Tri-Levlen Side Effects

Generic name: ethinyl estradiol / levonorgestrel

Medically reviewed by Drugs.com. Last updated on Jun 25, 2024.

Note: This document provides detailed information about Tri-Levlen Side Effects associated with ethinyl estradiol / levonorgestrel. Some dosage forms listed on this page may not apply specifically to the brand name Tri-Levlen.

Applies to ethinyl estradiol / levonorgestrel: oral tablet, oral tablet chewable.

Other dosage forms:

• oral tablet
• transdermal patch extended release

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 older than 35 years, and with the number of cigarettes smoked.

Women who use oral contraceptives should be strongly advised not to smoke.

Serious side effects of Tri-Levlen

Along with its needed effects, ethinyl estradiol/levonorgestrel 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 ethinyl estradiol/levonorgestrel:

Incidence not known

• absent, missed, or irregular menstrual periods
• anxiety
• bloody stools
• blurred vision
• breast tenderness, enlargement, discharge
• changes in skin color, pain, tenderness, or swelling of the foot or leg
• chest pain or discomfort
• chills
• clay-colored stools
• confusion
• cough
• dark or cloudy urine
• decrease in urine output or decrease in urine-concentrating ability
• diarrhea
• difficult, burning, or painful urination
• difficulty in speaking
• dizziness or lightheadedness
• double vision
• dull ache or feeling of pressure or heaviness in the legs
• fainting
• fast heartbeat
• fever
• fluid-filled skin blisters
• frequent urge to urinate
• headache, severe and throbbing
• inability to move the arms, legs, or facial muscles
• inability to speak
• itching of the vagina or outside the genitals
• itching skin near damaged veins
• light vaginal bleeding between regular menstrual periods
• loss of appetite
• nausea
• nervousness
• pain during sexual intercourse
• pain or discomfort in the arms, jaw, back or neck
• pelvic pain
• pounding in the ears
• sensitivity to the sun
• skin thinness
• slow or fast heartbeat
• slow speech
• stomach bloating and cramping
• stomach pain and tenderness
• stopping of menstrual bleeding
• sweating
• swelling, pain, or tenderness in the upper abdominal area
• swollen feet and ankles
• tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area
• thick, white curd-like vaginal discharge without odor or with mild odor
• troubled breathing
• twitching, uncontrolled movements of the tongue, lips, face, arms, or legs
• unpleasant breath odor
• unusual tiredness or weakness
• vomiting
• vomiting of blood
• yellow eyes or skin

Other side effects of Tri-Levlen

Some side effects of ethinyl estradiol / levonorgestrel 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:

Incidence not known

• acne
• changes in appetite
• changes in weight
• decreased interest in sexual intercourse
• decreased milk production
• loss in sexual ability, desire, drive, or performance
• mental depression
• patchy brown or dark brown discoloration of the skin

For healthcare professionals

Applies to ethinyl estradiol / levonorgestrel: oral tablet, oral tablet chewable, transdermal film.

General

The most frequently reported side effects were headache, heavy/irregular vaginal bleeding, nausea/vomiting, acne, dysmenorrhea, weight increased, mood changed, anxiety/panic attack, breast pain, and migraines.^[Ref]

Genitourinary

• Very common (10% or more): Irregular/heavy uterine bleeding (up to 17%), menorrhagia (up to 11.6%), breast pain (up to 11.2%), dysmenorrhea (up to 11%), breakthrough bleeding/spotting
• Common (1% to 10%): Breast tenderness/discomfort, vaginitis, candidiasis, breast enlargement, breast secretion, breast tension, intermenstrual bleeding/metrorrhagia
• Uncommon (0.1% to 1%): Breast enlargement, breast hypertrophy, menstrual flow changed
• Rare (less than 0.1%): Breast discharge, vaginal discharge, amenorrhea
• Frequency not reported: Uterine myoma, temporary infertility, cervical erosion changed, cervical secretion changed, diminution in lactation
• Postmarketing reports: Menstrual flow reduced, withdrawal bleeding missed, post pill amenorrhea^[Ref]

