Additional Adverse Reactions (Additional Adv Drug Reactions)
Gemfibrozil Tablet
Product Images NDC 72162-2119
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Product Visual Gallery
This gallery contains 7 technical images submitted to the FDA as part of the official labeling for Gemfibrozil (NDC 72162-2119). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.
As provided by Bryant Ranch Prepack, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.
Adverse Reactions (Adv Reactions)
GEMFIBROZIL PLACEBO (N = 2046) (N = 2035)
Frequency in percent of subjects
Gastrointestinal reactions - GEMFIBROZIL: 342, PLACEBO: 238
Dyspepsia - GEMFIBROZIL: 19.6, PLACEBO: 119
Abdominal pain - GEMFIBROZIL: 9.8, PLACEBO: 56
Acute appendicitis (histologically confirmed in most cases where data were available) - GEMFIBROZIL: 12, PLACEBO: 06
Atrial fibrillation - GEMFIBROZIL: 0.7, PLACEBO: 01
Adverse events reported by more than 1% of subjects, but without a significant difference between groups:
Diarrhea - GEMFIBROZIL: 72, PLACEBO: 6.5
Fatigue - GEMFIBROZIL: 38, PLACEBO: 35
Nausea/Vomiting - GEMFIBROZIL: 25, PLACEBO: 21
Eczema - GEMFIBROZIL: 19, PLACEBO: 12
Rash - GEMFIBROZIL: 17, PLACEBO: 13
Vertigo - GEMFIBROZIL: 15, PLACEBO: 13
Constipation - GEMFIBROZIL: 14, PLACEBO: 13
Headache - GEMFIBROZIL: 12, PLACEBO: 11*
Struct (Structure Gemfibrozil)
Table1 (Table 1)
Table2 (Table 2)
Table II presents the number of cardiac events and all-cause mortality per 1000 patients during the 3.5 year open-label follow-up of the Helsinki Heart Study. The data is divided into six groups based on the original randomization and the drug taken during the follow-up period. The groups are designated as PDrop, PN, PG, GDrop, GN, and GG. The number of patients in each group is provided, along with the corresponding values for cardiac events and all-cause mortality.*
Table3 (Table 3)
Table II displays the results of the Helsinki Heart Study, specifically focused on cardiac events, cardiac deaths, non-cardiac deaths, and all-cause mortality over a span of 0-8.5 years. The study compared the effects of gemfibrozil (a medication) to a placebo.
The table showcases the number of events in each group, as well as the hazard ratio (risk) and confidence intervals. The intention-to-treat analysis was conducted, disregarding any open-label treatment switches and exposure to study conditions.
Overall, the findings indicate that gemfibrozil had a lower hazard ratio for cardiac events and all-cause mortality compared to placebo, though the difference was not statistically significant. The hazard ratio for cardiac deaths and non-cardiac deaths were similar between the two groups. The study also included fatal and non-fatal myocardial infarctions and sudden cardiac deaths within the 8.5 year period.*
Label (Lbl721622119)
Gemfibrozil is a medication that comes in tablet form. Each tablet contains 600 mg of the active ingredient, Gemfibrozil. The National Drug Code (NDC) for this medication is 72162-2119-6. It is important to keep this medication out of the reach of children and store it at a controlled room temperature of 20-25°C (68-77°F). The tablets should be dispensed in child-resistant containers and protected from light and humidity. This medication is available only with a prescription and has been relabeled by Bryant Ranch Prepack, Inc. The manufacturing company is Ascent Pharmaceuticals, Inc located in Burbank, CA 91504, USA.*
* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.
