Ulipristal Side Effects

It is possible that some side effects of ulipristal may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to ulipristal: oral tablet

As well as its needed effects, ulipristal may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking ulipristal, check with your doctor immediately:

More common
  • Cramps
  • heavy bleeding
  • pain

Some ulipristal side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned 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

-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.

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

General

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

Dermatologic

Common (1% to 10%): Acne, hyperhidrosis
Uncommon (0.1% to 1%): Alopecia, dry skin, skin lesion, pruritus
Rare (less than 0.1%): Urticaria

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

Immunologic

Uncommon (0.1% to 1%): Influenza

Metabolic

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

Musculoskeletal

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

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

Ocular

Uncommon (0.1% to 1%): Visual disturbance
Rare (less than 0.1%): Abnormal sensation in eye, ocular hyperemia, photophobia

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

Respiratory

Uncommon (0.1% to 1%): Epistaxis
Rare (less than 0.1%): Dry throat

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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