Drug Profile Symbols

These are new elements that have been added to the site to improve the reporting of drug-reactions. We are in the process of adding these symbols to drug profiles as and where relevant, and expect to complete this exercise soon.

  

Percentages or percentage ranges in coloured boxes after a reaction indicate the incidence or prevalence of the listed reactions. These are essentially vague and should be viewed in the context of the detailed references. The key to the colour coding for these percentage values is available on the right hand side of the screen.

  

Logos depicted and described in the symbol key to the right of the page represent warnings in special populations.  These may appear at the top of the drug profile to apply to the whole drug as per prescribing information or FDA labels.  The logos can also appear next to a reference if the reaction has been noted specifically in that population within that study.

Flags at the side of a reference or reaction indicate the severity of the reaction observed.  The flags can apply to the reaction to the drug being viewed, or to a reference (study) in which the seriousness is noted.

FDA Pregnancy Categories

The FDA-assigned pregnancy categories as used in the Drug Formulary are as follows:
 

Category A

Adequate and well-controlled studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters).

Category B

Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

Category C

Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Category D

There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Category X

Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.