What the label lists and what reports show
Nizatidine side effects
Nizatidine's FDA label lists its adverse reactions in its own words. FAERS holds 1,516 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is chronic kidney disease (264 reports).
- Generic listed
Check it at the source: the nizatidine FDA label on DailyMed (effective January 2, 2025, Epic Pharma, LLC); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsWorldwide, 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. …
Source: FDA drug label, Epic Pharma, LLC, effective January 2, 2025 (SPL set e9957997-8b85-48a0-9bb3-b878cb223236), via openFDA; the full label on DailyMed
What do FAERS reports show?
1,516 reports list nizatidine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 159 are coded as a death and 573 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 23 reactions below, 8 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Nizatidine: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions