Locoid Lotion Side Effects Center

Last updated on RxList: 4/4/2022
Locoid Lotion Side Effects Center

What Is Locoid Lotion?

Locoid (hydrocortisone butyrate) Lotion is a corticosteroid used for the topical treatment of mild to moderate atopic dermatitis.

What Are Side Effects of Locoid Lotion?

Common side effects of Locoid Lotion include application site reactions (such as burning, itching, swelling [dermatitis], redness, eczema, inflammation, or irritation), acne, loss of skin pigment, thinning of the skin, and stretch marks.

Dosage for Locoid Lotion

Apply a thin layer dose of Locoid Lotion to the affected skin areas two times daily, and rub in gently.

What Drugs, Substances, or Supplements Interact with Locoid Lotion?

Locoid Lotion may interact with other drugs. Tell your doctor all medications and supplements you use.

Locoid Lotion During Pregnancy or Breastfeeding

During pregnancy, Locoid Lotion should be used only if prescribed. This drug passes into breast milk when taken orally. It is unknown if it passes into breast milk when applied topically. Consult your doctor before breastfeeding.

Additional Information

Our Locoid (hydrocortisone butyrate) Lotion Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Locoid Lotion Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • worsening of your skin condition;
  • redness, warmth, swelling, oozing, or severe irritation of any treated skin;
  • high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor; or
  • possible signs of absorbing this medicine through your skin--weight gain (especially in your face or your upper back and torso), slow wound healing, thinning or discolored skin, increased body hair, muscle weakness, nausea, diarrhea, tiredness, mood changes, menstrual changes, sexual changes.

Less serious side effects may be more likely, and you may have none at all.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Locoid Lotion (Hydrocortisone Butyrate Lotion)

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Locoid Lotion Professional Information

SIDE EFFECTS

The following adverse reactions are discussed in greater detail in other sections of the labeling:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared to rates in other clinical trials and may not reflect the rates observed in clinical practice.

The safety data derived from Locoid® Lotion clinical trials reflect exposure to Locoid® Lotion twice daily for up to four weeks in separate clinical trials involving pediatric subjects 3 months to 18 years of age and adult subjects 18 years of age and older with mild to moderate atopic dermatitis.

Adverse reactions shown in the tables below include those for which there is some basis to believe there is a causal relationship to Locoid® Lotion. Although the rates of application site reactions in the vehicle group were greater than those in the Locoid® group in both studies, these rates are included in the tables (Table 1 and Table 2) because skin irritation is a known adverse reaction of topical corticosteroids.

TABLE 1: Frequency of adverse reactions in pediatric subjects with mild to moderate atopic dermatitis

  Locoid® Lotion
(n=139)
n (%)
Vehicle
(n=145)
n (%)
Application site reactions, including application site burning, pruritus, dermatitis, erythema, eczema, inflammation, or irritation 2 (1) 20 (14)
Infantile acne 1 (1) 0 (0)
Skin depigmentation 1 (1) 0 (0)

TABLE 2: Frequency of adverse reactions in adult subjects with mild to moderate atopic dermatitis

  Locoid® Lotion
(n=151)
n (%)
Vehicle
(n=150)
n (%)
Application site reactions, including application site burning, dermatitis, eczema, erythema, or pruritus 5 (3) 7 (5)

Postmarketing Experience

Because adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

The following additional local adverse reactions have been reported infrequently with topical corticosteroids, and they may occur more frequently with the use of occlusive dressings and higher potency corticosteroids. These reactions included: irritation, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, miliaria and telangiectasia.

Read the entire FDA prescribing information for Locoid Lotion (Hydrocortisone Butyrate Lotion)

© Locoid Lotion Patient Information is supplied by Cerner Multum, Inc. and Locoid Lotion Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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