Skip to main content

What the label lists and what reports show

Mupirocin side effects

Mupirocin's FDA label lists its adverse reactions in its own words. FAERS holds 13,755 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 nausea (954 reports).

  • Generic listed

Check it at the source: the mupirocin FDA label on DailyMed (effective October 28, 2025, Glenmark Pharmaceuticals Inc., USA); the FDA FAERS public dashboard.

What does the patient leaflet say about side effects?

From the patient leaflet: What are the possible side effects of mupirocin ointment?

Mupirocin ointment may cause serious side effects, including: • severe allergic reactions. Stop using mupirocin ointment and call your healthcare provider or go to the nearest emergency room right away if you have any of the following signs or symptoms of a severe allergic reaction: • hives • trouble breathing or wheezing • swelling of your face, lips, mouth, or tongue • dizziness, fast heartbeat or pounding in your chest • a rash over your whole body • eye irritation. Do not get mupirocin ointment in your eyes. If mupirocin ointment gets in your eyes, rinse your eyes well with water. • irritation in the area mupirocin ointment is used. Stop using mupirocin ointment and call your healthcare provider if you develop an irritation, severe itching, or a rash while using mupirocin ointment. • a type of diarrhea called clostridium difficile -associated diarrhea (CDAD). […]

Source: FDA drug label, Glenmark Pharmaceuticals Inc., USA, effective October 28, 2025 (SPL set ff7428fb-9ce9-4743-b58c-01a05424a57a), via openFDA; the full label on DailyMed

What does the label list?

From the label: adverse reactions

The following adverse reactions are discussed in more detail in other sections of the labeling: • Severe Allergic Reactions [see Warnings and Precautions ( 5.1 )] • Eye Irritation [see Warnings and Precautions ( 5.2 )] • Local Irritation [see Warnings and Precautions ( 5.3 )] • Clostridium difficile -Associated Diarrhea [see Warnings and Precautions ( 5.4 )] • The most frequent adverse reactions (at least 1%) were burning, stinging or pain, and itching. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Glenmark Pharmaceuticals Inc., USA at 1 (888) 721-7115 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …

Source: FDA drug label, Glenmark Pharmaceuticals Inc., USA, effective October 28, 2025 (SPL set ff7428fb-9ce9-4743-b58c-01a05424a57a), via openFDA; the full label on DailyMed

What do FAERS reports show?

13,755 reports list mupirocin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 942 are coded as a death and 3,638 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, 5 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)1,566
  • Off Label Use (a use or a product term, not a reaction)989
  • Nausea (named in the label)954
  • Pain936
  • Product Use In Unapproved Indication (a use or a product term, not a reaction)849
  • Fatigue821
  • Macular Degeneration820
  • Headache765
  • Diarrhoea (named in the label)705
  • Rash (named in the label)615
  • Pruritus589
  • Chronic Kidney Disease585
  • Weight Decreased583
  • Pyrexia548
  • Dyspnoea532
  • Malaise525
  • Pneumonia459
  • Renal Failure458
  • Death (an outcome recorded in the report)450
  • Arthralgia443
  • Acute Kidney Injury434
  • Erythema (named in the label)419
  • Condition Aggravated (a use or a product term, not a reaction)418
  • Dizziness (named in the label)416
  • Constipation404

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

What next?

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