IMOVANE: 73 Adverse Event Reports & Safety Profile
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73
Total FAERS Reports
10 (13.7%)
Deaths Reported
49
Hospitalizations
73
As Primary/Secondary Suspect
13
Life-Threatening
First Report: 20101017 · Latest Report: 20140511
What Are the Most Common IMOVANE Side Effects?
#1 Most Reported
Hyperhidrosis
16 reports (21.9%)
#2 Most Reported
Agitation
12 reports (16.4%)
#3 Most Reported
Dyskinesia
11 reports (15.1%)
All IMOVANE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Hyperhidrosis | 16 | 21.9% | 0 | 6 |
| Agitation | 12 | 16.4% | 0 | 7 |
| Coma | 11 | 15.1% | 3 | 8 |
| Dyskinesia | 11 | 15.1% | 0 | 5 |
| Abdominal pain | 10 | 13.7% | 0 | 5 |
| Aggression | 10 | 13.7% | 0 | 5 |
| Amenorrhoea | 10 | 13.7% | 0 | 5 |
| Blood prolactin increased | 10 | 13.7% | 0 | 5 |
| Dysuria | 10 | 13.7% | 0 | 5 |
| Fatigue | 10 | 13.7% | 0 | 5 |
| Galactorrhoea | 10 | 13.7% | 0 | 5 |
| Muscle spasms | 10 | 13.7% | 0 | 5 |
| Muscular weakness | 10 | 13.7% | 0 | 5 |
| Palpitations | 10 | 13.7% | 0 | 5 |
| Swelling | 10 | 13.7% | 0 | 5 |
| Tremor | 10 | 13.7% | 0 | 5 |
| Weight increased | 10 | 13.7% | 0 | 5 |
| Breast enlargement | 9 | 12.3% | 0 | 4 |
| Dyspnoea | 9 | 12.3% | 0 | 4 |
| Ovarian germ cell cancer stage ii | 8 | 11.0% | 0 | 3 |
Who Reports IMOVANE Side Effects? Age & Gender Data
Average age: 54.8 years. Most reports from: FR. View detailed demographics →
Is IMOVANE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2010 | 1 | 0 | 1 |
| 2011 | 1 | 0 | 1 |
| 2012 | 8 | 2 | 6 |
| 2013 | 33 | 4 | 29 |
| 2014 | 15 | 3 | 9 |
What Is IMOVANE Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 30 |
| Insomnia | 12 |
Official FDA Label for IMOVANE
Official prescribing information from the FDA-approved drug label.