Drug · FAERS side-effect profile with label screen

Drospirenone combination (4 ingredients) side effects: what 1,806 FDA adverse event reports show

Drospirenone/Ethinyl Estradiol/Levomefolate Calcium And Levomefolate Calcium · Slynd · 50 reaction terms · 2,304 drug–reaction co-reports · data 2026-09-14

Drug class

Progestin

FDA label, Indications wording

Brand names

Slynd

openFDA label

Who reports

1,806 reports · 47% serious · 25 with death outcome · 100% 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 33 strongest signals

Labeled adverse reaction 6Labeled (related wording) 3Reporting / coding artifact 4Not in label — unassessed 20

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.
Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
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. 17 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
Metrorrhagia	84	56.7 46.0–69.9ROR 59.4 · χ² 4,519 / p <1e-300	55.7 EB05 46.4 · IC025 +5.0 3/3 methods agree	Labeled adverse reaction exact term	serious n=8 · 89% consumer	no trial data cached
Menstruation delayed	46	51.6 38.8–68.7ROR 53.0 · χ² 2,225 / p <1e-300	50.4 EB05 39.3 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious n=6 · 96% consumer	no trial data cached
Deep vein thrombosis (leg blood clot)	275	49.1 44.0–54.7ROR 57.7 · χ² 12,892 / p <1e-300	48.7 EB05 44.1 · IC025 +5.3 3/3 methods agree	Labeled (related wording) related wording	serious PRR 60.6	no trial data cached
Pulmonary embolism (lung blood clot)	343	41.9 38.1–46.1ROR 51.4 · χ² 13,653 / p <1e-300	41.6 EB05 38.1 · IC025 +5.1 3/3 methods agree	Labeled (related wording) related wording	serious PRR 51.1	no trial data cached
Injury	253	41.7 37.2–46.8ROR 48.4 · χ² 10,011 / p <1e-300	41.4 EB05 37.3 · IC025 +5.1 3/3 methods agree	Not in label — unassessed	serious PRR 62.4	no trial data cached
Anhedonia	84	36.9 30.0–45.5ROR 38.7 · χ² 2,895 / p <1e-300	36.5 EB05 30.4 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious PRR 49.7	no trial data cached
Menorrhagia (heavy periods)	45	26.3 19.7–35.1ROR 26.9 · χ² 1,068 / p 2e-234	26.0 EB05 20.2 · IC025 +3.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 8.0 · 93% consumer	no trial data cached
Emotional distress	175	16.7 14.5–19.3ROR 18.4 · χ² 2,586 / p <1e-300	16.7 EB05 14.7 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious PRR 23.0	no trial data cached
Vaginal haemorrhage	54	14.7 11.3–19.2ROR 15.2 · χ² 679 / p 7e-150	14.6 EB05 11.5 · IC025 +3.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 24.6 · 91% consumer	no trial data cached
Genital haemorrhage	16	14.4 8.8–23.4ROR 14.5 · χ² 186 / p 1e-42	13.5 EB05 8.2 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 21.9	no trial data cached
Dysmenorrhoea	16	14.2 8.7–23.2ROR 14.3 · χ² 184 / p 4e-42	13.3 EB05 8.1 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious n=2	no trial data cached
Amenorrhoea (missed periods)	18	12.5 7.9–19.8ROR 12.6 · χ² 180 / p 3e-41	11.6 EB05 7.2 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 1.9	no trial data cached
Cholecystectomy	12	12.3 7.0–21.6ROR 12.3 · χ² 113 / p 1e-26	10.6 EB05 5.8 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 15.5	no trial data cached
