METHYLENE BLUE

N/A

Manufactured by American Regent, Inc.

4,684 FDA adverse event reports analyzed

Last updated: 2026-04-15

About METHYLENE BLUE

METHYLENE BLUE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by American Regent, Inc.. The most commonly reported adverse reactions for METHYLENE BLUE include SEROTONIN SYNDROME, DRUG INTERACTION, DRUG INEFFECTIVE, HYPOTENSION, OFF LABEL USE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for METHYLENE BLUE.

Top Adverse Reactions

SEROTONIN SYNDROME462 reports
DRUG INTERACTION355 reports
DRUG INEFFECTIVE285 reports
HYPOTENSION202 reports
OFF LABEL USE170 reports
TOXICITY TO VARIOUS AGENTS133 reports
OVERDOSE101 reports
INTENTIONAL OVERDOSE94 reports
ENCEPHALOPATHY81 reports
TOXIC ENCEPHALOPATHY76 reports
BLOOD CREATINE PHOSPHOKINASE INCREASED72 reports
CONFUSIONAL STATE72 reports
ACUTE KIDNEY INJURY70 reports
VASOPLEGIA SYNDROME69 reports
ALANINE AMINOTRANSFERASE INCREASED67 reports
BLOOD POTASSIUM INCREASED62 reports
AGITATION61 reports
AMYLASE INCREASED60 reports
BLOOD LACTATE DEHYDROGENASE INCREASED60 reports
BRADYCARDIA60 reports
LACTIC ACIDOSIS60 reports
MYOGLOBIN URINE PRESENT60 reports
TROPONIN INCREASED60 reports
COMA58 reports
CARDIAC ARREST57 reports
SHOCK56 reports
CONDITION AGGRAVATED53 reports
METHAEMOGLOBINAEMIA53 reports
CARDIOGENIC SHOCK49 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION48 reports
PRODUCT USE IN UNAPPROVED INDICATION47 reports
METABOLIC ACIDOSIS46 reports
MYDRIASIS41 reports
RHABDOMYOLYSIS41 reports
MULTIPLE ORGAN DYSFUNCTION SYNDROME40 reports
DEPRESSED LEVEL OF CONSCIOUSNESS39 reports
CLONUS37 reports
DISTRIBUTIVE SHOCK36 reports
HYPERREFLEXIA35 reports
TACHYCARDIA34 reports
CHROMATURIA32 reports
NYSTAGMUS30 reports
HYPERKALAEMIA28 reports
MUSCLE RIGIDITY28 reports
MENTAL STATUS CHANGES27 reports
BLOOD CREATININE INCREASED26 reports
SUICIDE ATTEMPT26 reports
ANAPHYLACTIC REACTION25 reports
HYPERHIDROSIS25 reports
SEIZURE25 reports
SOMNOLENCE25 reports
HAEMOLYTIC ANAEMIA24 reports
COMA SCALE ABNORMAL23 reports
DELIRIUM23 reports
DYSKINESIA23 reports
HYPOXIA22 reports
ILEUS22 reports
RENAL FAILURE22 reports
ANXIETY21 reports
HAEMODYNAMIC INSTABILITY21 reports
HYPERTENSION21 reports
PULSE ABSENT21 reports
SKIN DISCOLOURATION21 reports
CIRCULATORY COLLAPSE20 reports
COMPARTMENT SYNDROME20 reports
DRUG LEVEL BELOW THERAPEUTIC20 reports
HYPERTHERMIA20 reports
PNEUMONIA20 reports
PYREXIA20 reports
DISORIENTATION19 reports
NAUSEA18 reports
THERAPY NON RESPONDER18 reports
APHASIA17 reports
GENERALISED TONIC CLONIC SEIZURE16 reports
RESPIRATORY FAILURE16 reports
UNRESPONSIVE TO STIMULI16 reports
VOMITING16 reports
ACIDOSIS15 reports
ELECTROCARDIOGRAM QRS COMPLEX PROLONGED15 reports
LINEAR IGA DISEASE15 reports
PULMONARY OEDEMA15 reports
RESPIRATORY DEPRESSION15 reports
ACUTE RESPIRATORY DISTRESS SYNDROME14 reports
FATIGUE14 reports
HYPERTONIA14 reports
RESTLESSNESS14 reports
TREMOR14 reports
HEADACHE13 reports
NEUROTOXICITY13 reports
POST PROCEDURAL COMPLICATION13 reports
THROMBOCYTOPENIA13 reports
ANAPHYLACTIC SHOCK12 reports
ASPARTATE AMINOTRANSFERASE INCREASED12 reports
BLOOD PRESSURE DECREASED12 reports
DELAYED RECOVERY FROM ANAESTHESIA12 reports
DIZZINESS12 reports
MUSCLE TWITCHING12 reports
MYOCLONUS12 reports
SEPSIS12 reports
SPEECH DISORDER12 reports

Report Outcomes

Out of 1,465 classified reports for METHYLENE BLUE:

Serious 93.7%Non-Serious 6.3%

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

Female725 (54.8%)
Male596 (45.1%)
Unknown1 (0.1%)

Reports by Age

Age 4984 reports
Age 6156 reports
Age 6054 reports
Age 6437 reports
Age 5434 reports
Age 7032 reports
Age 5931 reports
Age 6731 reports
Age 3028 reports
Age 1527 reports
Age 5127 reports
Age 6527 reports
Age 6627 reports
Age 7527 reports
Age 2024 reports
Age 6223 reports
Age 5522 reports
Age 7422 reports
Age 2521 reports
Age 5321 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 METHYLENE BLUE?

This profile reflects 4,684 FDA FAERS reports that mention METHYLENE BLUE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for METHYLENE BLUE?

Frequently reported terms in FAERS include SEROTONIN SYNDROME, DRUG INTERACTION, DRUG INEFFECTIVE, HYPOTENSION, OFF LABEL USE, TOXICITY TO VARIOUS AGENTS. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures METHYLENE BLUE?

Labeling and FAERS entries often list American Regent, Inc. in connection with METHYLENE BLUE. 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.