scholarly journals Analysis of Adverse Events Associated with Low-dose Estrogen-Progestin Based on Data from the Japanese Adverse Drug Event Report Database and the Relief System for Sufferers from Adverse Drug Reactions

2019 ◽  
Vol 45 (2) ◽  
pp. 115-124
Author(s):  
Tomohiro Ariyama ◽  
Moegi Sato ◽  
Hiroyuki Tanaka ◽  
Toshihiro Ishii
Keyword(s):  
Adverse Events ◽  
Adverse Drug Reactions ◽  
Adverse Drug Event ◽  
Low Dose ◽  
Drug Event ◽  
Drug Reactions ◽  
Event Report ◽  
Relief System

scholarly journals Methodology for Estimating the Risk of Adverse Drug Reactions in Pregnant Women: Analysis of the Japanese Adverse Drug Event Report Database

2016 ◽  
Vol 136 (3) ◽  
pp. 499-505 ◽  
Author(s):  
Takamasa Sakai ◽  
Fumiko Ohtsu ◽  
Yasuaki Sekiya ◽  
Chiyo Mori ◽  
Hiroshi Sakata ◽  
...  
Keyword(s):  
Pregnant Women ◽  
Adverse Drug Reactions ◽  
Adverse Drug Event ◽  
Drug Event ◽  
Drug Reactions ◽  
Event Report

Estimated incidence per population of adverse drug reactions to Kampo medicines from the Japanese adverse drug event report database (JADER)

2020 ◽  
Vol 7 (1) ◽  
pp. 3-16 ◽  
Author(s):  
Ichiro Arai ◽  
Yusuke Harada ◽  
Hiroshi Koda ◽  
Kiichiro Tsutani ◽  
Yoshiharu Motoo
Keyword(s):  
Adverse Drug Reactions ◽  
Adverse Drug Event ◽  
Drug Event ◽  
Drug Reactions ◽  
Event Report

scholarly journals Analysis of patients with hypomagnesemia using the Japanese Adverse Drug Event Report database (JADER)

2018 ◽  
Vol 21 ◽  
pp. 46-53 ◽  
Author(s):  
Hiroyuki Tanaka ◽  
Yuka Yoshiba ◽  
Tomoko Watanabe ◽  
Mitsutoshi Satoh ◽  
Toshihiro Ishii
Keyword(s):  
Adverse Events ◽  
Adverse Drug Event ◽  
Antitumor Agent ◽  
Drug Event ◽  
Reporting Odds Ratio ◽  
Event Report ◽  
Drug Involvement ◽  
Large Peak ◽  
Egfr Antibody ◽  
Electrolyte Abnormalities

Summary – Purpose. In order to clarify the occurrence of hypomagnesemia in Japan, we conducted a database search and analysis using the Japanese Adverse Drug Event Report database (JADER). Methods. Among the cases recorded in JADER between April 2004 and December 2015, we targeted “hypomagnesemia” and analyzed the patients’ backgrounds, drug involvement, other adverse events reported with hypomagnesemia, the time of hypomagnesemia onset, outcomes, and year when reported. For drugs with three or more reports, the signal index was calculated using the Reporting Odds Ratio (ROR) method. In addition, the association between hypomagnesemia onset and other adverse events was investigated using association analysis. Results. The total number of reported hypomagnesemia cases was 201. Males accounted for 62.7%, and patients in their sixties formed a large peak. Three or more cases were reported for 23 causative drugs, among which anti-EGFR antibody, calcineurin inhibitor, platinum antitumor agent and proton pump inhibitor accounted for the majority. ROR analysis detected signals for 18 drugs, and an association was found between hypomagnesemia and other electrolyte abnormalities for those drugs. The median time until onset of hypomagnesemia was classified into three patterns: around 10 days, around 30 days, and longer. Analysis of the report year revealed an increasing tendency in recent years, although increases/decreases were evident depending on fiscal years. Conclusion. Our survey was able to reveal the factors associated with the occurrence of hypomagnesemia.

scholarly journals Characteristics of Adverse Events Following Immunization Reporting in Children: The Japanese Adverse Drug Event Report Database

Vaccines ◽  
2020 ◽  
Vol 8 (3) ◽  
pp. 357
Author(s):  
Aoi Noda ◽  
Takamasa Sakai ◽  
Masami Tsuchiya ◽  
Gen Oyanagi ◽  
Taku Obara ◽  
...  
Keyword(s):  
Human Papillomavirus ◽  
Adverse Events ◽  
Adverse Drug Event ◽  
Haemophilus Influenzae Type ◽  
Drug Event ◽  
Loss Of Consciousness ◽  
Haemophilus Influenzae Type B ◽  
Type B ◽  
Event Report ◽  
Pharmacovigilance Activity

The present study aimed to describe the trends and characteristics of adverse events following immunization (AEFI) reporting for children in the Japanese Adverse Drug Event Report database (JADER). We used 6280 AEFI reports for children aged <19 years among 504,407 ADR reports included in the JADER from 2004 to 2017. The number of AEFI reports gradually increased among children aged <10 years and was the highest in 2011 among children aged 10–19 years. The number of suspected vaccines per AEFI report increased after 2011 among children aged <10 years. The percentage of “death” and “did not recover” as AEFI outcomes reported were 4.3% and 3.7% among children aged <10 years and 0.2% and 21.1% among children aged 10–19 years, respectively. The most frequently reported vaccine–reaction pair was Haemophilus influenzae type b conjugate vaccine and pyrexia among children aged <10 years and recombinant adsorbed bivalent human papillomavirus-like particle vaccine and a loss of consciousness among children aged 10–19 years. It is necessary to consider the Weber effects to understand the trend and characteristics of AEFI reporting because pharmacovigilance activity regarding vaccination is not sufficient in Japan.

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