Tri Sprintec Side Effects

Contents

Check with your doctor immediately if any of the following side effects occur while taking ethinyl estradiol/norgestimate:

Tri-Sprintec

Generic name: Ethinyl Estradiol and Norgestimate [ ETH-in-il-es-tra-DYE-ole-& nor-JES-ti-mate ]
Brand names: Estarylla, Femynor, Mili, Mono-Linyah, MonoNessa, . show all 25 brands Ortho Tri-Cyclen (28), Ortho Tri-Cyclen Lo, Ortho-Cyclen (28), Previfem, Sprintec 28, Tri Femynor, Tri-Estarylla, Tri-Linyah, Tri-Lo-Estarylla, Tri-Lo-Marzia, Tri-Lo-Mili, Tri-Lo-Sprintec, Tri-Mili, Tri-Previfem, Tri-Sprintec, Tri-VyLibra, Tri-VyLibra Lo, TriNessa (28), TriNessa Lo, VyLibra
Drug class: Contraceptives

Medically reviewed by Drugs.com. Last updated on Jul 16, 2022.

Warning

Smoking cigarettes while using Tri-Sprintec (ethinyl estradiol and norgestimate) raises the chance of very bad heart and blood-related side effects. This chance is raised with age (mainly in women older than 35 years of age). It is also raised with the number of cigarettes smoked. It is strongly advised not to smoke. Do not use Tri-Sprintec (ethinyl estradiol and norgestimate) if you smoke and are older than 35 years of age.

Uses of Tri-Sprintec:

It is used to prevent pregnancy.
It is used to treat pimples (acne).
It may be given to you for other reasons. Talk with the doctor.

What do I need to tell my doctor BEFORE I take Tri-Sprintec?

If you have an allergy to ethinyl estradiol, norgestimate, or any other part of Tri-Sprintec (ethinyl estradiol and norgestimate).
If you are allergic to Tri-Sprintec (ethinyl estradiol and norgestimate); any part of Tri-Sprintec (ethinyl estradiol and norgestimate); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
If you have had any of these health problems: Blood clots, blood clotting problem, breast cancer or other cancer where hormones make it grow, diseased blood vessels in the brain or heart, disease of a heart valve with problems, heart disease, chest pain caused by angina, heart attack, stroke, high blood pressure, liver disease, liver tumor, very bad headache or migraine, or diabetes that affects blood flow.
If you have had any of these health problems: Endometrial cancer, cancer of the cervix or vagina, or vaginal bleeding where the cause is not known.
If you turned yellow during pregnancy or with estrogen-based or hormone contraceptive use.
If you are pregnant or may be pregnant. Do not take Tri-Sprintec (ethinyl estradiol and norgestimate) if you are pregnant.
If you are breast-feeding or plan to breast-feed.
If you are taking ombitasvir, paritaprevir, and ritonavir (with or without dasabuvir).

This is not a list of all drugs or health problems that interact with Tri-Sprintec (ethinyl estradiol and norgestimate).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Tri-Sprintec (ethinyl estradiol and norgestimate) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Tri-Sprintec?

Tell all of your health care providers that you take Tri-Sprintec (ethinyl estradiol and norgestimate). This includes your doctors, nurses, pharmacists, and dentists. This medicine may need to be stopped before certain types of surgery as your doctor has told you. If Tri-Sprintec (ethinyl estradiol and norgestimate) is stopped, your doctor will tell you when to start taking Tri-Sprintec (ethinyl estradiol and norgestimate) again after your surgery or procedure.
This medicine may raise the chance of blood clots, a stroke, or a heart attack. Talk with the doctor.
Talk with your doctor if you will need to be still for long periods of time like long trips, bedrest after surgery, or illness. Not moving for long periods may raise your chance of blood clots.
If you have high blood sugar (diabetes), talk with your doctor. This medicine may raise blood sugar.
Check your blood sugar as you have been told by your doctor.
High blood pressure has happened with drugs like this one. Have your blood pressure checked as you have been told by your doctor.
Have blood work checked as you have been told by the doctor. Talk with the doctor.
This medicine may cause high cholesterol and triglyceride levels. Talk with the doctor.
Be sure to have regular breast exams and gynecology check-ups. You will also need to do breast self-exams as you have been told.
If you drink grapefruit juice or eat grapefruit often, talk with your doctor.
This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take Tri-Sprintec (ethinyl estradiol and norgestimate).
Certain drugs, herbal products, or health problems could cause Tri-Sprintec (ethinyl estradiol and norgestimate) to not work as well. Be sure your doctor knows about all of your drugs and health problems.
This medicine does not stop the spread of diseases like HIV or hepatitis that are passed through having sex. Do not have any kind of sex without using a latex or polyurethane condom. If you have questions, talk with your doctor.
Do not use in children who have not had their first menstrual period.
If you have any signs of pregnancy or if you have a positive pregnancy test, call your doctor right away.

How is this medicine (Tri-Sprintec) best taken?

