Note: This document contains side effect information about ammonium lactate topical. Some dosage forms listed on this page may not apply to the brand name Amlactin Ultra.

Applies to ammonium lactate topical: external cream, external lotion.

Serious side effects of Amlactin Ultra

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Very bad irritation where this drug is used.

Other side effects of Amlactin Ultra

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Irritation where this drug is used.
• Burning.
• Stinging.
• Itching.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

For Healthcare Professionals

Applies to ammonium lactate topical: compounding solution, topical cream, topical lotion.

Dermatologic

Dermatologic side effects have been reported in patients with xerosis including transient stinging (1 in 30 patients), burning (1 in 30 patients), erythema (1 in 50 patients) and peeling (1 in 60 patients). Irritation, eczema, petechiae, dryness, and hyperpigmentation have been reported less frequently.

Due to the more severe initial skin conditions associated with ichthyosis, there was a higher incidence of transient stinging, burning and erythema (each occurring in 1 in 10 patients).^[Ref]