Drospirenone side effects: what 4,984 FDA adverse event reports show

Drospirenone · Slynd · 77 reaction terms · 3,862 drug–reaction co-reports · data 2026-09-14

Drug class

Progestin

FDA label, Indications wording

Brand names

Slynd

openFDA label

Who reports

4,984 reports · 20% serious · 23 with death outcome · 99% female

openFDA FAERS counts, all years, deduplication not applied

Used for

SLYND is a progestin indicated for use by females of reproductive potential to prevent pregnancy. SLYND is a progestin indicated for use by females of reproductive potential to prevent pregnancy. ( 1 )

FDA label, Indications and Usage

What it is

SLYND (drospirenone) is for use as an oral contraceptive. It is supplied as clear to a slightly opaque PVC-PVDC/Aluminum blister cards, each holding of 24 white tablets each containing 4 mg of drospirenone, a synthetic progestational compound and 4 green inert tablets.

FDA label, Description section

Boxed warning

None in the current label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 40 strongest signals

Labeled adverse reaction 7Reporting / coding artifact 9Not in label — unassessed 24

What the badges mean

Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.

Strongest disproportionality signals

Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 37 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Amenorrhoea (missed periods)	799	211.4 198.0–225.7ROR 251.5 · χ² 159,101 / p <1e-300	200.2 EB05 188.8 · IC025 +7.4 3/3 methods agree	Not in label — unassessed	serious PRR 15.2 · 99% consumer	no trial data cached
Dysmenorrhoea	352	116.3 105.0–128.8ROR 125.0 · χ² 39,040 / p <1e-300	112.4 EB05 102.9 · IC025 +6.4 3/3 methods agree	Not in label — unassessed	serious n=12 · 98% consumer	no trial data cached
Menstruation delayed	102	41.7 34.4–50.5ROR 42.5 · χ² 3,970 / p <1e-300	41.0 EB05 34.7 · IC025 +4.8 3/3 methods agree	Not in label — unassessed	serious n=2 · 100% consumer	no trial data cached
Intentional dose omission	184	28.5 24.7–32.8ROR 29.5 · χ² 4,822 / p <1e-300	28.2 EB05 24.9 · IC025 +4.5 3/3 methods agree	Reporting / coding artifact	serious PRR 7.4 · 96% consumer	no trial data cached
Product prescribing issue	134	27.9 23.6–32.9ROR 28.6 · χ² 3,423 / p <1e-300	27.6 EB05 23.9 · IC025 +4.4 3/3 methods agree	Reporting / coding artifact	serious PRR 14.3 · 96% consumer	no trial data cached
Vaginal discharge	66	27.8 21.9–35.3ROR 28.1 · χ² 1,667 / p <1e-300	27.4 EB05 22.3 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	serious n=2 · 98% consumer	no trial data cached
Menstruation irregular	152	24.2 20.7–28.3ROR 24.9 · χ² 3,343 / p <1e-300	24.0 EB05 21.0 · IC025 +4.2 3/3 methods agree	Labeled adverse reaction exact term	serious n=6 · 97% consumer	no trial data cached
Breast pain	30	11.9 8.3–16.9ROR 11.9 · χ² 287 / p 1e-64	11.3 EB05 8.0 · IC025 +2.7 3/3 methods agree	Labeled adverse reaction exact term	serious n=4 · 90% consumer	no trial data cached
Libido decreased (lower sex drive)	31	10.5 7.4–15.0ROR 10.6 · χ² 258 / p 3e-58	9.9 EB05 7.1 · IC025 +2.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 10.6 · 84% consumer	no trial data cached
Mood swings	58	7.7 5.9–9.9ROR 7.7 · χ² 329 / p 9e-74	7.3 EB05 5.8 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 5.4 · 91% consumer	no trial data cached
Acne	108	6.0 4.9–7.2ROR 6.1 · χ² 442 / p 2e-98	5.8 EB05 5.0 · IC025 +2.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 10.3 · 97% consumer	no trial data cached
Hepatic cytolysis	17	5.9 3.6–9.4ROR 5.9 · χ² 64 / p 8e-16	5.1 EB05 3.4 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 16.1	no trial data cached
Mood altered	37	5.7 4.2–7.9ROR 5.8 · χ² 140 / p 2e-32	5.4 EB05 4.1 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 8.0 · 81% consumer	no trial data cached
