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