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rabeprazole Side Effects

Also known as: Aciphex

Analysis of 21,352 adverse event reports submitted to the FDA from 2004 to 2025.

Total Reports

21,352

Death-Related

2,472

11.6% of reports

Hospitalizations

9,750

45.7% of reports

Top Indication

Product Used For Unknown Indication

Most Reported Adverse Reactions

DRUG INEFFECTIVE
1,860
OFF LABEL USE
1,771
NAUSEA
1,541
DIARRHOEA
1,319
PAIN
1,314
HEADACHE
1,284
DYSPNOEA
1,276
ARTHRALGIA
1,266
FATIGUE
1,210
MALAISE
1,149
PNEUMONIA
1,096
FALL
952
COUGH
922
DIZZINESS
869
PYREXIA
822
RASH
803
WEIGHT DECREASED
798
VOMITING
792
ASTHENIA
764
PAIN IN EXTREMITY
694

Who Reports Side Effects

Gender Distribution

Female 11,212 (58%)
Male 8,211 (42%)
Unknown 24

Age Distribution

0-17 239 (2%)
18-44 1,982 (13%)
45-64 5,301 (33%)
65-74 4,059 (26%)
75+ 4,243 (27%)

Reporting Trend by Year

2004 2025

Reactions in Death Reports

Top reactions reported in 2,472 reports where death was an outcome. These are voluntarily reported and do not establish causation.

Reaction Reports
DEATH 535
PNEUMONIA 219
DYSPNOEA 145
OFF LABEL USE 137
DIARRHOEA 125
NAUSEA 116
SEPSIS 114
PYREXIA 111
FATIGUE 109
DECREASED APPETITE 108
INTERSTITIAL LUNG DISEASE 108
ANAEMIA 102
CARDIAC FAILURE 101
MALAISE 98
RASH 97
RENAL FAILURE 93
PLATELET COUNT DECREASED 91
ASTHENIA 83
CONSTIPATION 82
CARDIAC ARREST 80

Reactions in Hospitalization Reports

Top reactions in 9,750 reports where hospitalization was an outcome.

Reaction Reports
PNEUMONIA 777
DYSPNOEA 685
DIARRHOEA 666
NAUSEA 639
MALAISE 583
PYREXIA 579
FALL 569
OFF LABEL USE 541
DRUG INEFFECTIVE 539
VOMITING 468
HEADACHE 444
PAIN 426
COUGH 422
FATIGUE 417
ASTHENIA 413
ANAEMIA 412
ARTHRALGIA 407
WEIGHT DECREASED 341
RASH 339
ABDOMINAL PAIN 317

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What the FAERS Data Reveals About rabeprazole Side Effects

The FDA Adverse Event Reporting System (FAERS) contains 21,352 voluntary reports linked to rabeprazole and its brand equivalents (Aciphex), spanning 2004 through 2025. Of those, 2,472 (11.6%) listed death as an outcome and 9,750 (45.7%) 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, 58% were female and 42% male; age distribution skews toward 45-64, with 5,301 reports in that bracket. The single most reported reaction is drug ineffective with 1,860 submissions, followed by off label use and nausea.

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.