What the label lists and what reports show
Drospirenone side effects
Drospirenone's FDA label: “Most common adverse reactions (>1%) are: acne, metrorrhagia, headache, breast pain, weight increased, dysmenorrhea, nausea, vaginal hemorrhage, libido decreased, breast tenderness, menstruation irregular ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact …” FAERS holds 4,989 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is intermenstrual bleeding (1,551 reports).
- No generic listed
Check it at the source: the drospirenone FDA label on DailyMed (effective August 27, 2026, Exeltis USA, Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible serious side effects of SLYND?SLYND may cause serious side effects, including: High potassium levels in your blood (hyperkalemia). Certain medicines and conditions can also increase the potassium levels in your blood. Your healthcare provider may check the potassium levels in your blood before and during treatment with SLYND. Call you healthcare provider or go to a hospital emergency room right away if you have signs or symptoms of high potassium levels in your blood including: weakness or numbness in an arm or leg palpitations (feel like your heart is racing or fluttering) or irregular heartbeat nausea vomiting severe pain in your chest shortness of breath Blood clot forming in blood vessels (thromboembolism problems). Tell your healthcare provider if you have had a blood clot. Tell your healthcare provider if you plan to have surgery or are not able to be active due to illness or injury. […]
Source: FDA drug label, Exeltis USA, Inc., effective August 27, 2026 (SPL set db32bc55-f295-4d87-9dbb-0a2f45573dcf), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (>1%) are: acne, metrorrhagia, headache, breast pain, weight increased, dysmenorrhea, nausea, vaginal hemorrhage, libido decreased, breast tenderness, menstruation irregular ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Exeltis USA, Inc.
Table 3 Adverse Reactions Occurring in ≥ 1% of Females Receiving SLYND in Four Pooled Studies
| Adverse Reaction | Total N = 2598 n (%) |
|---|---|
| Any adverse reaction | 627 (24.1) |
| Acne | 98 (3.8) |
| Metrorrhagia | 72 (2.8) |
| Headache | 71 (2.7) |
| Breast pain | 57 (2.2) |
| Weight increased | 50 (1.9) |
| Dysmenorrhea | 49 (1.9) |
| Nausea | 47 (1.8) |
| Vaginal hemorrhage | 45 (1.7) |
| Libido decreased | 33 (1.3) |
| Breast tenderness | 31 (1.2) |
| Menstruation irregular | 30 (1.2) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following clinically significant adverse reactions are described elsewhere in other sections of the labeling: Hyperkalemia [see Warnings and Precautions (5.1) ] Bleeding Irregularities and Amenorrhea [see Warnings and Precautions (5.8) ] Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data described below reflect the exposure of SLYND in females of reproductive potential desiring to prevent pregnancy based on four clinical studies including Study CF111/303 [see Clinical Studies (14) ]. The mean time of SLYND exposure ranged from 197 to 328 days. The demographic profile for the pooled study data was: mean age 28 years; mean BMI 25 kg/m 2 ; racial distribution was 83% White; 14% Black; 1% Asian and 2% Other.
Source: FDA drug label, Exeltis USA, Inc., effective August 27, 2026 (SPL set db32bc55-f295-4d87-9dbb-0a2f45573dcf), via openFDA; the full label on DailyMed
What do FAERS reports show?
4,989 reports list drospirenone among the medicines taken, each a report of something that happened, not proof the medicine caused it; 23 are coded as a death and 290 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2025 (1,314, against a median of 95 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 16 reactions below, 6 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Drospirenone: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions