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Tri-Sprintec

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Tri-Sprintec

Tri-Sprintec

Tri-Sprintec Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Tri-Sprintec (norgestimate and ethinyl estradiol) is used as contraception to prevent pregnancy. It 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. Tri-Sprintec is a combination of the hormones estrogen and progesterone. Common side effects include nausea, vomiting, headache, stomach cramping/bloating, dizziness, vaginal discomfort, vaginal discharge, or breast tenderness/enlargement. Bleeding between periods (spotting) or missed/irregular periods may occur, especially during the first few months of use.

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

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Tri-Sprintec in Detail - Patient Information: Side Effects

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

Stop taking this medicine and call your doctor at once if you have a serious side effect such as:

  • sudden numbness or weakness, especially on one side of the body;
  • sudden severe headache, confusion, problems with vision, speech, or balance;
  • sudden cough, wheezing, rapid breathing, coughing up blood;
  • pain, swelling, warmth, or redness in one or both legs;
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • a change in the pattern or severity of migraine headaches;
  • pain in your upper stomach, jaundice (yellowing of the skin or eyes);
  • a lump in your breast;
  • swelling in your hands, ankles, or feet; or
  • symptoms of depression (sleep problems, weakness, mood changes).

Less serious side effects may include:

  • mild nausea or vomiting, appetite or weight changes;
  • breast swelling or tenderness;
  • headache, nervousness, dizziness;
  • problems with contact lenses;
  • freckles or darkening of facial skin, loss of scalp hair; or
  • vaginal itching or discharge.

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) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Tri-Sprintec FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives (See WARNINGS section).

  • Thrombophlebitis and venous thrombosis with or withoutembolism.
  • Arterial thromboembolism.
  • Pulmonary embolism
  • Myocardial infarction.
  • Cerebral hemorrhage.
  • Cerebral thrombosis.
  • Hypertension.
  • Gallbladder disease
  • Hepatic adenomas or benignliver tumors

The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug-related:

  • Nausea.
  • Vomiting.
  • Gastrointestinal symptoms(such as abdominal crampsand bloating).
  • Breakthrough bleeding.
  • Spotting.
  • Change in menstrual flow.
  • Amenorrhea.
  • Temporary infertility after dis-continuation of treatment.
  • Edema.
  • Melasma which may persist.
  • Breast changes: tenderness, enlargement, secretion.
  • Change in weight (increase or decrease).
  • Change in cervical erosion and secretion.
  • Diminution in lactation when given immediately postpartum.
  • Cholestatic jaundice.
  • Migraine.
  • Rash (allergic).
  • Mental depression.
  • Reduced tolerance to carbohydrates.
  • Vaginal candidiasis.
  • Change in corneal curvature (steepening).
  • Intolerance to contact lenses.

The following adverse reactions have been reported in users of oral contraceptives and the association has been neither confirmed nor refuted:

  • Pre-menstrual syndrome.
  • Cataracts.
  • Changes in appetite.
  • Cystitis-like syndrome.
  • Headache.
  • Nervousness.
  • Dizziness.
  • Hirsutism.
  • Loss of scalp hair.
  • Erythema multiforme.
  • Erythema nodosum.
  • Hemorrhagic eruption.
  • Vaginitis.
  • Porphyria.
  • Impaired renal function.
  • Hemolytic uremic syndrome.
  • Acne.
  • Changes in libido.
  • Colitis.
  • Budd-Chiari Syndrome.

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

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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