Meningioma	17	4.9 3.0–7.8ROR 4.9 · χ² 48 / p 2e-12	4.3 EB05 2.9 · IC025 +1.3 3/3 methods agree	Not in label — unassessed	serious PRR 14.2	no trial data cached
Crying	35	4.0 2.9–5.6ROR 4.1 · χ² 77 / p 9e-19	3.8 EB05 2.9 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 8.6 · 94% consumer	no trial data cached
Vaginal haemorrhage	40	4.0 2.9–5.4ROR 4.0 · χ² 85 / p 1e-20	3.8 EB05 2.9 · IC025 +1.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 3.1 · 85% consumer	no trial data cached
Brain fog	13	3.7 2.2–6.5ROR 3.8 · χ² 24 / p 6e-7	3.4 EB05 2.1 · IC025 +0.8 3/3 methods agree	Not in label — unassessed	serious PRR 8.1	no trial data cached
Abscess	14	3.7 2.2–6.2ROR 3.7 · χ² 25 / p 3e-7	3.3 EB05 2.1 · IC025 +0.9 3/3 methods agree	Not in label — unassessed	serious PRR 12.0	no trial data cached
Product use in unapproved indication	213	3.7 3.2–4.2ROR 3.8 · χ² 415 / p 2e-92	3.6 EB05 3.2 · IC025 +1.6 3/3 methods agree	Reporting / coding artifact	serious PRR 6.0 · 85% consumer	no trial data cached
Depressed mood	45	3.6 2.7–4.8ROR 3.6 · χ² 82 / p 7e-20	3.5 EB05 2.7 · IC025 +1.3 3/3 methods agree	Not in label — unassessed	serious PRR 8.6 · 96% consumer	no trial data cached
Emotional disorder	26	3.5 2.4–5.2ROR 3.5 · χ² 45 / p 1e-11	3.3 EB05 2.4 · IC025 +1.1 3/3 methods agree	Not in label — unassessed	serious PRR 3.6 · 100% consumer	no trial data cached
Pelvic pain	15	3.5 2.1–5.7ROR 3.5 · χ² 24 / p 5e-7	3.2 EB05 2.1 · IC025 +0.8 3/3 methods agree	Not in label — unassessed	serious PRR 4.6	no trial data cached
Product dose omission issue	226	3.3 2.9–3.8ROR 3.4 · χ² 373 / p 3e-83	3.3 EB05 3.0 · IC025 +1.5 3/3 methods agree	Reporting / coding artifact	serious PRR 2.4 · 94% consumer	no trial data cached
Wrong technique in product usage process	155	3.2 2.8–3.8ROR 3.3 · χ² 238 / p 5e-54	3.2 EB05 2.8 · IC025 +1.4 3/3 methods agree	Reporting / coding artifact	serious PRR 0.7 · 99% consumer	no trial data cached
Product dose omission in error	20	3.1 2.0–4.9ROR 3.1 · χ² 27 / p 1e-7	3.0 EB05 2.0 · IC025 +0.8 3/3 methods agree	Reporting / coding artifact	serious PRR 5.4 · 70% consumer	no trial data cached
Migraine	70	3.1 2.5–3.9ROR 3.1 · χ² 98 / p 2e-23	3.1 EB05 2.5 · IC025 +1.2 3/3 methods agree	Not in label — unassessed	serious PRR 4.1 · 87% consumer	no trial data cached
Abdominal distension (bloating)	73	3.0 2.4–3.7ROR 3.0 · χ² 93 / p 3e-22	2.9 EB05 2.4 · IC025 +1.2 3/3 methods agree	Not in label — unassessed	serious PRR 4.0 · 85% consumer	no trial data cached
Panic attack	24	2.8 1.9–4.1ROR 2.8 · χ² 25 / p 2e-7	2.7 EB05 1.9 · IC025 +0.7	Not in label — unassessed	serious PRR 8.3 · 96% consumer	no trial data cached
Inappropriate schedule of product administration	116	2.8 2.3–3.3ROR 2.8 · χ² 129 / p 3e-30	2.7 EB05 2.3 · IC025 +1.1 3/3 methods agree	Reporting / coding artifact	serious PRR 2.6 · 88% consumer	no trial data cached
Drug effective for unapproved indication	19	2.7 1.7–4.3ROR 2.7 · χ² 19 / p 6e-6	2.6 EB05 1.8 · IC025 +0.6	Not in label — unassessed	–	no trial data cached
Suicidal ideation (thoughts of suicide)	57	2.6 2.0–3.4ROR 2.6 · χ² 55 / p 5e-14	2.6 EB05 2.1 · IC025 +0.9 3/3 methods agree	Not in label — unassessed	serious PRR 7.8 · 84% consumer	no trial data cached
Irritability	36	2.5 1.8–3.5ROR 2.5 · χ² 31 / p 1e-8	2.5 EB05 1.9 · IC025 +0.7	Not in label — unassessed	serious PRR 4.3 · 83% consumer	no trial data cached
Psychotic disorder	17	2.4 1.5–3.9ROR 2.4 · χ² 13 / p 2e-4	2.3 EB05 1.6 · IC025 +0.4	Not in label — unassessed	serious PRR 7.3	no trial data cached
Thirst	10	2.4 1.3–4.4ROR 2.4 · χ² 7 / p 0.005	2.2 EB05 1.3 · IC025 +0.1	Not in label — unassessed	serious PRR 2.6	no trial data cached
Intentional product use issue	48	2.3 1.7–3.0ROR 2.3 · χ² 34 / p 3e-9	2.3 EB05 1.8 · IC025 +0.7	Reporting / coding artifact	serious PRR 2.5 · 75% consumer	no trial data cached
