Adverse Drug Reactions and Serious Adverse Events
First written in FY2016. 19 of 23 entries say "Restated". Latest entry: 2026-10-22.
Kissei Pharmaceutical moved to the "Worse" side of this theme in 2026, 2 years after the typical company in this theme (2024).
The whole theme swung hardest in 2026: 6 of 20 companies on the "Worse" side.
5 other companies' latest entry also says "Materialised".
- 2026-10-22MaterialisedOther Disclosures
「本剤を投与中の患者については、中止又は代替治療への切替えを原則として、対応を検討すること。」
タブネオスについて、既開示の重篤な肝機能障害に加え、投与中患者の中止または代替治療への切替えを原則とする対応が示され、副作用・重篤な有害事象に関するリスク対応がさらに具体化した。 - FY2026MaterialisedAnnual report
「On 31 March 2026, the FDA issued a notification urging patients and healthcare professionals to exercise caution, stating that it had identified severe drug-induced liver injury in patients who had taken this drug. …On 21 May 2026, in accordance with instructions from Japan’s Ministry of Health, Labour and Welfare under applicable laws and regulations, we revised the Japanese package insert regarding serious liver dysfunction and issued a safety alert, known as a Blue Letter, to inform healthcare professionals and urge caution.」
Severe drug-induced liver injury was identified in patients taking Tavneos, resulting in a revision of the Japanese package insert and the issuance of a Blue Letter in Japan. The risk of adverse reactions and serious adverse events has materialized. - 2026-05-12MaterialisedEarnings presentation
「The FDA issued a notification urging patients and healthcare professionals to exercise caution, stating that it had identified severe drug-induced liver injury in patients who had taken Tabuneos.」
For Tabuneos, the identification of severe drug-induced liver injury and the resulting safety alert were disclosed, giving concrete form to the drug's adverse-event risk. - FY2024RestatedAnnual report
「Drugs may cause unknown adverse reactions that were not identified during development. If unexpected adverse reactions or serious adverse events occur, their use may be restricted or, in some cases, their sale may be discontinued.」
The potential for unknown adverse reactions or serious adverse events to result in restrictions on use or discontinuation of sales has been reconfirmed. - FY2024-Q2RestatedAnnual report
「During the cumulative second quarter under review, there were no significant changes in the matters described in this quarterly report regarding the business and accounting conditions that management recognizes could materially affect the financial position, operating results and cash flows of the consolidated companies, or in the “Business and Other Risks” described in the securities report for the previous fiscal year.」
It has been reconfirmed that there have been no material changes in the risk of drug adverse reactions and serious adverse events. - FY2023-Q3RestatedAnnual report
「During the cumulative third quarter under review, there were no significant changes in the matters described in this quarterly report regarding the business and accounting conditions that management recognizes could materially affect the financial position, operating results and cash flows of the consolidated companies, or in the “Business and Other Risks” described in the securities report for the previous fiscal year.」
It has been reconfirmed that there have been no material changes in the risk of drug adverse reactions and serious adverse events. - FY2023-Q2RestatedAnnual report
「During the cumulative second quarter under review, there were no significant changes in the matters described in this quarterly report regarding the business and accounting conditions that management recognizes could materially affect the financial position, operating results and cash flows of the consolidated companies, or in the “Business and Other Risks” described in the securities report for the previous fiscal year.」
It has been reconfirmed that there have been no material changes in the risk of drug adverse reactions and serious adverse events. - FY2023-Q1RestatedAnnual report
「During the three-month period ended 30 June, there were no new risks that management recognizes as having the potential to materially affect the financial position, operating results or cash flows of the consolidated companies, and no material changes to the business risks described in the annual securities report for the previous fiscal year.」
It has been reconfirmed that there have been no material changes in the risk of drug adverse reactions and serious adverse events. - FY2022-Q3RestatedAnnual report
「During the cumulative third quarter under review, there were no significant changes in the matters described in this quarterly report regarding the business and accounting conditions that management recognizes could materially affect the financial position, operating results and cash flows of the consolidated companies, or in the “Business and Other Risks” described in the securities report for the previous fiscal year.」
It has been reconfirmed that there have been no material changes in the risk of drug adverse reactions and serious adverse events. - FY2022-Q2RestatedAnnual report
「During the cumulative second quarter under review, there were no significant changes in the matters described in this quarterly report regarding the business and accounting conditions that management recognizes could materially affect the financial position, operating results and cash flows of the consolidated companies, or in the “Business and Other Risks” described in the securities report for the previous fiscal year.」
It has been reconfirmed that there have been no material changes in the risk of drug adverse reactions and serious adverse events. - FY2021-Q2RestatedAnnual report
