Nizatidine side effects: what 1,516 FDA adverse event reports show
Drug class
Histamine-2 Receptor Antagonist
Who reports
1,516 reports · 87% serious · 159 with death outcome · 61% female
Used for
Nizatidine oral solution is indicated for up to 8 weeks for the treatment of active duodenal ulcer. In most patients, the ulcer will heal within 4 weeks. Nizatidine oral solution is indicated for maintenance therapy for duodenal ulcer patients at a reduced dosage of 150 mg h.s. after healing of an active duodenal ulcer. The consequences of continuous therapy with nizatidine for longer than 1 year are not known.
What it is
Description: Nizatidine (USP) is a histamine H 2 -receptor antagonist.
Boxed warning
None in the current label
Causality screen of the 22 strongest signals
What the badges mean
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 34 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| End stage renal disease | 72 | 54.3 43.3–68.1ROR 57.0 · χ² 3,703 / p <1e-300 | 53.4 EB05 43.8 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious PRR 35.7 | no trial data cached |
| Chronic kidney disease | 264 | 47.8 42.9–53.4ROR 57.7 · χ² 12,061 / p <1e-300 | 47.5 EB05 42.9 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious PRR 32.0 | no trial data cached |
| Renal injury | 59 | 27.3 21.2–35.0ROR 28.3 · χ² 1,465 / p <1e-300 | 27.0 EB05 21.7 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 18.0 | no trial data cached |
| Tubulointerstitial nephritis | 31 | 22.9 16.2–32.5ROR 23.4 · χ² 628 / p 6e-139 | 22.6 EB05 16.7 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 15.2 | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 161 | 14.6 12.7–16.9ROR 16.3 · χ² 2,046 / p <1e-300 | 14.6 EB05 12.8 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 9.7 | no trial data cached |
| Renal failure (kidney failure) | 135 | 14.0 11.9–16.4ROR 15.3 · χ² 1,623 / p <1e-300 | 13.9 EB05 12.0 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 9.3 | no trial data cached |
| Disseminated intravascular coagulation | 13 | 12.8 7.4–21.9ROR 12.9 · χ² 129 / p 3e-30 | 11.3 EB05 6.3 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 8.4 | no trial data cached |
| Circulatory collapse | 13 | 10.5 6.1–18.1ROR 10.6 · χ² 103 / p 2e-24 | 8.9 EB05 5.1 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 7.0 | no trial data cached |
| Gastrooesophageal reflux disease (acid reflux) | 56 | 9.7 7.5–12.5ROR 10.0 · χ² 428 / p 2e-95 | 9.3 EB05 7.3 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 9.8 | no trial data cached |
| Neurotoxicity | 12 | 9.6 5.4–16.8ROR 9.6 · χ² 84 / p 3e-20 | 7.8 EB05 4.5 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.4 | no trial data cached |
| Glossodynia (burning tongue/mouth pain) | 13 | 8.1 4.7–13.8ROR 8.1 · χ² 73 / p 5e-18 | 6.6 EB05 4.0 · IC025 +1.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.1 | no trial data cached |
| Hepatic function abnormal | 21 | 7.8 5.1–12.0ROR 7.9 · χ² 119 / p 6e-28 | 6.9 EB05 4.7 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 · ♀ 38% (drug 61%) | no trial data cached |
| Diabetes mellitus inadequate control | 10 | 7.8 4.2–14.5ROR 7.9 · χ² 53 / p 2e-13 | 6.1 EB05 3.4 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.1 | no trial data cached |
| Depressed level of consciousness | 20 | 7.0 4.5–10.8ROR 7.1 · χ² 97 / p 3e-23 | 6.2 EB05 4.2 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 | no trial data cached |
| Chromaturia | 10 | 6.1 3.3–11.4ROR 6.2 · χ² 38 / p 4e-10 | 4.9 EB05 2.9 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 | no trial data cached |
| Acute myocardial infarction | 13 | 6.1 3.5–10.4ROR 6.1 · χ² 50 / p 7e-13 | 5.1 EB05 3.2 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 | no trial data cached |
| Interstitial lung disease | 21 | 6.0 3.9–9.2ROR 6.1 · χ² 83 / p 4e-20 | 5.4 EB05 3.7 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 · 90% clinician | no trial data cached |
| International normalised ratio increased | 12 | 5.8 3.3–10.1ROR 5.8 · χ² 43 / p 3e-11 | 4.8 EB05 2.9 · IC025 +1.3 3/3 methods agree | Lab value / disease marker | serious PRR 3.9 | no trial data cached |
| Cerebral infarction | 10 | 5.7 3.1–10.5ROR 5.7 · χ² 34 / p 3e-9 | 4.6 EB05 2.7 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 3.7 | no trial data cached |
