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Logilia Side Effects

Generic Name: ulipristal

Note: This document contains side effect information about ulipristal. Some of the dosage forms listed on this page may not apply to the brand name Logilia.

For the Consumer

Applies to ulipristal: oral tablet

Along with its needed effects, ulipristal (the active ingredient contained in Logilia) 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

Incidence Not Known

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. "Product Information. ella (ulipristal)." Afaxys Inc., Charleston, SC.

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Further information

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.

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