Drug · FAERS side-effect profile with label screen
Lorazepam side effects: what 178,697 FDA adverse event reports show
Who reports
178,697 reports · 77% serious · 25,768 with death outcome · 64% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Lorazepam tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.
FDA label, Indications and Usage
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 (related wording) 1Likely indication confounding 1Lab value / disease marker 7Not in label — unassessed 31
What the badges mean
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
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, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,134 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Grip strength | 153 | 231.1 175.5–304.2ROR 231.3 · calibrated p 2e-10 ✓ | 76.6 EB05 67.0 · IC025 +5.7 3/3 methods agree vs other Benzodiazepines: only this drug | Not in label — unassessed | serious n=153 · ♀ 100% (drug 64%) · 100% clinician | not reported in cached trials |
| Deep vein thrombosis postoperative | 813 | 83.1 75.9–90.9ROR 83.5 · calibrated p 4e-7 ✓ | 48.6 EB05 45.8 · IC025 +5.4 3/3 methods agree vs other Benzodiazepines: only this drug | Not in label — unassessed | serious n=813 · ♀ 100% (drug 64%) · 90% clinician | not reported in cached trials |
| Lupus vulgaris | 490 | 82.1 73.1–92.2ROR 82.3 · calibrated p 5e-7 ✓ | 48.2 EB05 44.7 · IC025 +5.4 3/3 methods agree vs other Benzodiazepines: only this drug | Not in label — unassessed | serious n=490 · ♀ 100% (drug 64%) · 100% clinician | not reported in cached trials |
| C-reactive protein | 339 | 69.9 61.0–79.9ROR 70.0 · calibrated p 2e-6 ✓ | 43.7 EB05 39.9 · IC025 +5.2 3/3 methods agree vs other Benzodiazepines: only this drug | Lab value / disease marker | serious n=339 · ♀ 100% (drug 64%) · 100% clinician | not reported in cached trials |
| Subcutaneous drug absorption impaired | 192 | 63.7 53.4–76.0ROR 63.8 · calibrated p 3e-6 ✓ | 41.2 EB05 36.5 · IC025 +5.0 3/3 methods agree vs other Benzodiazepines: only this drug | Not in label — unassessed | serious n=192 · ♀ 100% (drug 64%) · 100% clinician | not reported in cached trials |
| Adjustment disorder with depressed mood | 595 | 49.0 44.5–53.9ROR 49.1 · calibrated p 2e-5 ✓ | 34.6 EB05 32.3 · IC025 +4.9 3/3 methods agree vs other Benzodiazepines: only this drug | Likely indication confounding shares a disease stem with the indications wording | serious n=591 · ♀ 100% (drug 64%) · 100% clinician | not reported in cached trials |
| X-ray abnormal | 502 | 45.7 41.2–50.7ROR 45.9 · calibrated p 2e-5 ✓ | 32.9 EB05 30.6 · IC025 +4.9 3/3 methods agree vs other Benzodiazepines: only this drug | Lab value / disease marker | serious n=502 · ♀ 100% (drug 64%) · 100% clinician | not reported in cached trials |
| Anti-cyclic citrullinated peptide antibody | 184 | 44.5 37.5–52.7ROR 44.5 · calibrated p 3e-5 ✓ | 32.2 EB05 28.5 · IC025 +4.7 3/3 methods agree vs other Benzodiazepines: only this drug | Lab value / disease marker | serious n=184 · ♀ 100% (drug 64%) · 100% clinician | not reported in cached trials |
| Swollen joint count increased | 816 | 41.4 38.2–44.8ROR 41.6 · calibrated p 4e-5 ✓ | 30.7 EB05 28.9 · IC025 +4.8 3/3 methods agree vs other Benzodiazepines: only this drug | Lab value / disease marker | serious n=816 · ♀ 100% (drug 64%) · 100% clinician | not reported in cached trials |
