Drospirenone 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 June 20, 2025[1]
4).
How to take
GBOfficial regulatory label· revised June 20, 2025
CACanada· Health Canada
16 products
Uses
CAOfficial regulatory label· revised March 22, 2025[2]
SLYND is indicated for conception control in adolescent and adult women. SLYND tablets contain progestin only and do not contain an estrogen agent. Progestin-only pills may be called POPs or the "mini-pill". 1 Pediatrics Pediatrics (12-17 years of age): Safety and efficacy of SLYND have been established in adolescents.
Use of this product before menarche is not indicated. 2 Geriatrics Geriatrics (≥ 65 years of age): SLYND is not indicated for use in postmenopausal women.
How to take
USUnited States· FDA
5 products
Uses
USOfficial regulatory label· revised May 29, 2025[3]
1 INDICATIONS AND USAGE Yaz is a combination of drospirenone, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to: • Prevent pregnancy. 1 ) • Treat symptoms of premenstrual dysphoric disorder (PMDD) for females of reproductive potential who choose to use an oral contraceptive for contraception.
2 ) • Treat moderate acne for women at least 14 years old only if the patient desires an oral contraceptive for birth control. 1 Oral Contraceptive Yaz ® is indicated for use by females of reproductive potential to prevent pregnancy.
2 Premenstrual Dysphoric Disorder (PMDD) Yaz is also indicated for the treatment of symptoms of premenstrual dysphoric disorder (PMDD) in females of reproductive potential who choose to use an oral contraceptive as their method of contraception.
The effectiveness of Yaz for PMDD when used for more than three menstrual cycles has not been evaluated. The essential features of PMDD according to the Diagnostic and Statistical Manual-4th edition (DSM-IV) include markedly depressed mood, anxiety or tension, affective lability, and persistent anger or irritability.
Drug interactions
Known interactions involving Drospirenone. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 242. Type above to find a specific drug.
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) · PL498760004 · revised June 20, 2025
[2]Health Canada (DPD) · 02522802 · revised March 22, 2025
[3]FDA DailyMed · 065f33e4-b587-4e… · revised May 29, 2025 [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 How to take Dretine Film-coated Tablets The tablets must be taken every day at about the same time, if necessary with a little liquid, in the order shown on the blister pack. One tablet is to be taken daily for 21 consecutive days.
Each subsequent pack is started after a 7-day tablet-free interval, during which time a withdrawal bleed usually occurs. This usually starts on day 2-3 after the last tablet and may not have finished before the next pack is started.
e. the first day of her menstrual bleeding). • Changing from a combined hormonal contraceptive (combined oral contraceptive (COC), vaginal ring, or transdermal patch) The woman should start with Dretine preferably on the day after the last active tablet (the last tablet containing the active substances) of her previous COC, but at the latest on the day following the usual tablet-free or placebo tablet interval of her previous COC.
In case a vaginal ring or transdermal patch has been used, the woman should start using Dretine preferably on the day of removal, but at the latest when the next application would have been due. • Changing from a progestogen-only-method (progestogen-only pill, injection, implant) or from a progestogen-releasing intrauterine system (IUS) The woman may switch any day from the progestogen-only pill (from an implant or the IUS on the day of its removal, from an injectable when the next injection would be due) but should in all of these cases be advised to additionally use a barrier method for the first 7 days of tablet-taking.
• Following first-trimester abortion The woman may start immediately. When doing so, she need not take additional contraceptive measures. • Following delivery or second-trimester abortion Women should be advised to start at day 21 to 28 after delivery or second- trimester abortion.
When starting later, the woman should be advised to additionally use a barrier method for the first 7 days. However, if intercourse has already occurred, pregnancy should be excluded before the actual start of COC use or the woman has to wait for her first menstrual period.
6. Management of missed tablets If the user is less than 12 hours late in taking any tablet, contraceptive protection is not reduced. The woman should take the tablet as soon as she remembers and should take further tablets at the usual time.
If she is more than 12 hours late in taking any tablet, contraceptive protection may be reduced. The management of missed tablets can be guided by the following two basic rules: 1. tablet-taking must never be discontinued for longer than 7 days 2.
7 days of uninterrupted tablet-taking are required to attain adequate suppression of the hypothalamic-pituitary-ovarian-axis. Accordingly the following advice can be given in daily practice: • Week 1 The user should take the last missed tablet as soon as she remembers, even if this means taking two tablets at the same time.
She then continues to take tablets at her usual time. In addition, a barrier method such as a condom should be used for the next 7 days. If intercourse took place in the preceding 7 days, the possibility of a pregnancy should be considered.
The more tablets are missed and the closer they are to the regular tablet-free interval, the higher the risk of a pregnancy. • Week 2 The user should take the last missed tablet as soon as she remembers, even if this means taking two tablets at the same time.
She then continues to take tablets at her usual time. Provided that the woman has taken her tablets correctly in the 7 days preceding the first missed tablet, there is no need to use extra contraceptive precautions. However, if she has missed more than 1 tablet, the woman should be advised to use extra precautions for 7 days.
• Week 3 The risk of reduced reliability is imminent because of the forthcoming 7-day tablet-free interval. However, by adjusting the tablet-intake schedule, reduced contraceptive protection can still be prevented. By adhering to either of the following two options, there is therefore no need to use extra contraceptive precautions, provided that in the 7 days preceding the first missed tablet the woman has taken all tablets correctly.
If this is not the case, she should follow the first of these two options and use extra precautions for the next 7 days as well. 1. The user should take the last missed tablet as soon as she remembers, even if this means taking two tablets at the same time.
