Desogestrel and Ethinyl Estradiol side effects: what 3,245 FDA adverse event reports show

Desogestrel And Ethinyl Estradiol · Volnea · 267 reaction terms · 57,942 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Brand names

Volnea

openFDA label

Who reports

3,245 reports · 73% serious · 561 with death outcome · 99% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Volnea™ (desogestrel and ethinyl estradiol and ethinyl estradiol) tablets are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table 2 lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception.

FDA label, Indications and Usage

What it is

DESCRIPTION Volnea™ (desogestrel and ethinyl estradiol tablets, USP and ethinyl estradiol tablets, USP) provides an oral contraceptive regimen of 21 white round tablets each containing 0.15 mg.

FDA label, Description section

Boxed warning

Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives are strongly advised not to smoke.

FDA 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 — boxed warning 2Labeled (related wording) 2Reporting / coding artifact 3Not in label — unassessed 33

What the badges mean

Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
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. 227 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
Folliculitis	821	558.4 524.6–594.4ROR 747.2 · χ² 419,721 / p <1e-300	507.4 EB05 478.9 · IC025 +8.5 3/3 methods agree	Not in label — unassessed	serious PRR 473.4 · 91% clinician	not reported in cached trials
Helicobacter infection	668	453.4 422.5–486.5ROR 570.6 · χ² 281,219 / p <1e-300	418.3 EB05 392.3 · IC025 +8.2 3/3 methods agree	Not in label — unassessed	serious PRR 351.3 · 91% clinician	not reported in cached trials
Pemphigus	681	374.7 349.6–401.5ROR 473.9 · χ² 239,486 / p <1e-300	350.4 EB05 328.9 · IC025 +8.0 3/3 methods agree	Not in label — unassessed	serious PRR 278.7 · 91% clinician	not reported in cached trials
Hand deformity	636	330.3 307.4–354.9ROR 410.6 · χ² 198,323 / p <1e-300	311.1 EB05 291.4 · IC025 +7.8 3/3 methods agree	Not in label — unassessed	serious PRR 268.2 · 90% clinician	not reported in cached trials
Pericarditis	676	273.3 255.1–292.8ROR 344.9 · χ² 175,734 / p <1e-300	260.2 EB05 244.1 · IC025 +7.7 3/3 methods agree	Not in label — unassessed	serious PRR 207.5 · 91% clinician	not reported in cached trials
Synovitis	673	250.4 233.7–268.2ROR 315.6 · χ² 160,732 / p <1e-300	239.3 EB05 224.5 · IC025 +7.5 3/3 methods agree	Not in label — unassessed	serious PRR 198.2 · 91% clinician	not reported in cached trials
Irritable bowel syndrome	771	242.0 227.2–257.7ROR 317.1 · χ² 178,200 / p <1e-300	231.8 EB05 218.4 · IC025 +7.5 3/3 methods agree	Not in label — unassessed	serious PRR 232.2 · 92% clinician	not reported in cached trials
Glossodynia (burning tongue/mouth pain)	637	189.5 176.6–203.5ROR 235.6 · χ² 115,961 / p <1e-300	183.1 EB05 171.5 · IC025 +7.2 3/3 methods agree	Not in label — unassessed	serious PRR 209.0	not reported in cached trials
Impaired healing	788	158.9 149.4–169.0ROR 209.5 · χ² 120,667 / p <1e-300	154.5 EB05 145.6 · IC025 +7.0 3/3 methods agree	Reporting / coding artifact	serious PRR 147.3 · 91% clinician	not reported in cached trials
