FLUVASTATIN SODIUM

N/A

Manufactured by Sandoz Inc

11,133 FDA adverse event reports analyzed

Last updated: 2026-04-15

About FLUVASTATIN SODIUM

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

Top Adverse Reactions

MYALGIA318 reports
NAUSEA315 reports
DIZZINESS294 reports
FATIGUE275 reports
DRUG INEFFECTIVE253 reports
DIARRHOEA251 reports
DYSPNOEA245 reports
ASTHENIA243 reports
MYOCARDIAL INFARCTION219 reports
FALL205 reports
VOMITING205 reports
ARTHRALGIA196 reports
HEADACHE191 reports
CEREBROVASCULAR ACCIDENT180 reports
PYREXIA179 reports
ABDOMINAL PAIN172 reports
PRURITUS165 reports
PAIN164 reports
INSOMNIA163 reports
MALAISE161 reports
CHEST PAIN149 reports
COUGH138 reports
RENAL FAILURE137 reports
PAIN IN EXTREMITY136 reports
DRUG INTERACTION135 reports
HYPERTENSION131 reports
BLOOD CREATINE PHOSPHOKINASE INCREASED126 reports
ALANINE AMINOTRANSFERASE INCREASED125 reports
ASPARTATE AMINOTRANSFERASE INCREASED124 reports
ABDOMINAL PAIN UPPER117 reports
SOMNOLENCE114 reports
OEDEMA PERIPHERAL113 reports
RHABDOMYOLYSIS113 reports
DECREASED APPETITE108 reports
ANAEMIA103 reports
BACK PAIN103 reports
DEPRESSION103 reports
ANXIETY102 reports
BLOOD PRESSURE INCREASED102 reports
BLOOD CREATININE INCREASED100 reports
SEPSIS100 reports
GAIT DISTURBANCE99 reports
SYNCOPE98 reports
WEIGHT DECREASED98 reports
CHILLS97 reports
DEATH97 reports
MUSCULAR WEAKNESS97 reports
PNEUMONIA97 reports
HYPOTENSION91 reports
RENAL FAILURE ACUTE91 reports
TACHYCARDIA91 reports
CARDIAC FAILURE CONGESTIVE86 reports
MUSCLE SPASMS86 reports
BLOOD GLUCOSE INCREASED85 reports
CARDIO RESPIRATORY ARREST84 reports
RASH82 reports
FEELING ABNORMAL80 reports
ATRIAL FIBRILLATION79 reports
COMA79 reports
LOSS OF CONSCIOUSNESS79 reports
VISION BLURRED79 reports
BLINDNESS78 reports
DEHYDRATION78 reports
EYE PAIN73 reports
ASCITES72 reports
CONDITION AGGRAVATED72 reports
PARAESTHESIA72 reports
ALTERED STATE OF CONSCIOUSNESS71 reports
CORONARY ARTERY DISEASE71 reports
HAEMATEMESIS70 reports
HAEMATURIA70 reports
HYPOAESTHESIA69 reports
HAEMOGLOBIN DECREASED68 reports
HEAD DISCOMFORT68 reports
BLOOD CHOLESTEROL INCREASED67 reports
HAEMORRHAGIC STROKE66 reports
CONFUSIONAL STATE65 reports
GAMMA GLUTAMYLTRANSFERASE INCREASED65 reports
BLOOD ALKALINE PHOSPHATASE INCREASED64 reports
DRUG HYPERSENSITIVITY64 reports
OCULAR DISCOMFORT64 reports
WEIGHT INCREASED64 reports
AMAUROSIS FUGAX63 reports
BRADYCARDIA63 reports
PRESYNCOPE63 reports
HYPERKALAEMIA62 reports
GASTROOESOPHAGEAL REFLUX DISEASE61 reports
CONSTIPATION60 reports
CHRONIC KIDNEY DISEASE58 reports
DIABETES MELLITUS58 reports
TINNITUS58 reports
URINARY TRACT INFECTION58 reports
OFF LABEL USE57 reports
ACUTE KIDNEY INJURY55 reports
ERYTHEMA55 reports
TRANSIENT ISCHAEMIC ATTACK54 reports
DIPLOPIA53 reports
BLOOD UREA INCREASED52 reports
HYPOKALAEMIA52 reports
TREMOR52 reports

Report Outcomes

Out of 4,436 classified reports for FLUVASTATIN SODIUM:

Serious 81.4%Non-Serious 18.6%

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

Female2,310 (54.9%)
Male1,884 (44.8%)
Unknown13 (0.3%)

Reports by Age

Age 74114 reports
Age 76112 reports
Age 78112 reports
Age 73104 reports
Age 70101 reports
Age 72101 reports
Age 65100 reports
Age 7590 reports
Age 6689 reports
Age 6889 reports
Age 6187 reports
Age 7187 reports
Age 6485 reports
Age 5982 reports
Age 6282 reports
Age 6781 reports
Age 7778 reports
Age 6977 reports
Age 6374 reports
Age 5869 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 FLUVASTATIN SODIUM?

This profile reflects 11,133 FDA FAERS reports that mention FLUVASTATIN SODIUM. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for FLUVASTATIN SODIUM?

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

Who manufactures FLUVASTATIN SODIUM?

Labeling and FAERS entries often list Sandoz Inc in connection with FLUVASTATIN 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.