Drug Safety Information for VALCYTE (Valganciclovir hydrochloride)

Safety-related Labeling Changes for VALCYTE (VALGANCICLOVIR HYDROCHLORIDE) Rx Drug: FDA Link

Adverse Drug Reactions for VALCYTE* (Valganciclovir hydrochloride)

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 VALCYTE
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Pyrexia357
2Death324
3Cytomegalovirus infection299
4Diarrhoea289
5Leukopenia221
6Blood creatinine increased217
7Pneumonia195
8Neutropenia193
9Nausea*190
10Anaemia184
11Sepsis173
12Vomiting170
13Transplant rejection161
14Pancytopenia151
15Renal failure acute147
16White blood cell count decreased135
17Urinary tract infection132
18Thrombocytopenia128
19Kidney transplant rejection128
20Renal failure124

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

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

Reason # of FDA Reports
1Product used for unknown indication2545
2Antiviral prophylaxis1333
3Cytomegalovirus infection1213
4Prophylaxis678
5Infection prophylaxis488
6Cytomegalovirus chorioretinitis282
7Renal transplant180
8Cytomegalovirus viraemia112
9Encephalitis cytomegalovirus101
10Antiviral treatment100

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


Types of Adverse Events for VALCYTE

Total Reports Filed with FDA: 20080


Number of FDA Adverse Event Reports by Patient Age for VALCYTE

Total Reports Filed with FDA: 20080*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Valganciclovir hydrochloride (Valganciclovir, Valganciclovir hcl, Valcyte)

Charts are based on 20080 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 VALCYTE Reviews and Review Summary .

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.

Visit   DrugInformer.com more on VALCYTE's side effects.