Drug Safety Information for XANAX (Alprazolam)

Safety-related Labeling Changes for XANAX (ALPRAZOLAM) Rx Drug: FDA Link

Safety-related Labeling Changes for XANAX XR (ALPRAZOLAM) Rx Drug: FDA Link

Adverse Drug Reactions for XANAX* (Alprazolam)

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 XANAX
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Nausea5504
2Drug ineffective4962
3Anxiety*4775
4Fatigue*4270
5Pain4204
6Headache3915
7Dyspnoea3894
8Depression*3745
9Dizziness*3639
10Completed suicide3585
11Drug abuse3541
12Insomnia3531
13Diarrhoea3224
14Vomiting3220
15Toxicity to various agents2997
16Asthenia2979
17Fall2709
18Malaise2557
19Death2416
20Feeling abnormal2392

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

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

Reason # of FDA Reports
1Anxiety*52063
2Product used for unknown indication41660
3Depression*9596
4Panic attack*5906
5Insomnia*5607
6Sleep disorder3584
7Panic disorder*2259
8Nervousness1618
9Anxiety disorder*1617
10Ill-defined disorder1552

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


Types of Adverse Events for XANAX

Total Reports Filed with FDA: 402888


Number of FDA Adverse Event Reports by Patient Age for XANAX

Total Reports Filed with FDA: 402888*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Alprazolam (Apo-alpraz, Alprazolam, Xanax, Cassadan, Tafil, Novo-alprazol, Trankimazin, Alprox, Novo alprazol, Kalma, Xanax xr, Niravam)

Charts are based on 402888 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 XANAX 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.