Cimetidine postmarket outpatient surveillance program. Interim report on phase I.
A postmarket surveillance program in outpatients receiving cimetidine was initiated seven months after its approval for marketing. During the first phase of the program, data were obtained over a three-month period for 9,907 patients who received the drug. The overall incidence of adverse effects reported was 4.4%, and the types of adverse effects did not differ from those reported in premarketing controlled studies. Physician response was excellent (85.1%), and the methods used were successful in providing data on a large number of patients who received the drug in routine clinical practice. The results confirmed the safety profile of cimetidine. A follow-up phase, initiated six months after the initial phase of the surveillance program, will provide longer-term data on these patients.
D000293:Adolescent; D000328:Adult; D000368:Aged; D002927:Cimetidine / Q000009:adverse effects* / Q000627:therapeutic use; D003221:Confusion / Q000139:chemically induced; D004064:Digestive System / Q000187:drug effects; D004702:Endocrine Glands / Q000187:drug effects; D005260:Female; D005500:Follow-Up Studies; D005767:Gastrointestinal Diseases / Q000188:drug therapy; D006146:Guanidines / Q000009:adverse effects*; D006801:Humans; D007880:Legislation, Drug; D008297:Male; D008875:Middle Aged; D014481:United States; D014486:United States Food and Drug Administration
D006146:Guanidines; D002927:Cimetidine