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famciclovir Side Effects

Also known as: Famvir

Analysis of 2,678 adverse event reports submitted to the FDA from 2004 to 2025.

Total Reports

2,678

Death-Related

265

9.9% of reports

Hospitalizations

836

31.2% of reports

Top Indication

Product Used For Unknown Indication

Most Reported Adverse Reactions

FATIGUE
185
DIARRHOEA
179
NAUSEA
145
HEADACHE
135
DRUG INEFFECTIVE
133
OFF LABEL USE
125
PAIN
118
RASH
113
DIZZINESS
98
PYREXIA
87
DEATH
86
DYSPNOEA
86
PNEUMONIA
85
VOMITING
77
HERPES ZOSTER
72
ARTHRALGIA
70
FEBRILE NEUTROPENIA
69
MALAISE
69
ASTHENIA
65
MUSCLE SPASMS
65

Who Reports Side Effects

Gender Distribution

Female 1,474 (59%)
Male 1,004 (40%)
Unknown 9

Age Distribution

0-17 72 (4%)
18-44 252 (14%)
45-64 647 (37%)
65-74 438 (25%)
75+ 332 (19%)

Reporting Trend by Year

2004 2025

Reactions in Death Reports

Top reactions reported in 265 reports where death was an outcome. These are voluntarily reported and do not establish causation.

Reaction Reports
DEATH 86
SEPSIS 21
PNEUMONIA 19
NEUTROPENIA 15
DIARRHOEA 12
OFF LABEL USE 12
PLASMA CELL MYELOMA 12
PYREXIA 12
THROMBOCYTOPENIA 12
CARDIAC ARREST 11
ANAEMIA 10
PANCYTOPENIA 10
ABDOMINAL PAIN 9
DRUG INEFFECTIVE 9
DRUG INTOLERANCE 9
HYPOTENSION 9
NAUSEA 9
POST TRANSPLANT LYMPHOPROLIFERATIVE DISORDER 9
ALOPECIA 8
COMPLETED SUICIDE 8

Reactions in Hospitalization Reports

Top reactions in 836 reports where hospitalization was an outcome.

Reaction Reports
PNEUMONIA 58
DIARRHOEA 55
FATIGUE 48
PYREXIA 47
NAUSEA 46
FEBRILE NEUTROPENIA 41
DYSPNOEA 40
VOMITING 36
PAIN 35
FALL 34
URINARY TRACT INFECTION 34
ACUTE KIDNEY INJURY 33
DIZZINESS 33
HYPOTENSION 33
ASTHENIA 31
RASH 31
HEADACHE 29
OFF LABEL USE 28
SEPSIS 28
BACK PAIN 26

Nearby — Related Medications

Compare famciclovir vs acyclovir →

What the FAERS Data Reveals About famciclovir Side Effects

The FDA Adverse Event Reporting System (FAERS) contains 2,678 voluntary reports linked to famciclovir and its brand equivalents (Famvir), spanning 2004 through 2025. Of those, 265 (9.9%) listed death as an outcome and 836 (31.2%) involved hospitalization. The most common indication reported alongside adverse events was Product Used For Unknown Indication.

Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 59% were female and 40% male; age distribution skews toward 45-64, with 647 reports in that bracket. The single most reported reaction is fatigue with 185 submissions, followed by diarrhoea and nausea.

FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice — speak with a licensed clinician about any side-effect concerns.