Opalmon Adverse Reactions

Improvement of various ischemic symptoms such as ulcer, pain and feeling of coldness associated with thromboangiitis obliterans: Two hundred and forty nine adverse reactions to OPALMON, including abnormal laboratory test values, were observed in 184 (4.0%) of 4,582 patients evaluated in the investigation conducted up to the time of approval and in the Drug Use Investigation. The major adverse reactions were diarrhea in 49 patients (1.1%), retching ·nausea·vomiting in 22 patients (0.5%), flushing·hot flushes in 22 patients (0.5%), rash in 17 patients (0.4%), abdominal discomfort·epigastric discomfort in 18 patients (0.4%), abdominal pain·epigastric pain in 15 patients (0.3%), headache·heaviness of head in 14 patients (0.3%), hepatic function abnormalities such as increases in AST(GOT)·ALT(GPT) in 12 patients (0.3%), anorexia in 10 patients (0.2%), etc. (At the end of the re-examination period)
Improvement of subjective symptoms (pain and numbness of lower legs) and gait ability associated with acquired lumbar spinal canal stenosis (in patients with bilateral intermittent claudication showing normal SLR test result): Fifty four adverse reactions to OPALMON, including abnormal laboratory test values, were observed in 34 (9.1%) of 373 patients evaluated in the investigation conducted up to the time of approval. The major adverse reactions were stomach discomfort in 8 patients (2.1%), rash in 6 patients (1.6%), headache, heaviness of head in 4 patients (1.1%), diarrhea in 4 patients (1.1%), diarrhea in 4 patients (1.1%), anemia in 3 patients (0.8%), etc. (At the time of approval)
One hundred sixty nine (169) adverse reactions to this product, including abnormal laboratory test values, were observed in 136 (5.8%) of the 2,327 patients evaluated in the post-marketing Drug Use Investigation. The major adverse reactions were stomach·abdominal discomfort in 34 patients (1.5%), abdominal pain in 13 patients (0.6%), diarrhea in 10 patients (0.4%), headache in 10 patients (0.4%), nausea in 7 patients (0.3%) and heartburn in 7 patients (0.3%), etc. (At the end of the re-examination)
Clinically significant adverse reactions: Hepatic function disorder or jaundice: Hepatic function disorder or jaundice (both incidences unknown) accompanied by remarkably increased AST(GOT)·ALT(GPT) may occur. Patients should be carefully monitored. If any abnormalities are observed, appropriate therapeutic measures such as discontinuing the administration should be taken.
Other adverse reactions: See Table 2.

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The ADR classified into "Incidence Unknown" is the one collected from spontaneous reports.
Note: 1) If such symptoms are observed, appropriate therapeutic measures such as discontinuing administration should be taken.
2) The patient should be carefully monitored. If any abnormality is observed, administration should be discontinued.