Desogestrel is an active pharmaceutical ingredient in the Progestogens group (G03AC). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
GBOfficial regulatory label· revised March 6, 2026[1]
Contraception
How to take
GBOfficial regulatory label· revised March 6, 2026
CACanada· Health Canada
12 products
Uses
CAOfficial regulatory label· revised September 15, 2025[2]
1 Pediatrics Pediatrics: The safety and efficacy of MARVELON® has not been established in women under the age of 18 years. Use of this product before menarche is not indicated. 2 Geriatrics Geriatrics: MARVELON® is not indicated in postmenopausal women.
How to take
CA
USUnited States· FDA
3 products
Uses
USOfficial regulatory label· revised January 11, 2024[3]
INDICATIONS AND USAGE
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.
The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates. TABLE 2 Percentage of women experiencing an unintended pregnancy during the first year of typical use and the first year of perfect use of contraception and the percentage continuing use at the end of the first year, United States.
% of Women Experiencing an Unintended Pregnancy within the First Year of Use % of Women Continuing Use at One Year Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. Method (1) Typical Use Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason.
Drug interactions
Known interactions involving Desogestrel. Select one for details. This list is informational and not a complete interaction checker.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
[1]MHRA (UK) · PL345180015 · revised March 6, 2026
[2]Health Canada (DPD) · 02042479 · revised September 15, 2025
[3]FDA DailyMed · 0e65209d-329a-4d… · revised January 11, 2024 [PDF]
[4]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.
Posology To achieve contraceptive effectiveness, Desogestrel 75 microgram film-coated tablets must be used as directed (see 'How to take Desogestrel 75 microgram film-coated tablets ' and 'How to start Desogestrel 75 microgram film-coated tablets').
Special populations Renal impairment No clinical studies have been performed in patients with renal impairment. Hepatic impairment No clinical studies have been performed in patients with hepatic insufficiency. 3). Paediatric population The safety and efficacy of Desogestrel 75 microgram film-coated tablets in adolescents below 18 years has not been established.
No data are available. Method of administration Oral use. How to take Desogestrel 75 microgram film-coated tablets Tablets must be taken every day at about the same time so that the interval between two tablets always is 24 hours. The first tablet should be taken on the first day of menstrual bleeding.
Thereafter one tablet each day is to be taken continuously, without taking any notice on possible bleeding. A new blister is started directly the day after the previous one. How to start Desogestrel 75 microgram film-coated tablets No preceding hormonal contraceptive use [in the past month] Tablet-taking has to start on day 1 of the woman’s natural cycle (day 1 is the first day of her menstrual bleeding).
Starting on days 2-5 is allowed, but during the first cycle a barrier method is recommended for the first 7 days of tablet-taking.
Following first-trimester abortion:
After first-trimester abortion it is recommended to start immediately. In that case there is no need to use an additional method of contraception.
Following delivery or second-trimester abortion:
The woman should be advised to start any day between day 21 to 28 after delivery or second-trimester abortion. When starting later, she should be advised to additionally use a barrier method until completion of the first 7 days of tablet-taking.
However, if intercourse has already occurred, pregnancy should be excluded before the actual start of Desogestrel 75 microgram film- coated tablets use or the woman has to wait for her first menstrual period. 6. How to start Desogestrel 75 microgram film-coated tablets when changing from other contraceptive methods Changing from a combined hormonal contraceptive (combined ooral contraceptive (COC), vaginal ring or transdermal patch) The woman should start Desogestrel 75 microgram film-coated tablets preferably on the day after the last active tablet (the last tablet containing the active substances) of her previous COC or on the day of removal of her vaginal ring or transdermal patch.
In these cases, the use of an additional contraceptive is not necessary. Not all contraceptive methods may be available in all EU countries. The woman may also start at the latest on the day following the usual tablet- free, patch-free, ring-free, or placebo tablet interval of her previous combined hormonal contraceptive, but during the first 7 days of tablet-taking an additional barrier method is recommended.
Changing from a progestogen-only method (minipill, injection, implant) or from a progestogen-releasing intrauterine system (IUS) The woman may switch any day from the minipill (from an implant or the IUS on the day of its removal, from an injectable when the next injection would be due.
Management of missed tablets Contraceptive protection may be reduced if more than 36 hours have elapsed between two tablets. If the user is less than 12 hours late in taking any tablet, the missed tablet should be taken as soon as it is remembered and the next tablet should be taken at the usual time.
If she is more than 12 hours late, she should use an additional method of contraception for the next 7 days. If tablets were missed in the first week after initiation of Desogestrel 75 microgram film-coated tablets and intercourse took place in the week before the tablets were missed, the possibility of a pregnancy should be considered.
Advice in case of gastrointestinal disturbances In case of severe gastrointestinal disturbance, absorption may not be complete and additional contraceptive measures should be taken. If vomiting occurs within 3-4 hours after tablet taking absorption may not be complete.
2 is applicable. Treatment surveillance Before prescription, a thorough case history should be taken and a thorough gynaecological examination is recommended to exclude pregnancy. Bleeding disturbances, such as oligomenorrhoea and amenorrhoea should be investigated before prescription.
The interval between check-ups depends on the circumstances in each individual case. 4), the control examinations should be timed accordingly. Despite the fact that Desogestrel 75 microgram film-coated tablets is taken regularly, bleeding disturbances may occur.
If the bleeding is very frequent and irregular, another contraceptive method should be considered. If the symptoms persist, an organic cause should be ruled out. Management of amenorrhoea during treatment depends on whether or not the tablets have been taken in accordance with the instructions and may include a pregnancy test.
