What the label lists and what reports show
Alprazolam side effects
Alprazolam's FDA label: “The most common adverse reactions reported in clinical trials for generalized anxiety disorder and panic disorder (incidence >5% and at least twice that of placebo) include: impaired coordination, hypotension, dysarthria, and increased libido.” FAERS holds 204,916 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is nausea (13,094 reports).
- Generic listed
- Boxed warning
- DEA Schedule IV
Check it at the source: the alprazolam FDA label on DailyMed (effective January 18, 2023, PHARMACIA & UPJOHN COMPANY LLC); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of XANAX?XANAX may cause serious side effects, including: • See “What is the most important information I should know about XANAX?” • Seizures. Stopping XANAX can cause seizures and seizures that will not stop (status epilepticus). • Mania. XANAX may cause an increase in activity and talking (hypomania and mania) in people who have depression. o XANAX can make you sleepy or dizzy and can slow your thinking and motor skills. Do not drive, operate heavy machinery, or do other dangerous activities until you know how XANAX affects you. o Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking XANAX without first talking to your healthcare provider. When taken with alcohol or drugs that cause sleepiness or dizziness, XANAX may make your sleepiness or dizziness much worse. […]
Source: FDA drug label, PHARMACIA & UPJOHN COMPANY LLC, effective January 18, 2023 (SPL set 388e249d-b9b6-44c3-9f8f-880eced0239f), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions reported in clinical trials for generalized anxiety disorder and panic disorder (incidence >5% and at least twice that of placebo) include: impaired coordination, hypotension, dysarthria, and increased libido.
Table 2: Adverse Reactions Occurring in ≥1% in XANAX-treated Patients and Greater than Placebo-treated Patients in Placebo-Controlled Trials (Up to 10 Weeks) for Panic Disorder
| Reaction | XANAX n=1388 | Placebo n=1231 |
|---|---|---|
| Drowsiness | 77% | 43% |
| Fatigue and Tiredness | 49% | 42% |
| Impaired Coordination | 40% | 18% |
| Irritability | 33% | 30% |
| Memory Impairment | 33% | 22% |
| Cognitive Disorder | 29% | 21% |
| Decreased Libido | 14% | 8% |
| Dysarthria | 23% | 6% |
| Confusional state | 10% | 8% |
| Increased libido | 8% | 4% |
| Change in libido (not specified) | 7% | 6% |
| Disinhibition | 3% | 2% |
| Talkativeness | 2% | 1% |
| Derealization | 2% | 1% |
| Constipation | 26% | 15% |
| Increased salivation | 6% | 4% |
| Rash | 11% | 8% |
| Increased appetite | 33% | 23% |
| Decreased appetite | 28% | 24% |
| Weight gain | 27% | 18% |
| Weight loss | 23% | 17% |
| Micturition difficulties | 12% | 9% |
| Menstrual disorders | 11% | 9% |
| Sexual dysfunction | 7% | 4% |
| Incontinence | 2% | 1% |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following clinically significant adverse reactions are described elsewhere in the labeling: • Risks from Concomitant Use with Opioids [see Warnings and Precautions (5.1) ] • Abuse, Misuse, and Addiction [see Warnings and Precautions (5.2) ] • Dependence and Withdrawal Reactions [see Warnings and Precautions (5.3) ] • Effects on Driving and Operating Machinery [see Warnings and Precautions (5.4) ] • Patients with Depression [see Warnings and Precautions (5.6) ] • Neonatal Sedation and Withdrawal Syndrome [see Warnings and Precautions (5.8) ] • Risks in Patients with Impaired Respiratory Function [see Warnings and Precautions (5.9) ] The most common adverse reactions reported in clinical trials for generalized anxiety disorder and panic disorder (incidence >5% and at least twice that of placebo) include: impaired coordination, hypotension, dysarthria, and increased libido. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Viatris at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Source: FDA drug label, PHARMACIA & UPJOHN COMPANY LLC, effective January 18, 2023 (SPL set 388e249d-b9b6-44c3-9f8f-880eced0239f), via openFDA; the full label on DailyMed
What do FAERS reports show?
204,916 reports list alprazolam among the medicines taken, each a report of something that happened, not proof the medicine caused it; 33,446 are coded as a death and 65,648 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 19 reactions below, 8 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Alprazolam: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions