Drug Safety Information for ELLA (Ulipristal acetate)

Safety-related Labeling Changes for ELLA (ULIPRISTAL ACETATE) Rx Drug: FDA Link

Adverse Drug Reactions for ELLA* (Ulipristal acetate)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with ELLA
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Unintended pregnancy16
2Nausea9
3Abdominal pain8
4Headache6
5Abortion induced6
6Muscle spasms5
7Migraine4
8Dizziness4
9Drug ineffective4
10Uterine leiomyoma4
11Drug interaction3
12Vomiting3
13Fatigue3
14Pregnancy after post coital contraception3
15Abdominal pain upper3
16No therapeutic response3
17Abortion spontaneous3
18Caesarean section2
19Dry mouth2
20Menorrhagia2

* This side effect also appears in "Top 10 Side Effects of ELLA " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking ELLA
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Post coital contraception52
2Uterine leiomyoma47
3Contraception44
4Product used for unknown indication5

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for ELLA

Total Reports Filed with FDA: 192


Number of FDA Adverse Event Reports by Patient Age for ELLA

Total Reports Filed with FDA: 192*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Ulipristal acetate (Ella)

Charts are based on 192 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and ELLA Reviews and Review Summary .

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.