The treatment should be stopped if a pregnancy occurs. Women should be advised that Desogestrel 75 microgram film-coated tablets does not protect against HIV (AIDS) and other sexually transmitted diseases.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
GBOfficial regulatory label· Adverse reactions· revised March 6, 2026[1]
The most commonly reported undesirable effect in the clinical trials is bleeding irregularity. Some kind of bleeding irregularity has been reported in up to 50% of women using Desogestrel 75 microgram film-coated tablets. Since Desogestrel 75 microgram film-coated tablets causes ovulation inhibition close to 100%, in contrast to other progestogen-only pills, irregular bleeding is more common than with other progestogen-only pills.
In 20 - 30% of the women, bleeding may become more frequent, whereas in another 20% bleeding may become less frequent or totally absent. Vaginal bleeding may also be of longer duration. After a couple of months of treatment, bleedings tend to become less frequent.
Information, counselling and a bleeding diary can improve the woman’s acceptance of the bleeding pattern. 5%) were acne, mood changes, breast pain, nausea and weight increase. The undesirable effects are mentioned in the table below.
0 Breast discharge may occur during use of Desogestrel 75 microgram film- coated tablets. 4). 4). In women using (combined) oral contraceptives a number of (serious) undesirable effects have been reported. g. 4. 5). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
GBOfficial regulatory label· Warnings and precautions· revised March 6, 2026[1]
If any of the conditions/risk factors mentioned below is present the benefits of progestogen use should be weighed against the possible risks for each individual woman and discussed with the woman before she decides to start Desogestrel 75 microgram film-coated tablets.
In the event of aggravation, exacerbation, or first appearance of any of these conditions, the woman should contact her physician. The physician should then decide on whether the use of Desogestrel 75 microgram film-coated tablets should be discontinued.
The risk for breast cancer increases in general with increasing age. During the use of combined oral contraceptives (COCs) the risk for having breast cancer diagnosed is slightly increased. This increased risk disappears gradually within 10 years after discontinuation of COC use and is not related to the duration of use, but to the age of the woman when using the COC.
The expected number of cases diagnosed per 10,000 women who use combined COCs (up to 10 years after stopping) relative to never users over the same period has been calculated for the respective age groups and is presented in the table below.
7 44 30-34 years 110 100 35-39 years 180 160 40-44 years 260 230 The risk in users of progestogen-only contraceptives (POCs), such as Desogestrel 75 microgram film-coated tablets, is possibly of similar magnitude as that associated with COCs.
However, for POCs the evidence is less conclusive. Compared to the risk of getting breast cancer even in life, the increased risk associated with COCs is low. The cases of breast cancer diagnosed in COC users tend to be less advanced than in those who have not used COCs.
The increased risk in COC users may be due to an earlier diagnosis, biological effects of the pill or a combination of both. Since a biological effect of progestogens on liver cancer cannot be excluded an individual benefit/risk assessment should be made in women with liver cancer.
When acute or chronic disturbances of liver function occur, the woman should be referred to a specialist for examination and advice. Epidemiological investigations have associated the use of COCs with an increased incidence of venous thromboembolism (VTE, deep venous thrombosis and pulmonary embolism).
Although the clinical relevance of this finding for desogestrel used as a contraceptive in the absence of an oestrogenic component is unknown, Desogestrel 75 microgram film-coated tablets should be discontinued in the event of a thrombosis.
Discontinuation of Desogestrel 75 microgram film-coated tablets should also be considered in case of long- term immobilisation due to surgery or illness. Women with a history of thrombo-embolic disorders should be made aware of the possibility of a recurrence.
Although progestogens may have an effect on peripheral insulin resistance and glucose tolerance, there is no evidence for a need to alter the therapeutic regimen in diabetics using progestogen-only pills. However, diabetic patients should be carefully observed during the first months of use.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
GBOfficial regulatory label· Contraindications· revised March 6, 2026[1]
Active venous thromboembolic disorder. Presence or history of severe hepatic disease as long as liver function values have not returned to normal. Known or suspected sex-steroid sensitive malignancies. Undiagnosed vaginal bleeding.
1.
This is not medical advice. Consult a qualified healthcare professional.
1 Dosing Considerations Patients should be instructed to read the package insert prior to starting MARVELON® and any time they are unsure of administration. In the case of MARVELON® 28, patients should be instructed to read the package insert and the Day of the Week Label Strip.
If they have additional questions, they should call their doctor or clinic. MARVELON® tablets may be prescribed as a 21-day or a 28-day regimen. MARVELON® tablets must be taken at approximately the same time every day until the pack is empty.
, the first day of menstrual flow) or on the first Sunday after her period begins. If the patient’s period starts on Sunday, she should start that same day. 2 Recommended Dose and Dosage Adjustment MARVELON® 21 (21-Day Regimen): One white tablet is to be taken for 21 consecutive days (three weeks).
Tablets are then discontinued for one week. The patient must not be off the pill for more than seven consecutive days. A new pack will be started on the eighth day. ) MARVELON® 28 (28-Day Regimen): One white tablet is to be taken for 21 consecutive days (three weeks), followed by a green tablet for seven consecutive days (one week).
A new pack (white tablet) will be started on the eighth day, following the completion of the green tablets. The patient will have a period while they are on the green tablet. On this regimen the patient must not go a day without taking a pill.
4 Administration It is recommended that MARVELON® be taken at the same time each day. The patient should be counselled to associate taking the pill with some regular activity like eating a meal or going to bed. , latex condoms and spermicidal foam or gel) for the first seven days of the first cycle of pill use.
This will provide a back-up in case pills are forgotten while they are getting used to taking them. If spotting, light bleeding, or feeling sick to their stomach occurs during the first three months the women should be counselled to not stop taking the pill.
The problem will usually go away. If it does not subside, the patient should consult her doctor or clinic. , the pill should not be stopped) even if the women does not have sex very often. When receiving any medical treatment, patients should tell their doctor that they are using birth control pills.
