ATARAX: 78 Adverse Event Reports & Safety Profile
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78
Total FAERS Reports
5 (6.4%)
Deaths Reported
55
Hospitalizations
78
As Primary/Secondary Suspect
10
Life-Threatening
First Report: 2001 · Latest Report: 20140502
What Are the Most Common ATARAX Side Effects?
#1 Most Reported
Dyspnoea
10 reports (12.8%)
#2 Most Reported
Tremor
7 reports (9.0%)
#3 Most Reported
Post procedural haemorrhage
7 reports (9.0%)
All ATARAX Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Dyspnoea | 10 | 12.8% | 0 | 8 |
| Muscle spasms | 7 | 9.0% | 0 | 5 |
| Muscular weakness | 7 | 9.0% | 0 | 5 |
| Post procedural haemorrhage | 7 | 9.0% | 0 | 7 |
| Tremor | 7 | 9.0% | 0 | 5 |
| Agitation | 6 | 7.7% | 0 | 4 |
| Dyskinesia | 6 | 7.7% | 0 | 4 |
| Abdominal pain | 5 | 6.4% | 0 | 3 |
| Aggression | 5 | 6.4% | 0 | 3 |
| Amenorrhoea | 5 | 6.4% | 0 | 3 |
| Blood prolactin increased | 5 | 6.4% | 0 | 3 |
| Breast enlargement | 5 | 6.4% | 0 | 3 |
| Drug hypersensitivity | 5 | 6.4% | 0 | 1 |
| Dysuria | 5 | 6.4% | 0 | 3 |
| Fatigue | 5 | 6.4% | 0 | 3 |
| Galactorrhoea | 5 | 6.4% | 0 | 3 |
| Hyperhidrosis | 5 | 6.4% | 0 | 3 |
| Palpitations | 5 | 6.4% | 0 | 3 |
| Swelling | 5 | 6.4% | 0 | 3 |
| Weight increased | 5 | 6.4% | 0 | 3 |
Who Reports ATARAX Side Effects? Age & Gender Data
Average age: 50.6 years. Most reports from: FR. View detailed demographics →
Is ATARAX Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2001 | 2 | 0 | 2 |
| 2009 | 4 | 0 | 4 |
| 2011 | 1 | 0 | 1 |
| 2012 | 14 | 1 | 12 |
| 2013 | 22 | 3 | 18 |
| 2014 | 23 | 1 | 15 |
What Is ATARAX Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 20 |
| Anxiety | 8 |
Official FDA Label for ATARAX
Official prescribing information from the FDA-approved drug label.