Vocinti Adverse Reactions

Gastric ulcer, duodenal ulcer, reflux esophagitis: Adverse reactions, including abnormalities in laboratory data, were observed in 186 (8.2%) of 2,271 patients who received once daily administration of 10 mg or 20 mg of Vonoprazan in the clinical trials performed before approval. The most common adverse reaction was constipation (0.7%).
Prevention of recurrence of gastric ulcer or duodenal ulcer during low-dose aspirin administration: Adverse reactions, including abnormalities in laboratory data, were observed in 73 (16.9%) of 431 patients who received once daily administration of 10 mg or 20 mg of Vonoprazan in the clinical trials performed before approval. The most common adverse reaction was constipation (1.9%).
Prevention of recurrence of gastric ulcer or duodenal ulcer during NSAIDs administration: Adverse reactions, including abnormalities in laboratory data, were observed in 78 (17.0%) of 460 patients who received once daily administration of 10 mg or 20 mg of Vonoprazan in the clinical trials performed before approval. The most common adverse reaction was constipation (1.5%).
Adjunct to Helicobacter pylori eradication in the case of gastric ulcer or duodenal ulcer: Adverse reactions, including abnormalities in laboratory data, were observed in 67 (20.4%) of 329 patients administered with Vonoprazan fumarate, amoxicillin and clarithromycin in the clinical trials before approval. The most common adverse reaction was diarrhea (10.6%).
Adjunct to Helicobacter pylori eradication in the case of gastric MALT lymphoma, idiopathic thrombocytopenic purpura, the stomach after endoscopic resection of early stage gastric cancer, or Helicobacter pylori gastritis: Concerning concomitant administration of vonoprazan fumarate, amoxicillin hydrate, and clarithromycin or metronidazole, no study such as clinical trials to determine the frequency of adverse reactions has been conducted.
With Vonoprazan fumarate, amoxicillin and metronidazole, adverse reactions including abnormalities in laboratory data were observed in 8 (16.0%) of 50 patients in the clinical trials before approval.
Following adverse reactions may occur. Therefore, close observation should be made, and if abnormality is observed, administration of this drug should be discontinued, and appropriate measures should be taken.
Clinically significant adverse reactions: All Indications: Pancytopenia, agranulocytosis, leukocytopenia, and thrombocytopenia (Frequency unknown).
Toxic epidermal necrolysis: TEN, Stevens-Johnson syndrome and erythema multiforme (Frequency unknown).
Adjunct to Helicobacter pylori eradication: Serious colitis accompanied with bloody stools, such as pseudomembranous colitis (Frequency unknown). If abdominal pain and frequent diarrhea occur, appropriate measures, such as immediate discontinuation of the treatment, should be taken. Serious colitis accompanied with bloody stools, such as pseudomembranous colitis may occur due to amoxicillin hydrate or clarithromycin being used for Helicobacter pylori eradication.
Hepatotoxicity: Hepatic function abnormalities including liver injury have been reported in clinical studies. Post marketing reports have also been received in patients treated with Vonoprazan, many of which occurred shortly after initiation of treatment. Discontinuation of Vonoprazan is recommended in patients who have evidence of liver function abnormalities or if they develop signs or symptoms suggestive of liver dysfunction.
Other adverse reactions: When the following adverse reactions are observed, appropriate measures should be taken according to the symptoms: (See Tables 3 and 4.)

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Postmarketing: Following is a list of ADRs which have been observed in postmarketing and are not included as previously mentioned: (See Table 5.)

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