| Angina pectoris | 11 | 5.3 2.9–9.5ROR 5.3 · χ² 34 / p 3e-9 | 4.4 EB05 2.6 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 | no trial data cached |
| Angioedema (deep swelling of face/throat) | 16 | 5.0 3.1–8.2ROR 5.1 · χ² 48 / p 3e-12 | 4.4 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.5 | no trial data cached |
| Product substitution issue | 11 | 2.6 1.5–4.8ROR 2.7 · χ² 10 / p 9e-4 | 2.5 EB05 1.5 · IC025 +0.3 | Reporting / coding artifact | serious PRR 2.7 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Chronic kidney disease | 264 | 47.8 42.9–53.4ROR 57.7 · χ² 12,061 / p <1e-300 | 47.5 EB05 42.9 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious PRR 32.0 | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 161 | 14.6 12.7–16.9ROR 16.3 · χ² 2,046 / p <1e-300 | 14.6 EB05 12.8 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 9.7 | no trial data cached |
| Renal failure (kidney failure) | 135 | 14.0 11.9–16.4ROR 15.3 · χ² 1,623 / p <1e-300 | 13.9 EB05 12.0 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 9.3 | no trial data cached |
| End stage renal disease | 72 | 54.3 43.3–68.1ROR 57.0 · χ² 3,703 / p <1e-300 | 53.4 EB05 43.8 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious PRR 35.7 | no trial data cached |
| Renal injury | 59 | 27.3 21.2–35.0ROR 28.3 · χ² 1,465 / p <1e-300 | 27.0 EB05 21.7 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 18.0 | no trial data cached |
| Gastrooesophageal reflux disease (acid reflux) | 56 | 9.7 7.5–12.5ROR 10.0 · χ² 428 / p 2e-95 | 9.3 EB05 7.3 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 9.8 | no trial data cached |
| Tubulointerstitial nephritis | 31 | 22.9 16.2–32.5ROR 23.4 · χ² 628 / p 6e-139 | 22.6 EB05 16.7 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 15.2 | no trial data cached |
| Interstitial lung disease | 21 | 6.0 3.9–9.2ROR 6.1 · χ² 83 / p 4e-20 | 5.4 EB05 3.7 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 · 90% clinician | no trial data cached |
| Hepatic function abnormal | 21 | 7.8 5.1–12.0ROR 7.9 · χ² 119 / p 6e-28 | 6.9 EB05 4.7 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 · ♀ 38% (drug 61%) | no trial data cached |
| Depressed level of consciousness | 20 | 7.0 4.5–10.8ROR 7.1 · χ² 97 / p 3e-23 | 6.2 EB05 4.2 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 | no trial data cached |
| Angioedema (deep swelling of face/throat) | 16 | 5.0 3.1–8.2ROR 5.1 · χ² 48 / p 3e-12 | 4.4 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.5 | no trial data cached |
| Acute myocardial infarction | 13 | 6.1 3.5–10.4ROR 6.1 · χ² 50 / p 7e-13 | 5.1 EB05 3.2 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 | no trial data cached |
| Glossodynia (burning tongue/mouth pain) | 13 | 8.1 4.7–13.8ROR 8.1 · χ² 73 / p 5e-18 | 6.6 EB05 4.0 · IC025 +1.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.1 | no trial data cached |
| Circulatory collapse | 13 | 10.5 6.1–18.1ROR 10.6 · χ² 103 / p 2e-24 | 8.9 EB05 5.1 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 7.0 | no trial data cached |
| Disseminated intravascular coagulation | 13 | 12.8 7.4–21.9ROR 12.9 · χ² 129 / p 3e-30 | 11.3 EB05 6.3 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 8.4 | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- End stage renal disease — n=72, PRR 54.3
- Chronic kidney disease — n=264, PRR 47.8
- Renal injury — n=59, PRR 27.3
- Tubulointerstitial nephritis — n=31, PRR 22.9
- Acute kidney injury — n=161, PRR 14.6
- Renal failure — n=135, PRR 14.0
- Gastrooesophageal reflux disease — n=56, PRR 9.7
- Hepatic function abnormal — n=21, PRR 7.8
- Depressed level of consciousness — n=20, PRR 7.0
- Interstitial lung disease — n=21, PRR 6.0
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Nizatidine?
In FDA FAERS, the most frequently co-reported reaction terms for Nizatidine are chronic kidney disease, acute kidney injury, renal failure, end stage renal disease, renal injury, gastrooesophageal reflux disease. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Nizatidine have an FDA boxed warning?
No. The FDA label retrieved for Nizatidine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Nizatidine causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 39e62997-8781-449a-e054-00144ff88e88, effective 20241023; matched on
openfda.generic_name.exact:"NIZATIDINE") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 56 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.