Tri-Sprintec

Last reviewed on RxList: 4/3/2020
Tri-Sprintec Side Effects Center

What Is Tri-Sprintec?

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.

QUESTION

Which of the following are methods for contraception? See Answer
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.

Read the entire detailed patient monograph for Tri-Sprintec (Norgestimate and Ethinyl Estradiol Tablets-Triphasic Regimen)

SLIDESHOW

Choosing Your Birth Control Method See Slideshow
Tri-Sprintec Professional Information

SIDE EFFECTS

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

Adverse reactions commonly reported by COC users are:

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;

Cardiac Disorders: Tachycardia, palpitations;

Vascular Events: Deep vein thrombosis, pulmonary embolism, retinal vascular thrombosis, hot flush;

Arterial Events: Arterial thromboembolism, myocardial infarction, cerebrovascular accident;

Respiratory, Thoracic and Mediastinal Disorders: Dyspnea;

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

Hepatobiliary Disorders: Hepatitis;

Skin and Subcutaneous Tissue Disorders: Angioedema, erythema nodosum, hirsutism, night sweats, hyperhidrosis, photosensitivity reaction, urticaria, pruritus, acne;

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.

Read the entire FDA prescribing information for Tri-Sprintec (Norgestimate and Ethinyl Estradiol Tablets-Triphasic Regimen)

© 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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