Tri-Estarylla Side Effects
Generic name: ethinyl estradiol / norgestimate
Medically reviewed by Drugs.com. Last updated on Nov 20, 2023.
Note: This document provides detailed information about Tri-Estarylla Side Effects associated with ethinyl estradiol / norgestimate. Some dosage forms listed on this page may not apply specifically to the brand name Tri-Estarylla.
Applies to ethinyl estradiol / norgestimate: oral tablet.
Important warnings
This medicine can cause some serious health issues
Oral route (tablet)
Cigarette Smoking and Serious Cardiovascular Events. Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (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 are contraindicated in women who are over 35 years of age and smoke
Precautions
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and does not cause unwanted effects. These visits will usually be every 6 to 12 months, but some doctors require them more often. Your doctor may also want to check your blood pressure while taking this medicine.
Although you are using this medicine to prevent pregnancy, you should know that using this medicine while you are pregnant could harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away. Make sure your doctor knows if you had given birth within 4 weeks before you start using this medicine.
Do not use this medicine together with medicine to treat hepatitis C virus infection, including ombitasvir/paritaprevir/ritonavir, with or without dasabuvir (Technivie®, Viekira Pak®).
This medicine will not protect you from getting HIV/AIDS, herpes, or other sexually transmitted diseases. Tell your doctor if you or your partner begin to have sexual intercourse with other people, or you or your partner tests positive for a sexually transmitted disease. If this is a concern for you, talk with your doctor.
Vaginal bleeding of various amounts may occur between your regular menstrual periods during the first 3 months of use. This is sometimes called spotting when slight, or breakthrough bleeding when heavier.
- If this should occur, continue with your regular dosing schedule.
- The bleeding usually stops within 1 week. Check with your doctor if the bleeding continues for more than 1 week.
- If the bleeding continues after you have been taking hormonal contraceptives on schedule and for more than 3 months, check with your doctor.
Check with your doctor right away if you miss a menstrual period. Missed periods may occur if you skip one or more tablets and have not taken your pills exactly as directed. If you miss two periods in a row, talk to your doctor. You might need a pregnancy test.
If you suspect that you may be pregnant, Stop taking ethinyl estradiol/norgestimate immediately and check with your doctor.
Do not use this medicine if you smoke cigarettes or if you are over 35 years of age. If you smoke while using birth control pills, you increase your risk of having a blood clot, heart attack, or stroke. Your risk is even higher if you are over age 35, if you have diabetes, high blood pressure, high cholesterol, or if you are overweight. Talk with your doctor about ways to stop smoking. Keep your diabetes under control. Ask your doctor about diet and exercise to control your weight and blood cholesterol level.
Using this medicine may increase your risk of having blood clotting problems. Check with your doctor right away if you have pain in the chest, groin, or legs, especially the calves, difficulty with breathing, a sudden, severe headache, slurred speech, a sudden, unexplained shortness of breath, a sudden unexplained shortness of breath, a sudden loss of coordination, or vision changes while using this medicine.
Using this medicine may increase your risk of breast cancer or cervical cancer. Talk with your doctor about this risk. Check with your doctor immediately if your experience abnormal vaginal bleeding.
Check with your doctor immediately if you wear contact lenses or if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want an eye doctor (ophthalmologist) to check your eyes.
Check with your doctor right away if you have pain or tenderness in the upper stomach, dark urine or pale stools, or yellow eyes or skin. These could be symptoms of a serious liver problem.
Using this medicine may increase your risk for gallbladder surgery. Talk with your doctor about this risk.
This medicine may make your skin more sensitive to sunlight. Wear sunscreen. Do not use sunlamps or tanning beds. Tell your doctor if you have a history of dark patches of skin around the forehead, nose, cheeks, and around the mouth, especially during pregnancy.
Check with your doctor before refilling an old prescription, especially after a pregnancy. You will need another physical examination and your doctor may change your prescription.
Make sure any doctor or dentist who treats you knows that you are using this medicine. The results of some medical tests may be affected by this medicine. You may also need to stop using this medicine at least 4 weeks before and 2 weeks after having major surgery.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.
Serious side effects of Tri-Estarylla
Along with its needed effects, ethinyl estradiol/norgestimate 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 / norgestimate:
Incidence not known
- absent, missed, or irregular menstrual periods
- anxiety
- change in vision
- changes in skin color
- chest pain or discomfort
- chills
- clay-colored stools
- constipation
- cough
- dark urine
- diarrhea
- dizziness or lightheadedness
- fainting
- fever
- headache
- hives or welts
- itching skin
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- loss of appetite
- medium to heavy, irregular vaginal bleeding between regular monthly periods, which may require the use of a pad or a tampon
- nausea
- pain or discomfort in the arms, jaw, back, or neck
- pain, tenderness, or swelling of the foot or leg
- pains in the chest, groin, or legs, especially in the calves of the legs
- pounding in the ears
- rash
- redness of the skin
- severe headaches of sudden onset
- slow or fast heartbeat
- stomach pain
- sudden loss of coordination or slurred speech
- sudden trouble breathing
- sweating
- unusual tiredness or weakness
- vomiting
- vomiting of blood
Other side effects of Tri-Estarylla
Some side effects of ethinyl estradiol / norgestimate 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
- bloating
- blotchy spots on the exposed skin
- breast enlargement or tenderness
- discouragement
- feeling sad or empty
- irritability
- itching of the vagina or outside the genitals
- loss of interest or pleasure
- pain during sexual intercourse
- stomach cramps
- thick, white curd-like vaginal discharge without odor or with mild odor
- tiredness
- trouble concentrating
- trouble sleeping
- trouble wearing contact lenses
For healthcare professionals
Applies to ethinyl estradiol / norgestimate: oral tablet.