「During the cumulative second quarter under review, there were no significant changes in the matters described in this quarterly report regarding the business and accounting conditions that management recognizes could materially affect the financial position, operating results and cash flows of the consolidated companies, or in the “Business and Other Risks” described in the securities report for the previous fiscal year.」
It has been reconfirmed that there have been no material changes in the risk of drug adverse reactions and serious adverse events. - FY2021-Q1RestatedAnnual report
「No new business or other risks arose during the three months ended 30 June. There were also no material changes to the business and other risks described in the securities report for the previous fiscal year.」
It has been reconfirmed that there have been no material changes in the risk of drug adverse reactions and serious adverse events. - FY2020-Q3RestatedAnnual report
「No new business or other risks arose during the nine months ended [the current third quarter]. There have also been no material changes to the business and other risks described in the annual securities report for the previous fiscal year.」
It has been reconfirmed that there have been no material changes in the risk of drug adverse reactions and serious adverse events. - FY2020-Q2RestatedAnnual report
「During the cumulative second quarter of the current consolidated fiscal year, there were no newly arising business or other risks. In addition, there were no material changes to the business or other risks described in the annual securities report for the previous fiscal year.」
It has been reconfirmed that there have been no material changes in the risk of drug adverse reactions and serious adverse events. - FY2020-Q1RestatedAnnual report
「During the first quarter of the current consolidated fiscal year, there were no newly arising business or other risks. In addition, there were no material changes to the business or other risks described in the annual securities report for the previous fiscal year.」
It has been reconfirmed that there have been no material changes in the risk of drug adverse reactions and serious adverse events. - FY2019RestatedAnnual report
「Drugs may cause unknown adverse reactions that were not identified during development. If unexpected adverse reactions or serious adverse events occur, their use may be restricted or, in some cases, their marketing may be discontinued.」
The potential for unknown adverse reactions or serious adverse events to result in restrictions on use or discontinuation of marketing has been reconfirmed. - FY2019-Q3RestatedAnnual report
「No new business or other risks arose during the nine months ended [the current third quarter]. There have also been no material changes to the business and other risks described in the annual securities report for the previous fiscal year.」
It has been reconfirmed that there have been no material changes in the risk of drug adverse reactions and serious adverse events. - FY2019-Q2RestatedAnnual report
「During the cumulative second quarter of the current consolidated fiscal year, there were no newly arising business or other risks. In addition, there were no material changes to the business or other risks described in the annual securities report for the previous fiscal year.」
It has been reconfirmed that there have been no material changes in the risk of drug adverse reactions and serious adverse events. - FY2018RestatedAnnual report
「Drugs may cause unknown adverse reactions that were not identified during development. If unexpected adverse reactions or serious adverse events occur, their use may be restricted or, in some cases, their marketing may be discontinued.」
The potential for unknown adverse reactions or serious adverse events to result in restrictions on use or discontinuation of marketing has been reconfirmed. - FY2018-Q3RestatedAnnual report
「No new business or other risks arose during the nine months ended [the current third quarter]. There have also been no material changes to the business and other risks described in the annual securities report for the previous fiscal year.」
It has been reconfirmed that there have been no material changes in the risk of drug adverse reactions and serious adverse events. - FY2018-Q2RestatedAnnual report
「During the cumulative second quarter of the current consolidated fiscal year, there were no newly arising business or other risks. In addition, there were no material changes to the business or other risks described in the annual securities report for the previous fiscal year.」
It has been reconfirmed that there have been no material changes in the risk of drug adverse reactions and serious adverse events. - FY2017RestatedAnnual report
「Drugs may cause unknown adverse reactions that were not identified during development. If unexpected adverse reactions or serious adverse events occur, their use may be restricted or, in some cases, their marketing may be discontinued.」
The potential for unknown adverse reactions or serious adverse events to result in restrictions on use or discontinuation of marketing has been reconfirmed. - FY2016First statedAnnual report
「Drugs may cause unknown adverse reactions that were not identified during development. If unexpected adverse reactions or serious adverse events occur, their use may be restricted or, in some cases, their marketing may be discontinued.」
The potential for unknown adverse reactions or serious adverse events to result in restrictions on product use or discontinuation of marketing is documented.