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What the label lists and what reports show

Cisplatin side effects

Cisplatin's FDA label lists its adverse reactions in its own words. FAERS holds 77,664 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 (5,438 reports).

  • Generic listed
  • Boxed warning

Check it at the source: the cisplatin FDA label on DailyMed (effective September 16, 2021, WG Critical Care, LLC); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

Nephrotoxicity Dose-related and cumulative renal insufficiency, including acute renal failure, is the major dose-limiting toxicity of cisplatin. Renal toxicity has been noted in 28% to 36% of patients treated with a single dose of 50 mg/m 2 . It is first noted during the second week after a dose and is manifested by elevations in BUN and creatinine, serum uric acid and/or a decrease in creatinine clearance. Renal toxicity becomes more prolonged and severe with repeated courses of the drug. Renal function must return to normal before another dose of cisplatin can be given. Elderly patients may be more susceptible to nephrotoxicity (see PRECAUTIONS, Geriatric Use ). Impairment of renal function has been associated with renal tubular damage. The administration of cisplatin using a 6- to 8-hour infusion with intravenous hydration, and mannitol has been used to reduce nephrotoxicity. …

Source: FDA drug label, NDA018057 (Hq Spclt Pharma), as published by WG Critical Care, LLC, effective September 16, 2021 (SPL set 2bf8d2fb-80c8-401d-8e9b-d58463f5e954), via openFDA; the full label on DailyMed

What do FAERS reports show?

77,664 reports list cisplatin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 14,919 are coded as a death and 32,401 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, 7 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

  • Off Label Use (a use or a product term, not a reaction)5,885
  • Nausea (named in the label)5,438
  • Neutropenia (named in the label)4,876
  • Disease Progression (a use or a product term, not a reaction)4,658
  • Febrile Neutropenia4,607
  • Vomiting (named in the label)4,566
  • Anaemia (named in the label)4,050
  • Thrombocytopenia (named in the label)3,787
  • Diarrhoea (named in the label)3,759
  • Pyrexia3,398
  • Drug Ineffective (a use or a product term, not a reaction)3,296
  • Malignant Neoplasm Progression3,290
  • Death (an outcome recorded in the report)2,724
  • Myelosuppression (named in the label)2,662
  • Fatigue2,505
  • Dehydration2,459
  • Pneumonia2,362
  • Sepsis2,096
  • Asthenia2,057
  • Dyspnoea1,942
  • Mucosal Inflammation1,927
  • Pancytopenia1,912
  • Decreased Appetite1,884
  • Acute Kidney Injury1,863
  • Platelet Count Decreased1,763

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

What next?

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