She then continues to take tablets at her usual time. , no gap should be left between packs. The user is unlikely to have a withdrawal bleed until the end of the second pack, but she may experience spotting or breakthrough bleeding on tablet-taking days.
2. The woman may also be advised to discontinue tablet-taking from the current blister pack. She should then have a tablet-free interval of up to 7 days, including the days she missed tablets, and subsequently continue with the next blister pack.
If the woman missed tablets and subsequently has no withdrawal bleed in the first normal tablet–free interval, the possibility of a pregnancy should be considered. , vomiting or diarrhoea), absorption may not be complete and additional contraceptive measures should be taken.
If vomiting occurs within 3-4 hours after tablet-taking, a new (replacement) tablet should be taken as soon as possible. The new tablet should be taken within 12 hours of the usual time of tablet-taking if possible. 2 “Management of missed tablets” is applicable.
If the woman does not […]
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
GBOfficial regulatory label· Adverse reactions· revised June 20, 2025[1]
4. 4 Special warnings and precautions for use: • Venous thromboembolic disorders; • Arterial thromboembolic disorders; • Hypertension; • Liver tumours; • Occurrence or deterioration of conditions for which association with COC use is not conclusive: Crohn’s disease, ulcerative colitis, epilepsy, migraine, uterine myoma, porphyria, systemic lupus erythematosus, herpes gestationis, Sydenham's chorea, haemolytic uremic syndrome, cholestatic jaundice; • Chloasma; • Acute or chronic disturbances of liver function may necessitate the discontinuation of COC use until markers of liver function return to normal.
The frequency of diagnosis of breast cancer is very slightly increased among COC users. As breast cancer is rare in women under 40 years of age the excess number is small in relation to the overall risk of breast cancer. Causation with COC use is unknown.
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.
By reporting side effects you can help provide more information on the safety of this medicine.
GBOfficial regulatory label· Warnings and precautions· revised June 20, 2025[1]
Warnings • If any of the conditions or risk factors mentioned below is present, the suitability of Dretine should be discussed with the woman. • In the event of aggravation, or first appearance of any of these conditions or risk factors, the woman should be advised to contact her doctor to determine whether the use of Dretine should be discontinued.
• In case of suspected or confirmed VTE or ATE, CHC use should be discontinued. In case anti-coagulant therapy is started, adequate alternative contraception should be initiated because of the teratogenicity of anticoagulant therapy (coumarins).
• Circulatory Disorders Risk of venous thromboembolism (VTE) The use of any combined hormonal contraceptive (CHC) increases the risk of venous thromboembolism (VTE) compared with no use. Products that contain levonorgestrel, norgestimate or norethisterone are associated with the lowest risk of VTE.
Other products such as Dretine may have up to twice this level of risk. The decision to use any product other than one with the lowest VTE risk should be taken only after a discussion with the woman to ensure she understands the risk of VTE with Dretine, how her current risk factors influence this risk, and that her VTE risk is highest in the first ever year of use.
There is also some evidence that the risk is increased when a CHC is re-started after a break in use of 4 weeks or more. In women who do not use a CHC and are not pregnant about 2 out of 10,000 will develop a VTE over the period of one year.
However, in any individual woman the risk may be far higher, depending on her underlying risk factors (see below). It is estimated1 that out of 10,000 women who use a CHC containing drospirenone, between 9 and 12 women will develop a VTE in one year; this compares with about 62 in women who use a levonorgestrel- containing CHC.
In both cases, the number of VTEs per year is fewer than the number expected during pregnancy or in the postpartum period. VTE may be fatal in 1-2% of cases. g. hepatic, mesenteric, renal or retinal veins and arteries. Risk factors for VTE The risk for venous thromboembolic complications in CHC users may increase substantially in a woman with additional risk factors, particularly if there are multiple risk factors (see table).
3). If a woman has more than one risk factor, it is possible that the increase in risk is greater than the sum of the individual factors – in this case her total risk of VTE should be considered. 3). 1 These incidences were estimated from the totality of the epidemiological study data, using relative risks for the different products compared with levonorgestrel-containing CHCs.
6 Table: Risk factors for VTE Risk factor Comment Obesity (body mass index over 30 kg/m²) Risk increases substantially as BMI rises. Particularly important to consider if other risk factors also present. Prolonged immobilisation, major surgery, any surgery to the legs or pelvis, neurosurgery, or major trauma In these situations it is advisable to discontinue use of the patch/pill/ring (in the case of elective surgery at least four weeks in advance) and not resume until two weeks after complete remobilisation.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
GBOfficial regulatory label· Contraindications· revised June 20, 2025[1]
Combined hormonal contraceptives (CHCs) should not be used in the following conditions. Should any of the conditions appear for the first time during CHC use, the product should be stopped immediately. g. g. g. g. transient ischaemic attack, TIA) o Known hereditary or acquired predisposition for arterial thromboembolism, such as hyperhomocysteinaemia and antiphospholipid-antibodies (anticardiolipin-antibodies, lupus anticoagulant).
o History of migraine with focal neurological symptoms. g. 1
This is not medical advice. Consult a qualified healthcare professional.
CAOfficial regulatory label· revised March 22, 2025[2]
1 Dosing Considerations There is a potential for an increase in serum potassium concentration in women taking SLYND with other drugs that may increase serum potassium concentration (for example, ACE inhibitors, angiotensin-II receptor antagonists, potassium-sparing diuretics, potassium supplementation, heparin, aldosterone antagonists, and NSAIDS (see Warnings and Precautions-Hyperkalemia).
2 Recommended Dose and Dosage Adjustment One SLYND (white active or green inert tablets) is swallowed whole once daily. SLYND should be started using a Day 1 Start (Table 1). Take one tablet daily for 28 consecutive days: one white active tablet daily the first 24 days and one green inert tablet daily during the 4 following days.