Photophobia (light sensitivity)	10	2.3 1.2–4.2ROR 2.3 · χ² 6 / p 0.008	2.1 EB05 1.3 · IC025 +0.0	Not in label — unassessed	serious PRR 7.5	no trial data cached
Anger	18	2.2 1.4–3.5ROR 2.2 · χ² 11 / p 5e-4	2.2 EB05 1.5 · IC025 +0.3	Not in label — unassessed	serious PRR 1.8	no trial data cached
Menorrhagia (heavy periods)	10	2.1 1.1–3.9ROR 2.1 · χ² 5 / p 0.014	2.0 EB05 1.2 · IC025 -0.1 PRR-only: not supported by EBGM or IC	Labeled adverse reaction exact term	–	no trial data cached
Depression	112	2.1 1.7–2.5ROR 2.1 · χ² 61 / p 3e-15	2.1 EB05 1.8 · IC025 +0.7	Labeled adverse reaction exact term	serious PRR 3.7 · 85% consumer	no trial data cached
Therapeutic response unexpected	22	2.1 1.4–3.1ROR 2.1 · χ² 11 / p 5e-4	2.0 EB05 1.4 · IC025 +0.3	Reporting / coding artifact	100% consumer	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Amenorrhoea (missed periods)	799	211.4 198.0–225.7ROR 251.5 · χ² 159,101 / p <1e-300	200.2 EB05 188.8 · IC025 +7.4 3/3 methods agree	Not in label — unassessed	serious PRR 15.2 · 99% consumer	no trial data cached
Dysmenorrhoea	352	116.3 105.0–128.8ROR 125.0 · χ² 39,040 / p <1e-300	112.4 EB05 102.9 · IC025 +6.4 3/3 methods agree	Not in label — unassessed	serious n=12 · 98% consumer	no trial data cached
Product dose omission issue	226	3.3 2.9–3.8ROR 3.4 · χ² 373 / p 3e-83	3.3 EB05 3.0 · IC025 +1.5 3/3 methods agree	Reporting / coding artifact	serious PRR 2.4 · 94% consumer	no trial data cached
Product use in unapproved indication	213	3.7 3.2–4.2ROR 3.8 · χ² 415 / p 2e-92	3.6 EB05 3.2 · IC025 +1.6 3/3 methods agree	Reporting / coding artifact	serious PRR 6.0 · 85% consumer	no trial data cached
Intentional dose omission	184	28.5 24.7–32.8ROR 29.5 · χ² 4,822 / p <1e-300	28.2 EB05 24.9 · IC025 +4.5 3/3 methods agree	Reporting / coding artifact	serious PRR 7.4 · 96% consumer	no trial data cached
Wrong technique in product usage process	155	3.2 2.8–3.8ROR 3.3 · χ² 238 / p 5e-54	3.2 EB05 2.8 · IC025 +1.4 3/3 methods agree	Reporting / coding artifact	serious PRR 0.7 · 99% consumer	no trial data cached
Menstruation irregular	152	24.2 20.7–28.3ROR 24.9 · χ² 3,343 / p <1e-300	24.0 EB05 21.0 · IC025 +4.2 3/3 methods agree	Labeled adverse reaction exact term	serious n=6 · 97% consumer	no trial data cached
Product prescribing issue	134	27.9 23.6–32.9ROR 28.6 · χ² 3,423 / p <1e-300	27.6 EB05 23.9 · IC025 +4.4 3/3 methods agree	Reporting / coding artifact	serious PRR 14.3 · 96% consumer	no trial data cached
Inappropriate schedule of product administration	116	2.8 2.3–3.3ROR 2.8 · χ² 129 / p 3e-30	2.7 EB05 2.3 · IC025 +1.1 3/3 methods agree	Reporting / coding artifact	serious PRR 2.6 · 88% consumer	no trial data cached
Depression	112	2.1 1.7–2.5ROR 2.1 · χ² 61 / p 3e-15	2.1 EB05 1.8 · IC025 +0.7	Labeled adverse reaction exact term	serious PRR 3.7 · 85% consumer	no trial data cached
Acne	108	6.0 4.9–7.2ROR 6.1 · χ² 442 / p 2e-98	5.8 EB05 5.0 · IC025 +2.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 10.3 · 97% consumer	no trial data cached
Menstruation delayed	102	41.7 34.4–50.5ROR 42.5 · χ² 3,970 / p <1e-300	41.0 EB05 34.7 · IC025 +4.8 3/3 methods agree	Not in label — unassessed	serious n=2 · 100% consumer	no trial data cached
Abdominal distension (bloating)	73	3.0 2.4–3.7ROR 3.0 · χ² 93 / p 3e-22	2.9 EB05 2.4 · IC025 +1.2 3/3 methods agree	Not in label — unassessed	serious PRR 4.0 · 85% consumer	no trial data cached
Migraine	70	3.1 2.5–3.9ROR 3.1 · χ² 98 / p 2e-23	3.1 EB05 2.5 · IC025 +1.2 3/3 methods agree	Not in label — unassessed	serious PRR 4.1 · 87% consumer	no trial data cached
Vaginal discharge	66	27.8 21.9–35.3ROR 28.1 · χ² 1,667 / p <1e-300	27.4 EB05 22.3 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	serious n=2 · 98% consumer	no trial data cached