Advice in case of vomiting In case of severe gastro-intestinal disturbance, absorption may not be complete and additional contraceptive measures should be taken. If vomiting occurs within 3-4 hours after tablet- taking, the advice concerning the Management of missed tablets is outlined below.
If the woman does not want to change her normal tablet-taking schedule, she has to take the extra tablet(s) needed from another pack.
When to start MARVELON® No hormonal contraceptive use in the preceding cycle:
Tablet taking should start on Day 1 of the woman’s menstrual cycle or on the first Sunday after her period begins. Switching from another combination hormonal contraceptive (combined oral contraceptive (COC), vaginal ring, or transdermal patch): The woman should start MARVELON® preferably on the day after the last active tablet of her previous COC, but at the latest, on the day following the usual tablet-free or inactive tablet of her previous COC.
In case a vaginal ring or transdermal patch has been used, the woman should start using MARVELON® preferably on the day of removal, but at the latest when the next application would have been due. Switching from a progestogen-only-method (mini-pill, injection, implant) or from a progestogen-releasing intrauterine system (IUS): The woman may switch from the mini-pill to MARVELON® on any day of her cycle.
Patients using a progestogen injection should start MARVELON® on the day the next injection is due. Patients using an implant or an IUS should start MARVELON® on the day it is removed. In all cases, the woman should be advised to use an additional barrier method for the first 7 days of MARVELON® use.
Following complete first-trimester abortion:
The woman may start using MARVELON® immediately. When doing so, she need not take additional contraceptive measures.
Following delivery or second-trimester abortion:
Women should be advised to start MARVELON (desogestrel and ethinyl estradiol) Page 7 of 56 Unclassified / Non classifié MARVELON® on Day 21 to 28 after delivery or second trimester abortion, after consulting with their physician. When starting later, the woman should be advised to use an additional barrier method for the first seven days of tablet-taking.
However, if intercourse has already occurred, pregnancy should be excluded before the actual start of use or the woman should be advised to wait for her first menstrual period prior to starting MARVELON®. The increased risk of venous thromboembolism (VTE) during the postpartum period should be considered when restarting MARVELON® (see 7 WARNINGS AND PRECAUTIONS).
For breastfeeding women, see 7 WARNINGS AND PRECAUTIONS – Breastfeeding. 5 Missed Dose The patient should be instructed to use the following chart if she misses one or more of her birth control pills. She should be told to match the number of pills missed with the appropriate starting time for her dosing regimen.
MARVELON (desogestrel and ethinyl estradiol) Page 8 of 56 Unclassified / Non classifié Sunday Start Day One Start Miss One Pill Miss One Pill Take it as soon as you remember, and take the next pill at the usual time. This means that you might take 2 pills in one day.
Take it as soon as you remember, and take the next pill at the usual time. This means that you might take 2 pills in […]
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
CAOfficial regulatory label· Adverse reactions· revised September 15, 2025[2]
, retinal thrombosis) • pulmonary embolism • thrombophlebitis The following other adverse reactions also have been reported in patients receiving combination hormonal contraceptives: nausea and vomiting, usually the most common adverse reaction, occurs in approximately 10% or fewer of patients during the first cycle.
The following other reactions, as a general rule, are seen less frequently or only occasionally: • abdominal pain • amenorrhea during and after treatment • angioedema (exogenous estrogens may induce or exacerbate symptoms of hereditary and acquired angioedema )a • auditory disturbances • breakthrough bleeding • breast changes (tenderness, enlargement, and secretion) • cataracts • changes in appetite • change in corneal curvature (steepening) • changes in glucose tolerance or effect on peripheral insulin resistance MARVELON (desogestrel and ethinyl estradiol) Page 18 of 56 Unclassified / Non classifié • changes in libido • change in menstrual flow • change in weight (increase or decrease) • chloasma or melasma which may persist • cholestatic jaundice • chorea • Crohn’s disease • cystitis-like syndrome • diarrhea • dizziness • dysmenorrhea • edema • endocervical hyperplasia • erythema multiforme • erythema nodosum • gallstone formationa • gastrointestinal symptoms (such as abdominal cramps and bloating) • headache • hemolytic uremic syndrome • hemorrhagic eruption • herpes gestationisa • hirsutism • hypersensitivity • hypertension a • hypertriglyceridemia (increased risk of pancreatitis when using COCs) • impaired renal function • increase in size of uterine leiomyomata • intolerance to contact lenses • jaundice related to cholestasisa • liver function disturbances • loss of scalp hair • mental depression • migraine • nervousness • optic neuritis • otosclerosis-related hearing lossa • pancreatitis • porphyria • possible diminution in lactation when given immediately postpartum • premenstrual-like syndrome • pruritus related to cholestasisa • rash (allergic) • Raynaud's phenomenon • reduced tolerance to carbohydrates • retinal thrombosis • rhinitis • spotting • Sydenham’s choreaa MARVELON (desogestrel and ethinyl estradiol) Page 19 of 56 Unclassified / Non classifié • Systemic lupus erythematosusa • temporary infertility after discontinuation of treatment • ulcerative colitis • urticaria • vaginal candidiasis • vaginal discharge • vaginitis a Occurrence or deterioration of conditions for which association with COC use is not conclusive.
2 Clinical Trial Adverse Reactions Because clinical trials are conducted under very specific conditions, the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. Eighty-six per cent of the 1,195 subjects reported 1 or more adverse experiences. The majority of these (64%) were considered (by the investigators) to be unrelated to MARVELON® usage.
Of the total population, approximately 12% of the subjects discontinued due to an adverse experience. 2) a Percentages are of total patients entered. b Starter/Switcher status could not be determined in one subject. c A total of 145 patients actually had a clinical AE as the primary reason for discontinuation.
With the exception of menses-related adverse experiences, no significant changes in the incidence of adverse experiences over time were seen. No drug-related adverse effects were observed during general physical or pelvic examination.
