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What the label lists and what reports show

Hydrocortisone and pramoxine side effects

Hydrocortisone and pramoxine's FDA label lists its adverse reactions in its own words. FAERS holds 1,001 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is device delivery system issue (70 reports).

  • Generic listed

Check it at the source: the hydrocortisone and pramoxine FDA label on DailyMed (effective June 30, 2025, Legacy Pharma USA Inc.); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: Burning Hypertrichosis Maceration of the skin Itching Acneiform eruptions Secondary infection Irritation Hypopigmentation Skin atrophy Dryness Perioral dermatitis Striae Folliculitis Allergic contact dermatitis Miliaria

Source: FDA drug label, Legacy Pharma USA Inc., effective June 30, 2025 (SPL set 6a9fb75b-a2f7-4eca-8dce-d7eb5c122476), via openFDA; the full label on DailyMed

What do FAERS reports show?

1,001 reports list hydrocortisone and pramoxine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 48 are coded as a death and 213 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 19 reactions below, none is named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

Reports received each year

The 25 most reported reactions

  • Off Label Use (a use or a product term, not a reaction)165
  • Product Quality Issue (a use or a product term, not a reaction)110
  • Drug Ineffective (a use or a product term, not a reaction)88
  • Device Delivery System Issue70
  • Pain59
  • Diarrhoea52
  • Device Leakage50
  • Chronic Kidney Disease44
  • Product Leakage44
  • Nausea41
  • Fatigue37
  • Wrong Technique In Product Usage Process (a use or a product term, not a reaction)37
  • Dyspnoea35
  • Device Issue34
  • Rash34
  • Anxiety31
  • Incorrect Dose Administered (a use or a product term, not a reaction)31
  • Condition Aggravated (a use or a product term, not a reaction)30
  • Device Difficult To Use30
  • Haemorrhoids30
  • Headache27
  • Insomnia26
  • Pruritus26
  • Vomiting26
  • Arthralgia25

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Hydrocortisone and pramoxine: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions