Desogestrel and ethinyl estradiol

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For desogestrel and ethinyl estradiol, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to desogestrel and ethinyl estradiol or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies on the relationship of age to the effects of desogestrel and ethinyl estradiol combination have not been performed in the pediatric population. However, pediatric-specific problems that would limit the usefulness of this medication in teenagers are not expected. desogestrel and ethinyl estradiol may be used for birth control in teenage females but should not be used before the start of menstruation.

Geriatric

Appropriate studies on the relationship of age to the effects of desogestrel and ethinyl estradiol combination have not been performed in the geriatric population. desogestrel and ethinyl estradiol should not be used in elderly women.

Pregnancy

Breast Feeding

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using desogestrel and ethinyl estradiol.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking desogestrel and ethinyl estradiol, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using desogestrel and ethinyl estradiol with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Dasabuvir
• Ombitasvir
• Paritaprevir
• Ritonavir
• Tranexamic Acid

Using desogestrel and ethinyl estradiol with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Anagrelide
• Aprepitant
• Boceprevir
• Bosentan
• Bupropion
• Carbamazepine
• Ceritinib
• Dabrafenib
• Darunavir
• Dexamethasone
• Donepezil
• Eliglustat
• Enzalutamide
• Fosphenytoin
• Griseofulvin
• Idelalisib
• Isotretinoin
• Lesinurad
• Lixisenatide
• Lumacaftor
• Mitotane
• Modafinil
• Oxcarbazepine
• Paclitaxel
• Paclitaxel Protein-Bound
• Phenytoin
• Piperaquine
• Pitolisant
• Prednisone
• Rifabutin
• Rifampin
• St John's Wort
• Sugammadex
• Theophylline
• Tizanidine
• Topiramate
• Ulipristal
• Valproic Acid

Using desogestrel and ethinyl estradiol with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alprazolam
• Amprenavir
• Atazanavir
• Bacampicillin
• Betamethasone
• Bexarotene
• Clarithromycin
• Colesevelam
• Cyclosporine
• Delavirdine
• Efavirenz
• Eslicarbazepine Acetate
• Etoricoxib
• Fosamprenavir
• Fosaprepitant
• Ginseng
• Lamotrigine
• Licorice
• Mycophenolate Mofetil
• Mycophenolic Acid
• Nelfinavir
• Parecoxib
• Prednisolone
• Rifapentine
• Ritonavir
• Roflumilast
• Rosuvastatin
• Rufinamide
• Selegiline
• Telaprevir
• Tipranavir
• Troglitazone
• Troleandomycin
• Valdecoxib
• Voriconazole
• Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using desogestrel and ethinyl estradiol with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use desogestrel and ethinyl estradiol, or give you special instructions about the use of food, alcohol, or tobacco.

• Caffeine
• Grapefruit Juice

Other Medical Problems

The presence of other medical problems may affect the use of desogestrel and ethinyl estradiol. Make sure you tell your doctor if you have any other medical problems, especially:

• Abnormal or unusual vaginal bleeding or
• Blood clots (eg, deep vein thrombosis, pulmonary embolism), or history of or
• Breast cancer, known or suspected or
• Diabetes with kidney, eye, nerve, or blood vessel damage or
• Endometrial cancer or
• Heart attack, history of or
• Heart or blood vessel disease (eg, coronary artery disease, heart valve problems), or history of or
• Hypertension (high blood pressure) that is not under good control or
• Jaundice during pregnancy or from using hormonal therapy in the past or
• Liver disease, including tumors or cancer or
• Major surgery with prolonged periods of immobilization or
• Migraine headache or
• Stroke, history of or
• Tumors (estrogen-dependent), known or suspected—Should not be used in patients with these conditions.

• Breast cancer, family history of or
• Cervical cancer or
• Depression, history of or
• Edema (fluid retention or body swelling) or
• Epilepsy (seizures) or
• Gallbladder disease or
• Hypertension (high blood pressure)—Use with caution. May make these conditions worse.

• Diabetes or
• Hyperlipidemia (high cholesterol or fats in the blood) or
• Hypertension (high blood pressure) or
• Kidney disease or
• Obesity, or history of—Use with caution. These conditions may increase risk for more serious side effects.

To make using oral contraceptives as safe and reliable as possible, you should understand how and when to take them and what effects may be expected.

desogestrel and ethinyl estradiol comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

desogestrel and ethinyl estradiol is available in blister packs with a tablet dispenser. Each blister pack contains 28 tablets with different colors that need to be taken in the same order as directed on the blister pack.

