DANTROLENE SODIUM

N/A

Manufactured by Endo USA, Inc.

2,376 FDA adverse event reports analyzed

Last updated: 2026-04-15

About DANTROLENE SODIUM

DANTROLENE SODIUM is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Endo USA, Inc.. The most commonly reported adverse reactions for DANTROLENE SODIUM include NEUROLEPTIC MALIGNANT SYNDROME, PYREXIA, PNEUMONIA, ASTHENIA, RESPIRATORY FAILURE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for DANTROLENE SODIUM.

Top Adverse Reactions

NEUROLEPTIC MALIGNANT SYNDROME79 reports
PYREXIA62 reports
PNEUMONIA61 reports
ASTHENIA59 reports
RESPIRATORY FAILURE59 reports
DRUG INEFFECTIVE57 reports
OFF LABEL USE55 reports
VOMITING53 reports
URINARY TRACT INFECTION51 reports
DIARRHOEA47 reports
NAUSEA45 reports
MUSCULAR WEAKNESS44 reports
CONVULSION41 reports
FATIGUE41 reports
HYPERTENSION35 reports
DYSPNOEA34 reports
PAIN34 reports
CONDITION AGGRAVATED33 reports
HEADACHE33 reports
MUSCLE SPASMS32 reports
MALAISE31 reports
MUSCLE SPASTICITY31 reports
SOMNOLENCE31 reports
FALL30 reports
RENAL FAILURE30 reports
BLOOD CREATINE PHOSPHOKINASE INCREASED28 reports
DYSPHAGIA28 reports
MULTIPLE SCLEROSIS RELAPSE28 reports
TREMOR28 reports
HYPERHIDROSIS27 reports
HYPOTENSION27 reports
DRUG INTERACTION26 reports
RHABDOMYOLYSIS26 reports
MUSCULOSKELETAL STIFFNESS24 reports
INSOMNIA23 reports
TACHYCARDIA23 reports
PRURITUS21 reports
ANXIETY20 reports
DISSEMINATED INTRAVASCULAR COAGULATION20 reports
DIZZINESS20 reports
ABDOMINAL PAIN19 reports
AGITATION19 reports
HAEMOGLOBIN DECREASED19 reports
OVERDOSE19 reports
PRODUCT USE ISSUE19 reports
SEPSIS19 reports
ALANINE AMINOTRANSFERASE INCREASED18 reports
CARDIAC ARREST18 reports
CONSTIPATION18 reports
GAIT DISTURBANCE18 reports
HYPERKALAEMIA18 reports
HYPONATRAEMIA18 reports
PAIN IN EXTREMITY18 reports
CONFUSIONAL STATE17 reports
GAMMA GLUTAMYLTRANSFERASE INCREASED17 reports
HYPERTHERMIA17 reports
VISION BLURRED17 reports
ALTERED STATE OF CONSCIOUSNESS16 reports
ASPARTATE AMINOTRANSFERASE INCREASED16 reports
BLOOD PRESSURE INCREASED16 reports
DEATH16 reports
LIVER DISORDER16 reports
MUSCLE RIGIDITY16 reports
RASH16 reports
THROMBOCYTOPENIA16 reports
ANAEMIA15 reports
DEHYDRATION15 reports
DEPRESSED LEVEL OF CONSCIOUSNESS15 reports
HEPATIC FUNCTION ABNORMAL15 reports
HYPERTONIA15 reports
PNEUMONIA ASPIRATION15 reports
WEIGHT DECREASED15 reports
BACK PAIN14 reports
CARDIAC FAILURE14 reports
CARDIO RESPIRATORY ARREST14 reports
COUGH14 reports
ERYTHEMA14 reports
INFECTION14 reports
PARAESTHESIA14 reports
BLOOD PRESSURE DECREASED13 reports
COMA13 reports
COVID 1913 reports
DEPRESSION13 reports
GENERAL PHYSICAL HEALTH DETERIORATION13 reports
LOSS OF CONSCIOUSNESS13 reports
OEDEMA PERIPHERAL13 reports
SEIZURE13 reports
BLOOD CREATININE INCREASED12 reports
DECREASED APPETITE12 reports
DISORIENTATION12 reports
EPILEPSY12 reports
INTERSTITIAL LUNG DISEASE12 reports
LETHARGY12 reports
METABOLIC ACIDOSIS12 reports
MUSCLE TIGHTNESS12 reports
MYALGIA12 reports
PLATELET COUNT DECREASED12 reports
PULMONARY OEDEMA12 reports
URINARY RETENTION12 reports
WHITE BLOOD CELL COUNT DECREASED12 reports

Report Outcomes

Out of 1,129 classified reports for DANTROLENE SODIUM:

Serious 87.4%Non-Serious 12.6%

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

Male582 (54.8%)
Female469 (44.2%)
Unknown11 (1.0%)

Reports by Age

Age 5231 reports
Age 5421 reports
Age 6021 reports
Age 6519 reports
Age 5118 reports
Age 5318 reports
Age 6318 reports
Age 6618 reports
Age 4017 reports
Age 4317 reports
Age 4717 reports
Age 3016 reports
Age 8216 reports
Age 515 reports
Age 615 reports
Age 3215 reports
Age 4815 reports
Age 4915 reports
Age 4114 reports
Age 5014 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 DANTROLENE SODIUM?

This profile reflects 2,376 FDA FAERS reports that mention DANTROLENE SODIUM. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for DANTROLENE SODIUM?

Frequently reported terms in FAERS include NEUROLEPTIC MALIGNANT SYNDROME, PYREXIA, PNEUMONIA, ASTHENIA, RESPIRATORY FAILURE, DRUG INEFFECTIVE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures DANTROLENE SODIUM?

Labeling and FAERS entries often list Endo USA, Inc. in connection with DANTROLENE 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.