General adverse events
The most frequently reported side effects were headache/migraine, nausea/vomiting, gastrointestinal disorder, diarrhea, abdominal/gastrointestinal pain, vaginal infection, genital discharge, breast issues (including breast pain, discharge, and enlargement), dysmenorrhea, metrorrhagia, abnormal withdrawal bleeding, mood disorders (including depression and mood altered), flatulence, nervousness, rash, and changes in weight (including weight increased or decreased).[Ref]
Genitourinary
- Very common (10% or more): Breast issues (10.3%), dysmenorrhea, metrorrhagia, abnormal withdrawal bleeding
- Common (1% to 10%): Vaginal infection, genital discharge, breast tenderness, breast pain, breast enlargement, breast swelling, breast discharge, breast discomfort, nipple pain, menstrual discomfort, menstrual disorder, vulvovaginal infection, urinary tract infection, amenorrhea, premenstrual syndrome
- Uncommon (0.1% to 1%): Ovarian cyst, vulvovaginal dryness
- Rare (less than 0.1%): Vaginal discharge
- Frequency not reported: Suppressed lactation[Ref]
Some women experience oligomenorrhea and amenorrhea following termination or oral contraceptive use.[Ref]
Gastrointestinal
- Very common (10% or more): Nausea/vomiting (16.3%), gastrointestinal disorder, diarrhea
- Common (1% to 10%): Abdominal/gastrointestinal pain, flatulence, abdominal distention, constipation
- Rare (less than 0.1%): Pancreatitis[Ref]
Nervous system
- Very common (10% or more): Headache/migraine (up to 33.6%)
- Common (1% to 10%): Dizziness
- Uncommon (0.1% to 1%): Syncope, paresthesia
- Frequency not reported: Convulsion, cerebrovascular accident[Ref]
Cardiovascular
- Uncommon (0.1% to 1%): Palpitation, thrombosis, hypertension, hot flush
- Rare (less than 0.1%): Tachycardia, arterial thromboembolism
- Frequency not reported: Myocardial infarction, venous thromboembolic event, deep vein thrombosis[Ref]
Respiratory
- Uncommon (0.1% to 1%): Dyspnea
- Frequency not reported: Pulmonary embolism[Ref]
Dermatologic
- Common (1% to 10%): Rash, acne
- Uncommon (0.1% to 1%): Alopecia, hirsutism, urticaria, pruritus, erythema, skin discoloration
- Rare (less than 0.1%): Hyperhidrosis, photosensitivity reaction
- Frequency not reported: Angioedema, erythema nodosum, night sweats[Ref]
Metabolic
- Common (1% to 10%): Weight fluctuation, fluid retention
- Rare (less than 0.1%): Appetite disorder
- Frequency not reported: Dyslipidemia[Ref]
Musculoskeletal
- Common (1% to 10%): Muscle spasms, pain in extremity, back pain
- Uncommon (0.1% to 1%): Myalgia[Ref]
Oncologic
- Uncommon (0.1% to 1%): Cervical dysplasia
- Rare (less than 0.1%): Breast cyst
- Frequency not reported: Breast cancer, carcinoma of the cervix in situ, hepatic adenoma, breast cancer, benign breast neoplasm, focal nodular hyperplasia, fibroadenoma of breast[Ref]
Hepatic
- Rare (less than 0.1%): Hepatitis[Ref]
Psychiatric
- Common (1% to 10%): Depression, mood altered, mood disorder, nervousness, insomnia
- Uncommon (0.1% to 1%): Anxiety, libido disorder
- Frequency not reported: Irritability, mood swing[Ref]
Immunologic
- Common (1% to 10%): Hypersensitivity[Ref]
Other
- Common (1% to 10%): Weight increased, weight decreased, fatigue, chest pain, asthenic conditions, edema[Ref]
Ocular
- Uncommon (0.1% to 1%): Vision impaired, dry eye
- Frequency not reported: Contact lens intolerance, retinal vascular thrombosis[Ref]
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References
1. (2001) "Product Information. Ortho-Cyclen (ethinyl estradiol-norgestimate)." Ortho McNeil Pharmaceutical
2. Cerner Multum, Inc. "UK Summary of Product Characteristics."
3. (2017) "Product Information. Ortho Tri-Cyclen Lo (ethinyl estradiol-norgestimate)." Ortho McNeil Pharmaceutical
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Further information
Tri-Estarylla 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.