"Nov. 20, 2012 -- Oral contraceptives should be made available without a prescription to reduce unintended pregnancies, according to a newly published opinion by the American College of Obstetricians and Gynecologists (ACOG).
Next Choice Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Next Choice (levonorgestrel) is a progestin-only emergency contraceptive indicated for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure. Next Choice is available only by prescription for women younger than age 17 years, and available over the counter for women 17 years and older. Next Choice is not indicated for routine use as a contraceptive. Next Choice does not protect against HIV infection (AIDS) or other sexually transmitted infections (STIs). Common side effects of Next Choice include changes in your menstrual periods, nausea, vomiting, stomach or abdominal pain, diarrhea, fatigue, tired feeling, headache, dizziness, and breast pain or tenderness.
To obtain optimal efficacy, the first dose of Next Choice should be taken as soon as possible within 72 hours of intercourse. The second dose should be taken 12 hours later. Next Choice may interact with rifampin, barbiturates, or seizure medicines. Tell your doctor all medications and supplements you use. Do not use Next Choice if you are already pregnant. Next Choice emergency contraceptive will not terminate a pregnancy that has already begun (the fertilized egg has attached to the uterus). Next Choice passes into breast milk and may harm a nursing baby. Next Choice is not recommended for use while breastfeeding.Our Next Choice (levonorgestrel) 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.
Next Choice 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.
Call your doctor at once if you have severe pain in your lower stomach or side. This could be a sign of a tubal pregnancy (a pregnancy that implants in the fallopian tube instead of the uterus). A tubal pregnancy is a medical emergency.
Less serious side effects may include:
- nausea, diarrhea, or stomach pain;
- dizziness, tired feeling;
- breast pain or tenderness;
- changes in your menstrual periods; or
Read the entire detailed patient monograph for Next Choice (Levonorgestrel Tablets)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Next Choice FDA Prescribing Information: Side Effects
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.
A double-blind, controlled clinical trial in 1,955 evaluable women compared the efficacy and safety of levonorgestrel tablets (one 0.75 mg tablet of levonorgestrel taken within 72 hours of unprotected intercourse, and one tablet taken 12 hours later) to the Yuzpe regimen (two tablets each containing 0.25 mg levonorgestrel and 0.05 mg ethinyl estradiol, taken within 72 hours of intercourse, and two tablets taken 12 hours later).
The most common adverse events ( > 10%) in the clinical trial for women receiving levonorgestrel tablets included menstrual changes (26%), nausea (23%), abdominal pain (18%), fatigue (17%), headache (17%), dizziness (11%), and breast tenderness (11%). Table 1 lists those adverse events that were reported in ≥ 5% of levonorgestrel tablets users.
Table 1: Adverse Events in ≥ 5% of Women, by % Frequency
|Most Common Adverse Events|| Levonorgestrel
|Heavier Menstrual Bleeding||13.8|
|Lighter Menstrual Bleeding||12.5|
The following adverse reactions have been identified during post-approval use of Next Choice™. 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.
Abdominal Pain, Nausea, Vomiting
General Disorders and Administration Site Conditions
Nervous System Disorders
Reproductive System and Breast Disorders
Read the entire FDA prescribing information for Next Choice (Levonorgestrel Tablets)
Additional Next Choice Information
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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