Use Tri-Sprintec (ethinyl estradiol and norgestimate) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

Take Tri-Sprintec (ethinyl estradiol and norgestimate) at the same time of day.
Take with or without food. Take with food if it causes an upset stomach.
After starting Tri-Sprintec (ethinyl estradiol and norgestimate), you may need to use a non-hormone type of birth control like condoms to prevent pregnancy for some time. Follow what your doctor has told you to do about using a non-hormone type of birth control.
If you also take colesevelam, take it at least 4 hours after you take Tri-Sprintec (ethinyl estradiol and norgestimate).
Do not skip doses, even if you do not have sex very often.
If you throw up or have diarrhea, Tri-Sprintec (ethinyl estradiol and norgestimate) may not work as well to prevent pregnancy. Use an extra form of birth control, like condoms, until you check with your doctor.
If you miss 2 periods in a row, take a pregnancy test before starting a new cycle.

What do I do if I miss a dose?

If a dose is missed, check the package insert or call the doctor to find out what to do. If using Tri-Sprintec (ethinyl estradiol and norgestimate) to prevent pregnancy, another form of birth control may need to be used for some time to prevent pregnancy.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
Signs of gallbladder problems like pain in the upper right belly area, right shoulder area, or between the shoulder blades; yellow skin or eyes; fever with chills; bloating; or very upset stomach or throwing up.
Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
Depression or other mood changes.
Feeling very tired or weak.
Swelling.
Not able to pass urine or change in how much urine is passed.
A lump in the breast, breast pain or soreness, or nipple discharge.
Vaginal itching or discharge.
Eyesight changes or loss, bulging eyes, or change in how contact lenses feel.
Call your doctor right away if you have signs of a blood clot like chest pain or pressure; coughing up blood; shortness of breath; swelling, warmth, numbness, change of color, or pain in a leg or arm; or trouble speaking or swallowing.

What are some other side effects of Tri-Sprintec?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

Weight gain.
Headache.
Upset stomach or throwing up.
Gas.
Feeling nervous and excitable.
Stomach pain.
Bloating.
Feeling tired or weak.
Enlarged breasts.
Tender breasts.
Period (menstrual) changes. These include spotting or bleeding between cycles.
This medicine may cause dark patches of skin on your face. Avoid sun, sunlamps, and tanning beds. Use sunscreen and wear clothing and eyewear that protects you from the sun.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Tri-Sprintec?

Store at room temperature.
Protect from light.
Store in a dry place. Do not store in a bathroom.
Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

If your symptoms or health problems do not get better or if they become worse, call your doctor.
Do not share your drugs with others and do not take anyone else’s drugs.
Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Tri-Sprintec (ethinyl estradiol and norgestimate), please talk with your doctor, nurse, pharmacist, or other health care provider.
If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

More about Tri-Sprintec (ethinyl estradiol / norgestimate)

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Drug class: contraceptives

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Further information

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

Tri-Sprintec Side Effects Center

Tri-Sprintec (norgestimate and ethinyl estradiol) is a combination of the female hormones estrogen and progesterone used as contraception to prevent pregnancy. Tri-Sprintec is also used to treat severe acne. Birth control pills have also been shown to make periods more regular, decrease blood loss and painful periods (dysmenorrhea), and decrease risk of ovarian cysts.

What Are Side Effects of Tri-Sprintec?

Common side effects of Tri-Sprintec include:

nausea (especially when you first start taking Tri-Sprintec),
vomiting,
headache,
stomach cramping,
bloating,
dizziness,
vaginal discomfort,
vaginal itching or discharge, or
breast tenderness/enlargement,
nipple discharge,
freckles or darkening of facial skin,
increased hair growth,
loss of scalp hair,
changes in weight or appetite,
problems with contact lenses,
swelling of the ankles/feet (fluid retention), or
decreased sex drive.
Bleeding between periods (spotting) or missed/irregular menstrual periods may occur, especially during the first few months of use.

Dosage for Tri-Sprintec

Tri-Sprintec is a 28-day regimen of tablets, taken as prescribed.

What Drugs, Substances, or Supplements Interact with Tri-Sprintec?

Products that may adversely interact with Tri-Sprintec include aromatase inhibitors, raloxifene, sodium tetradecyl sulfate, tamoxifen, and medication for hypothyroidism. Drugs that may increase blood levels of Tri-Sprintec include acetaminophen, vitamin C, atorvastatin, and azole antifungals.

Tri-Sprintec During Pregnancy and Breastfeeding

Some medications may decrease birth control hormones in your body which can result in pregnancy, including griseofulvin, modafinil, rifamycins, St. John’s wort, drugs used to treat seizures, and HIV drugs. Discuss all medications you are taking with your doctor. Tri-Sprintec must not be used during pregnancy. This medication passes into breast milk, may affect milk production, and may have undesirable effects on a nursing infant. Consult your doctor before breastfeeding.

