Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Famotidine
Drug ID BADD_D00869
Description Famotidine is a competitive histamine-2 (H2) receptor antagonist that works to inhibit gastric acid secretion. It is commonly used in gastrointestinal conditions related to acid secretion, such as gastric ulcers and gastroesophageal reflux disease (GERD), in adults and children.[L11166] Compared to other H2 receptor antagonists, famotidine displays high selectivity towards this receptor; in a study consisting of healthy volunteers and patients with acid hypersecretory disease, famotidine was about 20 to 50 times more potent at inhibiting gastric acid secretion than [cimetidine] and eight times more potent than [ranitidine] on a weight basis.[A189462] Famotidine is used in various over-the-counter and off-label uses.[L11166] While oral formulations of famotidine are more commonly used, the intravenous solution of the drug is available for use in hospital settings.[L11142]
Indications and Usage Famotidine is indicated in pediatric and adult patients (with the bodyweight of 40 kg and above) for the management of active duodenal ulcer (DU), active gastric ulcer, symptomatic non-erosive gastroesophageal reflux disease (GERD), and erosive esophagitis due to GERD, diagnosed by biopsy.[L11139] It is also indicated in adult patients for the treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison Syndrome, multiple endocrine neoplasias) and reduction of the risk of DU recurrence.[L11139] The intravenous formulation of famotidine is available for some hospitalized patients with pathological hypersecretory conditions or intractable ulcers or as an alternative to the oral dosage form for short-term use in patients who are unable to take oral medication.[L11142] Over-the-counter famotidine is used for the management and prevention of heartburn caused by gastroesophageal reflux in children and adults. Off-label uses of famotidine include the reduction of NSAIDs-associated gastrointestinal effects, treatment of refractory urticarial, prevention of stress ulcer in critically-ill patients, and symptomatic relief of gastritis.[L11166,L11172]
Marketing Status approved
ATC Code Not Available
DrugBank ID DB00927
KEGG ID D00318
MeSH ID D015738
PubChem ID 3325
TTD Drug ID D0K0OZ
NDC Product Code 0904-5529; 55111-118; 59651-112; 65862-860; 16714-244; 21130-023; 24385-385; 41250-493; 43063-533; 43602-502; 43602-511; 43602-602; 49035-650; 50090-3888; 51655-233; 57896-769; 58602-828; 58602-859; 59640-023; 61442-122; 0363-0701; 62332-001; 63868-583; 67296-1859; 68016-097; 69842-928; 70934-877; 71205-634; 71205-781; 71335-1950; 71872-7235; 72288-151; 72606-510; 72657-113; 72789-027; 72789-331; 51552-1583; 51927-3408; 53069-0570; 63126-907; 70910-0002; 31722-017; 36800-141; 41167-0364; 41520-707; 41520-901; 43598-824; 0172-5728; 46122-735; 49035-118; 49035-507; 49035-589; 49348-128; 51407-683; 51407-684; 53002-2199; 53943-101; 55315-435; 61919-236; 62011-0143; 63981-194; 67457-448; 67457-457; 68001-397; 69230-326; 70000-0049; 70518-3301; 71335-0231; 72189-141; 72476-150; 72606-509; 72657-112; 72865-214; 80425-0329; 65977-0125; 16837-872; 21130-249; 0113-7194; 46122-168; 46122-394; 0187-4420; 0187-4440; 49035-396; 50090-1045; 51407-452; 53943-100; 55319-427; 55910-141; 55910-665; 58118-0859; 58602-705; 58602-706; 59779-194; 0363-0141; 63187-908; 63629-1013; 63739-645; 65862-859; 68016-096; 68071-2678; 68788-7191; 69842-063; 69842-267; 69842-659; 70518-1001; 70518-1415; 70710-1684; 71205-276; 71205-663; 71335-9615; 56062-194; 60429-721; 60760-327; 62011-0142; 0363-1899; 63187-723; 63187-999; 66715-9748; 67296-1383; 67296-1795; 67877-842; 67877-843; 68001-398; 68071-2842; 68071-3420; 68788-8485; 70710-1683; 70934-780; 70934-988; 71205-257; 71335-0409; 71335-2190; 71610-470; 71821-010; 72288-329; 0641-6023; 