Drug Safety Information for CISPLATIN (Cisplatin)

Safety-related Labeling Changes for CISPLATIN (CISPLATIN) Brand name discontinued; available as generic: FDA Link

Aortic thrombosis Evaluating

Adverse Drug Reactions for CISPLATIN* (Cisplatin)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with CISPLATIN
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Nausea2397
2Vomiting2247
3Dehydration1892
4Neutropenia1659
5Diarrhoea1652
6Febrile neutropenia1504
7Pyrexia1434
8Anaemia1203
9Thrombocytopenia1119
10Pneumonia975
11Dyspnoea918
12Asthenia902
13Renal failure acute897
14Fatigue884
15Mucosal inflammation873
16Haemoglobin decreased816
17Decreased appetite806
18White blood cell count decreased786
19Neoplasm malignant769
20Death734

* This side effect also appears in "Top 10 Side Effects of CISPLATIN " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking CISPLATIN
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Non-small cell lung cancer7196
2Gastric cancer3762
3Multiple myeloma3150
4Head and neck cancer2957
5Oesophageal carcinoma2124
6Small cell lung cancer stage unspecified2091
7Neoplasm malignant1944
8Squamous cell carcinoma1808
9Lung neoplasm malignant1414
10Chemotherapy1301

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for CISPLATIN

Total Reports Filed with FDA: 95558


Number of FDA Adverse Event Reports by Patient Age for CISPLATIN

Total Reports Filed with FDA: 95558*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Cisplatin (Platinol-aq, Cisplatin, Platosin, Platinex, Neoplatin, Platidiam, Platinol)

Charts are based on 95558 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and CISPLATIN Reviews and Review Summary .

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.