When you begin using desogestrel and ethinyl estradiol, your body will require at least 7 days to adjust before a pregnancy will be prevented. Use a second form of contraception, such as a condom, spermicide, or diaphragm, for the first 7 days of your first cycle of pills.

Take desogestrel and ethinyl estradiol at the same time each day. Birth control pills work best when no more than 24 hours pass between doses.

Do not skip or delay taking your pill by more than 24 hours. If you miss a dose, you could get pregnant. Ask your doctor for ways to help you remember to take your pills or about using another method of birth control.

You may feel sick or nauseated, especially during the first few months that you take desogestrel and ethinyl estradiol. If your nausea is continuous and does not go away, call your doctor.

Follow the instructions in the patient leaflet or call your doctor if you vomit or have diarrhea within 3 to 4 hours of taking desogestrel and ethinyl estradiol.

Dosing

The dose of desogestrel and ethinyl estradiol will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of desogestrel and ethinyl estradiol. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Your doctor may ask you to begin your dose on the first day of your menstrual period (called Day 1 start) or on the first Sunday after your menstrual period starts (called Sunday start). When you begin on a certain day it is important that you follow that schedule, even if you miss a dose. Do not change your schedule on your own. If the schedule that you use is not convenient, check with your doctor about changing it. For a Sunday start, you need to use another form of birth control (eg, condom, diaphragm, spermicide) for the first 7 days.

You should begin your next and all subsequent 28-day regimens of therapy on the same day of the week as the first regimen began and follow the same schedule.

• For oral dosage form (tablets):
  • For contraception (to prevent pregnancy):
    • Adults and teenagers—One light orange tablet taken at the same time each day for 21 consecutive days followed by one green (inert) tablet daily for 7 days per menstrual cycle.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

Call your doctor or pharmacist for instructions.

desogestrel and ethinyl estradiol has specific patient instructions on what to do if you miss a dose. Read and follow these instructions carefully and call your doctor if you have any questions.

Use a second form of birth control for 7 days after you miss a dose, to prevent pregnancy.

Make sure your doctor knows if you miss your period 2 months in a row, because this could mean that you are pregnant.

You may not have a period for that month if you miss more than one dose or change your schedule.

You could have light bleeding or spotting if you do not take a pill on time. The more pills you miss, the more likely you are to have bleeding.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Oral contraceptives have been shown to cause a decrease in glucose tolerance in a significant percentage of  users.17 This effect has been shown to be directly related to estrogen dose.65 In general, progestogens increase insulin secretion and create insulin resistance, this effect varying with different progestational agents.17,66 In the nondiabetic woman, oral contraceptives appear to have no effect on fasting blood  glucose.67 Because of these demonstrated effects, prediabetic and diabetic women should be carefully monitored while taking oral contraceptives.

A small proportion of women will have persistent hypertriglyceridemia while on the pill. As discussed earlier (see WARNINGS 1.a. and 1.d.), changes in serum triglycerides and lipoprotein levels have been reported in oral contraceptive users.

9. Elevated Blood Pressure

Women with significant hypertension should not be started on hormonal contraception.98 An increase in blood pressure has been reported in women taking oral contraceptives68 and this increase is more likely in older oral contraceptive users69 and with extended duration of use.61 Data from the Royal College of General Practitioners12 and subsequent randomized trials have shown that the incidence of hypertension increases with increasing progestational activity and concentrations of progestogens.

Women with a history of hypertension or hypertension-related diseases, or renal disease70 should be encouraged to use another method of contraception. If these women elect to use oral contraceptives, they should be monitored closely and if a clinically significant persistent elevation of blood pressure (BP) occurs (greater than or equal to 160 mm Hg systolic or greater than or equal to 100 mm Hg diastolic) and cannot be adequately controlled, oral contraceptives should be discontinued. In general, women who develop hypertension during hormonal contraceptive therapy should be switched to a non-hormonal contraceptive. If other contraceptive methods are not suitable, hormonal contraceptive therapy may continue combined with antihypertensive therapy. Regular monitoring of BP throughout hormonal contraceptive therapy is recommended.102 For most women, elevated blood pressure will return to normal after stopping oral contraceptives,69 and there is no difference in the occurrence of hypertension among former and never users.68,70,71

10. Headache

The onset or exacerbation of migraine or development of headache with a new pattern which is recurrent, persistent or severe requires discontinuation of oral contraceptives and evaluation of the cause.

