Drug Safety Information for FAMVIR (Famciclovir)

Safety-related Labeling Changes for FAMVIR (FAMCICLOVIR) Brand name discontinued; available as generic: FDA Link

Adverse Drug Reactions for FAMVIR* (Famciclovir)

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 FAMVIR
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Nausea	130
2	Pyrexia	104
3	Diarrhoea*	103
4	Pain*	99
5	Fatigue*	96
6	Dyspnoea	95
7	Headache*	95
8	Vomiting*	91
9	Dizziness*	91
10	Asthenia	88
11	Rash	84
12	Pneumonia	80
13	Anxiety	78
14	Anaemia	72
15	Herpes zoster	71
16	Malaise	69
17	Oedema peripheral	69
18	Drug ineffective	67
19	Abdominal pain	62
20	Thrombocytopenia	61

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

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

	Reason	# of FDA Reports
1	Herpes zoster*	1269
2	Product used for unknown indication	570
3	Herpes simplex	285
4	Prophylaxis	211
5	Herpes virus infection	202
6	Mouth ulceration	172
7	Infection prophylaxis	130
8	Oral herpes*	105
9	Antiviral prophylaxis	85
10	Genital herpes*	55

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

Types of Adverse Events for FAMVIR

Total Reports Filed with FDA: 12717

Number of FDA Adverse Event Reports by Patient Age for FAMVIR

Total Reports Filed with FDA: 12717*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Famciclovir (Famvir, Famciclovir)

Charts are based on 12717 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.