The breast examination showed a reduction in nodularity. No changes in body mass index or blood pressure were observed. Baseline distribution of abnormalities in cervical cytology was comparable to those at last visit. MARVELON (desogestrel and ethinyl estradiol) Page 20 of 56 Unclassified / Non classifié No patient developed a clinically significant abnormal value for routine laboratory analytes that led to either early discontinuation or hospitalization.
Detailed ophthalmologic examinations, including slit-lamp, were performed in a subset of 28 healthy women at baseline and after 12 cycles. No patients were found to have a decrease in visual acuity. Complete ophthalmological examination failed to identify possible MARVELON®-related changes.
0) […]
CAOfficial regulatory label· Warnings and precautions· revised September 15, 2025[2]
, due to MTHFR C677T, A1298 mutations), prothrombin mutation G20210A, and antiphospholipid-antibodies (anticardiolipin antibodies, lupus MARVELON (desogestrel and ethinyl estradiol) Page 5 of 56 Unclassified / Non classifié anticoagulant) o severe dyslipoproteinemia o smoking and over age 35 o diabetes mellitus with vascular involvement o major surgery associated with an increased risk of postoperative thromboembolism (see 7 WARNINGS AND PRECAUTIONS) o prolonged immobilization (see 7 WARNINGS AND PRECAUTIONS).
3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions Cigarette smoking increases the risk of serious adverse effects on the heart and blood vessels. This risk increases with age and becomes significant in oral contraceptive users older than 35 years of age, and with the number of cigarettes smoked.
For this reason, combination oral contraceptives, including MARVELON®, should not be used by women who are over 35 years of age and smoke (see 7 WARNINGS AND PRECAUTIONS). Patients should be counseled that birth control pills DO NOT PROTECT against sexually transmitted diseases (STDs) including HIV/AIDS.
For protection against STDs, patients should be counseled to use latex condoms IN COMBINATION WITH birth control pills. 1 Dosing Considerations Patients should be instructed to read the package insert prior to starting MARVELON® and any time they are unsure of administration.
In the case of MARVELON® 28, patients should be instructed to read the package insert and the Day of the Week Label Strip. If they have additional questions, they should call their doctor or clinic. MARVELON® tablets may be prescribed as a 21-day or a 28-day regimen.
MARVELON® tablets must be taken at approximately the same time every day until the pack is empty. , the first day of menstrual flow) or on the first Sunday after her period begins. If the patient’s period starts on Sunday, she should start that same day.
2 Recommended Dose and Dosage Adjustment MARVELON® 21 (21-Day Regimen): One white tablet is to be taken for 21 consecutive days (three weeks). Tablets are then discontinued for one week. The patient must not be off the pill for more than seven consecutive days.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
CAOfficial regulatory label· Contraindications· revised September 15, 2025[2]
Combined hormonal contraceptives (CHCs) should not be used in the presence of any of the conditions listed below. Should any of the conditions appear for the first time during CHC use, the product should be stopped immediately. • MARVELON® is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient or component of the container.
For a complete listing, see Dosage Forms, Strengths, Composition and Packaging. , due to MTHFR C677T, A1298 mutations), prothrombin mutation G20210A, and antiphospholipid-antibodies (anticardiolipin antibodies, lupus MARVELON (desogestrel and ethinyl estradiol) Page 5 of 56 Unclassified / Non classifié anticoagulant) o severe dyslipoproteinemia o smoking and over age 35 o diabetes mellitus with vascular involvement o major surgery associated with an increased risk of postoperative thromboembolism (see 7 WARNINGS AND PRECAUTIONS) o prolonged immobilization (see 7 WARNINGS AND PRECAUTIONS).
This is not medical advice. Consult a qualified healthcare professional.
(2) Perfect Use Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason.
(3) (4) Chance The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year.
This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. 85 85 Spermicides Foams, creams, gels, vaginal suppositories, and vaginal film.
26 6 40 Periodic abstinence 25 63 Calendar 9 Ovulation Method 3 Sympto-Thermal Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. 2 Post-Ovulation 1 Withdrawal 19 4 Cap With spermicidal cream or jelly.
Parous Women 40 26 42 Nulliparous Women 20 9 56 Sponge Parous Women 40 20 42 Nulliparous Women 20 9 56 Diaphragm 20 6 56 Condom Without spermicides. , 1998, Ref#1.
How to take
USOfficial regulatory label· revised January 11, 2024[3]
DOSAGE AND ADMINISTRATION
To achieve maximum contraceptive effectiveness, Volnea™ (desogestrel and ethinyl estradiol and ethinyl estradiol) tablets must be taken exactly as directed and at intervals not exceeding 24 hours Volnea ™ may be initiated using either a Sunday start or a Day 1 start.
NOTE:
Each blister card is preprinted with the days of the week, starting with Sunday, to facilitate a Sunday start regimen. Six different “day label strips” are provided with each blister card in order to accommodate a Day 1 start regimen.
In this case, the patient should place the self-adhesive “day label strip” that corresponds to her starting day over the preprinted days.
IMPORTANT:
The possibility of ovulation and conception prior to initiation of use of Volnea ™ should be considered. The use of Volnea™ for contraception may be initiated 4 weeks postpartum in women who elect not to breast-feed. When the tablets are administered during the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered (see CONTRAINDICATIONS and WARNINGS concerning thromboembolic disease.
See also PRECAUTIONS for Nursing Mothers ). If the patient starts on Volnea™ postpartum, and has not yet had a period, she should be instructed to use another method of contraception until a white tablet has been taken daily for 7 days.
SUNDAY START When initiating a Sunday start regimen, another method of contraception should be used until after the first 7 consecutive days of administration.
