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Alprazolam side effects: what 204,870 FDA adverse event reports show

Alprazolam · 1,153 reaction terms · 835,635 drug–reaction co-reports · data 2026-09-14
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Drug class

Benzodiazepine

FDA label (Established Pharmacologic Class) · compare the class

Who reports

204,870 reports · 71% serious · 33,446 with death outcome · 68% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Alprazolam extended-release tablets are indicated for the treatment of panic disorder with or without agoraphobia, in adults. Alprazolam extended-release tablets are a benzodiazepine indicated for the treatment of panic disorder with or without agoraphobia, in adults. ( 1 )

FDA label, Indications and Usage

What it is

Alprazolam is a member of the class of triazolobenzodiazepines that is 4H-[1,2,4]triazolo[4,3-a][1,4]benzodiazepine carrying methyl, phenyl and chloro substituents at positions 1, 6 and 8 respectively.

PubChem CID 2118 (ChEBI)

Boxed warning

RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for patients for whom alternative treatment options are inadequate.

FDA label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 40 strongest signals

Labeled — boxed warning 1Labeled adverse reaction 3Labeled (related wording) 6Likely indication confounding 1Reporting / coding artifact 5Outcome field, not a reaction 1Not in label — unassessed 23
What the badges mean

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. 1,113 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show:
ReactionReportsPRR 95% CI · ROR · χ²/pEBGM EB05 · IC025Label screenSerious-only & strataTrial cross-check
Vaginal flatulence188164.9
130.7–208.1ROR 165.0 · χ² 11,497 / p <1e-300
62.5 EB05 55.3 · IC025 +5.5
3/3 methods agree
Not in label — unassessedserious n=188 · ♀ 100% (drug 68%) · 100% cliniciannot reported in cached trials
Prescription form tampering18432.0
27.1–37.8ROR 32.0 · χ² 4,162 / p <1e-300
24.4 EB05 21.6 · IC025 +4.3
3/3 methods agree
Not in label — unassessedserious n=184 · ♀ 0% (drug 68%) · 100% cliniciannot reported in cached trials
Sopor2,10519.0
18.1–19.9ROR 19.2 · χ² 30,142 / p <1e-300
16.1 EB05 15.5 · IC025 +3.9
3/3 methods agree
Not in label — unassessedserious PRR 13.1 · 95% cliniciannot reported in cached trials
Poisoning deliberate1,43918.6
17.6–19.7ROR 18.7 · χ² 20,178 / p <1e-300
15.8 EB05 15.1 · IC025 +3.9
3/3 methods agree
Not in label — unassessedserious PRR 12.9 · 100% cliniciannot reported in cached trials
Drug abuse11,12115.6
15.3–15.9ROR 16.4 · χ² 131,675 / p <1e-300
13.6 EB05 13.4 · IC025 +3.7
3/3 methods agree
Reporting / coding artifactserious PRR 11.2 · ♀ 45% (drug 68%) · 91% cliniciannot reported in cached trials
Poisoning1,65915.4
14.6–16.2ROR 15.5 · χ² 19,314 / p <1e-300
13.4 EB05 12.9 · IC025 +3.7
