FDA Adverse Events Summary for ATIVAN* (Lorazepam)
(based on 344933 reports filed with the FDA between 2004 and June 2015)
These charts and graphs provide data on adverse effects and events attributed to ATIVAN. They are based on FDA Adverse Event reports received through the FDA Adverse Event Reporting System (FAERS) program.
Adverse Event Reports are submitted 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). 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.
Top 20 Adverse Effects Associated with ATIVAN
(reported in FDA Medwatch Reports)
| Side Effect | # of FDA Reports | |
|---|---|---|
| 1 | Nausea | 4567 |
| 2 | Fatigue | 3542 |
| 3 | Dyspnoea | 3312 |
| 4 | Anxiety* | 3229 |
| 5 | Diarrhoea | 3111 |
| 6 | Vomiting | 3073 |
| 7 | Pain | 2827 |
| 8 | Dizziness* | 2729 |
| 9 | Drug ineffective | 2716 |
| 10 | Headache* | 2636 |
| 11 | Asthenia | 2554 |
| 12 | Depression | 2508 |
| 13 | Fall | 2367 |
| 14 | Insomnia* | 2215 |
| 15 | Pyrexia | 2125 |
| 16 | Death | 1966 |
| 17 | Confusional state | 1905 |
| 18 | Pneumonia | 1893 |
| 19 | Somnolence* | 1825 |
| 20 | Hypotension | 1779 |
* This side effect also appears in "Top 10 Side Effects of ATIVAN " in the drug's Review Summary based on AskaPatient reviews.
Top 10 Reasons for Taking ATIVAN
(associated with FDA Medwatch Reports)
| Reason | # of FDA Reports | |
|---|---|---|
| 1 | Product used for unknown indication | 29696 |
| 2 | Anxiety* | 28986 |
| 3 | Insomnia* | 5545 |
| 4 | Depression* | 3534 |
| 5 | Sleep disorder | 2723 |
| 6 | Agitation | 2506 |
| 7 | Nausea* | 2238 |
| 8 | Sedation | 1443 |
| 9 | Convulsion | 1422 |
| 10 | Panic attack* | 1251 |
*Also a top-10 reason in AskaPatient Review Summary.
Types of Adverse Events for ATIVAN
Total Reports Filed with FDA: 344933
- Male
- Female
- Unknown
Number of FDA Adverse Event Reports by Patient Age for ATIVAN
Total Reports Filed with FDA: 344933*
Note: * Reports include 53,785 reports of unknown age.