| Dislocation of vertebra | 562 | 39.5 35.9–43.4ROR 39.6 · calibrated p 6e-5 ✓ | 29.6 EB05 27.6 · IC025 +4.7 3/3 methods agree vs other Benzodiazepines: only this drug | Not in label — unassessed | serious n=562 · ♀ 100% (drug 64%) · 100% clinician | not reported in cached trials |
| Facet joint syndrome | 740 | 35.8 33.0–38.9ROR 36.0 · calibrated p 1e-4 ✓ | 27.5 EB05 25.9 · IC025 +4.6 3/3 methods agree vs other Benzodiazepines: only this drug | Not in label — unassessed | serious n=740 · ♀ 100% (drug 64%) · 92% clinician | not reported in cached trials |
| Rheumatic fever | 933 | 31.7 29.5–34.1ROR 31.9 · calibrated p 2e-4 ✓ | 25.0 EB05 23.7 · IC025 +4.5 3/3 methods agree vs other Benzodiazepines: only this drug | Not in label — unassessed | serious n=933 · ♀ 100% (drug 64%) · 94% clinician | not reported in cached trials |
| Retinitis | 346 | 30.5 27.1–34.3ROR 30.6 · calibrated p 2e-4 ✓ | 24.3 EB05 22.2 · IC025 +4.4 3/3 methods agree vs other Benzodiazepines: only this drug | Not in label — unassessed | serious n=346 · ♀ 100% (drug 64%) · 100% clinician | not reported in cached trials |
| Duodenal ulcer perforation | 1,417 | 27.9 26.3–29.6ROR 28.1 · calibrated p 4e-4 ✓ | 22.6 EB05 21.7 · IC025 +4.4 3/3 methods agree vs other Benzodiazepines: only this drug | Not in label — unassessed | serious PRR 16.9 · ♀ 100% (drug 64%) · 93% clinician | not reported in cached trials |
| Peripheral venous disease | 767 | 27.7 25.6–30.0ROR 27.8 · calibrated p 4e-4 ✓ | 22.5 EB05 21.2 · IC025 +4.4 3/3 methods agree vs other Benzodiazepines: only this drug | Not in label — unassessed | serious n=766 · ♀ 100% (drug 64%) · 93% clinician | not reported in cached trials |
| Porphyria acute | 262 | 27.3 23.9–31.2ROR 27.4 · calibrated p 4e-4 ✓ | 22.2 EB05 20.1 · IC025 +4.2 3/3 methods agree vs other Benzodiazepines: PRR 242.6 (132.7–443.4) | Not in label — unassessed | serious n=262 · ♀ 100% (drug 64%) · 100% clinician | not reported in cached trials |
| Anti-cyclic citrullinated peptide antibody positive | 1,337 | 27.0 25.5–28.7ROR 27.2 · calibrated p 4e-4 ✓ | 22.1 EB05 21.1 · IC025 +4.4 3/3 methods agree vs other Benzodiazepines: only this drug | Lab value / disease marker | serious PRR 16.6 · ♀ 100% (drug 64%) · 96% clinician | not reported in cached trials |
| Rheumatoid factor positive | 1,048 | 25.9 24.2–27.7ROR 26.0 · calibrated p 6e-4 ✓ | 21.3 EB05 20.2 · IC025 +4.3 3/3 methods agree vs other Benzodiazepines: only this drug | Lab value / disease marker | serious n=1,047 · ♀ 100% (drug 64%) · 96% clinician | not reported in cached trials |
| Muscle injury | 1,351 | 23.0 21.7–24.3ROR 23.1 · calibrated p 1e-3 ✓ | 19.3 EB05 18.5 · IC025 +4.2 3/3 methods agree vs other Benzodiazepines: PRR 335.6 (246.1–457.8) | Not in label — unassessed | serious PRR 15.6 · ♀ 100% (drug 64%) · 93% clinician | not reported in cached trials |
| Catatonia | 849 | 22.7 21.1–24.4ROR 22.8 · calibrated p 0.001 ✓ | 19.1 EB05 18.0 · IC025 +4.1 3/3 methods agree vs other Benzodiazepines: PRR 9.2 (8.4–10.0) | Not in label — unassessed | serious n=831 | not reported in cached trials |
| Helicobacter infection | 1,540 | 20.7 19.6–21.9ROR 20.9 · calibrated p 0.002 ✓ | 17.7 EB05 17.0 · IC025 +4.1 3/3 methods agree vs other Benzodiazepines: PRR 61.3 (53.7–69.9) | Not in label — unassessed | serious PRR 14.0 · ♀ 100% (drug 64%) · 92% clinician | not reported in cached trials |
