FAMCICLOVIR

N/A

Manufactured by Apotex Corp.

5,037 FDA adverse event reports analyzed

Last updated: 2026-04-15

About FAMCICLOVIR

FAMCICLOVIR is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Apotex Corp.. The most commonly reported adverse reactions for FAMCICLOVIR include FATIGUE, DIARRHOEA, NAUSEA, HEADACHE, DRUG INEFFECTIVE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for FAMCICLOVIR.

Top Adverse Reactions

FATIGUE185 reports
DIARRHOEA179 reports
NAUSEA145 reports
HEADACHE135 reports
DRUG INEFFECTIVE133 reports
OFF LABEL USE125 reports
PAIN118 reports
RASH113 reports
DIZZINESS98 reports
PYREXIA87 reports
DEATH86 reports
DYSPNOEA86 reports
PNEUMONIA85 reports
VOMITING77 reports
HERPES ZOSTER72 reports
ARTHRALGIA70 reports
FEBRILE NEUTROPENIA69 reports
MALAISE69 reports
ASTHENIA65 reports
MUSCLE SPASMS65 reports
BACK PAIN64 reports
PRURITUS64 reports
URINARY TRACT INFECTION62 reports
ANXIETY61 reports
FALL61 reports
NEUROPATHY PERIPHERAL57 reports
WEIGHT DECREASED57 reports
CONSTIPATION55 reports
DECREASED APPETITE53 reports
HYPERTENSION53 reports
ACUTE KIDNEY INJURY52 reports
PLATELET COUNT DECREASED52 reports
ABDOMINAL PAIN51 reports
NEUTROPENIA50 reports
CONDITION AGGRAVATED48 reports
EYE PAIN48 reports
PRODUCT DOSE OMISSION ISSUE47 reports
INSOMNIA46 reports
PAIN IN EXTREMITY46 reports
WEIGHT INCREASED46 reports
HYPOTENSION45 reports
RENAL FAILURE44 reports
WHITE BLOOD CELL COUNT DECREASED44 reports
OEDEMA PERIPHERAL43 reports
VISION BLURRED43 reports
ANAEMIA42 reports
CHEST PAIN42 reports
COUGH42 reports
DRUG HYPERSENSITIVITY41 reports
SEPSIS41 reports
HYPOAESTHESIA39 reports
SINUSITIS39 reports
CHEST DISCOMFORT38 reports
COVID 1938 reports
DEPRESSION38 reports
PARAESTHESIA38 reports
CHRONIC KIDNEY DISEASE36 reports
GAIT DISTURBANCE35 reports
ABDOMINAL PAIN UPPER34 reports
HAEMOGLOBIN DECREASED34 reports
EMOTIONAL DISTRESS33 reports
ERYTHEMA33 reports
PANCYTOPENIA33 reports
THROMBOCYTOPENIA33 reports
APLASTIC ANAEMIA32 reports
EPISTAXIS32 reports
FEELING ABNORMAL32 reports
SOMNOLENCE32 reports
EYE IRRITATION31 reports
ALOPECIA30 reports
CONFUSIONAL STATE30 reports
INFECTION30 reports
STOMATITIS30 reports
DISEASE PROGRESSION28 reports
PALPITATIONS28 reports
PERIPHERAL SWELLING28 reports
PLASMA CELL MYELOMA28 reports
TREMOR28 reports
ABDOMINAL DISCOMFORT27 reports
CHILLS27 reports
DYSPEPSIA27 reports
FLUSHING27 reports
NASOPHARYNGITIS27 reports
RASH PRURITIC27 reports
RENAL IMPAIRMENT27 reports
ATRIAL FIBRILLATION26 reports
MYALGIA26 reports
ANHEDONIA25 reports
BLOOD CREATININE INCREASED25 reports
BLOOD PRESSURE INCREASED25 reports
BRONCHITIS25 reports
DEHYDRATION25 reports
DRUG INTERACTION25 reports
PRODUCT USE IN UNAPPROVED INDICATION25 reports
BALANCE DISORDER24 reports
DRUG RESISTANCE24 reports
CATARACT23 reports
HYPOKALAEMIA23 reports
HYPONATRAEMIA23 reports
ABDOMINAL DISTENSION22 reports

Report Outcomes

Out of 2,677 classified reports for FAMCICLOVIR:

Serious 69.9%Non-Serious 30.1%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female1,474 (59.3%)
Male1,004 (40.4%)
Unknown9 (0.4%)

Reports by Age

Age 6861 reports
Age 6057 reports
Age 6154 reports
Age 6254 reports
Age 7254 reports
Age 6950 reports
Age 6747 reports
Age 6346 reports
Age 6542 reports
Age 6441 reports
Age 7441 reports
Age 4839 reports
Age 7338 reports
Age 5637 reports
Age 7737 reports
Age 7036 reports
Age 7136 reports
Age 7535 reports
Age 8035 reports
Age 5734 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with FAMCICLOVIR?

This profile reflects 5,037 FDA FAERS reports that mention FAMCICLOVIR. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for FAMCICLOVIR?

Frequently reported terms in FAERS include FATIGUE, DIARRHOEA, NAUSEA, HEADACHE, DRUG INEFFECTIVE, OFF LABEL USE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures FAMCICLOVIR?

Labeling and FAERS entries often list Apotex Corp. in connection with FAMCICLOVIR. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.