pharmacopeia
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/api/v1/drug/cimetidine

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Histamine H2 Receptor Antagonists.

Histamine H2 Receptor

Indications

Sourced from openFDA
  • Cimetidine tablets are indicated in: 1. Short-term treatment of active duodenal ulcer.ICD-10: K26.9

Contraindications

Sourced from openFDA
  • Cimetidine tablets are contraindicated for patients known to have hypersensitivity to the product.contraindicated

Dosage & administration

Sourced from openFDA

Duodenal Ulcer Active Duodenal Ulcer Clinical studies have indicated that suppression of nocturnal acid is the most important factor in duodenal ulcer healing (see CLINICAL PHARMACOLOGY: Antisecretory Activity: Acid Secretion ). This is supported by recent clinical trials (see CLINICAL TRIALS: Duodenal Ulcer: Active Duodenal Ulcer ). Therefore, there is no apparent rationale, except for familiarity with use, for treating with anything other than a once-daily at bedtime dosage regimen. In a U.S. dose-ranging study of 400 mg at bedtime, 800 mg at bedtime and 1600 mg at bedtime, a continuous dose-response relationship for ulcer healing was demonstrated. However, 800 mg at bedtime is the dose of choice for most patients, as it provides a high healing rate (the difference between 800 mg at bedtime and 1,600 mg at bedtime being small), maximal pain relief, a decreased potential for drug interactions (see PRECAUTIONS: Drug Interactions ) and maximal patient convenience. Patients unhealed at 4 weeks, or those with persistent symptoms, have been shown to benefit from 2 to 4 weeks of continued therapy. It has been shown that patients who both have an endoscopically demonstrated ulcer larger than 1.0 cm and are also heavy smokers (i.e., smoke 1 pack of cigarettes or more per day) are more difficult to heal. There is some evidence which suggests that more rapid healing can be achieved in this subpopulation with 1,600 mg of cimetidine tablets at bedtime.

Adverse reactions

Sourced from openFDA

Adverse effects reported in patients taking cimetidine tablets are described as follows by body system. Incidence figures of 1 in 100 and greater are generally derived from controlled clinical studies. Gastrointestinal Diarrhea (usually mild) has been reported in approximately 1 in 100 patients. CNS Headaches, ranging from mild to severe, have been reported in 3.5% of 924 patients taking 1,600 mg/day, 2.1% of 2,225 patients taking 800 mg/day and 2.3% of 1,897 patients taking placebo. Dizziness and somnolence (usually mild) have been reported in approximately 1 in 100 patients on either 1,600 mg/day or 800 mg/day. Reversible confusional states, e.g., mental confusion, agitation, psychosis, depression, anxiety, hallucinations, disorientation, have been reported predominantly, but not exclusively, in severely ill patients. They have usually developed within 2 to 3 days of initiation of treatment with cimetidine tablets and have cleared within 3 to 4 days of discontinuation of the drug. Endocrine Gynecomastia has been reported in patients treated for 1 month or longer. In patients being treated for pathological hypersecretory states, this occurred in about 4% of cases while in all others the incidence was 0.3% to 1% in various studies. No evidence of induced endocrine dysfunction was found, and the condition remained unchanged or returned toward normal with continuing treatment with cimetidine tablets.

Overdosage

Sourced from openFDA

Studies in animals indicate that toxic doses are associated with respiratory failure and tachycardia that may be controlled by assisted respiration and the administration of a beta-blocker. Reported acute ingestions orally of up to 20 grams have been associated with transient adverse effects similar to those encountered in normal clinical experience. The usual measures to remove unabsorbed material from the gastrointestinal tract, clinical monitoring, and supportive therapy should be employed. There have been reports of severe CNS symptoms, including unresponsiveness, following ingestion of between 20 and 40 grams of cimetidine, and extremely rare reports following concomitant use of multiple CNS-active medications and ingestion of cimetidine at doses less than 20 grams. An elderly, terminally ill dehydrated patient with organic brain syndrome receiving concomitant antipsychotic agents and 4,800 mg of cimetidine intravenously over a 24-hour period experienced mental deterioration with reversal on discontinuation of cimetidine. There have been two deaths in adults who were reported to have ingested over 40 grams orally on a single occasion.

Approval history

Sourced from openFDA
  • May 17, 1994ANDAANDA074463Teva
  • May 17, 1994ANDAANDA074151Teva
  • May 17, 1994ANDAANDA074246Mylan
  • May 17, 1994ANDAANDA074329Chartwell Molecules
  • Dec 22, 1994ANDAANDA074251Chartwell Molecular
  • Jun 19, 1995NDANDA020238Medtech Products
  • Oct 28, 1997ANDAANDA074664Pai Holdings Pharm
  • Oct 29, 1998ANDAANDA075285L Perrigo Co

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
9,346 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Chronic Kidney Disease1,31714%
  2. 2Acute Kidney Injury7478.0%
  3. 3Renal Failure7157.7%
  4. 4Nausea6957.4%
  5. 5Fatigue6086.5%
  6. 6Drug Ineffective5085.4%
  7. 7Dyspnoea5065.4%
  8. 8Vomiting4975.3%
  9. 9Diarrhoea4494.8%
  10. 10Pain4334.6%
  11. 11Death4084.4%
  12. 12Dizziness3904.2%
  13. 13Off Label Use3824.1%
  14. 14Gastrooesophageal Reflux Disease3754.0%
  15. 15Headache3734.0%

Literature

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Recent PubMed references pinned to Cimetidine as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 152 ClinicalTrials.gov registrations naming Cimetidine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Cimetidine work?
Mechanism-of-action class: Histamine H2 Receptor Antagonists.
What is Cimetidine used for?
According to FDA labeling, Cimetidine carries indications including: Cimetidine tablets are indicated in: 1. Short-term treatment of active duodenal ulcer.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Cimetidine?
Cimetidine is classified as H2-receptor antagonists, Histamine-2 Receptor Antagonist, Histamine H2 Receptor Antagonists, Decreased Histamine Activity, Inhibition Gastric Acid Secretion.
What are the brand names for Cimetidine?
Cimetidine is marketed under brand names including Tagamet.
What are the contraindications for Cimetidine?
Cimetidine labeling lists contraindications including: Cimetidine tablets are contraindicated for patients known to have hypersensitivity to the product.. Always consult the full prescribing information and a clinician.
Note. Data for cimetidine is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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