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What the label lists and what reports show

Colistimethate side effects

Colistimethate's FDA label lists its adverse reactions in its own words. FAERS holds 1,645 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 acute kidney injury (83 reports).

  • Generic listed

Check it at the source: the colistimethate FDA label on DailyMed (effective January 12, 2026, Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

The following adverse reactions have been reported: Gastrointestinal: gastrointestinal upset Nervous System: tingling of extremities and tongue, slurred speech, dizziness, vertigo, paresthesia, and seizures Integumentary: generalized itching, urticaria and rash Body as a Whole: fever and anaphylaxis Laboratory Deviations: increased blood urea nitrogen (BUN), elevated creatinine and decreased creatinine clearance Respiratory System: respiratory distress and apnea Renal System: electrolyte and acid/base abnormalities (i.e., Pseudo-Bartter syndrome), nephrotoxicity and decreased urine output To report SUSPECTED ADVERSE REACTIONS, contact Avet Pharmaceuticals Inc. at 1-866-901-DRUG (3784) or MEDWATCH at 1-800-FDA-1088 (1-800-332-1088) or http://www.fda.gov/medwatch/.

Source: FDA drug label, Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc., effective January 12, 2026 (SPL set 6a335659-03b0-4a2d-9cd4-7dcf7da96fe6), via openFDA; the full label on DailyMed

What do FAERS reports show?

1,645 reports list colistimethate among the medicines taken, each a report of something that happened, not proof the medicine caused it; 214 are coded as a death and 904 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, 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)159
  • Hospitalisation (an outcome recorded in the report)131
  • Acute Kidney Injury83
  • Infective Pulmonary Exacerbation Of Cystic Fibrosis78
  • Condition Aggravated (a use or a product term, not a reaction)74
  • Drug Ineffective (a use or a product term, not a reaction)74
  • Dyspnoea72
  • Cystic Fibrosis67
  • Pneumonia (a use or a product term, not a reaction)67
  • Death (an outcome recorded in the report)64
  • Infection (a use or a product term, not a reaction)61
  • Septic Shock54
  • Renal Failure47
  • Multiple Organ Dysfunction Syndrome41
  • Cough39
  • Pseudomonas Infection39
  • Pyrexia39
  • Thrombocytopenia39
  • Pathogen Resistance38
  • Eosinophilia36
  • Leukocytosis35
  • Malaise35
  • Hepatic Cytolysis33
  • Nephropathy Toxic32
  • Rash Maculo-Papular31

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

What next?

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