Additional Information

Our Tri-Sprintec Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

Tri-Sprintec Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using birth control pills and call your doctor at once if you have:

signs of a stroke–sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
signs of a blood clot–sudden vision loss, stabbing chest pain, feeling short of breath, coughing up blood, pain or warmth in one or both legs;
heart attack symptoms–chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
liver problems–loss of appetite, upper stomach pain, tiredness, fever, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
severe headache, pounding in your neck or ears;
swelling in your hands, ankles, or feet;
changes in the pattern or severity of migraine headaches;
a breast lump; or
symptoms of depression–sleep problems, weakness, tired feeling, mood changes.

Common side effects may include:

stomach pain, gas, nausea, vomiting;
breast tenderness;
acne, darkening of facial skin;
headache, nervousness, mood changes;
problems with contact lenses;
changes in weight;
breakthrough bleeding;
vaginal itching or discharge; or
rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

Tri-Sprintec Professional Information

SIDE EFFECTS

The following serious adverse reactions with the use of COCs are discussed elsewhere in labeling:

Serious cardiovascular events and stroke [see BOX WARNING and WARNINGS AND PRECAUTIONS]
Vascular events [see WARNINGS AND PRECAUTIONS]
Liver disease [see WARNINGS AND PRECAUTIONS]

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The safety of Tri-Sprintec was evaluated in 4,826 healthy women of child-bearing potential who participated in 6 clinical trials and received at least 1 dose of Tri-Sprintec for contraception. Two trials were randomized active-controlled trials and 4 were uncontrolled open-label trials. In 3 trials, subjects were followed for up to 24 cycles; in 2 trials, subjects were followed for up to 12 cycles; and in 1 trial, subjects were followed for up to 6 cycles.

Common Adverse Reactions (≥ 2% Of Subjects)

The most common adverse reactions reported by at least 2% of the 4,826 women were the following in order of decreasing incidence: headache/migraine (33.6%), breast issues (including breast pain, enlargement, and discharge) (8%), vaginal infection (7.1%), abdominal/gastrointestinal pain (5.6%), mood disorders (including mood alteration and depression) (3.8%), genital discharge (3.2%), and changes in weight (including weight fluctuation, increased or decreased) (2.5%).

Adverse Reactions Leading To Study Discontinuation

Over the trials, between 9 to 27% of subjects discontinued the trial due to an adverse reaction. The most common adverse reactions (≥1%) leading to discontinuation were: metrorrhagia (4.3%), nausea/vomiting (2.8%), headache/migraine (2.4%), mood disorders (including depression and mood altered) (1.1%), and weight increased (1.1%).

Serious Adverse Reactions

breast cancer (1 subject), carcinoma of the cervix in situ (1 subject), hypertension (1 subject), and migraine (2 subjects).

Postmarketing Experience

The following additional adverse drug reactions have been reported from worldwide postmarketing experience with norgestimate/ethinyl estradiol. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Infections and Infestations: Urinary tract infection;

Neoplasms Benign, Malignant and Unspecified (Incl. Cysts and Polyps): Breast cancer, benign breast neoplasm, hepatic adenoma, focal nodular hyperplasia, breast cyst;

Immune System Disorders: Hypersensitivity;

Metabolism and Nutrition Disorders: Dyslipidemia;

Psychiatric Disorders: Anxiety, insomnia;

Nervous System Disorders: Syncope, convulsion, paresthesia, dizziness;

Eye Disorders: Visual impairment, dry eye, contact lens intolerance;

Ear and Labyrinth Disorders: Vertigo;

Respiratory, Thoracic and Mediastinal Disorders: Dyspnea;

Gastrointestinal Disorders: Pancreatitis, abdominal distension, diarrhea, constipation;

Hepatobiliary Disorders: Hepatitis;

Musculoskeletal, Connective Tissue, and Bone Disorders: Muscle spasms, pain in extremity, myalgia, back pain;

Reproductive System and Breast Disorders: Ovarian cyst, suppressed lactation, vulvovaginal dryness;

General Disorders and Administration Site Conditions: Chest pain, asthenic conditions.

© Tri-Sprintec Patient Information is supplied by Cerner Multum, Inc. and Tri-Sprintec Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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Tri-Sprintec Side Effects

Medically reviewed by Drugs.com. Last updated on Oct 3, 2022.

Note: This document contains side effect information about ethinyl estradiol / norgestimate. Some dosage forms listed on this page may not apply to the brand name Tri-Sprintec.

Warning

Oral route (Tablet)

Cigarette smoking increases the risk of serious cardiovascular side effects from combination oral contraceptive use. This risk increases with age and the number of cigarettes smoked and is quite marked in women over 35 years of age. Use of combination oral contraceptives is contraindicated in women over the age of 35 who smoke

Serious side effects of Tri-Sprintec

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 troubled breathing
sweating
unusual tiredness or weakness
vomiting
vomiting of blood

Other side effects of Tri-Sprintec

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

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

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

Frequency not reported: Myocardial infarction, venous thromboembolic event, deep vein thrombosis [Ref]

Respiratory

Uncommon (0.1% to 1%): Dyspnea

Dermatologic

Common (1% to 10%): Rash, acne

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]