DROSPIRENONE for Contraception: Side Effects & Safety Data
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There are 394 adverse event reports in the FDA FAERS database where DROSPIRENONE was used for 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)
Oral contraception (192)
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 Contraception
LEVONORGESTREL (55,471)
COPPER (28,180)
ETONOGESTREL (21,547)
ETHINYL ESTRADIOL\ETONOGESTREL (5,815)
MEDROXYPROGESTERONE (3,931)
MIRENA (2,813)
ETHINYL ESTRADIOL\NORELGESTROMIN (2,489)
ETHINYL ESTRADIOL\NORGESTIMATE (2,235)
ETHINYL ESTRADIOL\LEVONORGESTREL (1,968)
PARAGARD 380A (1,750)