Applies to hydrocortisone/pramoxine topical: external cream, external foam, rectal kit.

Serious side effects

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.
• Signs of a weak adrenal gland like a very bad upset stomach or throwing up, very bad dizziness or passing out, muscle weakness, feeling very tired, mood changes, not hungry, or weight loss.
• Signs of Cushing's disease like weight gain in the upper back or belly, moon face, very bad headache, or slow healing.
• Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
• Irritation where this drug is used.
• Very bad bleeding from rectum or rectal pain.

Other side effects

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:

• Dry skin.
• Burning.
• 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 hydrocortisone/pramoxine topical: rectal cream, rectal foam, rectal kit, rectal lotion, topical cream, topical foam, topical gel, topical lotion, topical ointment.

Local

Frequency not reported: Burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, miliaria^[Ref]

Endocrine

Frequency not reported: Reversible suppression of the hypothalamic-pituitary-adrenal axis, manifestations of Cushing's syndrome^[Ref]

Ocular

Frequency not reported: Blurred vision^[Ref]

Psychiatric

Frequency not reported: Affective disorders (e.g. irritable, euphoric, depressed, labile mood, suicidal thoughts), psychotic reactions (e.g. mania, delusions, hallucinations, aggravation of schizophrenia), behavioral disturbances, irritability, anxiety, sleep disturbances, cognitive dysfunction (including confusion and amnesia)^[Ref]