Drug Safety Information for ACYCLOVIR SODIUM (Acyclovir sodium)

Safety-related Labeling Changes for ZOVIRAX (ACYCLOVIR SODIUM) Rx Drug: FDA Link

Adverse Drug Reactions for ACYCLOVIR SODIUM* (Acyclovir sodium)

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 ACYCLOVIR SODIUM
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Pyrexia1848
2Pneumonia1328
3Diarrhoea*1275
4Nausea*1225
5Febrile neutropenia1147
6Drug ineffective1018
7Renal failure acute1006
8Dyspnoea983
9Fatigue*973
10Vomiting941
11Neutropenia896
12Sepsis815
13Pain*803
14Thrombocytopenia791
15Rash789
16Death773
17Anaemia769
18Asthenia735
19Platelet count decreased735
20Headache*717

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

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

Reason # of FDA Reports
1Product used for unknown indication11639
2Prophylaxis5378
3Herpes zoster*5199
4Antiviral prophylaxis4819
5Infection prophylaxis3102
6Herpes virus infection2070
7Herpes simplex*1691
8Oral herpes*1181
9Genital herpes*982
10Encephalitis herpes631

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


Types of Adverse Events for ACYCLOVIR SODIUM

Total Reports Filed with FDA: 125921


Number of FDA Adverse Event Reports by Patient Age for ACYCLOVIR SODIUM

Total Reports Filed with FDA: 125921*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Acyclovir sodium (Virolex, Acic, Sitavig, Acv, Acivir, Avirax, Acyclovir sodium, Aciclostad, Activir, Aciclovir, Acyclo-v, Aciclovir sodium, Virzin, Zovirax, Acyclovir)

Charts are based on 125921 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 ACYCLOVIR SODIUM 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.