Drug Safety Information for LEUCOVORIN CALCIUM (Leucovorin calcium)

Adverse Drug Reactions for LEUCOVORIN CALCIUM* (Leucovorin calcium)

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 LEUCOVORIN CALCIUM
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Diarrhoea1935
2Nausea*1379
3Vomiting1345
4Neutropenia1158
5Pyrexia1097
6Disease progression974
7Death833
8Dehydration822
9Abdominal pain789
10Dyspnoea778
11Febrile neutropenia777
12Fatigue*754
13Thrombocytopenia681
14Anaemia642
15Asthenia624
16Decreased appetite564
17Mucosal inflammation539
18Pulmonary embolism526
19Neuropathy peripheral507
20Sepsis500

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

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

Reason # of FDA Reports
1Colorectal cancer metastatic8762
2Colon cancer5814
3Colorectal cancer4781
4Product used for unknown indication4149
5Colon cancer metastatic2157
6Rectal cancer1852
7Chemotherapy1288
8Gastric cancer1182
9Metastases to liver699
10Pancreatic carcinoma649

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


Types of Adverse Events for LEUCOVORIN CALCIUM

Total Reports Filed with FDA: 77555


Number of FDA Adverse Event Reports by Patient Age for LEUCOVORIN CALCIUM

Total Reports Filed with FDA: 77555*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Leucovorin calcium (Wellcovorin, Levofolinic acid, Folinate calcium, Leucovorin, Leukovorin, Citrovorum, Levoleucovorin, Levofolinate, Lederfolin, Calcium folinate, Levofolinate calcium, Folinic acid, Lv, Acido folinico, Cf, Citrovorum factor, Leucovorin calcium)

Charts are based on 77555 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.

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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.