Drug Safety Information for DENAVIR (Penciclovir sodium)

Safety-related Labeling Changes for DENAVIR (PENCICLOVIR SODIUM) Rx Drug: FDA Link

Adverse Drug Reactions for DENAVIR* (Penciclovir 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 DENAVIR
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Headache	18
2	Pain	14
3	Asthenia	13
4	Chest pain	13
5	Anxiety	12
6	Back pain	12
7	Hypoaesthesia	12
8	Nausea	12
9	Hypertension	11
10	Dyspnoea	11
11	Dyspepsia	11
12	Drug ineffective	11
13	Vomiting	10
14	Depression	10
15	Abdominal pain	10
16	Diarrhoea	9
17	Injury	9
18	Economic problem	9
19	Fatigue	9
20	Paraesthesia	8

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

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

	Reason	# of FDA Reports
1	Product used for unknown indication	197
2	Oral herpes	129
3	Herpes simplex	115
4	Lip disorder	26
5	Psoriasis	14
6	Prophylaxis	13
7	Hepatitis c	12
8	Herpes zoster	10
9	Paraesthesia oral	5
10	Acne	4

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

Types of Adverse Events for DENAVIR

Total Reports Filed with FDA: 1363

Number of FDA Adverse Event Reports by Patient Age for DENAVIR

Total Reports Filed with FDA: 1363*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Penciclovir sodium (Penciclovir, Denavir)

Charts are based on 1363 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.

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.