VALGANCICLOVIR

N/A

Manufactured by H2-Pharma, LLC

36,658 FDA adverse event reports analyzed

Last updated: 2026-04-14

About VALGANCICLOVIR

VALGANCICLOVIR is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by H2-Pharma, LLC. The most commonly reported adverse reactions for VALGANCICLOVIR include OFF LABEL USE, CYTOMEGALOVIRUS INFECTION, DRUG INEFFECTIVE, NEUTROPENIA, PYREXIA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for VALGANCICLOVIR.

Top Adverse Reactions

OFF LABEL USE2,858 reports
CYTOMEGALOVIRUS INFECTION1,756 reports
DRUG INEFFECTIVE1,426 reports
NEUTROPENIA1,096 reports
PYREXIA940 reports
DIARRHOEA916 reports
LEUKOPENIA914 reports
ACUTE KIDNEY INJURY797 reports
DEATH753 reports
CYTOMEGALOVIRUS VIRAEMIA722 reports
PANCYTOPENIA662 reports
DRUG RESISTANCE637 reports
TRANSPLANT REJECTION631 reports
ANAEMIA620 reports
THROMBOCYTOPENIA605 reports
PNEUMONIA585 reports
PRODUCT USE IN UNAPPROVED INDICATION551 reports
NAUSEA501 reports
SEPSIS496 reports
RENAL IMPAIRMENT477 reports
CYTOMEGALOVIRUS INFECTION REACTIVATION468 reports
VOMITING436 reports
DRUG INTERACTION421 reports
BLOOD CREATININE INCREASED406 reports
URINARY TRACT INFECTION384 reports
INTENTIONAL PRODUCT USE ISSUE378 reports
RENAL FAILURE373 reports
PATHOGEN RESISTANCE359 reports
DYSPNOEA355 reports
FATIGUE353 reports
SEPTIC SHOCK345 reports
RESPIRATORY FAILURE331 reports
NO ADVERSE EVENT324 reports
FEBRILE NEUTROPENIA322 reports
CONDITION AGGRAVATED310 reports
COVID 19306 reports
ABDOMINAL PAIN305 reports
KIDNEY TRANSPLANT REJECTION303 reports
TOXICITY TO VARIOUS AGENTS298 reports
ASTHENIA295 reports
INFECTION285 reports
BK VIRUS INFECTION278 reports
HEADACHE268 reports
HYPOTENSION264 reports
WEIGHT DECREASED261 reports
COUGH259 reports
HAEMOGLOBIN DECREASED259 reports
CYTOMEGALOVIRUS COLITIS257 reports
MYELOSUPPRESSION251 reports
HYPERTENSION247 reports
WHITE BLOOD CELL COUNT DECREASED247 reports
EPSTEIN BARR VIRUS INFECTION240 reports
NEPHROPATHY TOXIC240 reports
MULTIPLE ORGAN DYSFUNCTION SYNDROME235 reports
PAIN235 reports
DECREASED APPETITE234 reports
PRODUCT USE ISSUE227 reports
AGRANULOCYTOSIS225 reports
CYTOMEGALOVIRUS CHORIORETINITIS221 reports
POLYOMAVIRUS ASSOCIATED NEPHROPATHY215 reports
THROMBOTIC MICROANGIOPATHY214 reports
RASH211 reports
POST TRANSPLANT LYMPHOPROLIFERATIVE DISORDER210 reports
TREMOR209 reports
MALAISE208 reports
OEDEMA PERIPHERAL202 reports
ASPERGILLUS INFECTION199 reports
HYPERKALAEMIA190 reports
PNEUMOCYSTIS JIROVECII PNEUMONIA188 reports
CHRONIC KIDNEY DISEASE186 reports
LYMPHOPENIA185 reports
PLEURAL EFFUSION181 reports
IMMUNOSUPPRESSANT DRUG LEVEL INCREASED176 reports
ENTEROCOCCAL INFECTION173 reports
PLATELET COUNT DECREASED172 reports
DIZZINESS170 reports
NOCARDIOSIS170 reports
DEHYDRATION169 reports
BONE MARROW FAILURE165 reports
COMPLICATIONS OF TRANSPLANTED KIDNEY165 reports
CANDIDA INFECTION164 reports
COLITIS164 reports
ESCHERICHIA INFECTION163 reports
RENAL TUBULAR NECROSIS163 reports
STAPHYLOCOCCAL INFECTION153 reports
BRONCHOPULMONARY ASPERGILLOSIS151 reports
KLEBSIELLA INFECTION151 reports
PSEUDOMONAS INFECTION149 reports
ATRIAL FIBRILLATION148 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION144 reports
FUNGAL INFECTION144 reports
CYTOPENIA143 reports
ENCEPHALITIS CYTOMEGALOVIRUS143 reports
GRAFT VERSUS HOST DISEASE141 reports
DIABETES MELLITUS140 reports
TRANSPLANT DYSFUNCTION140 reports
RESPIRATORY DISTRESS139 reports
CYTOMEGALOVIRUS TEST POSITIVE138 reports
END STAGE RENAL DISEASE137 reports
HYPONATRAEMIA137 reports

Report Outcomes

Out of 18,048 classified reports for VALGANCICLOVIR:

Serious 92.8%Non-Serious 7.2%

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

Male9,375 (59.4%)
Female6,362 (40.3%)
Unknown39 (0.2%)

Reports by Age

Age 63400 reports
Age 68342 reports
Age 66337 reports
Age 65335 reports
Age 55317 reports
Age 59313 reports
Age 56311 reports
Age 62296 reports
Age 64296 reports
Age 58291 reports
Age 52282 reports
Age 60282 reports
Age 54276 reports
Age 61272 reports
Age 57263 reports
Age 67251 reports
Age 53250 reports
Age 50243 reports
Age 43240 reports
Age 51230 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 VALGANCICLOVIR?

This profile reflects 36,658 FDA FAERS reports that mention VALGANCICLOVIR. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for VALGANCICLOVIR?

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

Who manufactures VALGANCICLOVIR?

Labeling and FAERS entries often list H2-Pharma, LLC in connection with VALGANCICLOVIR. 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.