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Marketing Status approved; withdrawn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)
Insomnia19.02.01.002; 17.15.03.002--
Jaundice23.03.03.030; 09.01.01.004; 01.06.04.004--Not Available
Leukopenia01.02.02.001--Not Available
Loss of libido19.08.03.003--Not Available
Malaise08.01.01.003--
Myalgia15.05.02.001--
Nausea07.01.07.001--
Pancreatitis07.18.01.001--
Pancytopenia01.03.03.003--Not Available
Pneumonia22.07.01.003; 11.01.09.003--Not Available
Pyrexia08.05.02.003--
Rash23.03.13.001--Not Available
Somnolence19.02.05.003; 17.02.04.006--
Tachycardia02.03.02.007--Not Available
Thrombocytopenia01.08.01.002--Not Available
Vasculitis24.12.04.027; 10.02.02.006--
Ventricular extrasystoles02.03.04.007--Not Available
Vertigo17.02.12.002; 04.04.01.003--
Vision blurred17.17.01.010; 06.02.06.007--
Vomiting07.01.07.003--
Tubulointerstitial nephritis20.05.02.002--Not Available
Breast disorder21.05.04.004--Not Available
Motor dysfunction17.01.02.031; 15.05.06.006--Not Available
Erectile dysfunction21.03.01.007; 19.08.04.001--
Full blood count abnormal13.01.07.003--Not Available
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