| C-reactive protein abnormal | 923 | 19.6 18.3–21.0ROR 19.7 · calibrated p 0.002 ✓ | 16.9 EB05 16.0 · IC025 +4.0 3/3 methods agree vs other Benzodiazepines: only this drug | Lab value / disease marker | serious n=921 · ♀ 100% (drug 64%) · 93% clinician | not reported in cached trials |
| Sleep disorder due to general medical condition, insomnia type | 914 | 19.3 18.0–20.7ROR 19.4 · calibrated p 0.002 ✓ | 16.6 EB05 15.8 · IC025 +3.9 3/3 methods agree vs other Benzodiazepines: PRR 160.5 (123.1–209.2) | Not in label — unassessed | serious n=910 · ♀ 100% (drug 64%) · 92% clinician | not reported in cached trials |
| Folliculitis | 1,358 | 17.6 16.7–18.7ROR 17.8 · calibrated p 0.003 ✓ | 15.4 EB05 14.7 · IC025 +3.8 3/3 methods agree vs other Benzodiazepines: PRR 69.5 (59.9–80.6) | Not in label — unassessed | serious PRR 13.4 · ♀ 96% (drug 64%) · 93% clinician | not reported in cached trials |
| Pemphigus | 1,608 | 17.3 16.4–18.2ROR 17.5 · calibrated p 0.004 ✓ | 15.2 EB05 14.6 · IC025 +3.8 3/3 methods agree vs other Benzodiazepines: PRR 348.5 (260.8–465.6) | Not in label — unassessed | serious PRR 11.4 · ♀ 100% (drug 64%) · 95% clinician | not reported in cached trials |
| Soft tissue disorder | 144 | 17.2 14.5–20.5ROR 17.2 · calibrated p 0.004 ✓ | 15.1 EB05 13.1 · IC025 +3.6 3/3 methods agree vs other Benzodiazepines: only this drug | Not in label — unassessed | serious n=143 · ♀ 100% (drug 64%) · 100% clinician | not reported in cached trials |
| Sopor | 1,626 | 16.1 15.3–17.0ROR 16.3 · calibrated p 0.005 ✓ | 14.3 EB05 13.7 · IC025 +3.7 3/3 methods agree vs other Benzodiazepines: PRR 4.2 (4.0–4.4) | Not in label — unassessed | age-adj. PRR 12.8 · serious PRR 10.7 · 93% clinician | not reported in cached trials |
| Hand deformity | 1,461 | 14.6 13.9–15.5ROR 14.8 · calibrated p 0.007 ✓ | 13.1 EB05 12.5 · IC025 +3.6 3/3 methods agree vs other Benzodiazepines: PRR 55.5 (48.8–63.2) | Not in label — unassessed | serious PRR 10.6 · ♀ 100% (drug 64%) · 93% clinician | not reported in cached trials |
| Neuroleptic malignant syndrome | 1,315 | 14.5 13.7–15.3ROR 14.6 · calibrated p 0.008 ✓ | 13.0 EB05 12.4 · IC025 +3.6 3/3 methods agree vs other Benzodiazepines: PRR 4.4 (4.1–4.7) | Not in label — unassessed | age-adj. PRR 12.6 · serious PRR 9.7 | not reported in cached trials |
| Lip dry | 987 | 14.4 13.5–15.4ROR 14.5 · calibrated p 0.008 ✓ | 12.9 EB05 12.2 · IC025 +3.6 3/3 methods agree vs other Benzodiazepines: only this drug | Not in label — unassessed | serious n=969 · ♀ 100% (drug 64%) · 93% clinician | not reported in cached trials |
| Bone erosion | 364 | 13.3 12.0–14.9ROR 13.4 · calibrated p 0.011 ✓ | 12.0 EB05 11.0 · IC025 +3.4 3/3 methods agree vs other Benzodiazepines: only this drug | Not in label — unassessed | serious n=364 · ♀ 100% (drug 64%) · 100% clinician | not reported in cached trials |
| Pericarditis | 1,648 | 12.8 12.1–13.4ROR 12.9 · calibrated p 0.013 ✓ | 11.6 EB05 11.1 · IC025 +3.5 3/3 methods agree vs other Benzodiazepines: PRR 46.6 (41.6–52.2) | Not in label — unassessed | serious PRR 8.7 · ♀ 95% (drug 64%) · 94% clinician | not reported in cached trials |
| Breast cancer stage iii | 616 | 12.3 11.3–13.4ROR 12.4 · calibrated p 0.015 ✓ | 11.2 EB05 10.5 · IC025 +3.3 3/3 methods agree vs other Benzodiazepines: only this drug | Not in label — unassessed | serious n=616 · ♀ 100% (drug 64%) · 100% clinician | not reported in cached trials |