Tablets should be taken every day at about the same time of the day so that the interval between two tablets is 24 hours. It is very important to take SLYND as directed; however, some patients may miss a pill from time to time. 2 Pharmacodynamics).
SLYND® (drospirenone tablets) Product Monograph Page 5 of 40 SLYND is not intended for use in prepubertal or in postmenopausal women. 4 Administration Table 1: Instructions for Starting SLYND or Switching from Another Contraceptive Method to SLYND Starting SLYND Start SLYND in women who are not currently using hormonal contraception (Day 1 Start) Important: Consider the possibility of ovulation and conception prior to initiation of this product.
Tablet color: • SLYND active tablets are white (Day 1 to Day 24). • SLYND inert tablets are green (Day 25 to Day 28). Day 1 Start: • Take first white active tablet on the first day of menses. • Take subsequent white active tablets once daily at the same time each day for a total of 24 days.
• Take one green inert tablet daily for 4 days and at the same time of day that active tablets were taken. • Begin each subsequent pack after taking the last inactive tablet. Switching from another contraceptive method to SLYND Start SLYND: • A combined oral contraceptive (COC) • On the day when the new pack of the previous COC would have started.
• Transdermal patch • On the day when next application would have been scheduled. • Vaginal ring • On the day when next insertion would have been scheduled. • Injection • On the day when next injection would have been scheduled. 5 Missed Dose Table 2: Instructions for Missed SLYND • If one white active tablet is missed Take the missed tablet as soon as possible.
Continue taking one tablet a day until the pack is finished. 2 Pharmacodynamics) • If two or more white active tablets are missed Take the last missed tablet as soon as possible. Continue one tablet a day until the pack is finished (one or more missed tablet(s) will remain in the blister pack).
Additional non-hormonal contraception (such as condoms or spermicide) should be used as back-up if the patient has sex within 7 days after missing tablets. • It one or more green inert tablets are missed Skip the missed pill days and continue taking one tablet a day until the pack is finished.
If vomiting or diarrhea occurs within 3-4 hours after tablet taking, another tablet (scheduled for the next day) should be taken as soon as possible. The new tablet should be taken within 12 hours of the usual time of tablet-taking if possible.
If vomiting or diarrhea last more than one day, the advice concerning missed tablets, including using backup non-hormonal contraception, given above is applicable.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
CAOfficial regulatory label· Adverse reactions· revised March 22, 2025[2]
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. The safety of SLYND (n= 2598) has been assessed in adult women in three Phase 3 clinical trials (CF111/301, CF111/302 and CF111/303; see Clinical Trials) as well as in one phase II clinical trial (CF111/205).
The overall mean time of SLYND exposure is 236 days, ranging from 197 to 328 days. All adverse reactions from clinical trials reported in Table 4 and Table 5 are listed by system organ class (SOC) and presented by preferred term. 2%).
No major differences between both BMI subgroups or as compared to the total population were observed regarding treatment-emergent adverse events. 1 Clinical Trial Adverse Reactions – Pediatrics The following lists the adverse reactions reported in at least 2% of subjects that occurred in adolescents aged 12-17 years (CF111/304).
9%). 7% of subjects). Across all Phase 3 studies in adults, the only laboratory abnormalities reported as serious adverse events were blood potassium increased (one subject) and hyperkalemia (six subjects). 1% of subjects overall); the only preferred terms leading to discontinuation of more than one subject across the Phase 3 studies in adults were gamma- glutamyltransferase increased (three subjects) and hyperkalemia (two subjects).
In the Phase 3 study in adolescents (CF111/304), abnormal laboratory values were reported as adverse events in the SOCs of blood and lymphatic system […]
CAOfficial regulatory label· Warnings and precautions· revised March 22, 2025[2]
Carcinogenesis and Mutagenesis Breast Cancer:
A meta-analysis from 54 epidemiological studies reported a slight increased relative risk of having breast cancer in women using combined oral contraceptives (COCs), without evidence for causation. The risk of having breast cancer diagnosed in users of progestogen-only preparations is possibly of similar magnitude to that associated with COCs.
However, for progestogen-only preparations, the evidence is based on much smaller populations of users and so is less conclusive than that for COCs. Increasing age and a strong family history are the most significant risk factors for the development of breast cancer.
Other established risk factors include obesity, nulliparity, and late age for first full-term pregnancy. Women receiving oral contraceptives (OCs) should be instructed in self-examination of their breasts. They should notify their physicians whenever any masses are detected.
A yearly clinical breast examination is also recommended.
Cervical Cancer:
Some studies suggest that use of combination hormonal contraceptives containing progestin and estradiol has been associated with an increase in the risk of cervical cancer or Route of Administration Dosage Form/ Strength/Composition Non-medicinal Ingredients Oral Tablet 4 mg drospirenone Anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol partially hydrolyzed, talc and titanium dioxide.
Oral Tablet Inert Colloidal silicon dioxide, corn starch, FD&C blue 2 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, polysorbate, povidone, titanium dioxide, triacetin, and yellow ferric oxide SLYND® (drospirenone tablets) Product Monograph Page 8 of 40 intraepithelial neoplasia.
However, there continues to be controversy about the extent to which such findings may be due to differences in sexual behavior and other factors.
Cardiovascular Thromboembolic Disorder:
In the three Phase III studies for SLYND (CF111/301, CF111/302 and CF111/303) which included 2575 women for 9 to 13 cycles, no thromboembolic events were reported. Epidemiological studies have not indicated an association between progestin-only preparations and an increased risk of myocardial infarction, cerebral thromboembolism, or venous thromboembolism.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
CAOfficial regulatory label· Contraindications· revised March 22, 2025[2]
SLYND is contraindicated in women 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.
