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alprazolam Side Effects

Also known as: Xanax

Analysis of 200,719 adverse event reports submitted to the FDA from 2001 to 2025.

Total Reports

200,719

Death-Related

32,899

16.4% of reports

Hospitalizations

64,280

32.0% of reports

Top Indication

Product Used For Unknown Indication

Most Reported Adverse Reactions

DRUG INEFFECTIVE
13,399
NAUSEA
12,856
FATIGUE
11,933
DRUG ABUSE
10,943
ANXIETY
10,174
HEADACHE
9,926
PAIN
9,818
TOXICITY TO VARIOUS AGENTS
8,863
DIARRHOEA
8,787
DYSPNOEA
8,255
DIZZINESS
7,861
COMPLETED SUICIDE
7,524
DEPRESSION
7,225
INSOMNIA
7,179
VOMITING
7,134
OFF LABEL USE
7,040
FALL
6,923
DEATH
6,889
ASTHENIA
6,711
MALAISE
6,546

Who Reports Side Effects

Gender Distribution

Female 128,117 (67%)
Male 61,107 (32%)
Unknown 666

Age Distribution

0-17 2,655 (2%)
18-44 37,986 (28%)
45-64 54,477 (40%)
65-74 23,665 (17%)
75+ 18,812 (14%)

Reporting Trend by Year

2001 2025

Reactions in Death Reports

Top reactions reported in 32,899 reports where death was an outcome. These are voluntarily reported and do not establish causation.

Reaction Reports
COMPLETED SUICIDE 7,504
DEATH 6,876
DRUG ABUSE 5,945
TOXICITY TO VARIOUS AGENTS 5,601
CARDIAC ARREST 3,108
CARDIO-RESPIRATORY ARREST 2,655
RESPIRATORY ARREST 2,621
OVERDOSE 1,893
POISONING 1,311
DRUG DEPENDENCE 768
DRUG INTERACTION 764
PNEUMONIA 734
ACCIDENTAL OVERDOSE 715
DYSPNOEA 704
FATIGUE 651
PAIN 614
RENAL FAILURE 585
NAUSEA 570
PULMONARY OEDEMA 553
ACUTE KIDNEY INJURY 551

Reactions in Hospitalization Reports

Top reactions in 64,280 reports where hospitalization was an outcome.

Reaction Reports
NAUSEA 4,427
FALL 4,053
DYSPNOEA 4,040
PAIN 3,718
ANXIETY 3,527
VOMITING 3,476
PNEUMONIA 3,450
FATIGUE 3,362
DIARRHOEA 3,247
TOXICITY TO VARIOUS AGENTS 3,142
ASTHENIA 3,135
DRUG ABUSE 3,052
HEADACHE 2,860
DEPRESSION 2,769
PYREXIA 2,574
DRUG INEFFECTIVE 2,494
HYPOTENSION 2,450
DIZZINESS 2,413
MALAISE 2,404
SOMNOLENCE 2,377

Nearby — Related Medications

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What the FAERS Data Reveals About alprazolam Side Effects

The FDA Adverse Event Reporting System (FAERS) contains 200,719 voluntary reports linked to alprazolam and its brand equivalents (Xanax), spanning 2001 through 2025. Of those, 32,899 (16.4%) listed death as an outcome and 64,280 (32.0%) 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, 67% were female and 32% male; age distribution skews toward 45-64, with 54,477 reports in that bracket. The single most reported reaction is drug ineffective with 13,399 submissions, followed by nausea and fatigue.

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.