| Hypercholesterolaemia | 886 | 11.9 11.1–12.7ROR 11.9 · calibrated p 0.017 ✓ | 10.8 EB05 10.3 · IC025 +3.3 3/3 methods agree vs other Benzodiazepines: PRR 13.3 (12.0–14.7) | Not in label — unassessed | serious PRR 8.4 | not reported in cached trials |
| Autoimmune disorder | 879 | 11.8 11.0–12.6ROR 11.8 · calibrated p 0.018 ✓ | 10.8 EB05 10.2 · IC025 +3.3 3/3 methods agree vs other Benzodiazepines: PRR 26.3 (23.3–29.8) | Not in label — unassessed | serious PRR 8.6 · ♀ 100% (drug 64%) | not reported in cached trials |
| Bursitis | 1,087 | 11.5 10.8–12.3ROR 11.6 · calibrated p 0.019 ✓ | 10.6 EB05 10.0 · IC025 +3.3 3/3 methods agree vs other Benzodiazepines: PRR 8.9 (8.2–9.6) | Not in label — unassessed | serious PRR 9.2 · ♀ 100% (drug 64%) | not reported in cached trials |
| Drug tolerance decreased | 250 | 11.4 10.0–13.0ROR 11.4 · calibrated p 0.021 ✓ | 10.4 EB05 9.4 · IC025 +3.2 3/3 methods agree vs other Benzodiazepines: only this drug | Labeled (related wording) related wording | serious n=240 · ♀ 100% (drug 64%) · 100% clinician | not reported in cached trials |
| Synovitis | 1,593 | 11.3 10.7–11.9ROR 11.4 · calibrated p 0.021 ✓ | 10.3 EB05 9.9 · IC025 +3.3 3/3 methods agree vs other Benzodiazepines: PRR 33.0 (29.8–36.5) | Not in label — unassessed | serious PRR 8.1 · ♀ 100% (drug 64%) · 92% clinician | not reported in cached trials |
| Joint range of motion decreased | 1,145 | 10.9 10.3–11.6ROR 11.0 · calibrated p 0.023 ✓ | 10.0 EB05 9.6 · IC025 +3.2 3/3 methods agree vs other Benzodiazepines: PRR 17.9 (16.3–19.7) | Not in label — unassessed | serious PRR 9.5 · ♀ 100% (drug 64%) · 92% clinician | not reported in cached trials |
| Wound infection | 914 | 10.7 10.0–11.4ROR 10.7 · calibrated p 0.025 ✓ | 9.8 EB05 9.3 · IC025 +3.2 3/3 methods agree vs other Benzodiazepines: PRR 21.7 (19.4–24.3) | Not in label — unassessed | serious PRR 7.9 · ♀ 100% (drug 64%) · 92% clinician | not reported in cached trials |
Clinical concept groups
MedDRA splits one clinical problem across several terms (e.g. "neutropenia", "neutrophil count decreased", "agranulocytosis"), which dilutes term-level signals. These rows count reports with any term in a concept group (an exact union, not a sum), compared with all other drugs. Groups are hand-built and listed in the methods.
| Concept | Reports | PRR 95% CI | Reading |
|---|---|---|---|
| Suicidality | 9,283 | 4.64.5–4.7 | signal |
| Extrapyramidal | 3,548 | 4.13.9–4.2 | signal |
| Hyponatraemia | 2,324 | 3.53.3–3.6 | signal |
| Depression | 7,181 | 3.03.0–3.1 | signal |
| Rhabdomyolysis / myopathy | 2,032 | 3.02.9–3.1 | signal |
| Seizure | 4,827 | 2.92.9–3.0 | signal |
| Neutropenia / agranulocytosis | 5,918 | 2.82.8–2.9 | signal |
| Arrhythmia / qt | 3,692 | 2.32.2–2.3 | signal |
| Liver injury | 5,571 | 2.22.1–2.2 | signal |
| Fall / fracture | 6,953 | 2.22.1–2.2 | signal |
| Pancreatitis | 1,469 | 2.22.0–2.3 | signal |
| Anaemia | 5,417 | 2.12.1–2.2 | signal |
| Interstitial lung disease | 1,689 | 2.12.0–2.2 | raised |
| Serious infection | 13,443 | 2.12.0–2.1 | signal |
| Thrombocytopenia | 3,655 | 2.01.9–2.0 | raised |
| Kidney injury | 7,193 | 1.91.8–1.9 | raised |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Lorazepam 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 (0 of 40 signal terms matched).
