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Ella

Last reviewed on RxList: 3/30/2015
Ella Side Effects Center

Last reviewed on RxList 12/9/2016

Ella (ulipristal acetate) is an emergency contraceptive used to prevent pregnancy in emergencies (unprotected sex, barrier contraceptive failure) by preventing ovarian egg release or egg implantation in the uterus. Ella is available in a generic form termed ulipristal acetate. Ella should not be used as a routine contraceptive. Pregnancy should be excluded before Ella is prescribed. The most common side effects of Ella are:

  • headache,
  • nausea, and
  • abdominal or stomach pain,
  • dizziness,
  • tired feeling, or
  • menstrual pain.

Ella is supplied in a 30 mg tablet. Females who decide this drug is necessary should take one tablet orally as soon as possible within 120 hours (5 days) after unprotected intercourse or after a known or suspected contraceptive failure. If vomiting occurs within 3 hours of taking Ella, the dose may not be effective and another dose is likely to be needed; Ella can be taken at any time during the menstrual cycle. Ella may interact with bosentan, dabigatran, digoxin, griseofulvin, loperamide, quinidine, St. John's wort, topiramate, rifabutin, rifampin, rifapentine, vinblastine, antifungal medications, barbiturates, or seizure medications. Tell your doctor all medications and supplements you use. Ella does not protect females from sexually transmitted diseases (STDs), human immunodeficiency virus (HIV), or other infections. Ella can harm a fetus or cause birth defects. Do not use emergency contraception such as Ella if you are already pregnant or think you might be pregnant. Ella IS NOT FOR USE IN TERMINATING AN EXISTING PREGNANCY. It is unknown if Ella passes into breast milk or if it could harm a nursing baby. Breastfeeding while using Ella is not recommended.

Our Ella (ulipristal acetate) 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.

Ella 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.

Call your doctor at once if you have severe pain in your lower stomach (especially on only one side) 3 to 5 weeks after using ulipristal.

Less serious side effects may include:

  • headache;
  • dizziness, tired feeling;
  • nausea, stomach pain; or
  • menstrual pain.

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 Ella (Ulipristal Acetate Tablet)

Ella Professional Information

SIDE EFFECTS

Clinical Trials 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.

ella was studied in an open-label multicenter trial (Open-Label Study) and in a comparative, randomized, single-blind, multicenter trial (Single-Blind Comparative Study). In these studies, a total of 2,637 (1,533 + 1,104) women in the 30 mg ulipristal acetate groups were included in the safety analysis. The mean age of women who received ulipristal acetate was 24.5 years and the mean body mass index (BMI) was 25.3. The racial demographics of those enrolled were 67% Caucasian, 20% Black or African American, 2% Asian, and 12% other.

The most common adverse reactions (≥ 10%) in the clinical trials for women receiving ella were headache (18% overall) and nausea (12% overall) and abdominal and upper abdominal pain (12% overall). Table 1 lists those adverse reactions that were reported in ≥ 5% of subjects in the clinical studies (14).

Table 1: Adverse Reactions in ≥ 5% of Women (%) Receiving a Single Dose of ella (30 mg Ulipristal Acetate)

Most Common Adverse Reactions Open-Label Study
N = 1,533
Single-Blind Comparative Study
N = 1,104
Headache 18 19
Nausea 12 13
Abdominal and upper abdominal pain 15 8
Dysmenorrhea 7 13
Fatigue 6 6
Dizziness 5 5

Postmarketing Experience

Adolescents: the safety profile observed in adolescents aged 17 and younger in studies and post-marketing is similar to the safety profile in adults [see Pediatric Use].

The following adverse reactions have been identified during post-approval use of ella:

Skin and Subcutaneous Tissue Disorders: Acne

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.

Read the entire FDA prescribing information for Ella (Ulipristal Acetate Tablet)

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