RELUGOLIX for Endometriosis: Side Effects & Safety Data
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There are 23 adverse event reports in the FDA FAERS database where RELUGOLIX was used for Endometriosis.
Most Reported Side Effects for RELUGOLIX
| Side Effect | Reports | % | Deaths | Hosp. |
|---|---|---|---|---|
| Hot flush | 6,845 | 33.1% | 22 | 313 |
| Fatigue | 5,203 | 25.2% | 44 | 297 |
| Therapy interrupted | 3,251 | 15.7% | 20 | 99 |
| Incorrect dose administered | 1,917 | 9.3% | 39 | 204 |
| Asthenia | 1,718 | 8.3% | 25 | 182 |
| Arthralgia | 1,385 | 6.7% | 6 | 93 |
| Diarrhoea | 1,383 | 6.7% | 11 | 107 |
| Product dose omission issue | 1,189 | 5.8% | 16 | 155 |
| Dizziness | 1,146 | 5.6% | 10 | 105 |
| Constipation | 902 | 4.4% | 9 | 84 |
| Death | 832 | 4.0% | 832 | 74 |
| Weight increased | 805 | 3.9% | 3 | 42 |
| Insomnia | 764 | 3.7% | 3 | 60 |
| Pain | 750 | 3.6% | 13 | 101 |
| Myalgia | 721 | 3.5% | 5 | 44 |
Other Indications for RELUGOLIX
Prostate cancer (18,752)
Product used for unknown indication (1,417)
Uterine leiomyoma (115)
Neoplasm malignant (65)
Prostate cancer metastatic (42)
Heavy menstrual bleeding (32)
Prostatic specific antigen increased (15)
Adenomyosis (14)
Hormone-refractory prostate cancer (13)
Anaemia (10)
Other Drugs Used for Endometriosis
LEUPROLIDE (4,494)
ELAGOLIX (1,889)
LUPRON DEPOT (356)
NORETHINDRONE (308)
ESTRADIOL\NORETHINDRONE\RELUGOLIX (306)
ISOPROPYL ALCOHOL\LEUPROLIDE\NORETHINDRONE (293)
LEVONORGESTREL (282)
MEDROXYPROGESTERONE (171)
DROSPIRENONE\ETHINYL ESTRADIOL (94)
ETHINYL ESTRADIOL\ETONOGESTREL (80)