SLYND is contraindicated in women with the following conditions: • Renal impairment • Adrenal insufficiency • Presence or history of cervical cancer or progestin sensitive cancers • Liver tumors, benign or malignant, or hepatic impairment • Undiagnosed abnormal uterine bleeding.
This is not medical advice. Consult a qualified healthcare professional.
Other features include decreased interest in usual activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of control. Physical symptoms associated with PMDD include breast tenderness, headache, joint and muscle pain, bloating and weight gain.
In this disorder, these symptoms occur regularly during the luteal phase and remit within a few days following onset of menses; the disturbance markedly interferes with work or school, or with usual social activities and relationships with others.
Diagnosis is made by healthcare providers according to DSM-IV criteria, with symptomatology assessed prospectively over at least two menstrual cycles. In making the diagnosis, care should be taken to rule out other cyclical mood disorders.
Yaz has not been evaluated for the treatment of premenstrual syndrome (PMS). 3 Acne Yaz is indicated for the treatment of moderate acne vulgaris in women at least 14 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche.
Yaz should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control.
How to take
USOfficial regulatory label· revised May 29, 2025[3]
2 DOSAGE AND ADMINISTRATION • Take one tablet daily by mouth at the same time every day. 1 ) • Tablets must be taken in the order directed on the blister pack. 1 How to Take Yaz Take one tablet by mouth at the same time every day. The failure rate may increase when pills are missed or taken incorrectly.
To achieve maximum contraceptive and PMDD effectiveness, Yaz must be taken exactly as directed, in the order directed on the blister pack. Single missed pills should be taken as soon as remembered. 2 How to Start Yaz Instruct the patient to begin taking Yaz either on the first day of her menstrual period (Day 1 Start) or on the first Sunday after the onset of her menstrual period (Sunday Start).
Day 1 Start During the first cycle of Yaz use, instruct the patient to take one light pink Yaz daily, beginning on Day 1 of her menstrual cycle. ) She should take one light pink Yaz daily for 24 consecutive days, followed by one white inert tablet daily on Days 25 through 28.
Yaz should be taken in the order directed on the package at the same time each day, preferably after the evening meal or at bedtime with some liquid, as needed. Yaz can be taken without regard to meals. If Yaz is first taken later than the first day of the menstrual cycle, Yaz should not be considered effective as a contraceptive until after the first 7 consecutive days of product administration.
Instruct the patient to use a non-hormonal contraceptive as back-up during the first 7 days. The possibility of ovulation and conception prior to initiation of medication should be considered. Sunday Start During the first cycle of Yaz use, instruct the patient to take one light pink Yaz daily, beginning on the first Sunday after the onset of her menstrual period.
She should take one light pink Yaz daily for 24 consecutive days, followed by one white inert tablet daily on Days 25 through 28. Yaz should be taken in the order directed on the package at the same time each day, preferably after the evening meal or at bedtime with some liquid, as needed.
Yaz can be taken without regard to meals. Yaz should not be considered effective as a contraceptive until after the first 7 consecutive days of product administration. Instruct the patient to use a non-hormonal contraceptive as back-up during the first 7 days.
The possibility of ovulation and conception prior to initiation of medication should be considered. The patient should begin her next and all subsequent 28-day regimens of Yaz on the same day of the week that she began her first regimen, following the same schedule.
She should begin taking her light pink tablets on the next day after ingestion of the last white tablet, regardless of whether or not a menstrual period has occurred or is still in progress. Anytime a subsequent cycle of Yaz is started later than the day following administration of the last white tablet, the patient should use another method of contraception until she has taken a light pink Yaz daily for seven consecutive days.
When switching from a different birth control pill When switching from another birth control pill, Yaz should be started on the same day that a new pack of the previous oral contraceptive would have been started. When switching from a method other than a birth control pill When switching from a transdermal patch or vaginal ring, Yaz should be started when the next application would have been due.
When switching from an injection, Yaz should be started when the next dose would have been due. When switching from an intrauterine contraceptive or an implant, Yaz should be started on the day of removal. Withdrawal bleeding usually occurs within 3 days following the last light pink tablet.
If spotting or breakthrough bleeding occurs while taking Yaz, instruct the patient to continue taking Yaz by the regimen described above. Counsel her that this type of bleeding is usually transient and without significance; however, advise her that if the bleeding is persistent or prolonged, she should consult her healthcare provider.
Although the occurrence of pregnancy is low if Yaz is taken according to directions, if withdrawal bleeding does not occur, consider the possibility of pregnancy. If the patient has not adhered to the prescribed dosing schedule (missed one or more active tablets or started taking them on a day later than she should have), consider the possibility of pregnancy at the time of the first missed period and take appropriate diagnostic measures.
If the patient has adhered to the prescribed regimen and misses two consecutive periods, rule out pregnancy. Discontinue Yaz if pregnancy is confirmed. The risk of pregnancy increases with each active light pink tablet missed. If breakthrough bleeding occurs following missed tablets, it will usually be transient and of no consequence.
If the patient misses one or more white tablets, she should still be protected against pregnancy provided she begins taking a new cycle of light pink tablets on the proper day. For postpartum women who do not breastfeed or after a second trimester abortion, start Yaz no earlier than 4 weeks postpartum due to the increased risk of thromboembolism.
If the patient starts on Yaz postpartum and has not yet had a period, evaluate for possible pregnancy, and instruct her to use an additional method of contraception until she has taken Yaz for 7 consecutive days. 3 Missed Doses Table 1: Instructions for Yaz Missed Doses If one light pink active tablet is missed Take the missed active tablet as soon as possible.