Unlabeled candidate signals

These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.

Amenorrhoea — n=799, PRR 211.4
Dysmenorrhoea — n=352, PRR 116.3
Menstruation delayed — n=102, PRR 41.7
Vaginal discharge — n=66, PRR 27.8
Mood swings — n=58, PRR 7.7
Mood altered — n=37, PRR 5.7
Crying — n=35, PRR 4.0
Depressed mood — n=45, PRR 3.6
Emotional disorder — n=26, PRR 3.5
Migraine — n=70, PRR 3.1

✓ A hand-written Bradford Hill causality assessment exists for this drug: Drospirenone/ethinyl estradiol ↔ Pulmonary embolism (venous thromboembolism).

Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.

Common questions

What are the most reported side effects of Drospirenone?

In FDA FAERS, the most frequently co-reported reaction terms for Drospirenone are amenorrhoea, dysmenorrhoea, menstruation irregular, depression, acne, menstruation delayed. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.

Does Drospirenone have an FDA boxed warning?

No. The FDA label retrieved for Drospirenone has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Drospirenone causes these side effects?

No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.

Sources & methods

FDA label via openFDA (set ID db32bc55-f295-4d87-9dbb-0a2f45573dcf, effective 20260827; matched on openfda.generic_name.exact:"DROSPIRENONE")
Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA count= aggregation, field patient.drug.openfda.generic_name.exact, 77 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction
Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
Seriousness and sex counts from openFDA count=serious, patient.patientsex, seriousnessdeath

Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.