Wound	618	146.9 136.7–157.9ROR 181.2 · χ² 87,514 / p <1e-300	143.0 EB05 133.8 · IC025 +6.9 3/3 methods agree	Not in label — unassessed	serious PRR 134.3 · 91% clinician	not reported in cached trials
Lower respiratory tract infection	925	134.7 127.4–142.3ROR 187.9 · χ² 120,306 / p <1e-300	131.5 EB05 124.6 · IC025 +6.8 3/3 methods agree	Not in label — unassessed	serious PRR 109.5 · 90% clinician	not reported in cached trials
Bursitis	243	132.8 117.5–150.1ROR 143.5 · χ² 31,031 / p <1e-300	128.8 EB05 115.8 · IC025 +6.5 3/3 methods agree	Not in label — unassessed	serious PRR 120.3 · 93% clinician	not reported in cached trials
Systemic lupus erythematosus	698	130.1 121.7–139.0ROR 165.4 · χ² 87,634 / p <1e-300	127.1 EB05 119.3 · IC025 +6.7 3/3 methods agree	Not in label — unassessed	serious PRR 102.7 · 91% clinician	not reported in cached trials
Joint range of motion decreased	257	126.7 112.5–142.6ROR 137.5 · χ² 31,317 / p <1e-300	123.1 EB05 111.0 · IC025 +6.4 3/3 methods agree	Not in label — unassessed	serious PRR 123.9 · 91% clinician	not reported in cached trials
Autoimmune disorder	167	114.7 98.8–133.2ROR 120.9 · χ² 18,392 / p <1e-300	111.3 EB05 97.9 · IC025 +6.1 3/3 methods agree	Not in label — unassessed	serious PRR 94.7	not reported in cached trials
Wound infection	183	110.7 96.0–127.5ROR 117.2 · χ² 19,449 / p <1e-300	107.6 EB05 95.1 · IC025 +6.1 3/3 methods agree	Not in label — unassessed	serious PRR 91.6 · 90% clinician	not reported in cached trials
Contraindicated product administered	495	107.8 99.3–117.0ROR 127.0 · χ² 51,480 / p <1e-300	105.6 EB05 98.0 · IC025 +6.4 3/3 methods agree	Reporting / coding artifact	serious PRR 103.7 · 91% clinician	not reported in cached trials
Blister	803	94.0 88.4–99.8ROR 124.5 · χ² 72,883 / p <1e-300	92.4 EB05 87.2 · IC025 +6.3 3/3 methods agree	Not in label — unassessed	serious PRR 119.8 · 90% clinician	not reported in cached trials
Therapeutic product effect decreased	630	93.0 86.7–99.9ROR 115.2 · χ² 56,570 / p <1e-300	91.5 EB05 85.6 · IC025 +6.3 3/3 methods agree	Reporting / coding artifact	serious PRR 142.0 · 90% clinician	not reported in cached trials
Stomatitis (mouth sores)	816	88.1 83.0–93.5ROR 117.4 · χ² 69,424 / p <1e-300	86.7 EB05 81.9 · IC025 +6.3 3/3 methods agree	Not in label — unassessed	serious PRR 102.3 · 91% clinician	not reported in cached trials
Hypercholesterolaemia	125	85.5 71.9–101.7ROR 88.9 · χ² 10,226 / p <1e-300	83.4 EB05 71.8 · IC025 +5.7 3/3 methods agree	Not in label — unassessed	serious PRR 70.5 · 93% clinician	not reported in cached trials
Fibromyalgia	312	84.1 75.6–93.5ROR 92.9 · χ² 25,229 / p <1e-300	82.6 EB05 75.2 · IC025 +6.0 3/3 methods agree	Not in label — unassessed	serious PRR 85.5 · 93% clinician	not reported in cached trials
Muscle spasticity	152	80.2 68.6–93.7ROR 84.1 · χ² 11,665 / p <1e-300	78.4 EB05 68.5 · IC025 +5.7 3/3 methods agree	Not in label — unassessed	serious PRR 88.9	not reported in cached trials
Arthropathy	658	77.1 72.0–82.6ROR 96.5 · χ² 48,907 / p <1e-300	76.1 EB05 71.3 · IC025 +6.0 3/3 methods agree	Not in label — unassessed	serious PRR 73.0 · 91% clinician	not reported in cached trials