Breakthrough bleeding and spotting are sometimes encountered in patients on oral contraceptives, especially during the first three months of use. Nonhormonal causes should be considered and adequate diagnostic measures taken to rule out malignancy or pregnancy in the event of breakthrough bleeding, as in the case of any abnormal vaginal bleeding. If pathology has been excluded, time or a change to another formulation may solve the problem. In the event of amenorrhea, pregnancy should be ruled out.

Some women may encounter post-pill amenorrhea or oligomenorrhea, especially when such a condition was pre-existent.

12. Ectopic Pregnancy

Ectopic as well as intrauterine pregnancy may occur in contraceptive failures.

Breakthrough bleeding and spotting are sometimes encountered in patients on oral contraceptives, especially during the first three months of use. Nonhormonal causes should be considered and adequate diagnostic measures taken to rule out malignancy or pregnancy in the event of breakthrough bleeding, as in the case of any abnormal vaginal bleeding. If pathology has been excluded, time or a change to another formulation may solve the problem. In the event of amenorrhea, pregnancy should be ruled out.

Some women may encounter post-pill amenorrhea or oligomenorrhea, especially when such a condition was pre-existent.

12. Ectopic Pregnancy

Ectopic as well as intrauterine pregnancy may occur in contraceptive failures.

Oral contraceptives may cause some degree of fluid retention. They should be prescribed with caution, and only with careful monitoring, in patients with conditions which might be aggravated by fluid retention.

Women with a history of depression should be carefully observed and the drug discontinued if depression recurs to a serious degree.

Contact lens wearers who develop visual changes or changes in lens tolerance should be assessed by an ophthalmologist.

Consult the labeling of concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations.

Effects of Other Drugs on Combined Hormonal Contraceptives

Substances decreasing the plasma concentrations of COCs and potentially diminishing the efficacy of COCs:

Drugs or herbal products that induce certain enzymes, including cytochrome P450 3A4 (CYP3A4), may decrease the plasma concentrations of COCs and potentially diminish the effectiveness of CHCs or increase breakthrough bleeding. Some drugs or herbal products that may decrease the effectiveness of hormonal contraceptives include phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate, rifabutin, rufinamide, aprepitant, and products containing St. John's wort. Interactions between hormonal contraceptives and other drugs may lead to breakthrough bleeding and/or contraceptive failure. Counsel women to use an alternative method of contraception or a back-up method when enzyme inducers are used with CHCs, and to continue back-up contraception for 28 days after discontinuing the enzyme inducer to ensure contraceptive reliability.

Substances increasing the plasma concentrations of COCs:

Co-administration of atorvastatin or rosuvastatin and certain COCs containing EE increase AUC values for EE by approximately 20% to 25%. Ascorbic acid and acetaminophen may increase plasma EE concentrations, possibly by inhibition of conjugation. CYP3A4 inhibitors such as itraconazole, voriconazole, fluconazole, grapefruit juice, or ketoconazole may increase plasma hormone concentrations.

Human immunodeficiency virus (HIV)/ Hepatitis C virus (HCV) protease inhibitors and non-nucleoside reverse transcriptase inhibitors:

Significant changes (increase or decrease) in the plasma concentrations of estrogen and/or progestin have been noted in some cases of co-administration with HIV protease inhibitors (decrease [e.g., nelfinavir, ritonavir, darunavir/ritonavir, (fos)amprenavir/ritonavir, lopinavir/ritonavir, and tipranavir/ritonavir] or increase [e.g., indinavir and atazanavir/ritonavir]) /HCV protease inhibitors (decrease [e.g., boceprevir and telaprevir]) or with non-nucleoside reverse transcriptase inhibitors (decrease [e.g., nevirapine] or increase [e.g., etravirine]).

Concomitant Use with HCV Combination Therapy – Liver Enzyme Elevation

Do not co-administer Desogestrel and Ethinyl Estradiol with HCV drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to potential for ALT elevations (see Warnings, RISK OF LIVER ENZYME ELEVATIONS WITH CONCOMITANT HEPATITIS C TREATMENT).

Colesevelam: Colesevelam, a bile acid sequestrant, given together with a combination oral hormonal contraceptive, has been shown to significantly decrease the AUC of EE. A drug interaction between the contraceptive and colesevelam was decreased when the two drug products were given 4 hours apart.

Effects of Combined Hormonal Contraceptives on Other Drugs

COCs containing EE may inhibit the metabolism of other compounds (e.g., cyclosporine, prednisolone, theophylline, tizanidine, and voriconazole) and increase their plasma concentrations. COCs have been shown to decrease plasma concentrations of acetaminophen, clofibric acid, morphine, salicylic acid, temazepam and lamotrigine. Significant decrease in plasma concentration of lamotrigine has been shown, likely due to induction of lamotrigine glucuronidation. This may reduce seizure control; therefore, dosage adjustments of lamotrigine may be necessary.