Libido decreased (lower sex drive)	12	11.3 6.4–19.8ROR 11.3 · χ² 102 / p 3e-24	9.5 EB05 5.3 · IC025 +2.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 2.0	no trial data cached
Menstruation irregular	24	10.5 7.1–15.6ROR 10.6 · χ² 197 / p 4e-45	9.7 EB05 6.6 · IC025 +2.5 3/3 methods agree	Labeled adverse reaction exact term	serious n=3 · 91% consumer	no trial data cached
General physical health deterioration	95	9.6 7.9–11.7ROR 10.1 · χ² 727 / p 2e-160	9.4 EB05 7.9 · IC025 +2.9 3/3 methods agree	Reporting / coding artifact	serious PRR 13.7	no trial data cached
Thrombosis	64	9.2 7.2–11.7ROR 9.5 · χ² 462 / p 9e-103	8.9 EB05 7.1 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 11.7	no trial data cached
Abdominal pain lower	17	7.8 4.9–12.5ROR 7.9 · χ² 94 / p 2e-22	6.7 EB05 4.3 · IC025 +1.9 3/3 methods agree	Labeled (related wording) related wording	serious PRR 4.2	no trial data cached
Pelvic pain	12	7.7 4.4–13.5ROR 7.7 · χ² 63 / p 1e-15	6.2 EB05 3.7 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 5.3	no trial data cached
Drug dose omission	110	7.6 6.4–9.1ROR 8.1 · χ² 631 / p 2e-139	7.4 EB05 6.3 · IC025 +2.6 3/3 methods agree	Reporting / coding artifact	serious PRR 1.5 · 92% consumer	no trial data cached
Cholelithiasis	20	7.1 4.6–11.0ROR 7.2 · χ² 99 / p 2e-23	6.2 EB05 4.2 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 9.1	no trial data cached
No adverse event	102	6.7 5.5–8.1ROR 7.0 · χ² 491 / p 5e-109	6.5 EB05 5.5 · IC025 +2.4 3/3 methods agree	Reporting / coding artifact	serious PRR 5.2 · 94% consumer	no trial data cached
Anxiety	154	6.3 5.4–7.3ROR 6.8 · χ² 686 / p 2e-151	6.2 EB05 5.4 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 10.6	no trial data cached
Mood altered	14	6.0 3.6–10.1ROR 6.0 · χ² 53 / p 1e-13	5.1 EB05 3.2 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 1.9	no trial data cached
Mood swings	15	5.5 3.3–9.0ROR 5.5 · χ² 50 / p 6e-13	4.7 EB05 3.1 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 3.1	no trial data cached
Acne	35	5.3 3.8–7.4ROR 5.4 · χ² 119 / p 4e-28	5.0 EB05 3.8 · IC025 +1.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 1.8 · 83% consumer	no trial data cached
Emotional disorder	13	4.9 2.8–8.4ROR 4.9 · χ² 36 / p 9e-10	4.2 EB05 2.6 · IC025 +1.2 3/3 methods agree	Not in label — unassessed	serious PRR 2.5	no trial data cached
Mental disorder	18	4.8 3.0–7.6ROR 4.8 · χ² 50 / p 6e-13	4.3 EB05 2.9 · IC025 +1.3 3/3 methods agree	Not in label — unassessed	serious PRR 5.9	no trial data cached
Fear	10	4.3 2.3–8.0ROR 4.3 · χ² 22 / p 1e-6	3.7 EB05 2.2 · IC025 +0.8 3/3 methods agree	Not in label — unassessed	serious PRR 6.4	no trial data cached
Crying	13	4.1 2.4–7.1ROR 4.2 · χ² 28 / p 6e-8	3.7 EB05 2.3 · IC025 +1.0 3/3 methods agree	Not in label — unassessed	serious PRR 3.3	no trial data cached
Inappropriate schedule of drug administration	25	4.0 2.7–5.9ROR 4.1 · χ² 54 / p 1e-13	3.8 EB05 2.7 · IC025 +1.3 3/3 methods agree	Reporting / coding artifact	serious PRR 2.1 · 88% consumer	no trial data cached
Irritability	19	3.7 2.3–5.7ROR 3.7 · χ² 34 / p 2e-9	3.4 EB05 2.3 · IC025 +1.0 3/3 methods agree	Not in label — unassessed	serious PRR 1.2	no trial data cached
Extra dose administered	10	2.9 1.6–5.4ROR 2.9 · χ² 11 / p 5e-4	2.7 EB05 1.6 · IC025 +0.3	Not in label — unassessed	serious n=1	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
