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What the label lists and what reports show

Alclometasone side effects

Alclometasone's FDA label lists its adverse reactions in its own words. FAERS holds 309 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 rash (29 reports).

  • Generic listed

Check it at the source: the alclometasone FDA label on DailyMed (effective April 5, 2021, Glenmark Pharmaceuticals Inc., USA); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

The following local adverse reactions have been reported with alclometasone dipropionate cream in approximately 2% of patients: itching and burning, erythema, dryness, irritation, and papular rashes. The following local adverse reactions have been reported with alclometasone dipropionate ointment in approximately 1% of patients: itching, burning, and erythema. The following additional local adverse reactions have been reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in approximate decreasing order of occurrence: folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, and miliaria.

Source: FDA drug label, Glenmark Pharmaceuticals Inc., USA, effective April 5, 2021 (SPL set 63e635e0-65d8-4b30-9f2a-ab16deba90bd), via openFDA; the full label on DailyMed

What do FAERS reports show?

309 reports list alclometasone among the medicines taken, each a report of something that happened, not proof the medicine caused it; 16 are coded as a death and 73 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 20 reactions below, 3 are 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.

The 25 most reported reactions

  • Rash (named in the label)29
  • Pruritus28
  • Drug Ineffective (a use or a product term, not a reaction)25
  • Product Use In Unapproved Indication (a use or a product term, not a reaction)22
  • Diarrhoea18
  • Nausea16
  • Fatigue13
  • Product Dose Omission Issue (a use or a product term, not a reaction)13
  • Dermatitis Atopic12
  • Erythema (named in the label)12
  • Dry Skin11
  • Off Label Use (a use or a product term, not a reaction)11
  • Dizziness10
  • Pain10
  • Eczema9
  • Headache9
  • Pain In Extremity9
  • Skin Exfoliation9
  • Dermatitis (named in the label)8
  • Fall8
  • Inappropriate Schedule Of Product Administration (a use or a product term, not a reaction)8
  • Nasopharyngitis8
  • Pyrexia8
  • Stomatitis8
  • Vomiting8

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

What next?

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