Drug Safety Information for VALACYCLOVIR HYDROCHLORIDE (Valacyclovir hydrochloride)

Safety-related Labeling Changes for VALTREX (VALACYCLOVIR HYDROCHLORIDE) Rx Drug: FDA Link

Adverse Drug Reactions for VALACYCLOVIR HYDROCHLORIDE* (Valacyclovir 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 VALACYCLOVIR HYDROCHLORIDE
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Drug ineffective1550
2Nausea*1256
3Headache*922
4Pyrexia921
5Dizziness*859
6Fatigue*842
7Diarrhoea*830
8Vomiting812
9Pain*778
10Renal failure acute758
11Rash649
12Dyspnoea616
13Pneumonia572
14Malaise553
15Asthenia541
16Decreased appetite503
17Febrile neutropenia460
18Anxiety455
19Blood creatinine increased451
20Herpes zoster437

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

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

Reason # of FDA Reports
1Herpes zoster*11984
2Product used for unknown indication9589
3Prophylaxis2635
4Herpes virus infection2612
5Genital herpes*2556
6Herpes simplex*1809
7Antiviral prophylaxis1633
8Oral herpes*1496
9Infection prophylaxis777
10Antiviral treatment247

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


Types of Adverse Events for VALACYCLOVIR HYDROCHLORIDE

Total Reports Filed with FDA: 85238


Number of FDA Adverse Event Reports by Patient Age for VALACYCLOVIR HYDROCHLORIDE

Total Reports Filed with FDA: 85238*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Valacyclovir hydrochloride (Valaciclovir, Valacyclovir, Valtrex)

Charts are based on 85238 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.