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 11.0 · 100% cliniciannot reported in cached trials
Female genital tract fistula21314.3
12.4–16.5ROR 14.3 · χ² 2,299 / p <1e-300
12.6 EB05 11.2 · IC025 +3.4
3/3 methods agree
Not in label — unassessedserious n=213 · ♀ 100% (drug 68%) · 100% cliniciannot reported in cached trials
Chronic kidney disease-mineral and bone disorder13214.2
11.8–17.0ROR 14.2 · χ² 1,406 / p <1e-300
12.5 EB05 10.8 · IC025 +3.3
3/3 methods agree
Not in label — unassessedserious n=132 · ♀ 0% (drug 68%)not reported in cached trials
Radiculopathy28912.5
11.1–14.1ROR 12.5 · χ² 2,705 / p <1e-300
11.2 EB05 10.1 · IC025 +3.3
3/3 methods agree
Not in label — unassessedserious n=283 · ♀ 100% (drug 68%)not reported in cached trials
Exposure via ingestion26711.9
10.4–13.5ROR 11.9 · χ² 2,363 / p <1e-300
10.6 EB05 9.6 · IC025 +3.2
3/3 methods agree
Reporting / coding artifactserious n=255 · ♀ 47% (drug 68%) · 100% cliniciannot reported in cached trials
Respiratory arrest2,80811.4
11.0–11.8ROR 11.5 · χ² 23,924 / p <1e-300
10.3 EB05 10.0 · IC025 +3.3
3/3 methods agree
Not in label — unassessedserious PRR 8.4 · 95% cliniciannot reported in cached trials
Nephrogenic anaemia45010.8
9.8–11.9ROR 10.8 · χ² 3,605 / p <1e-300
9.8 EB05 9.1 · IC025 +3.1
3/3 methods agree
Not in label — unassessedserious n=450not reported in cached trials
Substance abuse78210.8
10.0–11.6ROR 10.8 · χ² 6,243 / p <1e-300
9.8 EB05 9.2 · IC025 +3.2
3/3 methods agree
Reporting / coding artifactserious PRR 8.6 · ♀ 45% (drug 68%)not reported in cached trials
Hyperparathyroidism secondary24210.7
9.4–12.2ROR 10.7 · χ² 1,918 / p <1e-300
9.7 EB05 8.7 · IC025 +3.1
3/3 methods agree
Not in label — unassessedserious n=242not reported in cached trials
Multiple drug overdose48010.7
9.7–11.7ROR 10.7 · χ² 3,801 / p <1e-300
9.7 EB05 9.0 · IC025 +3.1
3/3 methods agree
Not in label — unassessedserious n=480 · 100% cliniciannot reported in cached trials
Bradypnoea25510.6
9.4–12.1ROR 10.7 · χ² 2,006 / p <1e-300
9.6 EB05 8.7 · IC025 +3.0
3/3 methods agree
Not in label — unassessedserious n=255 · 100% cliniciannot reported in cached trials
Temperature regulation disorder20610.6
9.1–12.2ROR 10.6 · χ² 1,603 / p <1e-300
9.5 EB05 8.5 · IC025 +3.0
3/3 methods agree
Not in label — unassessedserious n=197 · ♀ 100% (drug 68%) · 100% cliniciannot reported in cached trials
Accidental death17310.4
8.9–12.2ROR 10.5 · χ² 1,329 / p 2e-291
9.4 EB05 8.3 · IC025 +3.0
3/3 methods agree
Not in label — unassessedserious n=173 · ♀ 0% (drug 68%) · 100% cliniciannot reported in cached trials
Substance use disorder28310.3
9.1–11.6ROR 10.3 · χ² 2,141 / p <1e-300
9.3 EB05 8.5 · IC025 +3.0
3/3 methods agree
Labeled adverse reaction
exact term
serious n=283 · ♀ 36% (drug 68%) · 100% cliniciannot reported in cached trials
Chronic sinusitis34410.3
9.2–11.5ROR 10.3 · χ² 2,598 / p <1e-300
9.3 EB05 8.5 · IC025 +3.0
