pharmacopeia
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/api/v1/drug/nizatidine

Mechanism of action

Sourced from openFDA

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

Histamine H2 Receptor

Indications

Sourced from openFDA
  • Nizatidine is indicated for up to 8 weeks for the treatment of active duodenal ulcer. In most patients, the ulcer will heal within 4 weeks.ICD-10: K26.9

Dosage & administration

Sourced from openFDA

Active Duodenal Ulcer – The recommended oral dosage for adults is 300 mg once daily at bedtime. An alternative dosage regimen is 150 mg twice daily. Maintenance of Healed Duodenal Ulcer – The recommended oral dosage for adults is 150 mg once daily at bedtime. Gastroesophageal Reflux Disease – The recommended oral dosage in adults for the treatment of erosions, ulcerations, and associated heartburn is 150 mg twice daily. Active Benign Gastric Ulcer – The recommended oral dosage is 300 mg given either as 150 mg twice daily or 300 mg once daily at bedtime. Prior to treatment, care should be taken to exclude the possibility of malignant gastric ulceration. Dosage Adjustment for Patients With Moderate to Severe Renal Insufficiency – The dose for patients with renal dysfunction should be reduced as follows: Active Duodenal Ulcer, GERD and Benign Gastric Ulcer C cr Dose 20-50 mL/min 150 mg daily <20 mL/min 150 mg every other day Maintenance Therapy C cr Dose 20-50 mL/min 150 mg every other day <20 mL/min 150 mg every 3 days Some elderly patients may have creatinine clearances of less than 50 mL/min, and based on pharmacokinetic data in patients with renal impairment, the dose for such patients should be reduced accordingly. The clinical effects of this dosage reduction in patients with renal failure have not been evaluated.

Adverse reactions

Sourced from openFDA

Worldwide, controlled clinical trials of nizatidine included over 6,000 patients given nizatidine in studies of varying durations. Placebo-controlled trials in the United States and Canada included over 2,600 patients given nizatidine and over 1,700 given placebo. Among the adverse events in these placebo-controlled trials, anemia (0.2% vs 0%) and urticaria (0.5% vs 0.1%) were significantly more common in the nizatidine group. Incidence in Placebo-Controlled Clinical Trials in the United States and Canada – Table 5 lists adverse events that occurred at a frequency of 1% or more among nizatidine-treated patients who participated in placebo-controlled trials. The cited figures provide some basis for estimating the relative contribution of drug and nondrug factors to the side effect incidence rate in the population studied. Table 5.

Overdosage

Sourced from openFDA

Overdoses of nizatidine have been reported rarely. The following is provided to serve as a guide should such an overdose be encountered. Signs and Symptoms – There is little clinical experience with overdosage of nizatidine in humans. Test animals that received large doses of nizatidine have exhibited cholinergic-type effects, including lacrimation, salivation, emesis, miosis, and diarrhea. Single oral doses of 800 mg/kg in dogs and of 1,200 mg/kg in monkeys were not lethal. Intravenous median lethal doses in the rat and mouse were 301 mg/kg and 232 mg/kg respectively. Treatment – To obtain up-to-date information about the treatment of overdose, a good resource is your certified Regional Poison Control Center. Telephone numbers of certified poison control centers are listed in the Physicians' Desk Reference (PDR). In managing overdosage, consider the possibility of multiple drug overdoses, interaction among drugs, and unusual drug kinetics in your patient. If overdosage occurs, use of activated charcoal, emesis, or lavage should be considered along with clinical monitoring and supportive therapy.

Approval history

Sourced from openFDA
  • Jul 5, 2002ANDAANDA076178Epic Pharma Llc
  • Jul 9, 2002ANDAANDA075616Watson Labs
  • Sep 15, 2005ANDAANDA077314Dr Reddys Labs Ltd
  • Nov 18, 2009ANDAANDA090576Amneal Pharms

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.
1,498 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 Disease26418%
  2. 2Acute Kidney Injury16111%
  3. 3Renal Failure1359.0%
  4. 4End Stage Renal Disease724.8%
  5. 5Nausea714.7%
  6. 6Vomiting664.4%
  7. 7Renal Injury593.9%
  8. 8Dyspnoea563.7%
  9. 9Gastrooesophageal Reflux Disease563.7%
  10. 10Drug Ineffective493.3%
  11. 11Pyrexia493.3%
  12. 12Diarrhoea483.2%
  13. 13Dizziness483.2%
  14. 14Malaise463.1%
  15. 15Anaemia442.9%

Literature

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Recent PubMed references pinned to Nizatidine 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 12 ClinicalTrials.gov registrations naming Nizatidine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Nizatidine work?
Mechanism-of-action class: Histamine H2 Receptor Antagonists.
What is Nizatidine used for?
According to FDA labeling, Nizatidine carries indications including: Nizatidine is indicated for up to 8 weeks for the treatment of active duodenal ulcer. In most patients, the ulcer will heal within 4 weeks.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Nizatidine?
Nizatidine is classified as H2-receptor antagonists, Histamine-2 Receptor Antagonist, Histamine H2 Receptor Antagonists, Inhibition Gastric Acid Secretion.
Note. Data for nizatidine 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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