035-226; 49483-343; 52389-406; 55301-226; 0363-0226; 0363-3440; 66715-9799; 58624-0310; 65724-4000; 50804-262; 52389-155; 66715-5530; 72476-102; 76162-002; 38779-0419; 58624-0306; 58624-0314; 37808-409
UNII 3G6A5W338E
Synonyms Caffeine | 1,3,7-Trimethylxanthine | Vivarin | Caffedrine | Coffeinum N | Percutaféine | Dexitac | Durvitan | No Doz | Percoffedrinol N | Quick-Pep | Quick Pep | QuickPep | Coffeinum Purrum
Chemical Information
Molecular Formula C8H10N4O2
CAS Registry Number 58-08-2
SMILES CN1C=NC2=C1C(=O)N(C(=O)N2C)C
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Tremor17.01.06.0020.000388%
Urticaria23.04.02.001; 10.01.06.001--
Ventricular extrasystoles02.03.04.0070.000139%Not Available
Ventricular fibrillation02.03.04.0080.000139%
Ventricular tachycardia02.03.04.0100.000185%
Vertigo17.02.12.002; 04.04.01.003--
Vision blurred06.02.06.007; 17.17.01.010--
Vomiting07.01.07.0030.000554%
Wheezing22.03.01.009--
Mental status changes19.07.01.0010.000092%Not Available
Brain oedema17.07.02.003; 12.01.10.0100.000092%
Necrotising colitis07.08.01.013--Not Available
Haemodynamic instability24.03.02.006--Not Available
Infusion site phlebitis12.07.05.004; 24.12.03.002; 08.02.05.003--Not Available
Necrotising enterocolitis neonatal18.04.11.002; 07.08.03.011--Not Available
Haemorrhage24.07.01.002--Not Available
Infusion site inflammation08.02.05.020; 12.07.05.020--Not Available
Infusion site rash23.03.13.018; 12.07.05.017; 08.02.05.0170.000314%Not Available
Urine output increased13.13.03.002--Not Available
Cardiac disorder02.11.01.0030.000139%Not Available
Infestation23.11.01.002; 11.09.01.001--Not Available
Malnutrition14.03.02.004--Not Available
Inner ear disorder04.04.02.002--Not Available
Psychotic disorder19.03.01.0020.000092%
Regurgitation07.01.07.004--Not Available
Brain injury17.11.01.003; 19.07.03.007--Not Available
Acute kidney injury20.01.03.0160.000139%
Alcohol interaction08.06.03.003--Not Available
Accidental death12.01.08.040; 08.04.01.0130.000092%Not Available
Hypertension neonatal24.08.02.018; 18.04.07.0120.000277%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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