3/3 methods agree
Not in label — unassessedserious n=330 · ♀ 100% (drug 68%)not reported in cached trials
Completed suicide (death by suicide)7,64910.1
9.9–10.4ROR 10.5 · χ² 57,465 / p <1e-300
9.3 EB05 9.1 · IC025 +3.2
3/3 methods agree
Outcome field, not a reaction
boxed warning mentions mortality
serious PRR 7.6 · 96% cliniciannot reported in cached trials
Homicide1559.5
8.1–11.2ROR 9.5 · χ² 1,072 / p 2e-235
8.6 EB05 7.5 · IC025 +2.8
3/3 methods agree
Not in label — unassessedserious n=138 · ♀ 0% (drug 68%) · 100% consumernot reported in cached trials
Drug diversion4909.5
8.7–10.4ROR 9.5 · χ² 3,393 / p <1e-300
8.7 EB05 8.1 · IC025 +3.0
3/3 methods agree
Reporting / coding artifactserious n=272 · ♀ 24% (drug 68%) · 100% consumernot reported in cached trials
Macular degeneration9819.1
8.5–9.7ROR 9.1 · χ² 6,478 / p <1e-300
8.4 EB05 8.0 · IC025 +3.0
3/3 methods agree
Not in label — unassessedserious PRR 7.4 · ♀ 100% (drug 68%)not reported in cached trials
Alcohol abuse2148.7
7.6–10.1ROR 8.8 · χ² 1,343 / p 2e-294
8.0 EB05 7.2 · IC025 +2.8
3/3 methods agree
Reporting / coding artifactserious n=208not reported in cached trials
Proctitis2198.6
7.5–9.9ROR 8.6 · χ² 1,346 / p 7e-295
7.9 EB05 7.0 · IC025 +2.8
3/3 methods agree
Not in label — unassessedserious n=217 · ♀ 100% (drug 68%) · 100% cliniciannot reported in cached trials
Bradyphrenia4477.4
6.7–8.1ROR 7.4 · χ² 2,300 / p <1e-300
6.9 EB05 6.4 · IC025 +2.6
3/3 methods agree
Labeled adverse reaction
exact term
serious n=428not reported in cached trials
Cardio-respiratory arrest2,8507.4
7.1–7.6ROR 7.5 · χ² 14,627 / p <1e-300
6.9 EB05 6.7 · IC025 +2.7
3/3 methods agree
Not in label — unassessedserious PRR 5.7 · 96% cliniciannot reported in cached trials
Hallucinations, mixed2847.3
6.5–8.3ROR 7.3 · χ² 1,442 / p <1e-300
6.8 EB05 6.2 · IC025 +2.6
3/3 methods agree
Not in label — unassessedserious n=277not reported in cached trials
Panic disorder2567.2
6.3–8.1ROR 7.2 · χ² 1,263 / p 8e-277
6.7 EB05 6.0 · IC025 +2.5
3/3 methods agree
Likely indication confounding
term in indications; also in warnings
serious n=216not reported in cached trials
Pre-existing condition improved4097.0
6.4–7.8ROR 7.0 · χ² 1,970 / p <1e-300
6.6 EB05 6.1 · IC025 +2.6
3/3 methods agree
Not in label — unassessedserious n=182not reported in cached trials
Miosis5127.0
6.4–7.6ROR 7.0 · χ² 2,440 / p <1e-300
6.5 EB05 6.1 · IC025 +2.6
3/3 methods agree
Not in label — unassessedserious PRR 5.6 · ♀ 42% (drug 68%) · 100% cliniciannot reported in cached trials
Coma2,8726.5
6.3–6.7ROR 6.6 · χ² 12,574 / p <1e-300
6.2 EB05 6.0 · IC025 +2.6
3/3 methods agree
Labeled — boxed warning
exact term
serious PRR 5.0not reported in cached trials
Drug abuser3656.3
5.7–7.0ROR 6.3 · χ² 1,530 / p <1e-300
6.0 EB05 5.5 · IC025 +2.4
3/3 methods agree
Not in label — unassessedserious n=365 · ♀ 39% (drug 68%)not reported in cached trials