Using a Sunday start, tablets are taken daily without interruption as follows:
The first white tablet should be taken on the first Sunday after menstruation begins (if menstruation begins on Sunday, the first white tablet is taken on that day). One white tablet is taken daily for 21 days, followed by 1 green (inert) tablet daily for 2 days and 1 yellow (active) tablet daily for 5 days.
For all subsequent cycles, the patient then begins a new 28-tablet regimen on the next day (Sunday) after taking the last yellow tablet. ] If a patient misses 1 white tablet, she should take the missed tablet as soon as she remembers.
If the patient misses 2 consecutive white tablets in Week 1 or Week 2, the patient should take 2 tablets the day she remembers and 2 tablets the next day; thereafter, the patient should resume taking 1 tablet daily until she finishes the cycle pack.
The patient should be instructed to use a back-up method of birth control if she has intercourse in the 7 days after missing pills. If the patient misses 2 consecutive white tablets in the third week or misses 3 or more white tablets in a row at any time during the cycle, the patient should keep taking 1 white tablet daily until the next Sunday.
On Sunday the patient should throw out the rest of that cycle pack and start a new cycle pack that same day. The patient should be instructed to use a back-up method of birth control if she has intercourse in the 7 days after missing pills.
DAY 1 START Counting the first day of menstruation as “Day 1”, tablets are taken without interruption as follows: One white tablet daily for 21 days, one green (inert) tablet daily for 2 days followed by 1 yellow (ethinyl estradiol) tablet daily for 5 days.
For all subsequent cycles, the patient then begins a new 28-tablet regimen on the next day after taking the last yellow tablet. ] If a patient misses 1 white tablet, she should take the missed tablet as soon as she remembers. If the patient misses 2 consecutive white tablets in Week 1 or Week 2, the patient should take 2 tablets the day she remembers and 2 tablets the next day; thereafter, the patient should resume taking 1 tablet daily until she finishes the cycle pack.
The patient should be instructed to use a back-up method of birth control if she has intercourse in the 7 days after missing pills. If the patient misses 2 consecutive white tablets in the third week or if the patient misses 3 or more white tablets in a row at any time during the cycle, the patient should throw out the rest of that cycle pack and start a new cycle pack that same day.
The patient should be instructed to use a back-up method of birth control if she has intercourse in the 7 days after missing pills. ALL ORAL CONTRACEPTIVES Breakthrough bleeding, spotting, and amenorrhea are frequent reasons for patients discontinuing oral contraceptives.
In breakthrough bleeding, as in all cases of irregular bleeding from the vagina, non-functional causes should be borne in mind. In undiagnosed persistent or recurrent abnormal bleeding from the vagina, adequate diagnostic measures are indicated to rule out pregnancy or malignancy.
If both pregnancy and pathology have been excluded, time or a change to another preparation may solve the problem. Changing to an oral contraceptive with a higher estrogen content, while potentially useful in minimizing menstrual irregularity, should be done only if necessary since this may increase the risk of thromboembolic disease.
Use of oral contraceptives in the event of a missed menstrual period: 1. If the patient has not adhered to the prescribed schedule, the possibility of pregnancy should be considered at the time of the first missed period and oral contraceptive use should be discontinued until pregnancy is ruled out.
2. If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out before continuing oral contraceptive use.
This is not medical advice. Consult a qualified healthcare professional.
Most-reported reactions to the US regulator (12 mo to June 4, 2026): 203 reports total. [4]
Off Label Use 75
Condition Aggravated 60
C-Reactive Protein Abnormal 57
Drug Ineffective 55
Maternal Exposure During Pregnancy 50
Dyspnoea 49
Systemic Lupus Erythematosus 49
Infusion Related Reaction 46
Lower Respiratory Tract Infection 46
Pemphigus 43
Rheumatoid Arthritis 43
Discomfort 42
Side effects & warnings
USOfficial regulatory label· Adverse reactions· revised January 11, 2024[3]
ADVERSE REACTIONS
12 (Figure 1). Three studies compared breast cancer risk between current or recent COC users (<6 months since last use) and never users of COCs (Figure 1). One of these studies reported no association between breast cancer risk and COC use.
33 with current or recent use. 4 with more than 8- 10 years of COC use.
Figure 1:
Risk of Breast Cancer with Combined Oral Contraceptive Use RR = relative risk; OR = odds ratio; HR = hazard ratio. “ever COC” are females with current or past COC use; “never COC use” are females that never used COCs. For your reference, below are the studies reviewed by FDA to inform the breast cancer risk: References: 1.
Marchbanks PA, McDonald JA, Wilson HG, et al. Oral contraceptives and the risk of breast cancer. N Engl J Med . 2002;346(26):2025-2032. 2. Dumeaux V, Fournier A, Lund E, Clavel-Chapelon F. Previous oral contraceptive use and breast cancer risk according to hormone replacement therapy use among postmenopausal women.
Cancer Causes Control . 2005;16(5):537-544. 3. Dorjgochoo T, Shu XO, Li HL, et al. Use of oral contraceptives, intrauterine devices and tubal sterilization and cancer risk in a large prospective study, An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives (see WARNINGS section): • 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 from 1996 to 2006.
Int J Cancer . 2009;124(10):2442- 2449. 4. Hunter DJ, Colditz GA, Hankinson SE, et al. Oral contraceptive use and breast cancer: a prospective study of young women. Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology .
2010;19(10):2496- 2502. 5. Vessey M, Yeates D. Oral contraceptive use and cancer. Final report from the Oxford-Family Planning Association contraceptive study. Contraception. 2013; 88(6): 678-683. 6. Morch LS, Skovlund CW, Hannaford PC, Iversen L, Fielding S, Lidegaard O.