Obesity	178	72.9 63.1–84.2ROR 77.1 · χ² 12,417 / p <1e-300	71.5 EB05 63.2 · IC025 +5.7 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 65.3	not reported in cached trials
Ear pain	214	71.9 63.1–81.9ROR 76.9 · χ² 14,739 / p <1e-300	70.7 EB05 63.1 · IC025 +5.7 3/3 methods agree	Not in label — unassessed	serious PRR 89.7	not reported in cached trials
Ill-defined disorder	650	69.8 65.2–74.8ROR 87.1 · χ² 43,682 / p <1e-300	69.0 EB05 64.6 · IC025 +5.9 3/3 methods agree	Not in label — unassessed	serious PRR 81.6 · 90% clinician	not reported in cached trials
Infusion related reaction (reaction during infusion)	706	69.8 65.4–74.6ROR 88.9 · χ² 47,446 / p <1e-300	68.9 EB05 64.8 · IC025 +5.9 3/3 methods agree	Not in label — unassessed	serious PRR 68.2 · 91% clinician	not reported in cached trials
Night sweats	344	69.8 63.1–77.2ROR 77.9 · χ² 23,036 / p <1e-300	68.8 EB05 62.9 · IC025 +5.8 3/3 methods agree	Not in label — unassessed	serious PRR 92.3	not reported in cached trials
Discomfort	611	65.8 61.2–70.7ROR 80.8 · χ² 38,634 / p <1e-300	65.0 EB05 60.8 · IC025 +5.8 3/3 methods agree	Not in label — unassessed	serious PRR 88.7 · 91% clinician	not reported in cached trials
Liver injury	238	64.2 56.8–72.6ROR 69.2 · χ² 14,620 / p <1e-300	63.3 EB05 56.8 · IC025 +5.6 3/3 methods agree	Not in label — unassessed	serious PRR 51.8 · 92% clinician	not reported in cached trials
Hepatic enzyme increased	665	63.9 59.6–68.4ROR 80.1 · χ² 40,805 / p <1e-300	63.1 EB05 59.2 · IC025 +5.8 3/3 methods agree	Labeled (related wording) related wording	serious PRR 71.9 · 91% clinician	not reported in cached trials
Coeliac disease	96	63.8 52.3–77.8ROR 65.7 · χ² 5,817 / p <1e-300	62.4 EB05 52.6 · IC025 +5.2 3/3 methods agree	Not in label — unassessed	serious PRR 61.8	not reported in cached trials
Type 2 diabetes mellitus	327	63.2 57.0–70.0ROR 70.1 · χ² 19,782 / p <1e-300	62.3 EB05 56.9 · IC025 +5.7 3/3 methods agree	Labeled — boxed warning synonym match	serious PRR 51.8 · 90% clinician	not reported in cached trials
Swelling	851	59.4 56.1–63.0ROR 80.2 · χ² 48,590 / p <1e-300	58.8 EB05 55.6 · IC025 +5.7 3/3 methods agree	Not in label — unassessed	serious PRR 74.5 · 90% clinician	not reported in cached trials
Gastrointestinal disorder	778	57.4 53.9–61.0ROR 75.2 · χ² 42,836 / p <1e-300	56.8 EB05 53.5 · IC025 +5.7 3/3 methods agree	Labeled (related wording) related wording	serious PRR 67.4	not reported in cached trials
Lower limb fracture	168	57.3 49.5–66.5ROR 60.4 · χ² 9,171 / p <1e-300	56.5 EB05 49.7 · IC025 +5.4 3/3 methods agree	Not in label — unassessed	serious PRR 49.1	not reported in cached trials
Gait inability	277	54.5 48.7–61.1ROR 59.5 · χ² 14,401 / p <1e-300	53.9 EB05 48.8 · IC025 +5.4 3/3 methods agree	Not in label — unassessed	serious PRR 52.9	not reported in cached trials
Psoriatic arthropathy	334	54.1 48.9–59.9ROR 60.2 · χ² 17,245 / p <1e-300	53.5 EB05 48.9 · IC025 +5.5 3/3 methods agree	Not in label — unassessed	serious PRR 52.6 · 91% clinician	not reported in cached trials
Sinusitis	830	52.6 49.6–55.8ROR 70.3 · χ² 41,827 / p <1e-300	52.1 EB05 49.2 · IC025 +5.5 3/3 methods agree	Not in label — unassessed	serious PRR 81.6	not reported in cached trials

