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Sprintec

Last reviewed on RxList: 9/8/2016
Sprintec Side Effects Center

Last reviewed on RxList 9/19/2016

Sprintec (norgestimate and ethinyl estradiol) is a combination of the female hormones estrogen and progesterone used as contraception to prevent pregnancy. Sprintec is also used to treat severe acne. Sprintec is available in generic form. Common side effects of Sprintec include:

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

Sprintec is a 28-day regimen of tablets, with 21 days of active (containing hormones) tablets, and 7 days of inert tablets, taken as prescribed. Sprintec may interact with phenylbutazone, St. John's wort, antibiotics, seizure medicines, barbiturates, or HIV medicines. Some drugs can make ethinyl estradiol and norgestimate less effective, which may result in pregnancy. Discuss all medications you are taking with your doctor. 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.

Our Sprintec (norgestimate and ethinyl estradiol) 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.

Sprintec Consumer Information

Get emergency medical help if you have any of these 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 a serious side effect such as:

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

Less serious side effects may include:

  • mild nausea (especially when you first start taking this medicine), vomiting, bloating, stomach cramps;
  • breast tenderness or swelling, nipple discharge;
  • freckles or darkening of facial skin, increased hair growth, loss of scalp hair;
  • changes in weight or appetite;
  • problems with contact lenses;
  • vaginal itching or discharge; or
  • changes in your menstrual periods, decreased sex drive.

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 Sprintec (Norgestimate and Ethinyl Estradiol Tablets)

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 norgestimate and ethinyl estradiol was evaluated in 1,647 healthy women of child-bearing potential who participated in 3 clinical trials and received at least 1 dose of norgestimate and ethinyl estradiol for contraception. Two trials were randomized active-controlled trials and 1 was an uncontrolled open-label trial. In all 3 trials, subjects were followed for up to 24 cycles.

Common Adverse Reactions ( ≥ 2% of subjects): The most common adverse reactions reported by at least 2% of the 1,647 women were the following in order of decreasing incidence: headache/migraine (32.9%), abdominal/gastrointestinal pain (7.8%), vaginal infection (8.4%), genital discharge (6.8%), breast issues (including breast pain, discharge, and enlargement) (6.3%), mood disorders (including depression and mood altered) (5%), flatulence (3.2%), nervousness (2.9%), and rash (2.6%).

Adverse Reactions Leading to Study Discontinuation: Over the three trials, between 11 to 21% of subjects discontinued the trial due to an adverse reaction. The most common adverse reactions ( ≥ 1%) leading to discontinuation were: metrorrhagia (6.9%), nausea/vomiting (5%), headache (4.1%), mood disorders (including depression and mood altered) (2.4%), premenstrual syndrome (1.7%), hypertension (1.4%), breast pain (1.4%), nervousness (1.3%), amenorrhea (1.1%), dysmenorrhea (1.1%), weight increased (1.1%), and flatulence (1.1%).

Serious Adverse Reactions: breast cancer (1 subject), mood disorders including depression, irritability, and mood swings (1 subject), myocardial infarction (1 subject), and venous thromboembolic events including pulmonary embolism (1 subject) and deep vein thrombosis (DVT) (1 subject).

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 Sprintec (Norgestimate and Ethinyl Estradiol Tablets)

Related Resources for Sprintec

Read the Sprintec User Reviews »

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

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