Drospirenone / Ethinyl Estradiol / Levomefolate Calcium Side Effects
Medically reviewed by Drugs.com. Last updated on Dec 18, 2024.
Applies to drospirenone / ethinyl estradiol / levomefolate calcium: oral tablet.
Important warnings
This medicine can cause some serious health issues
Oral route (tablet)
Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (COC) use.
This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked.
For this reason, COCs should not be used by women who are over 35 years of age and smoke.
Serious side effects
Along with its needed effects, drospirenone/ethinyl estradiol/levomefolate calcium may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking drospirenone/ethinyl estradiol/levomefolate calcium:
More common side effects
- breast pain or tenderness
- headache, severe and throbbing
- heavy non-menstrual vaginal bleeding
- irregular menstrual periods
- nausea
- normal menstrual bleeding occurring earlier, possibly lasting longer than expected
Less common side effects
- longer or heavier menstrual periods
- unusual tiredness or weakness
- vomiting
Incidence not known
- chills
- clay-colored stools
- dark urine
- difficulty with breathing
- dizziness
- fever
- headache
- itching
- loss of appetite
- pain in the chest, groin, or legs, especially the calves
- rash
- slurred speech
- stomach pain
- sudden loss of coordination
- sudden, severe weakness or numbness in the arm or leg
- unpleasant breath odor
- unusual tiredness or weakness
- vision changes
- vomiting of blood
- yellow eyes or skin
Other side effects
Some side effects of drospirenone/ethinyl estradiol/levomefolate calcium may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Less common side effects
- crying
- decreased interest in sexual intercourse
- delusions of persecution, mistrust, suspiciousness, or combativeness
- false or unusual sense of well-being
- inability to have or keep an erection
- irritability
- loss in sexual ability, desire, drive, or performance
- mental depression
- quick to react or overreact emotionally
- rapidly changing moods
- weight gain
For healthcare professionals
Applies to drospirenone / ethinyl estradiol / levomefolate calcium: oral tablet.
General adverse events
The more commonly reported adverse events include menstrual irregularities, nausea/vomiting, breast pain/tenderness, and headache/migraine.
Cardiovascular
- Postmarketing reports: Venous and arterial thromboembolic events (including pulmonary emboli, deep vein thrombosis, cerebral thrombosis, retinal thrombosis, myocardial infarction and stroke), hypertension (including hypertensive crisis)[Ref]
Genitourinary
Combination Oral Contraceptives:
- Very common (10% or more): Menstrual irregularities (up to 24.9%)
- Frequency not reported: Menstrual irregularities including vaginal hemorrhage (primarily spotting), metrorrhagia, menorrhagia, breast tenderness, decreased libido, unscheduled (breakthrough or intracyclic) bleeding
The average number of episodes of bleeding per 90 days was 3.2 in Cycles 4 to 6; the average number of bleeding and/or spotting days was 15.1 days. The intensity of bleeding based on the ratio of spotting-only days versus total bleeding and/or spotting days was 5.2/15.1 day.
Gastrointestinal
- Common (1% to 10%): Nausea, vomiting,
- Postmarketing reports: Gallbladder disease, inflammatory bowel disease[Ref]
Hypersensitivity
- Postmarketing reports: Hypersensitivity including anaphylactic reaction[Ref]
Hepatic
- Postmarketing reports: Liver function disturbances, liver tumors[Ref]
Metabolic
- Postmarketing reports: Hyperkalemia, hypertriglyceridemia, changes in glucose tolerance or effect on peripheral insulin resistance (including diabetes mellitus)[Ref]
Nervous system
- Common (1% to 10%): Migraine, headaches[Ref]
Ocular
- Postmarketing reports: Retinal thrombosis[Ref]
Psychiatric
- Frequency not reported: Irritability, depression, affect lability[Ref]
Oncologic
Musculoskeletal
- Postmarketing reports: Systemic lupus erythematosus[Ref]
Dermatologic
- Postmarketing reports: Chloasma, angioedema, erythema nodosum, erythema multiforme[Ref]
Other
- Common (1% to 10%): Fatigue
References
1. (2010) "Product Information. Beyaz (drospirenone/ethinyl estradiol/levomefolate)." Bayer Pharmaceutical Inc
More about drospirenone / ethinyl estradiol / levomefolate calcium
- Check interactions
- Compare alternatives
- Pricing & coupons
- Reviews (260)
- Drug images
- Dosage information
- During pregnancy
- Drug class: contraceptives
- En español
Patient resources
- Drospirenone, ethinyl estradiol, and levomefolate drug information
- Drospirenone, ethinyl estradiol, and levomefolate (Advanced Reading)
Other brands
Beyaz, Tydemy, Rajani, Safyral
Professional resources
Other brands
Beyaz, Tydemy, Rajani, Safyral
Related treatment guides
Further information
Drospirenone/ethinyl estradiol/levomefolate calcium side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.