SOBRIL: 19 Adverse Event Reports & Safety Profile
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19
Total FAERS Reports
3 (15.8%)
Deaths Reported
9
Hospitalizations
19
As Primary/Secondary Suspect
3
Life-Threatening
First Report: 201210 · Latest Report: 20131113
What Are the Most Common SOBRIL Side Effects?
#1 Most Reported
Weight increased
11 reports (57.9%)
#2 Most Reported
Tremor
11 reports (57.9%)
#3 Most Reported
Swelling
10 reports (52.6%)
All SOBRIL Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Tremor | 11 | 57.9% | 0 | 5 |
| Weight increased | 11 | 57.9% | 0 | 5 |
| Abdominal pain | 10 | 52.6% | 0 | 5 |
| Aggression | 10 | 52.6% | 0 | 5 |
| Agitation | 10 | 52.6% | 0 | 5 |
| Amenorrhoea | 10 | 52.6% | 0 | 5 |
| Blood prolactin increased | 10 | 52.6% | 0 | 5 |
| Dyskinesia | 10 | 52.6% | 0 | 5 |
| Dysuria | 10 | 52.6% | 0 | 5 |
| Fatigue | 10 | 52.6% | 0 | 5 |
| Galactorrhoea | 10 | 52.6% | 0 | 5 |
| Hyperhidrosis | 10 | 52.6% | 0 | 5 |
| Muscle spasms | 10 | 52.6% | 0 | 5 |
| Muscular weakness | 10 | 52.6% | 0 | 5 |
| Palpitations | 10 | 52.6% | 0 | 5 |
| Swelling | 10 | 52.6% | 0 | 5 |
| Breast enlargement | 9 | 47.4% | 0 | 4 |
| Dyspnoea | 9 | 47.4% | 0 | 4 |
| Ovarian germ cell cancer stage ii | 8 | 42.1% | 0 | 3 |
| Genital neoplasm malignant female | 5 | 26.3% | 0 | 5 |
Who Reports SOBRIL Side Effects? Age & Gender Data
Average age: 39.3 years. Most reports from: SE. View detailed demographics →
Is SOBRIL Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2012 | 7 | 2 | 5 |
| 2013 | 3 | 0 | 3 |
What Is SOBRIL Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 14 |
Official FDA Label for SOBRIL
Official prescribing information from the FDA-approved drug label.