"The U.S. Food and Drug Administration on Wednesday approved a request by Danco Laboratories to expand authorized use of its abortion pill Mifeprex (mifepristone), formerly known as RU-486, to 70 days of gestation from 49 days.
(ulipristal acetate) Tablets
The ella (ulipristal acetate) tablet for oral use contains 30 mg of a single active steroid ingredient, ulipristal acetate [17αacetoxy-11β-(4-N,N-dimethylaminophenyl)-19-norpregna-4,9-diene-3,20-dione], a synthetic progesterone agonist/antagonist. The inactive ingredients are lactose monohydrate, povidone K-30, croscarmellose sodium and magnesium stearate.
Ulipristal acetate is a white to yellow crystalline powder which has a molecular weight of 475.6. The structural formula is:
What are the possible side effects of ulipristal (ella)?
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:
- 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....
What are the precautions when taking ulipristal acetate tablet (Ella)?
Before taking ulipristal, tell your doctor or pharmacist if you are allergic to it; or to progestins (such as levonorgestrel, norethindrone); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: unexplained vaginal bleeding.
This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and...
Last reviewed on RxList: 3/30/2015
This monograph has been modified to include the generic and brand name in many instances.
Additional Ella 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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