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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.

Ps-2896 Hydrocortisone Cream 1%, 0.9g (hydrocortisone cream)

corticosteroid
Last updated: June 18, 2026
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Ps-2896 Hydrocortisone Cream 1%, 0.9g is the brand name for hydrocortisone cream, a corticosteroid. According to the FDA-approved label, (s) For the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, and external genital, feminine, and. FAERS contains 65,426 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 Ps-2896 Hydrocortisone Cream 1%, 0.9g. 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.

OFF LABEL USE 9,171 (14.0%) DRUG INEFFECTIVE 7,280 (11.1%) FATIGUE 5,750 (8.8%) CONDITION AGGRAVATED 5,328 (8.1%) NAUSEA 4,873 (7.4%) RASH 4,779 (7.3%) DIARRHOEA 4,350 (6.6%) PAIN 4,334 (6.6%) HEADACHE 4,318 (6.6%) DYSPNOEA 4,160 (6.4%) ARTHRALGIA 4,158 (6.4%) PYREXIA 3,880 (5.9%) VOMITING 3,812 (5.8%) PRURITUS 3,589 (5.5%) MALAISE 3,527 (5.4%)

Patient Demographics

Patient sex and age across the FAERS submissions that named Ps-2896 Hydrocortisone Cream 1%, 0.9g. Percentages here are computed only from submissions where these fields were filled in - many leave them blank.

By Sex

Female Male Unknown

By Age Group

0-17 18-44 45-64 65+

Severity Outcomes

Severity flags recorded across the 65,426 FAERS submissions that named Ps-2896 Hydrocortisone Cream 1%, 0.9g. 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 9,483 (14.5%) HOSPITALIZATION 27,891 (42.6%) LIFE-THREATENING 8,353 (12.8%) DISABLING 5,345 (8.2%)

Submissions Per Quarter

Quarterly count of FAERS submissions that named Ps-2896 Hydrocortisone Cream 1%, 0.9g. 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.

2001 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026

From the FDA-Approved Label

Excerpts from the official FDA-approved prescribing information for Ps-2896 Hydrocortisone Cream 1%, 0.9g. This is the authoritative source on indications, warnings, and known adverse reactions.

Indications

(s) For the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, and external genital, feminine, and anal itching

Warnings

For External Use Only If pregnant or breast-feeding Ask a health professional before use Do not use • In the eyes • For diaper rash • For external genital or feminine itching if you have a vaginal discharge • More than the recommended daily dosage unless directed by a doctor • In the rectum by using fingers or any mechanical device or applicator Stop use and ask a doctor if • Condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days (do not continue to use this or any other hydrocortisone product for longer than 7 days) • Bleeding occurs due to anal itching Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

FDA label effective date: 2025-12-15

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.