Women on thyroid hormone replacement therapy may need increased doses of thyroid hormone because serum concentrations of thyroid-binding globulin increases with use of COCs.

Certain endocrine and liver function tests and blood components may be affected by oral contraceptives:

1. Increased prothrombin and factors VII, VIII, IX, and X; decreased antithrombin 3; increased norepinephrine-induced platelet aggregability.
2. Increased thyroid binding globulin (TBG) leading to increased circulating total thyroid hormone, as measured by protein-bound iodine (PBI), T4 by column or by radioimmunoassay. Free T3 resin uptake is decreased, reflecting the elevated TBG; free T4 concentration is unaltered.
3. Other binding proteins may be elevated in serum.
4. Sex hormone binding globulins are increased and result in elevated levels of total circulating sex steroids however, free or biologically active levels either decrease or remain unchanged.
5. Triglycerides may be increased and levels of various other lipids and lipoproteins may be affected.
6. Glucose tolerance may be decreased.
7. Serum folate levels may be depressed by oral contraceptive therapy. This may be of clinical significance if a woman becomes pregnant shortly after discontinuing oral contraceptives.

See WARNINGS.

Pregnancy Category X.

See CONTRAINDICATIONS and WARNINGS.

Small amounts of oral contraceptive steroids have been identified in the milk of nursing mothers and a few adverse effects on the child have been reported, including jaundice and breast enlargement. In addition, oral contraceptives given in the postpartum period may interfere with lactation by decreasing the quantity and quality of breast milk. If possible, the nursing mother should be advised not to use oral contraceptives but to use other forms of contraception until she has completely weaned her child.

Safety and efficacy of Desogestrel and Ethinyl Estradiol tablets have been established in women of reproductive age. Safety and efficacy are expected to be the same for postpubertal adolescents under the age of 16 and for users 16 years and older. Use of this product before menarche is not indicated.

This product has not been studied in women over 65 years of age and is not indicated in this population.

See Patient Labeling printed below.

See WARNINGS.

Pregnancy Category X.

See CONTRAINDICATIONS and WARNINGS.

Small amounts of oral contraceptive steroids have been identified in the milk of nursing mothers and a few adverse effects on the child have been reported, including jaundice and breast enlargement. In addition, oral contraceptives given in the postpartum period may interfere with lactation by decreasing the quantity and quality of breast milk. If possible, the nursing mother should be advised not to use oral contraceptives but to use other forms of contraception until she has completely weaned her child.

Safety and efficacy of Desogestrel and Ethinyl Estradiol tablets have been established in women of reproductive age. Safety and efficacy are expected to be the same for postpubertal adolescents under the age of 16 and for users 16 years and older. Use of this product before menarche is not indicated.

This product has not been studied in women over 65 years of age and is not indicated in this population.

See Patient Labeling printed below.

Safety and efficacy of Desogestrel and Ethinyl Estradiol tablets have been established in women of reproductive age. Safety and efficacy are expected to be the same for postpubertal adolescents under the age of 16 and for users 16 years and older. Use of this product before menarche is not indicated.

This product has not been studied in women over 65 years of age and is not indicated in this population.

See Patient Labeling printed below.

See Patient Labeling printed below.

An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives (see WARNINGS).

•   Thrombophlebitis and venous thrombosis with or without embolism
•   Arterial thromboembolism
•   Pulmonary embolism
•   Myocardial infarction
•   Cerebral hemorrhage
•   Cerebral thrombosis
•   Hypertension
•   Gallbladder disease
•   Hepatic adenomas or benign liver tumors

There is evidence of an association between the following conditions and the use of oral contraceptives:

•   Mesenteric thrombosis
•   Retinal thrombosis

The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug-related:

•   Nausea
•   Vomiting
•   Gastrointestinal symptoms (such as abdominal cramps and bloating)
•   Breakthrough bleeding
•   Spotting
•   Change in menstrual flow
•   Amenorrhea
•   Temporary infertility after discontinuation of treatment
•   Edema
•   Melasma which may persist
•   Breast changes: tenderness, enlargement, secretion
•   Change in weight (increase or decrease)
•   Change in cervical erosion and secretion
•   Diminution in lactation when given immediately postpartum
•   Cholestatic jaundice
•   Migraine
•   Allergic reaction, including rash, urticaria, and angioedema
•   Mental depression
•   Reduced tolerance to carbohydrates
•   Vaginal candidiasis
•   Change in corneal curvature (steepening)
•   Intolerance to contact lenses

