DROSPIRENONE for Oral contraception: Side Effects & Safety Data
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There are 192 adverse event reports in the FDA FAERS database where DROSPIRENONE was used for Oral contraception.
Most Reported Side Effects for DROSPIRENONE
| Side Effect | Reports | % | Deaths | Hosp. |
|---|---|---|---|---|
| Intermenstrual bleeding | 1,086 | 33.1% | 0 | 4 |
| Amenorrhoea | 603 | 18.4% | 0 | 2 |
| Heavy menstrual bleeding | 436 | 13.3% | 0 | 3 |
| Dysmenorrhoea | 240 | 7.3% | 0 | 0 |
| Product use in unapproved indication | 154 | 4.7% | 0 | 13 |
| Intentional dose omission | 123 | 3.8% | 0 | 0 |
| Nausea | 118 | 3.6% | 2 | 13 |
| Headache | 117 | 3.6% | 0 | 9 |
| Menstruation irregular | 117 | 3.6% | 0 | 2 |
| Product dose omission issue | 116 | 3.5% | 0 | 1 |
| Wrong technique in product usage process | 95 | 2.9% | 0 | 0 |
| Off label use | 93 | 2.8% | 0 | 12 |
| Fatigue | 87 | 2.7% | 3 | 4 |
| Acne | 82 | 2.5% | 0 | 2 |
| Depression | 76 | 2.3% | 0 | 1 |
Other Indications for DROSPIRENONE
Product used for unknown indication (2,255)
Contraception (394)
Heavy menstrual bleeding (81)
Endometriosis (63)
Menstrual cycle management (53)
Dysmenorrhoea (41)
Menstruation irregular (21)
Polycystic ovarian syndrome (21)
Polycystic ovaries (21)
Acne (14)
Other Drugs Used for Oral contraception
ETHINYL ESTRADIOL\LEVONORGESTREL (454)
DROSPIRENONE\ETHINYL ESTRADIOL (313)
ETHINYL ESTRADIOL\NORETHINDRONE (237)
ETHINYL ESTRADIOL\NORGESTIMATE (202)
LEVONORGESTREL (138)
DESOGESTREL\ETHINYL ESTRADIOL (97)
NORETHINDRONE (81)
DESOGESTREL (71)
NORGESTREL (41)
ETHINYL ESTRADIOL (34)