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What the label lists and what reports show

Colchicine and probenecid side effects

Colchicine and probenecid's FDA label lists its adverse reactions in its own words. FAERS holds 102 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 toxicity to various agents (39 reports).

  • Generic listed

Check it at the source: the colchicine and probenecid FDA label on DailyMed (effective January 27, 2026, Rising Pharma Holdings, Inc.); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

The following adverse reactions have been observed and within each category are listed in order of decreasing severity. Probenecid Central Nervous System: headache, dizziness. Metabolic: precipitation of acute gouty arthritis. Gastrointestinal: hepatic necrosis, vomiting, nausea, anorexia, sore gums. Genitourinary: nephrotic syndrome, uric acid stones with or without hematuria, renal colic, costovertebral pain, urinary frequency. Hypersensitivity: anaphylaxis, fever, urticaria, pruritus. Hematologic: aplastic anemia, leukopenia, hemolytic anemia which in some patients could be related to genetic deficiency of glucose-6-phosphate dehydrogenase in red blood cells, anemia. Integumentary: dermatitis, alopecia, flushing. Colchicine Side effects due to colchicine appear to be a function of dosage. …

Source: FDA drug label, Rising Pharma Holdings, Inc., effective January 27, 2026 (SPL set 3d2a3d4f-38a3-4669-ad78-ab1d7aef4ec3), via openFDA; the full label on DailyMed

What do FAERS reports show?

102 reports list colchicine and probenecid among the medicines taken, each a report of something that happened, not proof the medicine caused it; 24 are coded as a death and 54 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 21 reactions below, 6 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

  • Toxicity To Various Agents39
  • Diarrhoea (named in the label)29
  • Multiple Organ Dysfunction Syndrome18
  • Intentional Overdose (a use or a product term, not a reaction)16
  • Vomiting (named in the label)13
  • Drug Interaction (a use or a product term, not a reaction)12
  • Rhabdomyolysis11
  • Neuromyopathy10
  • Pancytopenia10
  • Myopathy9
  • Alopecia (named in the label)8
  • Disseminated Intravascular Coagulation8
  • Drug Intolerance8
  • Nausea (named in the label)8
  • Product Use In Unapproved Indication (a use or a product term, not a reaction)8
  • Acute Kidney Injury7
  • Leukocytosis7
  • Muscular Weakness (named in the label)7
  • Myalgia7
  • Abdominal Pain (named in the label)6
  • Hypotension6
  • Overdose (a use or a product term, not a reaction)6
  • Pyrexia6
  • Shock6
  • Thrombocytopenia6

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

What next?

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