Pulmonary embolism (lung blood clot)	343	41.9 38.1–46.1ROR 51.4 · χ² 13,653 / p <1e-300	41.6 EB05 38.1 · IC025 +5.1 3/3 methods agree	Labeled (related wording) related wording	serious PRR 51.1	no trial data cached
Deep vein thrombosis (leg blood clot)	275	49.1 44.0–54.7ROR 57.7 · χ² 12,892 / p <1e-300	48.7 EB05 44.1 · IC025 +5.3 3/3 methods agree	Labeled (related wording) related wording	serious PRR 60.6	no trial data cached
Injury	253	41.7 37.2–46.8ROR 48.4 · χ² 10,011 / p <1e-300	41.4 EB05 37.3 · IC025 +5.1 3/3 methods agree	Not in label — unassessed	serious PRR 62.4	no trial data cached
Emotional distress	175	16.7 14.5–19.3ROR 18.4 · χ² 2,586 / p <1e-300	16.7 EB05 14.7 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious PRR 23.0	no trial data cached
Anxiety	154	6.3 5.4–7.3ROR 6.8 · χ² 686 / p 2e-151	6.2 EB05 5.4 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 10.6	no trial data cached
Drug dose omission	110	7.6 6.4–9.1ROR 8.1 · χ² 631 / p 2e-139	7.4 EB05 6.3 · IC025 +2.6 3/3 methods agree	Reporting / coding artifact	serious PRR 1.5 · 92% consumer	no trial data cached
No adverse event	102	6.7 5.5–8.1ROR 7.0 · χ² 491 / p 5e-109	6.5 EB05 5.5 · IC025 +2.4 3/3 methods agree	Reporting / coding artifact	serious PRR 5.2 · 94% consumer	no trial data cached
General physical health deterioration	95	9.6 7.9–11.7ROR 10.1 · χ² 727 / p 2e-160	9.4 EB05 7.9 · IC025 +2.9 3/3 methods agree	Reporting / coding artifact	serious PRR 13.7	no trial data cached
Anhedonia	84	36.9 30.0–45.5ROR 38.7 · χ² 2,895 / p <1e-300	36.5 EB05 30.4 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious PRR 49.7	no trial data cached
Metrorrhagia	84	56.7 46.0–69.9ROR 59.4 · χ² 4,519 / p <1e-300	55.7 EB05 46.4 · IC025 +5.0 3/3 methods agree	Labeled adverse reaction exact term	serious n=8 · 89% consumer	no trial data cached
Thrombosis	64	9.2 7.2–11.7ROR 9.5 · χ² 462 / p 9e-103	8.9 EB05 7.1 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 11.7	no trial data cached
Vaginal haemorrhage	54	14.7 11.3–19.2ROR 15.2 · χ² 679 / p 7e-150	14.6 EB05 11.5 · IC025 +3.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 24.6 · 91% consumer	no trial data cached
Menstruation delayed	46	51.6 38.8–68.7ROR 53.0 · χ² 2,225 / p <1e-300	50.4 EB05 39.3 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious n=6 · 96% consumer	no trial data cached
Menorrhagia (heavy periods)	45	26.3 19.7–35.1ROR 26.9 · χ² 1,068 / p 2e-234	26.0 EB05 20.2 · IC025 +3.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 8.0 · 93% consumer	no trial data cached
Acne	35	5.3 3.8–7.4ROR 5.4 · χ² 119 / p 4e-28	5.0 EB05 3.8 · IC025 +1.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 1.8 · 83% 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.

Menstruation delayed — n=46, PRR 51.6
Injury — n=253, PRR 41.7
Anhedonia — n=84, PRR 36.9
Emotional distress — n=175, PRR 16.7
Thrombosis — n=64, PRR 9.2
Cholelithiasis — n=20, PRR 7.1
Anxiety — n=154, PRR 6.3

✓ 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 pulmonary embolism, deep vein thrombosis, injury, emotional distress, anxiety, anhedonia. 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, 50 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.