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Ella

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Ella

Ella Side Effects Center

Medical Editor: Charles Patrick Davis, MD, PhD

Ella (ulipristal acetate) is in the class of progestins, it may act 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 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. Some common drugs and compounds that may reduce the effectiveness of Ella are barbiturates, carbamazepine, phenytoin, rifampin, and St. John's Wort. Ella does not protect females from sexually transmitted diseases (STDs), human immunodeficiency virus (HIV), or other infections. Ella is contraindicated for use in pregnant females; its use in females under age 18 is suggested to be as effective as in those over age 18. Ella is not indicated for pre-menarche or post-menopausal females. It is unknown if the drug is excreted in breast milk.

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.

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.

Ella in Detail - Patient Information: Side Effects

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) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Ella Overview - Patient Information: Side Effects

SIDE EFFECTS: Headache, nausea, abdominal pain, tiredness, dizziness, or painful menstrual periods may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if this rare but serious side effect occurs: severe lower abdominal pain (especially 3 to 5 weeks after taking ulipristal).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Ella (Ulipristal Acetate Tablet)»

What is Prescribing information?

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

Ella FDA Prescribing Information: Side Effects
(Adverse Reactions)

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

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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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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