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Drug side effects

nizatidine Side Effects

The reactions most often reported to the FDA for nizatidine (also sold as Axid), with demographics, serious outcomes, and reporting trends.

Data updated 2026-05-15

1,480
FAERS reports

Data from the FDA Adverse Event Reporting System (FAERS), 1999 to 2025. A FAERS report records a temporal association, not proof of cause. See our methodology for how figures are compiled and de-duplicated.

The most commonly reported side effects of nizatidine come from 1,480 reports to the FDA, broken down here by frequency, patient demographics, and serious outcomes.

This page analyzes 1,480 reports to the FDA Adverse Event Reporting System (FAERS) for nizatidine (Axid): the reactions reported most often, who reported them, serious outcomes such as hospitalization, and year-over-year trends. A FAERS report does not prove the drug caused the effect, and report volume tracks how widely a drug is used, not how likely an effect is for any one person. Educational information, not medical advice.

Total Reports

1,480

Reports Mentioning Death

157

10.6% of reports — not proof the medicine caused the death

Hospitalizations

566

38.2% of reports

Top Indication

Product Used For Unknown Indication

Most Reported Adverse Reactions

CHRONIC KIDNEY DISEASE
264
ACUTE KIDNEY INJURY
161
RENAL FAILURE
135
END STAGE RENAL DISEASE
72
NAUSEA
69
VOMITING
66
RENAL INJURY
59
GASTROOESOPHAGEAL REFLUX DISEASE
56
DYSPNOEA
53
DIARRHOEA
48
PYREXIA
48
DIZZINESS
45
MALAISE
45
ANAEMIA
44
FATIGUE
42
PAIN
39
DEPRESSION
38
PNEUMONIA
38
HEADACHE
37

Who Reports Side Effects

Gender Distribution

Female 803 (60%)
Male 529 (40%)
Unknown 2

Age Distribution

0-17 19 (2%)
18-44 135 (14%)
45-64 344 (34%)
65-74 257 (26%)
75+ 243 (24%)

Reporting Trend by Year

1999 2025

Reactions in Death Reports

Top reactions reported in 157 reports where death was an outcome. These are voluntarily reported and do not establish causation.

Reaction Reports
DEATH 27
CHRONIC KIDNEY DISEASE 23
ACUTE KIDNEY INJURY 18
PNEUMONIA 16
RENAL FAILURE 16
END STAGE RENAL DISEASE 13
MALIGNANT NEOPLASM PROGRESSION 13
PLATELET COUNT DECREASED 11
SEPSIS 11
PYREXIA 10
NAUSEA 9
VOMITING 9
WHITE BLOOD CELL COUNT DECREASED 9
ANAEMIA 8
CONDITION AGGRAVATED 8
DECREASED APPETITE 8
DEPRESSED LEVEL OF CONSCIOUSNESS 8
DIARRHOEA 8
DISSEMINATED INTRAVASCULAR COAGULATION 8
PLEURAL EFFUSION 8

Reactions in Hospitalization Reports

Top reactions in 566 reports where hospitalization was an outcome.

Reaction Reports
PYREXIA 41
ACUTE KIDNEY INJURY 38
CHRONIC KIDNEY DISEASE 36
RENAL FAILURE 35
NAUSEA 31
ANAEMIA 30
DYSPNOEA 28
PNEUMONIA 28
MALAISE 26
VOMITING 24
DIARRHOEA 22
CHEST PAIN 20
DEHYDRATION 20
CONDITION AGGRAVATED 19
FALL 19
HEADACHE 19
LOSS OF CONSCIOUSNESS 19
CELLULITIS 18
HAEMOGLOBIN DECREASED 18
HYPOTENSION 18

Compare nizatidine vs alosetron →

What the FAERS Data Reveals About nizatidine Side Effects

The FDA Adverse Event Reporting System (FAERS) contains 1,480 voluntary reports linked to nizatidine and its brand equivalents (Axid), spanning 1999 through 2025. Of those, 157 (10.6%) listed death as an outcome and 566 (38.2%) involved hospitalization. The most common indication reported alongside adverse events was Product Used For Unknown Indication.

Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 60% were female and 40% male; age distribution skews toward 45-64, with 344 reports in that bracket. The single most reported reaction is chronic kidney disease with 264 submissions, followed by acute kidney injury and renal failure.

How to read these numbers

FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice, speak with a licensed clinician about any side-effect concerns.