Alesse-28 Side Effects
Generic name: ethinyl estradiol / levonorgestrel
Medically reviewed by Drugs.com. Last updated on Oct 29, 2023.
Note: This document contains side effect information about ethinyl estradiol / levonorgestrel. Some dosage forms listed on this page may not apply to the brand name Alesse-28.
Applies to ethinyl estradiol / levonorgestrel: oral tablet, oral tablet chewable. Other dosage forms:
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 Alesse-28
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
- 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
- clay-colored stools
- dark or cloudy urine
- decrease in urine output or decrease in urine-concentrating ability
- difficult, burning, or painful urination
- difficulty in speaking
- dizziness or lightheadedness
- double vision
- dull ache or feeling of pressure or heaviness in the legs
- fast heartbeat
- 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
- 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
- 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 of blood
- yellow eyes or skin
Other side effects of Alesse-28
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
- 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.
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]
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]
Uncommon (0.1% to 1%): Blood pressure increased
Rare (less than 0.1%): Venous thromboembolism, arterial thromboembolism
Postmarketing reports: Thrombosis[Ref]
Very common (10% or more): Headache (up to 33%)
Common (1% to 10%): Migraine, dizziness
Very rare (less than 0.01%): Chorea exacerbated
Common (1% to 10%): Application site disorder (transdermal system)
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
Postmarketing reports: Abdominal distention[Ref]
Rare (less than 0.1%): Benign liver tumor, malignant liver tumor, breast cancer[Ref]
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]
Common (1% to 10%): Mood changed, mood swings/alteration/affect lability, depression, anxiety/panic attack, nervousness, libido decreased, libido increased, depression
Postmarketing reports: Insomnia[Ref]
Rare (less than 0.1%): Hypersensitivity reaction, anaphylactic/anaphylactoid reaction
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]
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]
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]
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]
Common (1% to 10%): Back pain
Frequency not reported: Systemic lupus erythematosus
Postmarketing reports: Muscle spasm, pain in extremity[Ref]
Frequency not reported: Pulmonary embolism
Postmarketing reports: Pulmonary thrombosis[Ref]
More about Alesse-28 (ethinyl estradiol / levonorgestrel)
- Check interactions
- Compare alternatives
- Reviews (58)
- Drug images
- Dosage information
- During pregnancy
- Drug class: contraceptives
Related treatment guides
1. Product Information. Triphasil (ethinyl estradiol-levonorgestrel). Wyeth-Ayerst Laboratories. 2001.
2. Cerner Multum, Inc. UK Summary of Product Characteristics.
3. Cerner Multum, Inc. Australian Product Information.
4. Product Information. Alesse-28 (ethinyl estradiol-levonorgestrel). Wyeth-Ayerst Canada Inc. 2017.
5. Product Information. Quartette (ethinyl estradiol-levonorgestrel). Teva Pharmaceuticals USA. 2017.
6. Product Information. LoSeasonique (ethinyl estradiol-levonorgestrel). Teva Pharmaceuticals USA. 2017.
7. Product Information. Seasonale (ethinyl estradiol-levonorgestrel). Barr Pharmaceuticals Inc. 2017.
8. Product Information. Seasonique (ethinyl estradiol-levonorgestrel). Teva Pharmaceuticals USA. 2017.
9. Product Information. Twirla (ethinyl estradiol-levonorgestrel). Agile Therapeutics, Inc. 2021.
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.