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What the label lists and what reports show

Calcipotriene side effects

Calcipotriene's FDA label lists its adverse reactions in its own words. FAERS holds 3,502 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 diarrhoea (217 reports).

  • Generic listed

Check it at the source: the calcipotriene FDA label on DailyMed (effective August 7, 2020, Prasco Laboratories); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

Clinical Trials Experience In controlled clinical trials, the most frequent adverse reactions reported for Calcipotriene Ointment were burning, itching and skin irritation, which occurred in approximately 10-15% of patients. Erythema, dry skin, peeling, rash, dermatitis, worsening of psoriasis including development of facial/scalp psoriasis were reported in 1 to 10% of patients. Other experiences reported in less than 1% of patients included skin atrophy, hyperpigmentation, hypercalcemia, and folliculitis. Once daily dosing has not been shown to be superior in safety to twice daily dosing. Postmarketing Experience Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. …

Source: FDA drug label, NDA020273 (Leo Pharma As), as published by Prasco Laboratories, effective August 7, 2020 (SPL set fe7cd92a-f066-4c4a-80c8-e3f929ad4181), via openFDA; the full label on DailyMed

What do FAERS reports show?

3,502 reports list calcipotriene among the medicines taken, each a report of something that happened, not proof the medicine caused it; 66 are coded as a death and 474 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 17 reactions below, 2 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.

Reports received each year

The 25 most reported reactions

  • Drug Ineffective (a use or a product term, not a reaction)832
  • Psoriasis (a use or a product term, not a reaction)740
  • Diarrhoea217
  • Arthralgia209
  • Rash (named in the label)198
  • Nausea193
  • Pruritus180
  • Pain179
  • Headache174
  • Off Label Use (a use or a product term, not a reaction)168
  • Product Use In Unapproved Indication (a use or a product term, not a reaction)158
  • Fatigue148
  • Therapeutic Product Effect Incomplete (a use or a product term, not a reaction)145
  • Psoriatic Arthropathy137
  • Product Dose Omission Issue (a use or a product term, not a reaction)127
  • Skin Exfoliation123
  • Treatment Failure (a use or a product term, not a reaction)122
  • Abdominal Discomfort113
  • Erythema (named in the label)94
  • Contusion87
  • Vomiting87
  • Hypertension85
  • Peripheral Swelling85
  • Dyspnoea78
  • Condition Aggravated (a use or a product term, not a reaction)74

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

What next?

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