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What the label lists and what reports show

Permethrin side effects

Permethrin's FDA label lists its adverse reactions in its own words. FAERS holds 1,746 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 pruritus (142 reports).

  • Generic listed

Check it at the source: the permethrin FDA label on DailyMed (effective March 4, 2026, Aurobindo Pharma Limited); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

In clinical trials, generally mild and transient burning and stinging followed application with Permethrin Cream, 5% in 10% of patients and was associated with the severity of infestation. Pruritus was reported in 7% of patients at various times post-application. Erythema, numbness, tingling, and rash were reported in 1 to 2% or less of patients (see PRECAUTIONS: General ). Other adverse events reported since marketing Permethrin Cream, 5% include: headache, fever, dizziness, abdominal pain, diarrhea and nausea and/or vomiting. Although extremely uncommon and not expected when used as directed (see DOSAGE AND ADMINISTRATION ), rare occurrences of seizure have been reported. None have been medically confirmed as associated with Permethrin Cream, 5% treatment.

Source: FDA drug label, Aurobindo Pharma Limited, effective March 4, 2026 (SPL set 0c92aca1-0daa-4b24-9348-f9d42fec478a), via openFDA; the full label on DailyMed

What do FAERS reports show?

1,746 reports list permethrin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 59 are coded as a death and 232 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 18 reactions below, 8 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)361
  • Pruritus (named in the label)142
  • Off Label Use (a use or a product term, not a reaction)111
  • Pain92
  • Rash (named in the label)81
  • Headache (named in the label)76
  • Nausea (named in the label)76
  • Dry Skin71
  • Alopecia69
  • Anxiety69
  • Chronic Kidney Disease67
  • Diarrhoea (named in the label)55
  • Fatigue54
  • Inappropriate Schedule Of Product Administration (a use or a product term, not a reaction)52
  • Product Use In Unapproved Indication (a use or a product term, not a reaction)50
  • Dyspnoea49
  • Erythema (named in the label)49
  • Inappropriate Schedule Of Drug Administration (a use or a product term, not a reaction)49
  • Emotional Distress48
  • Dizziness (named in the label)45
  • Renal Failure45
  • Vomiting (named in the label)44
  • Wrong Technique In Product Usage Process (a use or a product term, not a reaction)40
  • Anhedonia39
  • Condition Aggravated (a use or a product term, not a reaction)38

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

What next?

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