Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Ranitidine hydrochloride
Drug ID BADD_D01914
Description Ranitidine is a commonly used drug, classified as a histamine H2-receptor antagonist, and belongs to the same drug class as [cimetidine] and [famotidine]. This drug helps to prevent and treat gastric-acid associated conditions, including ulcers, because of its ability to decrease gastric acid secretion.[A176759,L10818] Ranitidine is often referred to as Zantac, and is available in various forms, including tablet, injection, and effervescent tablet preparations.[L10818,F4253] The prevalence of GERD is thought to be 10-20% in western countries.[A176843] Ranitidine has proven to be an effective treatment for relieving uncomfortable symptoms of gastric acid associated conditions and is therefore widely used in GERD and other gastric-acid related conditions.[A176849,L10818]
Indications and Usage This drug is used alone or with concomitant antacids for the following conditions: short-term treatment of active duodenal ulcer, treating gastric acid hypersecretion due to Zollinger-Ellison syndrome, systemic mastocytosis, and other conditions that may pathologically raise gastric acid levels. It also used in the short term treatment of active benign gastric ulcers and maintenance therapy of gastric ulcers at a reduced dose. In addition to the above, ranitidine can be used for the treatment of GERD symptoms, treatment of erosive esophagitis (endoscopically diagnosed) and the maintenance of gastric or duodenal ulcer healing.[L10818,L10821]
Marketing Status approved; withdrawn
ATC Code Not Available
DrugBank ID DB00863
KEGG ID D00673
MeSH ID D011899
PubChem ID 3033332
TTD Drug ID D0B8WN
NDC Product Code 55111-002; 65841-764; 67835-0004; 67091-244; 0781-2855; 0781-2865; 68382-423; 72375-0002; 73377-035; 65841-763; 70710-1550; 49711-0107; 72643-012; 54838-550; 72785-0001; 58032-2002; 55111-129; 38779-3186; 55111-130; 68382-422; 38779-0536; 55111-862; 49452-6214
UNII BK76465IHM
Synonyms Ranitidine | Ranitidin | N (2-(((5-((Dimethylamino)methyl)-2-furanyl)methyl)thio)ethyl)-N'-methyl-2-nitro-1,1-ethenediamine | Biotidin | Ranisen | Sostril | Zantac | Zantic | AH-19065 | AH 19065 | AH19065 | Ranitidine Hydrochloride | Hydrochloride, Ranitidine
Chemical Information
Molecular Formula C13H23ClN4O3S
CAS Registry Number 66357-59-3
SMILES CNC(=C[N+](=O)[O-])NCCSCC1=CC=C(O1)CN(C)C.Cl
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)
Abdominal discomfort07.01.06.001--Not Available
Abdominal pain07.01.05.002--
Agitation19.06.02.001; 17.02.05.012--
Agranulocytosis01.02.03.001--Not Available
Alopecia23.02.02.001--
Anaphylactic reaction24.06.03.006; 10.01.07.001--
Angioedema10.01.05.009; 22.04.02.008; 23.04.01.001--Not Available
Aplastic anaemia01.03.03.002--Not Available
Arrhythmia02.03.02.001--Not Available
Arthralgia15.01.02.001--
Atrioventricular block02.03.01.002--Not Available
Blood creatinine increased13.13.01.004--
Bradycardia02.03.02.002--Not Available
Bronchospasm22.03.01.004; 10.01.03.012--
Confusional state19.13.01.001; 17.02.03.005--
Constipation07.02.02.001--
Depression19.15.01.001--
Diarrhoea07.02.01.001--
Dizziness02.11.04.006; 24.06.02.007; 17.02.05.003--
Eosinophilia01.02.04.001--
Erythema multiforme23.03.01.003; 10.01.03.015--
Galactorrhoea21.05.02.002; 05.03.04.002--Not Available
Granulocytopenia01.02.03.003--Not Available
Gynaecomastia21.05.04.003; 05.05.02.003--
Haemolytic anaemia01.06.03.002--Not Available
Hallucination19.10.04.003--
Hepatic failure09.01.03.002--
Hepatitis09.01.07.004--Not Available
Hepatitis cholestatic09.01.01.002--Not Available
Hypersensitivity10.01.03.003--
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