Trial evidence (ClinicalTrials.gov)

✓ Trial adverse-event data found on ClinicalTrials.gov

Largest completed trials with posted results that list Desogestrel and Ethinyl Estradiol as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (0 of 40 signal terms matched).

NCT01252186 — A Multicenter Study to Evaluate the Effects of a 91-Day Extended Cycle Oral Contraceptive on Hemostatic Parame (N=265, PHASE2; 5 AE terms posted; arms: 91-day Levonorgestrel Oral Contraceptive; 28-day Levonorgestrel Oral Contraceptive; 28-day Desogestrel Oral Contraceptive)

Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.

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
Pain	953	10.0 9.5–10.6ROR 13.8 · χ² 7,953 / p <1e-300	10.0 EB05 9.5 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 12.1	not reported in cached trials
Fatigue (tiredness)	944	7.9 7.4–8.3ROR 10.7 · χ² 5,856 / p <1e-300	7.8 EB05 7.4 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 11.3	not reported in cached trials
Rash	936	14.0 13.2–14.8ROR 19.2 · χ² 11,478 / p <1e-300	13.9 EB05 13.2 · IC025 +3.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 23.4	not reported in cached trials
Lower respiratory tract infection	925	134.7 127.4–142.3ROR 187.9 · χ² 120,306 / p <1e-300	131.5 EB05 124.6 · IC025 +6.8 3/3 methods agree	Not in label — unassessed	serious PRR 109.5 · 90% clinician	not reported in cached trials
Joint swelling	899	48.6 45.9–51.4ROR 66.8 · χ² 41,771 / p <1e-300	48.2 EB05 45.6 · IC025 +5.4 3/3 methods agree	Not in label — unassessed	serious PRR 65.2 · 90% clinician	not reported in cached trials
Dyspnoea (shortness of breath)	890	10.2 9.6–10.8ROR 13.7 · χ² 7,553 / p <1e-300	10.1 EB05 9.6 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 10.9	not reported in cached trials
Arthralgia (joint pain)	879	13.7 13.0–14.5ROR 18.5 · χ² 10,553 / p <1e-300	13.7 EB05 13.0 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 19.2	not reported in cached trials
Peripheral swelling	868	36.8 34.7–38.9ROR 49.8 · χ² 30,206 / p <1e-300	36.5 EB05 34.5 · IC025 +5.1 3/3 methods agree	Not in label — unassessed	serious PRR 49.1	not reported in cached trials
Pruritus (itching)	865	14.8 14.0–15.7ROR 19.8 · χ² 11,314 / p <1e-300	14.8 EB05 14.0 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious PRR 27.5	not reported in cached trials
Swelling	851	59.4 56.1–63.0ROR 80.2 · χ² 48,590 / p <1e-300	58.8 EB05 55.6 · IC025 +5.7 3/3 methods agree	Not in label — unassessed	serious PRR 74.5 · 90% clinician	not reported in cached trials
Confusional state (confusion)	845	33.9 32.0–35.9ROR 45.5 · χ² 27,013 / p <1e-300	33.7 EB05 31.8 · IC025 +4.9 3/3 methods agree	Not in label — unassessed	serious PRR 33.6 · 90% clinician	not reported in cached trials
Drug ineffective (drug did not work)	833	4.1 3.9–4.3ROR 5.2 · χ² 2,071 / p <1e-300	4.1 EB05 3.9 · IC025 +1.9 3/3 methods agree	Reporting / coding artifact	serious PRR 8.5	not reported in cached trials
Sinusitis	830	52.6 49.6–55.8ROR 70.3 · χ² 41,827 / p <1e-300	52.1 EB05 49.2 · IC025 +5.5 3/3 methods agree	Not in label — unassessed	serious PRR 81.6	not reported in cached trials
Weight increased (weight gain)	827	24.1 22.7–25.5ROR 32.0 · χ² 18,394 / p <1e-300	24.0 EB05 22.6 · IC025 +4.4 3/3 methods agree	Labeled (related wording) related wording	serious PRR 34.5	not reported in cached trials
Folliculitis	821	558.4 524.6–594.4ROR 747.2 · χ² 419,721 / p <1e-300	507.4 EB05 478.9 · IC025 +8.5 3/3 methods agree	Not in label — unassessed	serious PRR 473.4 · 91% clinician	not reported in cached trials

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.

Folliculitis — n=821, PRR 558.4
Helicobacter infection — n=668, PRR 453.4
Pemphigus — n=681, PRR 374.7
Hand deformity — n=636, PRR 330.3
Pericarditis — n=676, PRR 273.3
Synovitis — n=673, PRR 250.4
Irritable bowel syndrome — n=771, PRR 242.0
Glossodynia — n=637, PRR 189.5
Wound — n=618, PRR 146.9
Lower respiratory tract infection — n=925, PRR 134.7

✓ 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 Desogestrel and Ethinyl Estradiol?

In FDA FAERS, the most frequently co-reported reaction terms for Desogestrel and Ethinyl Estradiol are pain, fatigue, rash, lower respiratory tract infection, joint swelling, dyspnoea. 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 Desogestrel and Ethinyl Estradiol have an FDA boxed warning?

Yes. The current FDA label carries a boxed warning: Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives are strongly advised not to smoke.

Do FAERS signals prove that Desogestrel and Ethinyl Estradiol 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 0e65209d-329a-4d31-8afb-24348dc8d7e7, effective 20240111; matched on openfda.generic_name.exact:"DESOGESTREL AND ETHINYL ESTRADIOL")
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, 267 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
ClinicalTrials.gov API v2 (query DESOGESTREL, results-bearing studies sorted by enrollment)

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.