Take the next tablet at the regular time. This means two tablets may be taken in one day. A back-up birth control method is not required if the patient has sex. If two light pink active tablets in a row are missed in Week 1 or Week 2 Take two active tablets as soon as possible and two tablets the next day.
Then take one tablet a day until the pack is finished. Additional nonhormonal contraception (such as condoms and spermicide) should be used as back-up if the patient has sex within 7 days after missing tablets. If two light pink active tablets in a row are missed in Week 3 or Week 4 Day 1 Start: Throw out the rest of the tablet pack and start a new pack that same day.
Sunday Start:
Keep taking one tablet every day until Sunday. On Sunday, throw out the rest of the pack and start a new pack of tablets that same day. Additional nonhormonal contraception (such as condoms and spermicide) should be used as back-up if the patient has sex within 7 days after missing tablets.
The patient may not have their period this month but this is expected. However, if they miss their period two months in a row, they should call their healthcare provider because they might be pregnant. If three or more light pink active tablets in a row are missed during any week Day 1 Start: Throw out the rest of the tablet pack and start a new pack that same day.
Sunday Start:
Keep taking one tablet every day until Sunday. On Sunday, throw out the rest of the pack and start a new pack of tablets that same day. The patient could become pregnant if they have sex in the 7 days after they restart their tablets.
They must use another birth control method (such as condoms and spermicides) as a back-up for those 7 days. They should call their healthcare provider if they miss their period, because they might be pregnant. If any of the four white inactive tablets are missed in Week 4 Throw away the tablets that were missed.
Keep taking one tablet each day until the pack is empty. They do not need a back-up method.
Finally, if they are still not sure what to do about the tablets they have missed:
Use nonhormonal contraception (such as condoms and spermicides) anytime they have sex. Contact their healthcare provider and continue taking one active light pink tablet each day until otherwise directed. 4 Advice in Case of Gastrointestinal Disturbances In case of severe vomiting or diarrhea, absorption may not be complete and additional contraceptive measures should be taken.
If vomiting occurs within 3–4 hours after tablet-taking, this can be regarded as a missed tablet.
This is not medical advice. Consult a qualified healthcare professional.
Most-reported reactions to the US regulator (12 mo to June 4, 2026): 1,522 reports total. [4]
Intermenstrual Bleeding 442
Amenorrhoea 188
Heavy Menstrual Bleeding 152
Product Use In Unapproved Indication 94
Dysmenorrhoea 91
Nausea 84
Product Prescribing Issue 80
Product Dose Omission Issue 73
Headache 62
Dizziness 53
Fatigue 50
Intentional Dose Omission 50
Side effects & warnings
USOfficial regulatory label· Adverse reactions· revised May 29, 2025[3]
2%). 1%). 1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bayer HealthCare Pharmaceuticals Inc. 1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Contraception and Acne Clinical Trials The data provided reflect the experience with the use of Yaz in the adequate and well-controlled studies for contraception (N=1,056) and for moderate acne vulgaris (N=536). For contraception, a Phase 3, multicenter, multinational, open-label study was conducted to evaluate safety and efficacy up to one year in 1,027 women aged 17 – 36 who took at least one dose of Yaz.
A second Phase 3 study was a single center, open-label, active-controlled study to evaluate the effect of 7 28-day cycles of Yaz on carbohydrate metabolism, lipids and hemostasis in 29 women aged 18–35. For acne, two multicenter, double-blind, randomized, placebo-controlled studies, in 536 women aged 14–45 with moderate acne vulgaris who took at least one dose of Yaz, evaluated the safety and efficacy during up to 6 cycles.
The adverse reactions seen across the 2 indications overlapped, and are reported using the frequencies from the pooled dataset. 2%). PMDD Clinical Trials Safety data from trials for the indication of PMDD are reported separately due to differences in study design and setting in the Contraception and Acne studies as compared to the PMDD clinical program.
Two (one parallel and one crossover designed) multicenter, double-blind, randomized, placebo-controlled trials for the secondary indication of treating the symptoms of PMDD evaluated safety and efficacy of Yaz during up to 3 cycles among 285 women aged 18–42, diagnosed with PMDD and who took at least one dose of Yaz.
1%). 0%). 2%). 1%). 12 (Figure 3). Three studies compared breast cancer risk between current or recent COC users (<6 months since last use) and never users of COCs (Figure 3). 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 3:
Relative Studies of Risk of Breast Cancer with Combined Oral Contraceptives 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.
The following adverse reactions have been identified during post approval use of Yaz. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Adverse reactions are grouped into System Organ Classes, and ordered by frequency.
Vascular disorders:
Venous and arterial thromboembolic events (including pulmonary emboli, deep vein thrombosis, cerebral thrombosis, retinal thrombosis, myocardial infarction and stroke), hypertension (including hypertensive crisis) Hepatobiliary disorders: Gallbladder disease, liver function disturbances, liver tumors Immune system disorders: Hypersensitivity (including anaphylactic reaction) Metabolism and nutrition disorders: Hyperkalemia, hypertriglyceridemia, changes in glucose tolerance or effect on peripheral insulin resistance (including diabetes mellitus) Skin and subcutaneous tissue disorders: Chloasma, angioedema, erythema nodosum, erythema multiforme Gastrointestinal disorders: Inflammatory bowel disease Musculoskeletal and connective tissue disorders: Systemic lupus erythematosus Ever COC vs Never COC Use
USOfficial regulatory label· Warnings and precautions· revised May 29, 2025[3]
5 WARNINGS AND PRECAUTIONS • Vascular risks : Stop Yaz if a thrombotic event occurs. Stop at least 4 weeks before and through 2 weeks after major surgery. Start no earlier than 4 weeks after delivery, in women who are not breastfeeding.
