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Ulipristal Side Effects

For the Consumer

Applies to ulipristal: oral tablet

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
  • Cramps
  • heavy bleeding
  • pain

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
  • Abdominal or stomach pain
  • headache
  • nausea
  • unusual tiredness or weakness
Less common
  • Dizziness
Incidence not known
  • Blemishes on the skin
  • pimples

For Healthcare Professionals

Applies to ulipristal: oral tablet

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]

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]

General

-The most common adverse reactions (10% or more) reported were hot flush, headache, nausea, abdominal pain, and dysmenorrhea.[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

Uncommon (0.1% to 1%): Influenza[Ref]

Metabolic

Common (1% to 10%): Blood cholesterol increased
Uncommon (0.1% to 1%): Appetite disorders, blood triglycerides increased, weight increased[Ref]

Musculoskeletal

Common (1% to 10%): Myalgia, back pain, musculoskeletal pain
Uncommon (0.1% to 1%): Asthenia[Ref]

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." O 0

2. "Product Information. ella (ulipristal)." Watson Pharmaceuticals, Corona, CA.

Some side effects of ulipristal may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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