Doseloop Beta

Nizatidine

medication Under review

An H2 receptor antagonist used to treat gastroesophageal reflux disease and peptic ulcer disease by reducing stomach acid production.

Research summary

AI-Generated Content: This summary was created by AI and may contain errors. Always verify with peer-reviewed sources.

Human studies on nizatidine are extensive and focus primarily on acid-related gastrointestinal conditions. Randomized, double-blind, placebo-controlled trials in adults and adolescents show that standard prescription doses (150 mg twice daily or 300 mg at bedtime) improve endoscopically diagnosed esophagitis, heal erosive and ulcerative esophagitis, and reduce GERD symptoms while decreasing the need for supplemental antacids. Over-the-counter dose studies (75 mg) in generally healthy adults with episodic heartburn demonstrate faster and more reliable symptom relief compared with placebo in at-home, real-world conditions. Safety data from large clinical trial programs and post-marketing experience indicate that nizatidine is generally well tolerated, with adverse events overall similar to placebo in short-term use. Common side effects include mild gastrointestinal complaints and occasionally central nervous system symptoms such as headache or insomnia. Rare but clinically important events such as elevated liver enzymes, hepatitis, jaundice, anemia, thrombocytopenia, and sexual side effects (decreased libido, impotence, gynecomastia) have been reported, mostly in patient populations rather than specifically in healthy volunteers. Bioequivalence and pharmacokinetic studies in healthy adults confirm predictable absorption and support generic formulations. There is no strong evidence of antiandrogenic effects in controlled studies.

Reported Benefits

Reported Side Effects

Related health conditions

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Research (4 studies)

RCT

Bioequivalence Study of Nizatidine Capsules 300 mg of Dr. Reddy's Laboratories Limited and Axid Capsules 300 mg of Braintree Laboratories Inc. in Healthy Human Subjects

ClinicalTrials.gov record NCT01161927 • 2010 • n=24

Dr. Reddy's Laboratories Ltd.

RCT

Nizatidine gastroesophageal reflux disease trials in adolescents and adults

FDA-Approved Label Summary of Clinical Trials • 2005 • n=400

Axid (nizatidine) prescribing information, Braintree Laboratories

RCT

Effectiveness and safety of nizatidine, 75 mg, for the relief of episodic heartburn.

Alimentary Pharmacology & Therapeutics • 2001 • n=994

Nwokolo CU, Smith PM, Gervais P, Preston T, et al.

RCT

Multicenter, Double-Blind, Placebo-Controlled Crossover Study of Nizatidine in Gastroesophageal Reflux Disease

The American Journal of the Medical Sciences • 1985 • n=120

Cohen S, Booth GH, Bianchine JR, et al.

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At a glance

Users tracking 0
Linked studies 4
Researched benefits 3
Side effects noted 1