1) COCs containing DRSP may be associated with a higher risk of venous thromboembolism (VTE) than COCs containing levonorgestrel or some other progestins. Before initiating Yaz in a new COC user or a woman who is switching from a contraceptive that does not contain DRSP, consider the risks and benefits of a DRSP-containing COC in light of her risk of a VTE.
1 ) • Hyperkalemia : DRSP has anti-mineralocorticoid activity. Do not use in patients predisposed to hyperkalemia. Check serum potassium concentration during the first treatment cycle in women on long-term treatment with medications that may increase serum potassium concentration.
2 ) • Liver disease : Discontinue Yaz if jaundice occurs. 4 ) • High blood pressure : Do not prescribe Yaz for women with uncontrolled hypertension or hypertension with vascular disease. 6 ) • Carbohydrate and lipid metabolic effects : Monitor prediabetic and diabetic women taking Yaz.
Consider an alternate contraceptive method for women with uncontrolled dyslipidemia. 8 ) • Headache : Evaluate significant change in headaches and discontinue Yaz if indicated. 9 ) • Uterine bleeding : Evaluate irregular bleeding or amenorrhea.
1 Thromboembolic Disorders and Other Vascular Problems Stop Yaz if an arterial or venous thrombotic (VTE) event occurs. 03 mg ethinyl estradiol (that is, Yasmin), DRSP-containing COCs may be associated with a higher risk of venous thromboembolism (VTE) than COCs containing the progestin levonorgestrel or some other progestins.
Epidemiologic studies that compared the risk of VTE reported that the risk ranged from no increase to a three-fold increase. Before initiating use of Yaz in a new COC user or a woman who is switching from a contraceptive that does not contain DRSP, consider the risks and benefits of a DRSP-containing COC in light of her risk of a VTE.
Known risk factors for VTE include smoking, obesity, and family history of VTE, in addition to other factors that contraindicate use of COCs [see Contraindications ( 4 )] . 03 mg of EE and 3 mg of DRSP) to the risk for users of other COCs, including COCs containing levonorgestrel.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
USOfficial regulatory label· Contraindications· revised May 29, 2025[3]
4 CONTRAINDICATIONS Yaz is contraindicated in females who are known to have or develop the following conditions: • Renal impairment • Adrenal insufficiency • A high risk of arterial or venous thrombotic diseases. 3 )] . • Renal impairment ( 4 ) • Adrenal insufficiency ( 4 ) • A high risk of arterial or venous thrombotic diseases ( 4 ) • Undiagnosed abnormal uterine bleeding ( 4 ) • Breast cancer ( 4 ) • Liver tumors or liver disease ( 4 ) • Co-administration with Hepatitis C drug combinations containing ombitasvir, paritaprevir/ritonavir, with or without dasabuvir ( 4 )
This is not medical advice. Consult a qualified healthcare professional.
Another method of contraception should be used to avoid unintentional pregnancy. Note: temporary immobilisation including air travel >4 hours can also be a risk factor for VTE, particularly in women with other risk factors Antithrombotic treatment should be considered if Dretine has not been discontinued in advance.
g. before 50). If a hereditary predisposition is suspected, the woman should be referred to a specialist for advice before deciding about any CHC use Other medical conditions associated with VTE Cancer, systemic lupus erythematosus, haemolytic uraemic syndrome, chronic inflammatory bowel disease (Crohn’s disease or ulcerative colitis) and sickle cell disease Increasing age Particularly above 35 years There is no consensus about the possible role of varicose veins and superficial thrombophlebitis in the onset or progression of venous thrombosis.
6). Symptoms of VTE (deep vein thrombosis and pulmonary embolism) In the event of symptoms women should be advised to seek urgent medical attention and to inform the healthcare professional that she is taking a CHC. Symptoms of deep vein thrombosis (DVT) can include: - unilateral swelling of the leg and/or foot or along a vein in the leg; - pain or tenderness in the leg which may be felt only when standing or walking, - increased warmth in the affected leg; red or discoloured skin on the leg.
Symptoms of pulmonary embolism (PE) can include: - sudden onset of unexplained shortness of breath or rapid breathing; - sudden coughing which may be associated with haemoptysis; - sharp chest pain; - severe light headedness or dizziness; - rapid or irregular heartbeat.
g. g. respiratory tract infections). Other signs of vascular occlusion can include: sudden pain, swelling and slight blue discoloration of an extremity. If the occlusion occurs in the eye symptoms can range from painless […]
Combined oral contraceptives containing drospirenone and ethinyl estradiol may be associated with a higher risk of venous thromboembolism (VTE) than those containing some other progestins in combination with ethinyl estradiol. It is unknown whether the risk of VTE is increased with drospirenone alone; however, if there is a risk, it is expected to be lower than that of drospirenone in combination with ethinyl estradiol.
When prescribing SLYND, consider the increased risk of thromboembolism inherent in the postpartum period and in women with a history of thromboembolism. Discontinue SLYND if arterial or venous thromboembolic events occur. Consider discontinuing SLYND, if feasible, in case of prolonged immobilization due to surgery or illness.
Endocrine and Metabolism Bone metabolism:
Treatment with SLYND leads to decreased estradiol serum levels. It is unknown if this may cause a clinically relevant loss of bone mineral density.
Diabetes:
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 diabetic patients using POPs such as SLYND. However, diabetic patients should be carefully observed during the first months of use, because patients with diabetes may be at greater risk of hyperglycemia.
