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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.

Equate Cortisone (hydrocortisone 1)

corticosteroid
Last updated: June 18, 2026
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Equate Cortisone is the brand name for hydrocortisone 1, a corticosteroid. According to the FDA-approved label, For the temporary relief of itching associated with minor skin irritation and rashes due to eczema poison ivy, oak, and sumac cosmetics soaps and detergents jewelry insect bites Other uses of this product should be only under advice and supervision of a doctor. FAERS contains 64 submissions naming this drug from 2004 through 2025; the top three reactions cited are condition aggravated, drug ineffective, and skin exfoliation.

Most-Reported Reactions

Counts of the reactions most often cited in FAERS submissions that named Equate Cortisone. 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.

CONDITION AGGRAVATED 6 (9.4%) DRUG INEFFECTIVE 6 (9.4%) SKIN EXFOLIATION 6 (9.4%) PRURITUS 5 (7.8%) RASH 5 (7.8%) STEROID WITHDRAWAL SYNDROME 5 (7.8%) DEATH 4 (6.3%) DRY MOUTH 4 (6.3%) ERYTHEMA 4 (6.3%) HYPERTENSION 4 (6.3%) ECZEMA 3 (4.7%) FATIGUE 3 (4.7%) HYPOXIA 3 (4.7%) INSOMNIA 3 (4.7%) PYREXIA 3 (4.7%)

Patient Demographics

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

By Sex

Female Male

By Age Group

0-17 18-44 45-64 65+

Severity Outcomes

Severity flags recorded across the 64 FAERS submissions that named Equate Cortisone. 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.

DEATH 5 (7.8%) HOSPITALIZATION 25 (39.1%) LIFE-THREATENING 3 (4.7%) DISABLING 10 (15.6%)

Submissions Per Quarter

Quarterly count of FAERS submissions that named Equate Cortisone. 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.

2004 2005 2006 2007 2008 2009 2013 2014 2015 2016 2017 2018 2019 2020 2021 2023 2024 2025

From the FDA-Approved Label

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

Indications

For the temporary relief of itching associated with minor skin irritation and rashes due to eczema poison ivy, oak, and sumac cosmetics soaps and detergents jewelry insect bites Other uses of this product should be only under advice and supervision of a doctor.

Warnings

For external use only. Flammable. Keep away from fire or flame. Do not use for the treatment of diaper rash. Consult a doctor. When using this product avoid contact with eyes. In case of contact with eyes, flush thoroughly with water avoid contact with broken skin do not inhale or ingest contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120F. Stop use and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days.

FDA label effective date: 2023-12-27

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.