ACYCLOVIR SODIUM

N/A

Manufactured by AuroMedics Pharma LLC

4,002 FDA adverse event reports analyzed

Last updated: 2026-04-15

About ACYCLOVIR SODIUM

ACYCLOVIR SODIUM is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by AuroMedics Pharma LLC. The most commonly reported adverse reactions for ACYCLOVIR SODIUM include DRUG INEFFECTIVE, DYSPNOEA, HEADACHE, PYREXIA, NAUSEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ACYCLOVIR SODIUM.

Top Adverse Reactions

DRUG INEFFECTIVE110 reports
DYSPNOEA108 reports
HEADACHE106 reports
PYREXIA87 reports
NAUSEA82 reports
HYPERTENSION79 reports
ASTHMA75 reports
FATIGUE75 reports
OFF LABEL USE75 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE73 reports
BURNING SENSATION72 reports
SLEEP DISORDER DUE TO A GENERAL MEDICAL CONDITION71 reports
GASTROOESOPHAGEAL REFLUX DISEASE69 reports
DIARRHOEA66 reports
HYPOTHYROIDISM66 reports
CARDIAC DISORDER65 reports
CARPAL TUNNEL SYNDROME65 reports
LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES65 reports
FIBROMYALGIA64 reports
BLOOD TEST ABNORMAL63 reports
SENSITISATION63 reports
RENAL DISORDER62 reports
RHINITIS ALLERGIC62 reports
WHEEZING62 reports
POLYCYSTIC OVARIES61 reports
SLEEP APNOEA SYNDROME61 reports
EJECTION FRACTION54 reports
PLATELET COUNT DECREASED54 reports
PNEUMONIA53 reports
ASTHENIA52 reports
FULL BLOOD COUNT ABNORMAL52 reports
RASH49 reports
VOMITING49 reports
PAIN48 reports
INTENTIONAL PRODUCT USE ISSUE47 reports
NEUTROPENIA47 reports
EJECTION FRACTION ABNORMAL42 reports
OBSTRUCTIVE SLEEP APNOEA SYNDROME42 reports
ACUTE KIDNEY INJURY40 reports
RENAL FAILURE40 reports
ADVERSE EVENT39 reports
ANAEMIA39 reports
HOSPITALISATION38 reports
FEBRILE NEUTROPENIA36 reports
NEPHROPATHY36 reports
WHITE BLOOD CELL COUNT DECREASED35 reports
HAEMOGLOBIN DECREASED34 reports
NEPHRECTOMY34 reports
DIZZINESS33 reports
THROMBOCYTOPENIA32 reports
ANXIETY31 reports
FALL31 reports
RENAL FAILURE ACUTE31 reports
URINARY TRACT INFECTION31 reports
SEPSIS30 reports
DEATH29 reports
HYPOTENSION29 reports
CONSTIPATION28 reports
PRURITUS28 reports
SLEEP DISORDER DUE TO GENERAL MEDICAL CONDITION, INSOMNIA TYPE28 reports
DECREASED APPETITE27 reports
ABDOMINAL PAIN UPPER25 reports
MUCOSAL INFLAMMATION25 reports
CONDITION AGGRAVATED24 reports
DEPRESSION24 reports
INFECTION24 reports
BLOOD CREATININE INCREASED22 reports
COVID 1922 reports
HERPES ZOSTER22 reports
MALAISE22 reports
NEUROPATHY PERIPHERAL22 reports
EPSTEIN BARR VIRUS INFECTION21 reports
CYTOMEGALOVIRUS INFECTION20 reports
EMOTIONAL DISTRESS20 reports
MULTIPLE ORGAN DYSFUNCTION SYNDROME20 reports
PLASMA CELL MYELOMA20 reports
CONFUSIONAL STATE19 reports
PANCYTOPENIA19 reports
WEIGHT DECREASED19 reports
ABDOMINAL PAIN18 reports
ARTHRALGIA18 reports
BLOOD PRESSURE INCREASED18 reports
CHILLS18 reports
DRUG INTERACTION18 reports
ERYTHEMA18 reports
TREMOR18 reports
BACK PAIN17 reports
COUGH17 reports
GENERAL PHYSICAL HEALTH DETERIORATION17 reports
HAEMORRHAGE INTRACRANIAL17 reports
HYPOAESTHESIA17 reports
INSOMNIA17 reports
PRODUCT DOSE OMISSION ISSUE17 reports
ALANINE AMINOTRANSFERASE INCREASED16 reports
ATRIAL FIBRILLATION16 reports
LIVER FUNCTION TEST ABNORMAL16 reports
LYMPHOCYTE COUNT DECREASED16 reports
MUSCULAR WEAKNESS16 reports
POST TRANSPLANT LYMPHOPROLIFERATIVE DISORDER16 reports
RESPIRATORY FAILURE16 reports

Report Outcomes

Out of 1,207 classified reports for ACYCLOVIR SODIUM:

Serious 82.9%Non-Serious 17.1%

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

Female583 (57.4%)
Male431 (42.4%)
Unknown2 (0.2%)

Reports by Age

Age 5471 reports
Age 7223 reports
Age 6721 reports
Age 6218 reports
Age 6318 reports
Age 2317 reports
Age 5917 reports
Age 5816 reports
Age 6016 reports
Age 6416 reports
Age 6516 reports
Age 6916 reports
Age 7316 reports
Age 4114 reports
Age 6114 reports
Age 7014 reports
Age 8313 reports
Age 6612 reports
Age 2611 reports
Age 4511 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 ACYCLOVIR SODIUM?

This profile reflects 4,002 FDA FAERS reports that mention ACYCLOVIR SODIUM. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for ACYCLOVIR SODIUM?

Frequently reported terms in FAERS include DRUG INEFFECTIVE, DYSPNOEA, HEADACHE, PYREXIA, NAUSEA, HYPERTENSION. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures ACYCLOVIR SODIUM?

Labeling and FAERS entries often list AuroMedics Pharma LLC in connection with ACYCLOVIR SODIUM. 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.