Ulipristal Side Effects
Medically reviewed by Drugs.com. Last updated on Aug 3, 2024.
Applies to ulipristal: oral tablet.
Serious side effects of ulipristal
Along with its needed effects, ulipristal may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking ulipristal:
More common side effects
- cramps
- heavy bleeding
- pain
Other side effects of ulipristal
Some side effects of ulipristal may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common side effects
- headache
- nausea
- stomach pain
- unusual tiredness or weakness
Less common side effects
- dizziness
Incidence not known
For healthcare professionals
Applies to ulipristal: oral tablet.
General adverse events
The most common adverse reactions (10% or more) reported were hot flush, headache, nausea, abdominal pain, and dysmenorrhea.[Ref]
Other
- Very common (10% or more): Hot flush (up to 24%)
- Common (1% to 10%): Breast tenderness/pain, vertigo, edema
- Uncommon (0.1% to 1%): Hot flush, pyrexia, breast swelling/discomfort
- Rare (less than 0.1%): Thirst[Ref]
Genitourinary
- Very common (10% or more): Amenorrhea (up to 80.8%), endometrial thickening (up to 15%), dysmenorrhea (up to 13%)
- Common (1% to 10%): Pelvic pain, uterine hemorrhage, ovarian cyst
- Uncommon (0.1% to 1%): Menorrhagia, menstrual disorder, vaginitis, premenstrual syndrome, metrorrhagia, vaginal/genital discharge, urinary incontinence, ruptured ovarian cyst
- Rare (less than 0.1%): Genital pruritus, dyspareunia, vulvovaginal pain, hypomenorrhea[Ref]
Endometrial thickening (more than 16 mm) reverses when treatment is stopped and menstrual periods resume. This condition should not be mistaken for endometrial hyperplasia as these changes are reversible after treatment cessation.[Ref]
Dermatologic
- Common (1% to 10%): Acne, hyperhidrosis
- Uncommon (0.1% to 1%): Alopecia, dry skin, skin lesion, pruritus
- Rare (less than 0.1%): Urticaria[Ref]
Gastrointestinal
- Very common (10% or more): Abdominal pain (up to 15%), nausea (up to 13%)
- Common (1% to 10%): Abdominal discomfort, vomiting
- Uncommon (0.1% to 1%): Diarrhea, dry mouth, dyspepsia, flatulence[Ref]
Immunologic
Metabolic
- Common (1% to 10%): Blood cholesterol increased
- Uncommon (0.1% to 1%): Appetite disorders, blood triglycerides increased, weight increased[Ref]
Musculoskeletal
Nervous system
- Very common (10% or more): Headache (up to 19%)
- Common (1% to 10%): Fatigue, dizziness
- Uncommon (0.1% to 1%): Somnolence, migraine, chills, malaise
- Rare (less than 0.1%): Tremor, disturbance in attention, dysgeusia, syncope[Ref]
Ocular
- Uncommon (0.1% to 1%): Visual disturbance
- Rare (less than 0.1%): Abnormal sensation in eye, ocular hyperemia, photophobia[Ref]
Psychiatric
- Common (1% to 10%): Mood disorders
- Uncommon (0.1% to 1%): Emotional disorder, anxiety, insomnia, hyperactivity disorder, libido changes
- Rare (less than 0.1%): Disorientation[Ref]
Respiratory
- Uncommon (0.1% to 1%): Epistaxis
- Rare (less than 0.1%): Dry throat[Ref]
References
1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
2. (2022) "Product Information. Ella (ulipristal)." Afaxys Inc.
Frequently asked questions
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Further information
Ulipristal side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.