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Drug side effects

famciclovir Side Effects

The reactions most often reported to the FDA for famciclovir (also sold as Famvir), with demographics, serious outcomes, and reporting trends.

Data updated 2026-05-15

2,678
FAERS reports

Data from the FDA Adverse Event Reporting System (FAERS), 2004 to 2025. A FAERS report records a temporal association, not proof of cause. See our methodology for how figures are compiled and de-duplicated.

The most commonly reported side effects of famciclovir come from 2,678 reports to the FDA, broken down here by frequency, patient demographics, and serious outcomes.

This page analyzes 2,678 reports to the FDA Adverse Event Reporting System (FAERS) for famciclovir (Famvir): the reactions reported most often, who reported them, serious outcomes such as hospitalization, and year-over-year trends. A FAERS report does not prove the drug caused the effect, and report volume tracks how widely a drug is used, not how likely an effect is for any one person. Educational information, not medical advice.

Total Reports

2,678

Reports Mentioning Death

265

9.9% of reports — not proof the medicine caused the death

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
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
PLASMA CELL MYELOMA 12
PYREXIA 12
THROMBOCYTOPENIA 12
CARDIAC ARREST 11
ANAEMIA 10
PANCYTOPENIA 10
ABDOMINAL PAIN 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
SEPSIS 28
BACK PAIN 26

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.

How to read these numbers

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.

Drugs With a Similar FAERS Report Volume

Other medications with a total FDA adverse-event report count closest to famciclovir's 2,678.