Note: This document contains side effect information about drospirenone / ethinyl estradiol / levomefolate calcium. Some dosage forms listed on this page may not apply to the brand name Safyral.
Applies to drospirenone / ethinyl estradiol / levomefolate calcium: oral tablet.
Warning
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 of Safyral
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
- 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
- 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 of Safyral
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
- 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
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
Frequency not reported: Cervix carcinoma stage 0
Postmarketing reports: Cervical dysplasia[Ref]
Musculoskeletal
Postmarketing reports: Systemic lupus erythematosus[Ref]
Dermatologic
Postmarketing reports: Chloasma, angioedema, erythema nodosum, erythema multiforme[Ref]
Other
Common (1% to 10%): Fatigue
