Introvale Side Effects Center

Last updated on RxList: 3/28/2022
Introvale Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Introvale?

Introvale (levonorgestrel and ethinyl estradiol tablets) is an estrogen/progestin combined oral contraceptive (COC) indicated for use by women to prevent pregnancy. Introvale is available in generic form.

What Are Side Effects of Introvale?

Common side effects of Introvale include:

Dosage for Introvale

The dose of Introvale is one tablet daily by mouth at the same time every day for 91 days.

What Drugs, Substances, or Supplements Interact with Introvale?

Introvale may interact with phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate, rifabutin, rufinamide, aprepitant, St. John's wort, colesevelam, ascorbic acid (vitamin C), acetaminophen, azole antifungals, grapefruit juice, HIV or HCV protease inhibitors, cyclosporine, prednisolone, theophylline, tizanidine, clofibric acid, morphine, salicylic acid, temazepam, lamotrigine, thyroid hormone replacement therapy, and HCV drug combinations containing ombitasvir/paritaprevir/ritonavir. Tell your doctor all medications and supplements you use.

Introvale During Pregnancy or Breastfeeding

Combined oral contraceptives (COC) such as Introvale are not intended for use during pregnancy. Introvale may decrease milk production in lactating women. Other methods of contraception are recommended. Consult your doctor before breastfeeding.

Additional Information

Our Introvale (levonorgestrel and ethinyl estradiol tablets) for Oral Use 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.


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Introvale Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives; difficulty 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), severe headache, slurred speech, balance problems;
  • signs of a blood clot--sudden vision loss, stabbing chest pain, feeling short of breath, coughing up blood, swelling or redness in an arm or leg;
  • 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);
  • increased blood pressure--severe headache, blurred vision, 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:

  • 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 Introvale (Levonorgestrel and Ethinyl Estradiol Tablets)


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Introvale Professional Information


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

Adverse reactions commonly reported by COC users are:

  • Irregular uterine bleeding
  • Nausea
  • Breast tenderness
  • Headache

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 the rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The clinical trial that evaluated the safety and efficacy of levonorgestrel and ethinyl estradiol was a 12- month, randomized, multicenter, open-label study, which enrolled women aged 18 to 40, of whom 456 took at least one dose of levonorgestrel and ethinyl estradiol (345.14 woman-years of exposure) [see Clinical Studies].

Adverse Reactions Leading to Study Discontinuation: 14.9% of the women discontinued from the clinical trial due to an adverse reaction; the most common adverse reactions (≥1% of women) leading to discontinuation in the levonorgestrel and ethinyl estradiol group were menorrhagia (5.7%), mood swings (1.9%), weight/appetite increase (1.5%), and acne (1.3%).

Common Adverse Reactions (≥2% of women: headache (20.6%), menorrhagia (11.6%), nausea (7.5%), dysmenorrhea (5.7%), acne (4.6%), migraine (4.4%), breast tenderness (3.5%), weight increased (3.1%), and depression (2.1%).

Serious Adverse Reactions: pulmonary embolus, cholecystitis.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of levonorgestrel and ethinyl estradiol. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Gastrointestinal disorders: abdominal distension, vomiting

General disorders and administration site conditions: chest pain, fatigue, malaise, edema peripheral, pain

Immune system disorder: hypersensitivity reactions, including itching, rash, and angioedema

Investigations: blood pressure increased

Musculoskeletal and connective tissue disorders: muscle spasms, pain in extremity

Nervous system disorders: dizziness, loss of consciousness

Psychiatric disorders: insomnia

Reproductive and breast disorders: dysmenorrhea

Skin and subcutaneous tissue disorders: alopecia

Vascular disorders: thrombosis, pulmonary embolism, pulmonary thrombosis

Read the entire FDA prescribing information for Introvale (Levonorgestrel and Ethinyl Estradiol Tablets)

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

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