Special attention should be paid to diabetic patients with vascular involvement.
Genitourinary Vaginal Bleeding and Amenorrhea:
Women using SLYND may experience unscheduled (breakthrough or intracyclic) bleeding and spotting, especially during the first three months of use. Bleeding irregularities may resolve over time or by changing to a different contraceptive product.
If bleeding persists or occurs after previously regular cycles, evaluate for causes such as pregnancy or malignancy. 4% of participants experienced unscheduled bleeding or spotting during the first cycle. 3% by Cycle 13 (see Clinical Pharmacology).
A total of 91 out of 2598 subjects discontinued SLYND due to menstrual bleeding disorders including metrorrhagia, menstrual irregular, vaginal hemorrhage, menorrhagia, uterine hemorrhage, and amenorrhea. SLYND® (drospirenone tablets) Product Monograph Page 9 of 40 If scheduled bleeding does not occur, consider the possibility of pregnancy.
If the patient has not adhered to the prescribing dosing schedule (missed one or two active tablets or started taking them on a day later than she should have) consider the possibility of pregnancy at the time of the first missed period and perform appropriate diagnostic measures.
If the patient has adhered to the prescribed dosing schedule and misses two consecutive periods, rule out pregnancy.
Hematologic Hyperkalemia:
SLYND contains drospirenone, a progestin, which has anti-mineralocorticoid activity, including the potential for hyperkalemia in high-risk, comparable to a 25 mg dose of spironolactone. g. renal impairment, hepatic impairment, and adrenal insufficiency).
Women receiving daily, long-term treatment for chronic conditions or diseases with medications that may increase serum potassium concentration should have their serum potassium concentration checked prior to starting treatment and during the first treatment cycle.
, those treated with a strong CYP3A4 inhibitor long-term and concomitantly with SLYND. Strong CYP3A4 […]
Those that were required or sponsored by regulatory agencies are summarized in Table 2. 8) In addition to these "regulatory studies," other studies of various designs have been conducted. Overall, there are two prospective cohort studies (see Table 2): the US post-approval safety study Ingenix [Seeger 2007], the European post-approval safety study EURAS (European Active Surveillance Study) [Dinger 2007].
An extension of the EURAS study, the Long-Term Active Surveillance Study (LASS), did not enroll additional subjects, but continued to assess VTE risk. There are three retrospective cohort studies: one study in the US funded by the FDA (see Table 2), and two from Denmark [Lidegaard 2009, Lidegaard 2011].
There are two case-control studies: the Dutch MEGA study analysis [van Hylckama Vlieg 2009] and the German case-control study [Dinger 2010]. There are two nested case-control studies that evaluated the risk of non-fatal idiopathic VTE: the PharMetrics study [Jick 2011] and the GPRD study [Parkin 2011].
The results of all of these studies are presented in Figure 1.
Figure 1:
VTE Risk with Yasmin Relative to LNG-Containing COCs (adjusted risk#) Risk ratios displayed on logarithmic scale; risk ratio < 1 indicates a lower risk of VTE for DRSP, > 1 indicates an increased risk of VTE for DRSP. *Comparator "Other COCs", including LNG- containing COCs † LASS is an extension of the EURAS study #Some adjustment factors are indicated by superscript letters: a) Current heavy smoking, b) hypertension, c) obesity, d) family history, e) age, f) BMI, g) duration of use, h) VTE history, i) period of inclusion, j) calendar year, k) education, l) length of use, m) parity, n) chronic disease, o) concomitant medication, p) smoking, q) duration of exposure, r) site (References: Ingenix [Seeger 2007] 1 , EURAS (European Active Surveillance Study) [Dinger 2007] 2 , LASS (Long-Term Active Surveillance Study) [Dinger, unpublished document on file], FDA-funded study [Sidney 2011] 3 , Danish [Lidegaard 2009] 4 , Danish re-analysis [ Lidegaard 2011] 5 , MEGA study [van Hylckama Vlieg 2009] 6 , German Case-Control study [Dinger 2010] 7 , PharMetrics [Jick 2011] 8 , GPRD study [Parkin 2011] 9 ) Although the absolute VTE rates are increased for users of hormonal contraceptives compared to non-users, the rates during pregnancy are even greater, especially during the post-partum period (see Figure 2).
The risk of VTE in women using COCs has been estimated to be 3 to 9 per 10,000 woman-years. The risk of VTE is highest during the first year of use. Data from a large, prospective cohort safety study of various COCs suggest that this increased risk, as compared to that in non-COC users, is greatest during the first 6 months of COC use.
Data from this safety study indicate that the greatest risk of VTE is present after initially starting a COC or restarting (following a 4 week or greater pill-free interval) the same or a different COC. The risk of thromboembolic disease due to oral contraceptives gradually disappears after COC use is discontinued.
Figure 2 shows the risk of developing a VTE for women who are not pregnant and do not use oral contraceptives, for women who use oral contraceptives, for pregnant women, and for women in the postpartum period.
To put the risk of developing a VTE into perspective:
If 10,000 women who are not pregnant and do not use oral contraceptives are followed for one year, between 1 and 5 of these women will develop a VTE.
Figure 2:
Likelihood of Developing a VTE If feasible, stop Yaz at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of thromboembolism. Start Yaz no earlier than 4 weeks after delivery, in women who are not breastfeeding.
The risk of postpartum thromboembolism decreases after the third postpartum week, whereas the risk of ovulation increases after the third postpartum week. Use of COCs also increases the risk of arterial thromboses such as strokes and myocardial infarctions, especially in women with other risk factors for these events.
COCs 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 of age), hypertensive women who also smoke.