- NCT01566539 — Biological Basis of Individual Variation in Social Cooperation (N=707, NA; 6 AE terms posted; arms: Healthy Volunteers - Intranasal Vasopres; Healthy Volunteers - Intranasal Oxytocin; Healthy Volunteers - Intranasal Placebo; Within Subject Group)
- NCT00624780 — Safety and Efficacy Evaluation Of Pregabalin (Lyrica) With Patients With Generalized Anxiety Disorder (N=615, PHASE4; 44 AE terms posted; arms: Pregabalin High Dose, Pregabalin High Do; Pregabalin High Dose, Placebo; Pregabalin Low Dose, Pregabalin Low Dose; Pregabalin Low Dose, Placebo)
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.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Fatigue (tiredness) | 13,821 | 2.1 2.1–2.1ROR 2.2 · calibrated p 0.951 | 2.1 EB05 2.1 · IC025 +1.0 3/3 methods agree vs other Benzodiazepines: PRR 3.7 (3.7–3.8) | Labeled adverse reaction exact term | age-adj. PRR 1.8 · serious PRR 2.2 | NCT00624780: 5/50 (10.0%) on Lorazepam; 6/52 (11.5%) control |
| Nausea | 13,642 | 2.0 2.0–2.1ROR 2.1 · calibrated p 0.985 | 2.0 EB05 2.0 · IC025 +1.0 3/3 methods agree vs other Benzodiazepines: PRR 3.6 (3.6–3.7) | Labeled adverse reaction exact term | age-adj. PRR 1.7 · serious PRR 2.1 | NCT01566539: 1/104 (1.0%) control |
| Drug ineffective (drug did not work) | 12,492 | 1.1 1.1–1.1ROR 1.1 · calibrated p 0.388 | 1.1 EB05 1.1 · IC025 +0.1 vs other Benzodiazepines: PRR 2.4 (2.4–2.5) | Reporting / coding artifact | age-adj. PRR 1.3 · serious PRR 1.6 | not reported in cached trials |
| Diarrhoea (diarrhea) | 10,645 | 2.0 1.9–2.0ROR 2.0 · calibrated p 0.954 | 1.9 EB05 1.9 · IC025 +0.9 vs other Benzodiazepines: PRR 4.0 (4.0–4.1) | Not in label — unassessed | age-adj. PRR 1.7 · serious PRR 1.9 | NCT00624780: 1/50 (2.0%) on Lorazepam; 3/52 (5.8%) control |
| Off label use (used outside approved label) | 10,585 | 1.4 1.4–1.5ROR 1.5 · calibrated p 0.618 | 1.4 EB05 1.4 · IC025 +0.5 vs other Benzodiazepines: PRR 3.2 (3.2–3.3) | Reporting / coding artifact | age-adj. PRR 1.4 · serious PRR 1.6 | not reported in cached trials |
| Dyspnoea (shortness of breath) | 9,488 | 2.0 1.9–2.0ROR 2.0 · calibrated p 0.966 | 2.0 EB05 1.9 · IC025 +0.9 vs other Benzodiazepines: PRR 3.6 (3.5–3.6) | Not in label — unassessed | age-adj. PRR 1.7 · serious PRR 1.8 | not reported in cached trials |
| Anxiety | 9,034 | 3.8 3.7–3.9ROR 4.0 · calibrated p 0.386 | 3.7 EB05 3.7 · IC025 +1.9 3/3 methods agree vs other Benzodiazepines: PRR 3.0 (2.9–3.0) | Likely indication confounding term in indications; also in warnings | age-adj. PRR 3.6 · serious PRR 3.3 | NCT00624780: 1/154 (0.6%) on Lorazepam (serious AE) |
| Headache | 8,906 | 1.7 1.6–1.7ROR 1.7 · calibrated p 0.778 | 1.7 EB05 1.6 · IC025 +0.7 vs other Benzodiazepines: PRR 2.9 (2.8–3.0) | Labeled adverse reaction exact term | age-adj. PRR 1.4 · serious PRR 1.9 | NCT00624780: 10/50 (20.0%) on Lorazepam; 13/52 (25.0%) control |
| Pain | 8,871 | 1.7 1.7–1.7ROR 1.7 · calibrated p 0.793 | 1.7 EB05 1.7 · IC025 +0.7 vs other Benzodiazepines: PRR 2.9 (2.8–2.9) | Not in label — unassessed | age-adj. PRR 1.7 · serious PRR 1.7 | NCT00624780: 1/153 (0.7%) on Lorazepam; 1/52 (1.9%) control |
