This page presents data from the FDA Adverse Event Reporting System (FAERS) and the FDA-approved drug label. A report submitted to FAERS does not prove a drug caused the reported event. Always consult a healthcare provider about medications.

Hydrocortisone With Aloe (hydrocortisone cream 1 2)

corticosteroid

Last updated: October 12, 2026

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Hydrocortisone With Aloe is the brand name for hydrocortisone cream 1 2, a corticosteroid. According to the FDA-approved label, temporarily relieves of itching associated with minor skin irritations, inflammation, and rashes due to eczema insect bites cosmetics psoriasis detergents soaps poison ivy, oak, sumac jewelry seborrheic dermatitis temporarily relieves external anal and genital itching other uses. FAERS contains 66,687 submissions naming this drug from 2001 through 2026; the top three reactions cited are off label use, drug ineffective, and fatigue.

Most-Reported Reactions

Counts of the reactions most often cited in FAERS submissions that named Hydrocortisone With Aloe. Inclusion here does not establish causation - submitters describe what was observed, not what was confirmed. One submission can list several reactions, so the totals exceed the report count.

Patient Demographics

Patient sex and age across the FAERS submissions that named Hydrocortisone With Aloe. Percentages here are computed only from submissions where these fields were filled in - many leave them blank.

By Sex

By Age Group

Severity Outcomes

Severity flags recorded across the 66,687 FAERS submissions that named Hydrocortisone With Aloe. Each bar shows the count of those reports carrying that flag. A single case can carry more than one (a hospitalization that became life-threatening, for example), so these bars are independent rates - they don't sum to 100%. Inclusion of a case under any flag does not establish that the drug caused the outcome.

Submissions Per Quarter

Quarterly count of FAERS submissions that named Hydrocortisone With Aloe. Ups and downs on this chart can track prescribing volume, news cycles, or shifts in how reports get filed, rather than the drug becoming safer or more dangerous.

From the FDA-Approved Label

Excerpts from the official FDA-approved prescribing information for Hydrocortisone With Aloe. This is the authoritative source on indications, warnings, and known adverse reactions.

Indications

temporarily relieves of itching associated with minor skin irritations, inflammation, and rashes due to eczema insect bites cosmetics psoriasis detergents soaps poison ivy, oak, sumac jewelry seborrheic dermatitis temporarily relieves external anal and genital itching other uses of this product should be only under the advice and supervision of a doctor

Warnings

For external use only Do not use in the genital area if you have a vaginal discharge. Consult a doctor. for the treatment of diaper rash. Consult a doctor. When using this product avoid contact with eyes do not use more than directed unless told to do so by a doctor do not put directly into the rectum by using fingers or any mechanical device or applicator Stop use and ask a doctor if condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor rectal bleeding occurs Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

FDA label effective date: 2026-08-16

Disclaimer

AdverseEvent.ai is not affiliated with the FDA. Adverse-event counts come from the FDA Adverse Event Reporting System (FAERS). Drug labels come from the FDA drug label dataset. A report submitted to FAERS does not prove a drug caused the reported event — always consult a healthcare provider about medications. This site is for informational purposes only and is not medical advice.