Cardiovascular

• Uncommon (0.1% to 1%): Blood pressure increased
• Rare (less than 0.1%): Venous thromboembolism, arterial thromboembolism
• Frequency not reported: Deep vein thrombosis, hypertension, myocardial infarction, varicose veins exacerbated, thrombophlebitis, cerebral vascular disease, mitral valve prolapse
• Postmarketing reports: Thrombosis^[Ref]

Nervous system

• Very common (10% or more): Headache (up to 33%)
• Common (1% to 10%): Migraine, dizziness
• Very rare (less than 0.01%): Chorea exacerbated
• Frequency not reported: Loss of consciousness, epilepsy, Sydenham's chorea, transient ischemic attack, ischemic stroke, hemorrhagic stroke, stroke, cerebral hemorrhage, cerebral thrombosis^[Ref]

Local

• Common (1% to 10%): Application site disorder (transdermal system)

Gastrointestinal

• Very common (10% or more): Nausea/vomiting (up to 11%)
• Common (1% to 10%): Abdominal pain/cramps, diarrhea
• Very rare (less than 0.01%): Pancreatitis
• Frequency not reported: Crohn's disease, ulcerative colitis, bloating, mesenteric thrombosis
• Postmarketing reports: Abdominal distention^[Ref]

Oncologic

• Rare (less than 0.1%): Benign liver tumor, malignant liver tumor, breast cancer^[Ref]

Hepatic

• Rare (less than 0.1%): Cholestatic jaundice
• Very rare (less than 0.01%): Gallbladder disease, gallbladder disease exacerbated
• Frequency not reported: Cholecystitis, cholelithiasis, Budd-Chiari syndrome
• Postmarketing reports: Liver function disturbance^[Ref]

Hematologic

• Frequency not reported: Hemolytic uremic syndrome^[Ref]

Psychiatric

• Common (1% to 10%): Mood changed, mood swings/alteration/affect lability, depression, anxiety/panic attack, nervousness, libido decreased, libido increased, depression
• Frequency not reported: Major depressive disorder, suicide attempt, depressed mood, crying, major depression, affective disorder, depression suicidal, dysthymic disorder
• Postmarketing reports: Insomnia^[Ref]

Immunologic

• Rare (less than 0.1%): Hypersensitivity reaction, anaphylactic/anaphylactoid reaction
• Very rare (less than 0.01%): Systemic lupus erythematosus exacerbated^[Ref]

Ocular

• Rare (less than 0.1%): Contact lens intolerance
• Very rare (less than 0.01%): Retinal vein thrombosis
• Frequency not reported: Cataract, corneal curvature changed/steepening
• Postmarketing reports: Optic neuritis^[Ref]

Metabolic

• Common (1% to 10%): Appetite increased, fluid retention/edema
• Uncommon (0.1% to 1%): Appetite decreased, serum lipid levels changed, hypertriglyceridemia
• Rare (less than 0.1%): Glucose tolerance changed
• Frequency not reported: Tolerance to carbohydrates reduced^[Ref]

Dermatologic

• Common (1% to 10%): Acne
• Uncommon (0.1% to 1%): Urticaria, rash, chloasma
• Rare (less than 0.1%): Erythema nodosum, erythema multiforme, hereditary angioedema exacerbated
• Frequency not reported: Herpes gestationis, hirsutism, alopecia, melasma
• Postmarketing reports: Alopecia, itching, angioedema^[Ref]

Other

• Common (1% to 10%): Weight gain, weight changed, flu syndrome
• Rare (less than 0.1%): Weight decreased
• Very rare (less than 0.01%): Porphyria exacerbated
• Frequency not reported: Ectopic pregnancy, spontaneous abortion, porphyria, congenital anomaly, cystitis-like syndrome
• Postmarketing reports: Chest pain, fatigue, malaise, edema peripheral, pain, serum folate decreased^[Ref]

Musculoskeletal

• Common (1% to 10%): Back pain
• Frequency not reported: Systemic lupus erythematosus
• Postmarketing reports: Muscle spasm, pain in extremity^[Ref]

Renal

• Frequency not reported: Pulmonary embolism
• Postmarketing reports: Pulmonary thrombosis^[Ref]

Further information

Tri-Levlen 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.

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

Medical Disclaimer