Drug Safety Information for LORAZEPAM (Lorazepam)

Safety-related Labeling Changes for ATIVAN (LORAZEPAM) Rx Drug: FDA Link

Adverse Drug Reactions for LORAZEPAM* (Lorazepam)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with LORAZEPAM
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Nausea4567
2Fatigue3542
3Dyspnoea3312
4Anxiety*3229
5Diarrhoea3111
6Vomiting3073
7Pain2827
8Dizziness*2729
9Drug ineffective2716
10Headache*2636
11Asthenia2554
12Depression2508
13Fall2367
14Insomnia*2215
15Pyrexia2125
16Death1966
17Confusional state1905
18Pneumonia1893
19Somnolence*1825
20Hypotension1779

* This side effect also appears in "Top 10 Side Effects of LORAZEPAM " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking LORAZEPAM
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Product used for unknown indication29696
2Anxiety*28986
3Insomnia*5545
4Depression*3534
5Sleep disorder2723
6Agitation2506
7Nausea*2238
8Sedation1443
9Convulsion1422
10Panic attack*1251

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for LORAZEPAM

Total Reports Filed with FDA: 344933


Number of FDA Adverse Event Reports by Patient Age for LORAZEPAM

Total Reports Filed with FDA: 344933*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Lorazepam (Duralozam, Temesta, Ativan, Apo-lorazepam, Lorazepam intensol, Apo lorazepam, Idalprem, Orfidal wyeth, Novo-lorazem, Lorazepam ratiopharm, Laubeel, Lorazepam, Loraz)

Charts are based on 344933 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and LORAZEPAM Reviews and Review Summary .

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.