Trial evidence (ClinicalTrials.gov)

✓ Trial adverse-event data found on ClinicalTrials.gov

Largest completed trials with posted results that list Alprazolam as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (1 of 40 signal terms matched).

Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

ReactionReportsPRR 95% CI · ROR · χ²/pEBGM EB05 · IC025Label screenSerious-only & strataTrial cross-check
Drug ineffective (drug did not work)13,6411.1
1.0–1.1ROR 1.1 · χ² 50 / p 7e-13
1.1 EB05 1.0 · IC025 +0.1Reporting / coding artifactserious PRR 1.2not reported in cached trials
Nausea13,0941.7
1.7–1.7ROR 1.8 · χ² 3,946 / p <1e-300
1.7 EB05 1.7 · IC025 +0.7Labeled adverse reaction
exact term
serious PRR 1.6NCT03478982: 2/38 (5.3%) on Alprazolam; 1/40 (2.5%) control
Fatigue (tiredness)12,1861.6
1.6–1.6ROR 1.7 · χ² 2,916 / p <1e-300
1.6 EB05 1.6 · IC025 +0.7Labeled adverse reaction
exact term
serious PRR 1.5NCT03478982: 2/40 (5.0%) control
Drug abuse11,12115.6
15.3–15.9ROR 16.4 · χ² 131,675 / p <1e-300
13.6 EB05 13.4 · IC025 +3.7
3/3 methods agree
Reporting / coding artifactserious PRR 11.2 · ♀ 45% (drug 68%) · 91% cliniciannot reported in cached trials
Anxiety10,3153.8
3.7–3.9ROR 4.0 · χ² 20,807 / p <1e-300
3.7 EB05 3.6 · IC025 +1.9
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 3.2NCT03478982: 1/38 (2.6%) on Alprazolam
Headache10,1131.7
1.6–1.7ROR 1.7 · χ² 2,714 / p <1e-300
1.7 EB05 1.6 · IC025 +0.7Labeled adverse reaction
exact term
serious PRR 1.7NCT03478982: 1/38 (2.6%) on Alprazolam; 2/40 (5.0%) control
Pain9,9711.7
1.6–1.7ROR 1.7 · χ² 2,711 / p <1e-300
1.7 EB05 1.6 · IC025 +0.7Labeled adverse reaction
exact term
serious PRR 1.6NCT03478982: 1/38 (2.6%) on Alprazolam
Toxicity to various agents9,0575.8
5.7–5.9ROR 6.0 · χ² 34,145 / p <1e-300
5.5 EB05 5.4 · IC025 +2.4
3/3 methods agree
Not in label — unassessedserious PRR 4.6not reported in cached trials
Diarrhoea (diarrhea)9,0121.4
1.4–1.5ROR 1.5 · χ² 1,232 / p 4e-270
1.4 EB05 1.4 · IC025 +0.5Labeled adverse reaction
exact term
serious PRR 1.3not reported in cached trials
Dyspnoea (shortness of breath)8,4371.5
1.5–1.6ROR 1.6 · χ² 1,590 / p <1e-300
1.5 EB05 1.5 · IC025 +0.6Labeled adverse reaction
exact term
serious PRR 1.3not reported in cached trials
Dizziness8,0131.7
1.6–1.7ROR 1.7 · χ² 2,107 / p <1e-300
1.6 EB05 1.6 · IC025 +0.7Labeled adverse reaction
exact term
serious PRR 1.5NCT03478982: 2/38 (5.3%) on Alprazolam; 2/40 (5.0%) control
Completed suicide (death by suicide)7,64910.1
9.9–10.4ROR 10.5 · χ² 57,465 / p <1e-300
9.3 EB05 9.1 · IC025 +3.2
3/3 methods agree
Outcome field, not a reaction
boxed warning mentions mortality
serious PRR 7.6 · 96% cliniciannot reported in cached trials
Depression7,3243.4
3.3–3.4ROR 3.4 · χ² 11,848 / p <1e-300
3.3 EB05 3.2 · IC025 +1.7
3/3 methods agree
Labeled — boxed warning
exact term
serious PRR 3.0not reported in cached trials
Vomiting7,2931.6
1.6–1.6ROR 1.6 · χ² 1,657 / p <1e-300
1.6 EB05 1.6 · IC025 +0.6Labeled adverse reaction
exact term
serious PRR 1.5NCT03478982: 1/38 (2.6%) on Alprazolam; 1/40 (2.5%) control
Insomnia (trouble sleeping)7,2912.8
2.8–2.9ROR 2.9 · χ² 8,609 / p <1e-300
2.8 EB05 2.7 · IC025 +1.4
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 2.7not reported in cached trials

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.

✓ A hand-written Bradford Hill causality assessment exists for this drug: Alprazolam (benzodiazepines) ↔ Drug dependence / abuse.

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 Alprazolam?

In FDA FAERS, the most frequently co-reported reaction terms for Alprazolam are nausea, fatigue, anxiety, headache, pain, toxicity to various agents. 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 Alprazolam have an FDA boxed warning?

Yes. The current FDA label carries a boxed warning: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for patients for whom alternative treatment options are inadequate.

Do FAERS signals prove that Alprazolam 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

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.