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Tydemy Side Effects

Generic name: drospirenone / ethinyl estradiol / levomefolate calcium

Medically reviewed by Drugs.com. Last updated on Mar 29, 2023.

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 Tydemy.

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 Tydemy

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

Less common

Incidence not known

Other side effects of Tydemy

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

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

More about Tydemy (drospirenone / ethinyl estradiol / levomefolate calcium)

Patient resources

Other brands

Beyaz, Safyral, Rajani

Professional resources

Other brands

Beyaz, Safyral, Rajani

Related treatment guides

References

1. Product Information. Beyaz (drospirenone/ethinyl estradiol/levomefolate). Bayer Pharmaceutical Inc. 2010.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.