Ella (Ulipristal Acetate) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

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	Single-Blind Comparative Study
	N = 1,533	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.

REPORTS OF SUSPECTED ELLA SIDE EFFECTS / ADVERSE REACTIONS

Possible Ella side effects / adverse reactions in 32 year old female

Reported by a individual with unspecified qualification from Romania on 2011-10-12

Patient: 32 year old female

Reactions: Maternal Exposure During Pregnancy, Unintended Pregnancy

Suspect drug(s):
Ella

Possible Ella side effects / adverse reactions in 27 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-12-20

Patient: 27 year old female weighing 54.5 kg (119.9 pounds)

Reactions: Menstruation Irregular, Drug Prescribing Error

Suspect drug(s):
Ella
    Administration route: Oral
    Indication: Post Coital Contraception
    Start date: 2011-12-01
    End date: 2011-12-01

Plan B ONE-Step
    Dosage: 1.5 milligram;
    Administration route: Oral
    Indication: Post Coital Contraception
    Start date: 2011-12-01
    End date: 2011-12-01

Possible Ella side effects / adverse reactions in 33 year old female

Reported by a consumer/non-health professional from United States on 2012-03-14

Patient: 33 year old female weighing 58.5 kg (128.7 pounds)

Reactions: Drug Ineffective, Unintended Pregnancy

Suspect drug(s):
Ella