Locoa Adverse Reactions

Summary of the safety profile: In the clinical studies performed in a total of 1,391 patients, 415 adverse reactions were reported in 269 patients (19.3%), including application site dermatitis in 111 patients (8.0%), application site erythema in 44 patients (3.2%), and application site eczema in 32 patients (2.3%).
Tabulated list of adverse reactions reported in the clinical studies and from post-marketing experience: The following adverse reactions have been reported in all the clinical trials and from post-marketing experience with LOCOA. Adverse reactions listed as follows are classified according to frequency and system organ class (SOC). (See Table 5.)

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Clinically significant adverse reactions: Shock, anaphylaxis: Since shock and anaphylaxis have been reported (with an unknown incidence for both) with the use of esflurbiprofen, the condition of patients, should be carefully monitored, and treatment should be discontinued while taking appropriate actions if symptoms such as chest discomfort, chills, cold sweat, dyspnea, numbness in extremities, decreased blood pressure, angioedema, and urticaria are observed.
Acute kidney injury, nephrotic syndrome: Since acute kidney injury has been reported (with an unknown incidence) with the use of esflurbiprofen, this medicine may cause serious renal disorders including acute kidney injury and nephrotic syndrome. So the condition of patients should be carefully monitored, for example, with periodic tests, and appropriate actions should be taken such as discontinued treatment, if signs such as oliguria, hematuria, protein urine, increases in BUN and blood creatinine, hyperkalaemia, and hypoalbuminaemia are observed.
Gastrointestinal bleeding: Since gastrointestinal bleeding has been reported (with an unknown incidence) with the use of esflurbiprofen, the condition of patients should be carefully monitored, and treatment should be discontinued while taking appropriate treatment, if any abnormality is observed.
Aplastic anaemia: Since aplastic anaemia has been reported (with an unknown incidence) with the use of oral flurbiprofen, the condition of patients should be carefully monitored, and appropriate actions should be taken such as discontinued treatment.
Induced asthma attacks (aspirin-induced asthma): Since asthma attacks have been induced by the use of esflurbiprofen, treatment should be discontinued if initial symptoms such as dry rales, wheezing, and dyspnea are observed.
Toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, exfoliative dermatitis: Since Stevens-Johnson syndrome has been reported (with an unknown incidence) with the use of esflurbiprofen, this medicine may cause toxic epidermal necrolysis, Stevens-Johnson syndrome, and exfoliative dermatitis. So the condition of patients should be carefully monitored and treatment should be discontinued while taking appropriate treatment, if any abnormality is observed.
Impaired consciousness, convulsions with impaired consciousness: Since impaired consciousness and convulsions with impaired consciousness have been reported as a rare incidence (< 0.1%) with the use of flurbiprofen axetil [injections], the condition of patients should be carefully monitored, and treatment should be discontinued while taking appropriate treatment, if any abnormality is observed.