Does Vaniqa (eflornithine) cause side effects?

Vaniqa (eflornithine) is a topical drug (used on the skin) used to treat unwanted facial and chin hair. It does not remove the hair but rather slows its growth. 

The cells surrounding the base of each hair (called the hair follicle) undergo rapid growth and maturation as they transform into hairs. Certain proteins called polyamines are needed for this rapid cell growth and differentiation, and the production of these polyamines depends on the activity of an enzyme, ornithine decarboxylase (ODC). 

Vaniqa is believed to block ODC, slowing the growth and differentiation of the cells within the hair follicles.

Common side effects of Vaniqa include

  • acne,
  • swollen patches that are sometimes reddened and contain a buried hair (pseudofolliculitis barbae),
  • headache,
  • skin itching,
  • stinging,
  • burning,
  • dry or tingling skin,
  • rash,
  • hair loss, and
  • ingrown hairs.

Serious side effects of Vaniqa include

No drug interactions of Vaniqa are listed. 

There have been no studies of Vaniqa therapy in pregnant women. It is unknown if Vaniqa is secreted into breast milk. Consult your doctor before breastfeeding

What are the important side effects of Vaniqa (eflornithine)?

The most common side effects seen with eflornithine are:

  • acne,
  • swollen patches that are sometimes reddened and contain a buried hair (pseudofolliculitis barbae),
  • headache,
  • skin itching,
  • stinging,
  • burning,
  • dry or tingling skin,
  • rash,
  • hair loss, and
  • ingrown hairs.

Other important, but less common side effects are:

  • bleeding skin,
  • swollen lips,
  • nausea,
  • numbness,
  • contact dermatitis, and
  • herpes simplex.

Vaniqa (eflornithine) side effects list for healthcare professionals

Adverse events reported for most body systems occurred at similar frequencies in Vaniqa (eflornithine hydrochloride) cream, 13.9% and vehicle control groups. The most frequent adverse events related to treatment with Vaniqa were skin-related.

The following table notes the percentage of adverse events associated with the use of Vaniqa or its vehicle that occurred at greater than 1% in both the vehicle-controlled studies and the open-label safety studies up to 1 year of continuous use.

Adverse Event Term Vehicle-Controlled Studies Vehicle-Controlled and Open-Label Studies
Vaniqa
(n=393)
Vehicle
(n=201)
Vaniqa
(n=1373)
Acne 21.3 21.4 10.8
Pseudofolliculitis Barbae 16.3 15.4 4.9
Stinging Skin 7.9 2.5 4.1
Headache 3.8 5.0 4.0
Burning Skin 4.3 2.0 3.5
Dry Skin 1.8 3.0 3.3
Pruritus (itching) 3.8 4.0 3.1
Erythema (redness) 1.3 0.0 2.5
Tingling Skin 3.6 1.5 2.2
Dyspepsia 2.5 2.0 1.9
Skin Irritation 1.0 1.0 1.8
Rash 2.8 0.0 1.5
Alopecia 1.5 2.5 1.3
Dizziness 1.5 1.5 1.3
Folliculitis 0.5 0.0 1.0
Hair Ingrown 0.3 2.0 0.9
Facial Edema 0.3 3.0 0.7
Anorexia 1.0 2.0 0.7
Nausea 0.5 1.0 0.7
Asthenia 0.0 1.0 0.3
Vertigo 0.3 1.0 0.1

Treatment-related skin adverse events that occurred in less than 1% of the subjects treated with Vaniqa are:

  • bleeding skin,
  • cheilitis,
  • contact dermatitis,
  • swelling of lips,
  • herpes simplex,
  • numbness, and
  •  rosacea.

Adverse events were primarily mild in intensity and generally resolved without medical treatment or discontinuation of Vaniqa. Only 2% of subjects discontinued studies due to an adverse event related to use of Vaniqa.

Laboratory Test Abnormalities

No laboratory test abnormalities have been consistently found to be associated with Vaniqa. In an open-label study, some patients showed an increase in their transaminases; however, the clinical significance of these findings is not known.

What drugs interact with Vaniqa (eflornithine)?

It is not known if Vaniqa has any interaction with other topically applied drug products.

Treatment & Diagnosis

Medications & Supplements

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Medically Reviewed on 12/1/2020
References
FDA Prescribing Information

Professional side effects and drug interactions sections courtesy of the U.S. Food and Drug Administration.