81522-141; 45541-1175; 65841-135; 66406-0101; 72375-0003; 72640-018; 11822-1014; 21130-022; 41167-0360; 43063-695; 49483-720; 55319-426; 55910-814; 60687-595; 60760-736; 63868-584; 68016-800; 68382-444; 68475-400; 68788-7853; 69230-327; 69256-002; 0536-1298; 70860-752; 72036-026; 72288-141; 49452-3038; 67835-5012; 16837-855; 0113-0194; 30142-194; 36800-194; 37808-042; 41163-001; 41226-719; 43602-501; 46122-737; 46708-293; 49035-505; 50268-304; 50269-156; 55111-119; 0338-5197; 63629-2014; 63629-7926; 67296-1523; 67296-1776; 68016-008; 68016-801; 68071-3181; 68071-4197; 69256-141; 70518-1877; 70860-753; 71335-9748; 0615-4582; 0641-6022; 72865-215; 79903-115; 0904-5780; 0904-7193; 55111-396; 66406-0100; 11673-061; 11673-414; 11822-1194; 21130-777; 31722-018; 41163-313; 42291-281; 43598-960; 51655-553; 51662-1375; 53002-6670; 54257-180; 55319-377; 58602-829; 0363-1203; 63323-739; 0363-4400; 63629-2015; 63629-2782; 68016-010; 68645-140; 69238-2090; 69842-266; 70677-1102; 71205-637; 71821-012; 0832-6045; 55111-012; 67835-0021; 11822-6141; 30142-141; 42291-282; 50268-303; 55910-194; 56062-141; 59779-141; 60760-070; 61919-281; 63323-738; 0363-5300; 67751-214; 68071-3413; 68196-121; 68788-8269; 70000-0048; 70518-0163; 71205-535; 72476-299; 0641-6021; 80267-194; 12836-0307; 59651-053; 11822-0141; 43063-086; 43063-696; 46708-294; 49348-817; 50436-0999; 53002-3199; 55681-341; 55681-342; 59640-001; 60760-843; 61442-121; 62332-002; 67457-433; 68001-494; 68180-150; 68788-6859; 68788-7922; 68788-8285; 69842-087; 69842-924; 70860-751; 0574-0147; 71335-1520; 71872-7220; 72189-207; 0615-8301; 76162-300; 80267-501; 38779-0655; 69575-4050; 73377-072; 11673-031; 0113-0141; 37808-301; 41167-0361; 50090-1432; 50268-299; 50269-155; 50383-913; 50594-002; 51655-312; 54257-802; 55111-120; 63187-129; 63629-1014; 0363-9607; 68071-2306; 68391-300; 68645-594; 70771-1702; 70771-1703; 70954-316; 71335-0370; 71335-9724; 71610-399; 71713-701; 72288-194; 49711-0098; 53069-0210; 81842-604; 11822-0194; 21130-191; 41250-712; 43386-500; 0172-5729; 50090-5241; 55154-6843; 57896-767
UNII 5QZO15J2Z8
Synonyms Famotidine | YM-11170 | YM 11170 | YM11170 | Pepcid | Famotidine Hydrochloride | MK-208 | MK 208 | MK208
Chemical Information
Molecular Formula C8H15N7O2S3
CAS Registry Number 76824-35-6
SMILES C1=C(N=C(S1)N=C(N)N)CSCCC(=NS(=O)(=O)N)N
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)
Bradycardia02.03.02.002---
Breast cancer16.10.01.001; 21.05.01.0030.000159%-
Bronchitis11.01.09.001; 22.07.01.001--
Bronchospasm10.01.03.012; 22.03.01.004--
Cerebral infarction17.08.01.004; 24.04.06.0020.000113%-
Chest discomfort02.02.02.009; 08.01.08.019; 22.12.02.0020.000200%-
Chest pain02.02.02.011; 08.01.08.002; 22.12.02.0030.000191%-
Chills08.01.09.001; 15.05.03.0160.000045%
Cholangitis09.02.01.0020.000045%-
Cholecystitis chronic09.03.01.0040.000091%-
Cholelithiasis09.03.01.0020.000091%-
Chromaturia20.02.01.0020.000045%
Circulatory collapse24.06.02.0010.000045%-
Colon cancer07.21.01.001; 16.13.01.0010.000136%-
Condition aggravated08.01.03.0040.000204%-
Conduction disorder02.03.01.0080.000068%
Confusional state17.02.03.005; 19.13.01.001--
Constipation07.02.02.0010.000222%
Cough22.02.03.001--
Cutaneous vasculitis10.02.02.003; 23.06.02.001; 24.12.04.0080.000045%-
Decreased interest19.15.02.0040.000091%-
Defect conduction intraventricular02.03.01.0180.000091%-
Delirium19.13.02.0010.000182%
Depressed level of consciousness17.02.04.0020.000068%
Depression19.15.01.001--
Dermatitis23.03.04.002---
Diarrhoea07.02.01.001--
Disorientation17.02.05.015; 19.13.01.002---
Disseminated intravascular coagulation01.01.02.002; 24.01.01.0100.000045%
Dizziness02.11.04.006; 17.02.05.003; 24.06.02.007--
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ADReCS-Target
Drug Name ADR Term Target
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