Contemporary Hormonal Contraception and the Risk of Breast Cancer. N Engl J Med . 2017;377(23):2228-2239. An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives (see WARNINGS section): • 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 • Rash (allergic) • 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 the 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
USOfficial regulatory label· Warnings and precautions· revised January 11, 2024[3]
WARNINGS
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 should be strongly advised not to smoke. The use of oral contraceptives is associated with increased risks of several serious conditions including myocardial infarction, thromboembolism, stroke, hepatic neoplasia, and gallbladder disease, although the risk of serious morbidity or mortality is very small in healthy women without underlying risk factors.
The risk of morbidity and mortality increases significantly in the presence of other underlying risk factors such as hypertension, hyperlipidemias, obesity, and diabetes. Practitioners prescribing oral contraceptives should be familiar with the following information relating to these risks.
The information contained in this package insert is principally based on studies carried out in patients who used oral contraceptives with formulations of higher doses of estrogens and progestogens than those in common use today. The effect of long-term use of the oral contraceptives with formulations of lower doses of both estrogens and progestogens remains to be determined.
Throughout this labeling, epidemiologic studies reported are of two types: retrospective or case control studies and prospective or cohort studies. Case control studies provide a measure of the relative risk of a disease, namely, a ratio of the incidence of a disease among oral contraceptive users to that among non-users.
The relative risk does not provide information on the actual clinical occurrence of a disease. Cohort studies provide a measure of attributable risk, which is the difference in the incidence of disease between oral contraceptive users and non-users.
The attributable risk does provide information about the actual occurrence of a disease in the population (Adapted from refs. 2 and 3 with the author’s permission). For further information, the reader is referred to a text on epidemiologic methods.
1. Thromboembolic disorders and other vascular problems a. Thromboembolism An increased risk of thromboembolic and thrombotic disease associated with the use of oral contraceptives is well established. 5 to 6 for women with predisposing conditions for venous thromboembolic disease (2, 3, 19 to 24).
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
USOfficial regulatory label· Contraindications· revised January 11, 2024[3]
CONTRAINDICATIONS
Volnea is contraindicated in females who are known to have or develop the following conditions: • Thrombophlebitis or thromboembolic disorders • A past history of deep vein thrombophlebitis or thromboembolic disorders • Cerebral vascular or coronary artery disease • Current diagnosis of, or history of, breast cancer, which may be hormone sensitive • Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia • Undiagnosed abnormal genital bleeding • Cholestatic jaundice of pregnancy or jaundice with prior pill use • Hepatic adenomas or carcinomas • Known or suspected pregnancy • Are receiving Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations (see Warnings, RISK OF LIVER ENZYME ELEVATIONS WITH CONCOMITANT HEPATITIS C TREATMENT).
This is not medical advice. Consult a qualified healthcare professional.
If sustained hypertension develops during the use of Desogestrel 75 microgram film-coated tablets, or if a significant increase in blood pressure does not adequately respond to antihypertensive therapy, the discontinuation of Desogestrel 75 microgram film-coated tablets should be considered.
Treatment with Desogestrel 75 microgram film-coated tablets leads to decreased estradiol serum levels, to a level corresponding with the early follicular phase. It is as yet unknown whether the decrease has any clinically relevant effect on bone mineral density.
The protection with traditional progestogen-only pills against ectopic pregnancies is not as good as with combined oral contraceptives, which has been associated with the frequent occurrence of ovulations during the use of progestogen only pills.
Despite the fact that Desogestrel 75 microgram film- coated tablets consistently inhibits ovulation, ectopic pregnancy should be taken into account in the differential diagnosis if the woman gets amenorrhoea or abdominal pain. Chloasma may occasionally occur, especially in women with a history of chloasma gravidarum.
Women with a tendency to chloasma should avoid exposure to the sun or ultraviolet radiation whilst taking Desogestrel 75 microgram film-coated tablets. The following conditions have been reported both during pregnancy and during sex steroid use, but an association with the use of progestogens has not been established: jaundice and/or pruritus related to cholestasis; gallstone formation; porphyria; systemic lupus erythematosus; haemolytic uraemic syndrome; Sydenham's chorea; herpes gestations; otosclerosis-related hearing loss; (hereditary) angioedema.
8). Depression can be serious and is a well-known risk factor for suicidal behaviour and suicide. Women should be advised to contact their physician in case of mood changes and depressive symptoms, including shortly after initiating the treatment.
5). Desogestrel 75 mcg film-coated tablets contains lactose and therefore should not be administered to patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption.
g. corticosteroid […]
A new pack will be started on the eighth day. ) MARVELON® 28 (28-Day Regimen): One white tablet is to be taken for 21 consecutive days (three weeks), followed by a green tablet for seven consecutive days (one week). A new pack (white tablet) will be started on the eighth day, following the completion of the green tablets.
The patient will have a period while they are on the green tablet. On this regimen the patient must not go a day without taking a pill. 4 Administration It is recommended that MARVELON® be taken at the same time each day. The patient should be counselled to associate taking the pill with some regular activity like eating a meal or going to bed.
, latex condoms and spermicidal foam or gel) for the first seven days of the first cycle of pill use. This will provide a back-up in case pills are forgotten while they are getting used to taking them. If spotting, light bleeding, or feeling sick to their stomach occurs during the first three months the women should be counselled to not stop taking the pill.
The problem will usually go away. If it does not subside, the patient should consult her doctor or clinic. , the pill should not be stopped) even if the women does not have sex very often. When receiving any medical treatment, patients should tell their doctor that they are using birth control pills.
Advice in case of vomiting In case of severe gastro-intestinal disturbance, absorption may not be complete and additional contraceptive measures should be taken. If vomiting occurs within 3-4 hours after tablet- taking, the advice concerning the Management of missed tablets is outlined below.
If the woman does not want to change her normal tablet-taking schedule, she has to take the extra tablet(s) needed from another pack.