The following adverse reactions have been reported in users of oral contraceptives and a causal association has been neither confirmed nor refuted:

•   Pre-menstrual syndrome
•   Cataracts
•   Changes in appetite
•   Cystitis-like syndrome
•   Headache
•   Nervousness
•   Dizziness
•   Hirsutism
•   Loss of scalp hair
•   Erythema multiforme
•   Erythema nodosum
•   Hemorrhagic eruption
•   Vaginitis
•   Porphyria
•   Impaired renal function
•   Hemolytic uremic syndrome
•   Acne
•   Changes in libido
•   Colitis
•   Budd-Chiari Syndrome

Applies to desogestrel / ethinyl estradiol: oral tablet

Genitourinary

Common (1% to 10%): Breast pain/tenderness, amenorrhea, irregular bleeding
Uncommon (0.1% to 1%): Breast enlargement/hypertrophy, metrorrhagia
Rare (0.01% to 0.1%): Vaginal/breast discharge, vaginal candidiasis
Frequency not reported: Breakthrough bleeding, spotting, menstrual flow change, cervical ectropion and secretion, temporary infertility (after discontinuation), vaginitis, candidiasis, lactation diminution, premenstrual syndrome, dysmenorrhea, endometriosis, uterine myoma[Ref]

Diminution of lactation may theoretically occur when this drug is given immediately postpartum.[Ref]

Gastrointestinal

Common (1% to 10%): Nausea, abdominal pain
Uncommon (0.1% to 1%): Vomiting, diarrhea
Frequency not reported: Gallbladder disease, mesenteric thrombosis, gastrointestinal symptoms (e.g., abdominal pain, cramps, bloating), pancreatitis, colitis, Crohn's disease, ulcerative colitis[Ref]

Psychiatric

Common (1% to 10%): Depressed mood, altered mood
Uncommon (0.1% to 1%): Decreased libido, nervousness
Rare (0.01% to 0.1%): Increased libido
Frequency not reported: Depression/mental depression[Ref]

Nervous system

Common (1% to 10%): Headache, dizziness
Uncommon (0.1% to 1%): Migraine
Frequency not reported: Stroke, transient ischemic attack, cerebral hemorrhage/thrombosis, chorea exacerbation, Sydenham's chorea, epilepsy[Ref]

Metabolic

Common (1% to 10%): Increased weight
Uncommon (0.1% to 1%): Fluid retention
Rare (0.01% to 0.1%): Decreased weight
Frequency not reported: Decreased serum folate, porphyria exacerbation, decreased carbohydrate tolerance, increased/decreased folate[Ref]

Dermatologic

Uncommon (0.1% to 1%): Rash/allergic rash, urticaria, acne
Rare (0.01% to 0.1%): Erythema nodosum/multiforme, pruritus, alopecia, hirsutism
Frequency not reported: Scalp hair loss, melasma/chloasma or persistent melasma/chloasma, gestational herpes gestationis, hemorrhagic eruption[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Hypertension, fluid retention/edema
Rare (0.01% to 0.1%): Arterial/venous thromboembolism
Frequency not reported: Myocardial infarction, venous thrombosis, arterial/venous thromboembolic disorders, varicose vein aggravation, thrombophlebitis and venous thrombosis with/without embolism[Ref]

Ocular

Rare (0.01% to 0.1%): Contact lens intolerance, cataract
Frequency not reported: Retinal thrombosis, optic neuritis, partial/complete vision loss, corneal curvature change/steepening[Ref]

Hypersensitivity

Rare (0.01% to 0.1%): Hypersensitivity
Frequency not reported: Anaphylactic/anaphylactoid reactions, hereditary angioedema/angioedema, severe reactions with respiratory and circulatory symptoms[Ref]

Other

Rare (0.01% to 0.1%): Otosclerosis[Ref]

Hepatic

Frequency not reported: Cholestatic jaundice, Budd-Chiari syndrome, acute/chronic liver function disturbances, liver tumors/hepatic adenomas or benign liver tumors[Ref]

Oncologic

Frequency not reported: Hormone-dependent tumors, breast cancer[Ref]

Renal

Frequency not reported: Cystitis-like syndrome, impaired renal function[Ref]

Respiratory

Frequency not reported: Pulmonary embolism[Ref]

Hematologic

Frequency not reported: Hemolytic uremic syndrome[Ref]

Musculoskeletal

Frequency not reported: Systemic lupus erythematosus[Ref]

Some side effects of desogestrel / ethinyl estradiol may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.