THERALEN: 10 Adverse Event Reports & Safety Profile
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10
Total FAERS Reports
0
Deaths Reported
5
Hospitalizations
10
As Primary/Secondary Suspect
First Report: 201210 · Latest Report: 20121001
What Are the Most Common THERALEN Side Effects?
#1 Most Reported
Weight increased
9 reports (90.0%)
#2 Most Reported
Tremor
9 reports (90.0%)
#3 Most Reported
Swelling
9 reports (90.0%)
All THERALEN Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Abdominal pain | 9 | 90.0% | 0 | 4 |
| Aggression | 9 | 90.0% | 0 | 4 |
| Agitation | 9 | 90.0% | 0 | 4 |
| Amenorrhoea | 9 | 90.0% | 0 | 4 |
| Blood prolactin increased | 9 | 90.0% | 0 | 4 |
| Dyskinesia | 9 | 90.0% | 0 | 4 |
| Dysuria | 9 | 90.0% | 0 | 4 |
| Fatigue | 9 | 90.0% | 0 | 4 |
| Galactorrhoea | 9 | 90.0% | 0 | 4 |
| Hyperhidrosis | 9 | 90.0% | 0 | 4 |
| Muscle spasms | 9 | 90.0% | 0 | 4 |
| Muscular weakness | 9 | 90.0% | 0 | 4 |
| Palpitations | 9 | 90.0% | 0 | 4 |
| Swelling | 9 | 90.0% | 0 | 4 |
| Tremor | 9 | 90.0% | 0 | 4 |
| Weight increased | 9 | 90.0% | 0 | 4 |
| Breast enlargement | 8 | 80.0% | 0 | 3 |
| Dyspnoea | 8 | 80.0% | 0 | 3 |
| Ovarian germ cell cancer stage ii | 7 | 70.0% | 0 | 2 |
Who Reports THERALEN Side Effects? Age & Gender Data
Average age: 25.0 years. Most reports from: SE. View detailed demographics →
Is THERALEN Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2012 | 5 | 0 | 5 |
What Is THERALEN Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 7 |
Official FDA Label for THERALEN
Official prescribing information from the FDA-approved drug label.