What the label lists and what reports show
Triazolam side effects
Triazolam's FDA label: “Most common adverse reactions (incidence ≥4% and twice placebo) are drowsiness, dizziness, light-headedness, and coordination disorder/ataxia.” FAERS holds 3,986 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 drug abuse (336 reports).
- Generic listed
- Boxed warning
- DEA Schedule IV
Check it at the source: the triazolam FDA label on DailyMed (effective July 10, 2026, Mylan Pharmaceuticals Inc.); 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 triazolam?Triazolam may cause serious side effects, including: • See " What is the most important information I should know about triazolam? " • Increased daytime anxiety. • Abnormal thoughts and behavior. Symptoms include more outgoing or aggressive behavior than normal, confusion, agitation, hallucinations, worsening of depression, and suicidal thoughts or actions. • Memory loss • Triazolam can make you sleepy or dizzy and can slow your thinking and motor skills. o Do not drive, operate heavy machinery, or do other dangerous activities until you know how triazolam affects you. o Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking triazolam without first talking to your healthcare provider. When taken with alcohol or drugs that cause sleepiness or dizziness, triazolam may make your sleepiness or dizziness much worse. • Worsening depression. […]
Source: FDA drug label, NDA017892 (Pfizer), as published by Mylan Pharmaceuticals Inc., effective July 10, 2026 (SPL set 5add318e-11b9-42f8-b052-0d8cebb32fcf), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (incidence ≥4% and twice placebo) are drowsiness, dizziness, light-headedness, and coordination disorder/ataxia.
Table 1: Common Adverse Drug Reactions in 1% or More of Triazolam-Treated Subjects (and Greater than Placebo) Reported in Placebo-Controlled Clinical Trials
| Event | Triazolam (N=1003) % Patients Reporting | Placebo (N=997) % Patients Reporting |
|---|---|---|
| Drowsiness | 14.0 | 6.4 |
| Headache | 9.7 | 8.4 |
| Dizziness | 7.8 | 3.1 |
| Nervousness | 5.2 | 4.5 |
| Light-headedness | 4.9 | 0.9 |
| Coordination disorders/ataxia | 4.6 | 0.8 |
| Nausea/vomiting | 4.6 | 3.7 |
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 serious adverse reactions are discussed in greater detail in other sections: • 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) ] • Persistent or Worsening Insomnia [see Warnings and Precautions (5.4) ] • "Sleep-driving" and Other Complex Behaviors [see Warnings and Precautions (5.5) ] • Central Nervous System Manifestations [see Warnings and Precautions (5.6) ] • Effects on Driving and Operating Heavy Machinery [see Warnings and Precautions (5.7) ] • Patients with Depression [see Warnings and Precautions (5.9) ] • Neonatal Sedation and Withdrawal Syndrome [see Warnings and Precautions (5.10) ] • Compromised Respiratory Function [see Warnings and Precautions (5.11) ] Most common adverse reactions (incidence ≥4% and twice placebo) are drowsiness, dizziness, light-headedness, and coordination disorder/ataxia. ( 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. …
Source: FDA drug label, NDA017892 (Pfizer), as published by Mylan Pharmaceuticals Inc., effective July 10, 2026 (SPL set 5add318e-11b9-42f8-b052-0d8cebb32fcf), via openFDA; the full label on DailyMed
What do FAERS reports show?
3,986 reports list triazolam among the medicines taken, each a report of something that happened, not proof the medicine caused it; 638 are coded as a death and 1,599 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 18 reactions below, 7 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?
- Triazolam: 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