When to start MARVELON® No hormonal contraceptive use in the preceding cycle:
Tablet taking should start on Day 1 of the woman’s menstrual cycle or on the first Sunday after her period begins. Switching from another combination hormonal contraceptive (combined oral contraceptive (COC), vaginal ring, or transdermal patch): The woman should start MARVELON® preferably on the day after the last active tablet of her previous COC, but at the latest, on the day following the usual tablet-free or inactive tablet of her previous COC.
In case a vaginal ring or transdermal patch has […]
5 for new cases requiring hospitalization (25). The risk of thromboembolic disease associated with oral contraceptives is not related to length of use and disappears after pill use is stopped (2). Several epidemiologic studies indicate that third generation oral contraceptives, including those containing desogestrel, are associated with a higher risk of venous thromboembolism than certain second generation oral contraceptives (102 to 104).
In general, these studies indicate an approximate two-fold increased risk, which corresponds to an additional 1 to 2 cases of venous thromboembolism per 10,000 women-years of use. However, data from additional studies have not shown this two-fold increase in risk.
A two- to four-fold increase in relative risk of post-operative thromboembolic complications has been reported with the use of oral contraceptives (9, 26). The relative risk of venous thrombosis in women who have predisposing conditions is twice that of women without such medical conditions (9, 26).
If feasible, oral contraceptives should be discontinued at least four weeks prior to and for two weeks after elective surgery of a type associated with an increase in risk of thromboembolism and during and following prolonged immobilization.
Since the immediate postpartum period is also associated with an increased risk of thromboembolism, oral contraceptives should be started no earlier than four weeks after delivery in women who elect not to breast-feed. b. Myocardial infarction An increased risk of myocardial infarction has been attributed to oral contraceptive use.
This risk is primarily in smokers or women with other underlying risk factors for coronary artery disease such as hypertension, hypercholesterolemia, morbid obesity, and diabetes. The relative risk of heart attack for current oral contraceptive users has been estimated to be two to six (4 to 10).
The risk is very low in women under the age of 30. Smoking in combination with oral contraceptive use has been shown to contribute substantially to the incidence of myocardial infarction in women in their mid-thirties or older with smoking accounting for the majority of excess cases (11).
Mortality rates associated with circulatory disease have been shown to increase substantially in smokers, over the age of 35 and non-smokers over the age of 40 ( Table 3) among women who use oral contraceptives. M. Layde and V. Beral, ref.
#12. Oral contraceptives may compound the effects of well-known risk factors, such as hypertension, diabetes, hyperlipidemias, age and obesity (13). In particular, some progestogens are known to decrease HDL cholesterol and cause glucose intolerance, while estrogens may create a state of hyperinsulinism (14 to 18).
Oral contraceptives have been shown to increase blood pressure among users (see section 9 in WARNINGS ). Similar effects on risk factors have been associated with an increased risk of heart disease. Oral contraceptives must be used with caution in women with cardiovascular disease risk factors.
c. Cerebrovascular diseases Oral contraceptives have been shown to increase both the relative and attributable risks of cerebrovascular events (thrombotic and hemorrhagic strokes), although, in general, the risk is greatest among older (>35 years), hypertensive women who also smoke.
Hypertension was found to be a risk factor for both users and non-users, for both types of strokes, while smoking interacted to increase the risk for hemorrhagic strokes (27 to 29). In a large study, the relative risk of thrombotic strokes has been shown to range from 3 for normotensive users to 14 for users with severe hypertension (30).
7 for users with severe hypertension (30). The attributable risk is also greater in older women (3). d. Dose-related risk of vascular disease from oral contraceptives A positive association has been observed between the amount of estrogen and progestogen in oral contraceptives and the risk of vascular disease (31 to 33).
A decline in serum high-density lipoproteins (HDL) has been reported with many progestational agents (14 to 16). A decline in serum high-density lipoproteins has been associated with an increased incidence of ischemic heart disease.
Because estrogens increase HDL cholesterol, the net effect of an oral contraceptive depends on a balance achieved between doses of estrogen and progestogen and the nature and absolute amount of progestogens used in the contraceptives.
The amount of both hormones should be considered in the choice of an oral contraceptive. Minimizing exposure to estrogen and progestogen is in keeping with good principles of therapeutics. For any particular estrogen/progestogen combination, the dosage regimen prescribed should be one which contains the least amount of estrogen and progestogen that is compatible with a low failure rate and the needs of the individual patient.
035 mg or less of estrogen. e. Persistence of risk of vascular disease There are two studies which have shown persistence of risk of vascular disease for ever-users of oral contraceptives. In a study in the United States, the risk of developing myocardial infarction after discontinuing oral contraceptives persists for at least 9 years for women 40 to 49 years old who had used oral contraceptives for five or more years, but this increased risk was not demonstrated in other age groups (8).
In another study in Great Britain, the risk of developing cerebrovascular disease persisted for at least 6 years after discontinuation of oral contraceptives, although excess risk was very small (34). However, both studies were performed with oral contraceptive formulations containing 50 micrograms or more of estrogen.
2. Estimates of mortality from contraceptive use One study gathered data from a variety of sources which have estimated the mortality rate associated with different methods of contraception at different ages (Table 4). These estimates include the combined risk of death associated with contraceptive methods plus the risk attributable to pregnancy in the event of method failure.
Each method of contraception has its specific benefits and risks. The study concluded that with the exception of oral contraceptive users 35 and older who smoke and 40 and older who do not smoke, mortality associated with all methods of birth control is low and below that associated with childbirth.
The observation of a possible increase in risk of mortality with age for oral contraceptive users is based on data gathered in the 1970’s - but not reported until 1983 (35). However, current clinical practice involves the use of lower estrogen formulations combined with careful consideration of risk factors.
Because of these changes in practice and, also, because of some limited new data which suggest that the risk of cardiovascular disease with the use of oral contraceptives may now be less than previously observed (100, 101), the Fertility and Maternal Health Drugs Advisory Committee was asked to review the topic in 1989.
