Proveblue Adverse Reactions

Summary of the safety profile: The most commonly reported adverse reactions observed during clinical trials are dizziness, paraesthesia, dysgeusia, nausea, skin discoloration, chromaturia, sweating, injection site pain and pain in extremity.
Intravenous injection of methylthioninium chloride has occasionally caused hypotension and cardiac arrhythmias, and such disorders might prove fatal on rare occasions.
Tabulated list of adverse reactions: The adverse reactions listed in the table as follows occur in adults, children and adolescents (aged 0 to 17 years old) after intravenous administration. The frequencies are not known (cannot be estimated from the available data). When indicated, the frequency is based on a very small sample size.

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Paediatric population: Adverse reactions are the same as in adults (except hyperbilirubinaemia, reported in infants only).
Oral administration may cause gastrointestinal disturbances and dysuria.
Use of methylene blue for endoscopic tattoo has been associated with vascular necrosis, mucosal ulceration, mural necrosis, extramural fat necrosis and inflammatory changes in the colon.
Injection of methylene blue into joint space has resulted in effusion in the treated joint.
Reporting suspected adverse reactions: Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions to the National Competent Authority for pharmacovigilance.