Drug class · FAERS comparison
Benzodiazepine side effects compared: 13 drugs, 893,444 FDA adverse event reports
How to read this page. Report counts are not incidence rates: a drug with more reports is usually older, more widely used or more publicised, not more dangerous.
Signals are screened against each product's FDA label on its own page; a term flagged across most of a class usually reflects the shared mechanism or the shared patient population.
Members
| Drug | FAERS reports | Serious | Death outcome | Boxed warning | Top labeled signals | Unlabeled (unassessed) |
|---|---|---|---|---|---|---|
| Alprazolam | 204,870 | 71% | 33,446 | boxed | Suicide attempt; Coma; Poisoning | Cardio-respiratory arrest; Respiratory arrest |
| Lorazepam | 178,697 | 77% | 25,768 | boxed | Drug tolerance decreased | Pericarditis; Sopor |
| Clonazepam | 159,258 | 68% | 18,605 | boxed | Rhinitis allergic; Substance use disorder; Depression suicidal | Sleep apnoea syndrome; Neuroleptic malignant syndrome |
| Diazepam | 120,964 | 81% | 22,961 | boxed | Coma; Drug use disorder; Respiratory depression | Poisoning; Poisoning deliberate |
| Diazepam | 88,498 | 85% | 20,478 | boxed | Drug use disorder; Respiratory depression; Substance use disorder | Poisoning; Poisoning deliberate |
| Temazepam | 37,467 | 75% | 7,537 | boxed | – | Immunodeficiency; Food allergy |
| Midazolam (Nayzilam) | 26,764 | 93% | 5,139 | boxed | Upper airway obstruction; Negative pressure pulmonary oedema; Neonatal respiratory depression | Proctitis; Female genital tract fistula |
| Midazolam (Nayzilam) | 25,056 | 93% | 4,706 | boxed | Upper airway obstruction; Negative pressure pulmonary oedema; Neonatal respiratory depression | Propofol infusion syndrome; Proctitis |
| Clobazam | 24,263 | 79% | 1,565 | boxed | Epilepsy with myoclonic-atonic seizures | Drug withdrawal convulsions; Myoclonic epilepsy |
| Oxazepam | 21,381 | 98% | 4,840 | boxed | Sedation; Substance use disorder; Neonatal respiratory distress | Orthostatic hypotension; Poisoning deliberate |
| Triazolam | 3,986 | 81% | 638 | boxed | Suicide attempt; Coma; Depressed level of consciousness | Sopor; Toxicity to various agents |
| Estazolam | 1,940 | 89% | 305 | boxed | Coma; Arrhythmia; Agranulocytosis | Suicide attempt; Serotonin syndrome |
| Quazepam | 300 | 91% | 46 | boxed | Suicide attempt; Withdrawal syndrome | Altered state of consciousness |
Class-wide signals (flagged in at least 7 of 13 members)
No term is flagged in at least half the members.
Member-specific signals (flagged in exactly one drug)
| Reaction | Drug | Reports | PRR | Label screen |
|---|---|---|---|---|
| Rhesus incompatibility | Diazepam | 68 | 298.7 | Not in label — unassessed |
| Atonic seizures | Clobazam | 170 | 234.6 | Likely indication confounding |
| Grip strength | Lorazepam | 153 | 231.1 | Not in label — unassessed |
| Change in seizure presentation | Clobazam | 114 | 181.8 | Likely indication confounding |
| Epidural lipomatosis | Clobazam | 55 | 162.1 | Not in label — unassessed |
| Congenital nystagmus | Diazepam | 79 | 141.5 | Not in label — unassessed |
| Sudden unexplained death in epilepsy | Clobazam | 71 | 130.6 | Not in label — unassessed |
| Tonic convulsion | Clobazam | 147 | 101.2 | Not in label — unassessed |
| Deep vein thrombosis postoperative | Lorazepam | 813 | 83.1 | Not in label — unassessed |
| Lupus vulgaris | Lorazepam | 490 | 82.1 | Not in label — unassessed |
| Ejection fraction | Clonazepam | 218 | 78.3 | Not in label — unassessed |
| Stubbornness | Clonazepam | 151 | 70.0 | Not in label — unassessed |
| Subcutaneous drug absorption impaired | Lorazepam | 192 | 63.7 | Not in label — unassessed |
| Reduced facial expression | Oxazepam | 54 | 55.8 | Not in label — unassessed |
| Bezoar | Oxazepam | 72 | 54.0 | Not in label — unassessed |
| Stiff person syndrome | Diazepam | 61 | 51.8 | Not in label — unassessed |
| Adjustment disorder with depressed mood | Lorazepam | 595 | 49.0 | Likely indication confounding |
| Orthostatic hypotension | Oxazepam | 758 | 44.5 | Not in label — unassessed |
| Asphyxia | Oxazepam | 329 | 41.1 | Not in label — unassessed |
| Food allergy | Temazepam | 517 | 41.1 | Not in label — unassessed |
| Dislocation of vertebra | Lorazepam | 562 | 39.5 | Not in label — unassessed |
| Facet joint syndrome | Lorazepam | 740 | 35.8 | Not in label — unassessed |
| Multiple drug overdose accidental | Diazepam | 61 | 35.8 | Not in label — unassessed |
| Prescription form tampering | Alprazolam | 184 | 32.0 | Not in label — unassessed |
| Rheumatic fever | Lorazepam | 933 | 31.7 | Not in label — unassessed |
Common questions
Which benzodiazepine has the most FDA adverse event reports?
Alprazolam has the most FAERS co-reports in this class (204,870), followed by Lorazepam (178,697). Report volume tracks how widely and how long a drug has been used, and how much attention it has had, far more than its risk.
Which side effects are shared across benzodiazepine drugs?
No reaction term is flagged in at least half of the members; the signals in this class are largely product-specific or population-specific.
Does a FAERS signal mean the drug causes the reaction?
No. These are disproportionality signals from voluntary reports with no denominator. Each is screened against the FDA label (known vs unlabeled) on the drug pages; causality needs temporality, dose-response, plausibility and trial or cohort evidence.
Sources: openFDA FAERS pair statistics (OpenPV build 2026-09-14), FDA labels via openFDA, seriousness and death counts from openFDA count queries. Generated 2026-10-08. Not medical advice.