| Vomiting | 8,798 | 2.2 2.2–2.3ROR 2.3 · calibrated p 0.908 | 2.2 EB05 2.2 · IC025 +1.1 3/3 methods agree vs other Benzodiazepines: PRR 3.6 (3.5–3.6) | Not in label — unassessed | age-adj. PRR 1.9 · serious PRR 2.1 | not reported in cached trials |
| Dizziness | 8,313 | 2.0 1.9–2.0ROR 2.0 · calibrated p 0.957 | 2.0 EB05 1.9 · IC025 +0.9 vs other Benzodiazepines: PRR 3.2 (3.1–3.3) | Labeled adverse reaction exact term | age-adj. PRR 1.7 · serious PRR 2.0 | NCT00624780: 10/50 (20.0%) on Lorazepam; 17/52 (32.7%) control |
| Asthenia (weakness) | 7,264 | 2.3 2.2–2.3ROR 2.3 · calibrated p 0.881 | 2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree vs other Benzodiazepines: PRR 3.7 (3.6–3.8) | Labeled adverse reaction exact term | age-adj. PRR 2.0 · serious PRR 2.1 | not reported in cached trials |
| Death | 6,802 | 0.9 0.9–0.9ROR 0.9 · calibrated p 0.257 | 0.9 EB05 0.9 · IC025 -0.1 PRR-only: not supported by EBGM or IC vs other Benzodiazepines: PRR 3.0 (2.9–3.1) | Outcome field, not a reaction boxed warning mentions mortality | age-adj. PRR 1.0 · serious PRR 0.7 | not reported in cached trials |
| Fall | 6,564 | 2.3 2.3–2.4ROR 2.4 · calibrated p 0.859 | 2.3 EB05 2.3 · IC025 +1.2 3/3 methods agree vs other Benzodiazepines: PRR 2.6 (2.6–2.7) | Not in label — unassessed | age-adj. PRR 2.0 · serious PRR 1.9 | not reported in cached trials |
| Insomnia (trouble sleeping) | 6,414 | 2.9 2.8–2.9ROR 2.9 · calibrated p 0.647 | 2.8 EB05 2.8 · IC025 +1.5 3/3 methods agree vs other Benzodiazepines: PRR 2.7 (2.7–2.8) | Labeled adverse reaction exact term | age-adj. PRR 2.5 · serious PRR 2.9 | NCT00624780: 13/50 (26.0%) on Lorazepam; 15/52 (28.8%) control |
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.
- Grip strength — n=153, PRR 231.1
- Deep vein thrombosis postoperative — n=813, PRR 83.1
- Lupus vulgaris — n=490, PRR 82.1
- Subcutaneous drug absorption impaired — n=192, PRR 63.7
- Dislocation of vertebra — n=562, PRR 39.5
- Facet joint syndrome — n=740, PRR 35.8
- Rheumatic fever — n=933, PRR 31.7
- Retinitis — n=346, PRR 30.5
- Duodenal ulcer perforation — n=1,417, PRR 27.9
- Peripheral venous disease — n=767, PRR 27.7
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 Lorazepam?
In FDA FAERS, the most frequently co-reported reaction terms for Lorazepam are fatigue, nausea, diarrhoea, dyspnoea, anxiety, headache. 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 Lorazepam 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 Lorazepam 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
- FDA label via openFDA (set ID 08a30230-fc95-9025-e063-6394a90ae21b, effective 20250805; matched on
openfda.generic_name.exact:"LORAZEPAM" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG") - PubChem CID 3958 description (ChEBI)
- Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 1,174 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath - ClinicalTrials.gov API v2 (query
LORAZEPAM, results-bearing studies sorted by enrollment)
Page generated 2026-10-14. 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.