Ella Side Effects

Generic Name: ulipristal

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

Not all side effects for ella may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to ulipristal: oral tablet

In addition to its needed effects, some unwanted effects may be caused by ulipristal (the active ingredient contained in ella). In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking ulipristal:

More common
  • Cramps
  • heavy bleeding
  • pain

Some of the side effects that can occur with ulipristal may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

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.

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