COCs also increase the risk for stroke in women with other underlying risk factors. Oral contraceptives must be used with caution in women with cardiovascular disease risk factors. Stop Yaz if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions.
Evaluate for retinal vein thrombosis immediately. 2 Hyperkalemia Yaz contains 3 mg of the progestin DRSP which has anti-mineralocorticoid activity, including the potential for hyperkalemia in high-risk patients, comparable to a 25 mg dose of spironolactone.
Yaz is contraindicated in patients with conditions that predispose to hyperkalemia (that is, renal impairment, hepatic impairment, and adrenal insufficiency). Women receiving daily, long-term treatment for chronic conditions or diseases with medications that may increase serum potassium concentration should have their serum potassium concentration checked during the first treatment cycle.
Medications that may increase serum potassium concentration include ACE inhibitors, angiotensin-II receptor antagonists, potassium-sparing diuretics, potassium supplementation, heparin, aldosterone antagonists, and NSAIDS. Consider monitoring serum potassium concentration in high-risk patients who take a strong CYP3A4 inhibitor long-term and concomitantly.
g. 3 )] . 3 Malignant Neoplasms Breast Cancer Yaz is contraindicated in females who currently have or have had breast cancer because breast cancer may be hormonally sensitive [see Contraindications ( 4 )] . 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. 2 )]. Cervical Cancer Some studies sauggest that COCs are associated with an increase in the risk of cervical cancer or intraepithelial neoplasia.
However, there is controversy about the extent to which these findings may be due to differences in sexual behavior and other factors. 4 Liver Disease Discontinue Yaz if jaundice develops. Steroid hormones may be poorly metabolized in patients with impaired liver function.
Acute or chronic disturbances of liver function may necessitate the discontinuation of COC use until markers of liver function return to normal and COC causation has been excluded. Hepatic adenomas are associated with COC use. 3 cases/100,000 COC users.
Rupture of hepatic adenomas may cause death through intra‑abdominal hemorrhage. Studies have shown an increased risk of developing hepatocellular carcinoma in long‑term (>8 years) COC users. However, the attributable risk of liver cancers in COC users is less than one case per million users.
Oral contraceptive-related cholestasis may occur in women with a history of pregnancy-related cholestasis. Women with a history of COC-related cholestasis may have the condition recur with subsequent COC use. 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 Yaz prior to starting therapy with the combination drug regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir [see Contraindications ( 4 )]. Yaz can be restarted approximately 2 weeks following completion of treatment with the Hepatitis C combination drug regimen.
6 High Blood Pressure For women with well-controlled hypertension, monitor blood pressure and stop Yaz if blood pressure rises significantly. Women with uncontrolled hypertension or hypertension with vascular disease should not use COCs.
An increase in blood pressure has been reported in women taking COCs, and this increase is more likely in older women and with extended duration of use. The incidence of hypertension increases with increasing concentration of progestin.
7 Gallbladder Disease Studies suggest a small increased relative risk of developing gallbladder disease among COC users. 8 Carbohydrate and Lipid Metabolic Effects Carefully monitor prediabetic and diabetic women who are taking Yaz.
COCs may decrease glucose intolerance in a dose-related fashion. Consider alternative contraception for women with uncontrolled dyslipidemias. A small proportion of women will have adverse lipid changes while on COC's. Women with hypertriglyceridemia, or a family history thereof, may be at an increased risk of pancreatitis when using COCs.
9 Headache If a woman taking Yaz develops new headaches that are recurrent, persistent, or severe, evaluate the cause and discontinue Yaz if indicated. An increase in frequency or severity of migraine during COC use (which may be prodromal of a cerebrovascular event) may be a reason for immediate discontinuation of the COC.
10 Bleeding Irregularities Unscheduled (breakthrough or intracyclic) bleeding and spotting sometimes occur in patients on COCs, especially during the first three months of use. If bleeding persists or occurs after previously regular cycles, check for causes such as pregnancy or malignancy.
If pathology and pregnancy are excluded, bleeding irregularities may resolve over time or with a change to a different COC. Based on patient diaries from two contraceptive clinical trials of Yaz, 8 to 25% of women experienced unscheduled bleeding per 28-day cycle.
1%) discontinued due to menstrual disorders including intermenstrual bleeding, menorrhagia, and metrorrhagia. Women who use Yaz may experience absence of withdrawal bleeding, even if they are not pregnant. Based on subject diaries from contraception trials for up to 13 cycles, 6 to 10% of women experienced cycles with no withdrawal bleeding.
Some women may encounter post-pill amenorrhea or oligomenorrhea, especially when such a condition was pre-existent. If withdrawal bleeding does not occur, consider the possibility of pregnancy. If the patient has not adhered to the prescribed dosing schedule (missed one or more active tablets or started taking them on a day later than she should have), consider the possibility of pregnancy at the time of the first missed period and take appropriate diagnostic measures.
If the patient has adhered to the prescribed regimen and misses two consecutive periods, rule out pregnancy. 11 Depression Women with a history of depression should be carefully observed and Yaz discontinued if depression recurs to a serious degree.
12 Interference with Laboratory Tests The use of COCs may change the results of some laboratory tests, such as coagulation factors, lipids, glucose tolerance, and binding proteins. 2 )] . DRSP causes an increase in plasma renin activity and plasma aldosterone induced by its mild anti-mineralocorticoid activity.
13 Monitoring A woman who is taking COCs should have a yearly visit with her healthcare provider for a blood pressure check and for other indicated healthcare. 14 Other Conditions In women with hereditary angioedema, exogenous estrogens may induce or exacerbate symptoms of angioedema.
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 while taking COCs.