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Eflornithine topical Side Effects

For the Consumer

Applies to eflornithine topical: topical cream

Some side effects of eflornithine topical 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
  • Acne
  • stinging skin
Less common
  • Burning or bleeding skin
  • chapped, red lips
  • chronic acne
  • hair bumps
  • numbness
  • rash
  • reddening of skin
  • swelling of lips
  • tingling skin

For Healthcare Professionals

Applies to eflornithine topical: topical cream

General

The most frequently reported side effects were dermatologic in nature and included acne and pseudofolliculitis barbae.[Ref]

Dermatologic

Very common (10% or more): Acne (up to 21.3 %), pseudofolliculitis barbae (up to 16.3%)
Common (1% to 10%): Stinging skin, burning skin, dry skin, pruritus, erythema, tingling skin, skin irritated, rash, alopecia
Uncommon (0.1% to 1%): Ingrown hair, papular rash, skin bleeding, eczema, contact dermatitis, hair texture abnormal, hair growth abnormal, skin hypopigmentation, skin soreness
Rare (less than 0.1%): Rosacea, seborrheic dermatitis, maculopapular rash, skin cyst, vesiculobullous rash, skin disorder, hirsutism, skin tightness[Ref]

Nervous system

Common (1% to 10%): Headache, dizziness
Frequency not reported: Numbness[Ref]

Gastrointestinal

Common (1% to 10%): Dyspepsia
Uncommon (0.1% to 1%): Nausea, cheilitis, numb lip
Frequency not reported: Swollen lip[Ref]

Cardiovascular

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

Other

Common (1% to 10%): Folliculitis
Uncommon (0.1% to 1%): Facial edema, asthenia, vertigo, mouth edema, herpes simplex, furunculosis[Ref]

Metabolic

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

Oncologic

Rare (less than 0.1%): Skin neoplasm[Ref]

References

1. "Product Information. Vaniqa (eflornithine topical)" Bristol-Myers Squibb, Princeton, NJ.

2. Cerner Multum, Inc. "Australian Product Information." O 0

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

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

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