The Committee concluded that although cardiovascular disease risks may be increased with oral contraceptive use after age 40 in healthy non-smoking women (even with the newer low-dose formulations), there are also greater potential health risks associated with pregnancy in older women and with the alternative surgical and medical procedures which may be necessary if such women do not have access to effective and acceptable means of contraception.
Therefore, the Committee recommended that the benefits of low-dose oral contraceptive use by healthy non-smoking women over 40 may outweigh the possible risks. Of course, older women, as all women who take oral contraceptives, should take the lowest possible dose formulation that is effective.
W. Ory, ref. #35. *Deaths are birth related †Deaths are method related 3. Malignant Neoplasms Breast Cancer Volnea™ is contraindicated in females who currently have or have had breast cancer because breast cancer may be hormonally sensitive [see CONTRAINDICATIONS ].
Epidemiology studies have not found a consistent association between use of combined oral contraceptives (COCs) and breast cancer risk. Studies do not show an association between ever (current or past) use of COCs and risk of breast cancer.
However, some studies report a small increase in the risk of breast cancer among current or recent users (<6 months since last use) and current users with longer duration of COC use [see Postmarketing Experience]. Cervical Cancer Some studies suggest that oral contraceptive use has been associated with an increase in the risk of cervical intra-epithelial neoplasia in some populations of women (45 to 48).
However, there continues to be controversy about the extent to which such findings may be due to differences in sexual behavior and other factors. 4. Hepatic neoplasia Benign hepatic adenomas are associated with oral contraceptive use, although the incidence of benign tumors is rare in the United States.
3 cases/100,000 for users, a risk that increases after four or more years of use especially with oral contraceptives of higher dose (49). Rupture of rare, benign, hepatic adenomas may cause death through intra-abdominal hemorrhage (50, 51).
Studies from Britain have shown an increased risk of developing hepatocellular carcinoma (52 to 54) in long-term (>8 years) oral contraceptive users. S. and the attributable risk (the excess incidence) of liver cancers in oral contraceptive users approaches less than one per million users.
5. RISK OF LIVER ENZYME ELEVATIONS WITH CONCOMITANT HEPATITIS C TREATMENT During clinical trials with the Hepatitis C combination drug regimen that contains ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, ALT elevations greater than 5 times the upper limit of normal (ULN), including some cases greater than 20 times the ULN, were significantly more frequent in women using ethinyl estradiol-containing medications such as COCs.
Discontinue desogestrel and ethinyl estradiol and ethinyl estradiol prior to starting therapy with the combination drug regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir [see CONTRAINDICATIONS (4)]. Desogestrel and ethinyl estradiol and ethinyl estradiol can be restarted approximately 2 weeks following completion of treatment with the combination drug regimen.
6. Ocular lesions There have been clinical case reports of retinal thrombosis associated with the use of oral contraceptives. Oral contraceptives should be discontinued if there is unexplained partial or complete loss of vision; onset of proptosis or diplopia; papilledema; or retinal vascular lesions.
Appropriate diagnostic and therapeutic measures should be undertaken immediately. 7. Oral contraceptive use before or during early pregnancy Extensive epidemiologic studies have revealed no increased risk of birth defects in women who have used oral contraceptives prior to pregnancy (55 to 57).
Studies also do not suggest a teratogenic effect, particularly in so far as cardiac anomalies and limb reduction defects are concerned (55, 56, 58, 59), when oral contraceptives are taken inadvertently during early pregnancy. The administration of oral contraceptives to induce withdrawal bleeding should not be used as a test for pregnancy.
Oral contraceptives should not be used during pregnancy to treat threatened or habitual abortion. It is recommended that for any patient who has missed two consecutive periods, pregnancy should be ruled out before continuing oral contraceptive use.
If the patient has not adhered to the prescribed schedule, the possibility of pregnancy should be considered at the first missed period. Oral contraceptive use should be discontinued until pregnancy is ruled out. 8. Gallbladder disease Earlier studies have reported an increased lifetime relative risk of gallbladder surgery in users of oral contraceptives and estrogens (60, 61).
More recent studies, however, have shown that the relative risk of developing gallbladder disease among oral contraceptive users may be minimal (62 to 64). The recent findings of minimal risk may be related to the use of oral contraceptive formulations containing lower hormonal doses of estrogens and progestogens.
9. Carbohydrate and lipid metabolic effects Oral contraceptives have been shown to cause a decrease in glucose tolerance in a significant percentage of users (17). Oral contraceptives containing greater than 75 micrograms of estrogens cause hyperinsulinism, while lower doses of estrogen cause less glucose intolerance (65).
Progestogens increase insulin secretion and create insulin resistance, this effect varying with different progestational agents (17, 66). However, in the non-diabetic 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. a. ), changes in serum triglycerides and lipoprotein levels have been reported in oral contraceptive users.
10. Elevated blood pressure An increase in blood pressure has been reported in women taking oral contraceptives (68) and this increase is more likely in older oral contraceptive users (69) and with continued use (61). Data from the Royal College of General Practitioners (12) and subsequent randomized trials have shown that the incidence of hypertension increases with increasing quantities of progestogens.
Women with a history of hypertension or hypertension-related diseases, or renal disease (70) should be encouraged to use another method of contraception. If women elect to use oral contraceptives, they should be monitored closely and if significant elevation of blood pressure occurs, oral contraceptives should be discontinued.
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 between ever- and never-users (68, 70, 71). 11. 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.
12. Bleeding irregularities Breakthrough bleeding and spotting are sometimes encountered in patients on oral contraceptives, especially during the first three months of use. Non-hormonal 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.
13. Ectopic pregnancy Ectopic as well as intrauterine pregnancy may occur in contraceptive failures.