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Generic and trade name
The generic name is the official name of the drug while the trade name is the drug’s brand name.
Clinical uses and indications for use
Describes the purpose of the drug and when the drug is to be given to a patient.
Mechanism of action
Describes how the drug works.
Adverse and side effects and toxicity
Identifies the effects the drug has other than the therapeutic effect.
Signs and symptoms to monitor
Identifies the patient’s physiological response that must be evaluated after the drug is administered.
What to teach the patient
Specifies instructions that must be given to the patient before and after the drug is administered
Category X
Fetal abnormalities reported and positive evidence of fetal risk in
humans is available from animal and/or human studies. The risks
involved clearly outweigh the potential benefits. These drugs should not
be used in pregnant women
Category D
Positive human fetal risk has been reported from investigational or
marketing experience, or human studies. Considering potential benefit
versus risk may, in selected cases, warrant the use of these drugs in
pregnant women.
Category C
Animal reproduction studies have reported adverse effects on the fetus, however there are no well-controlled studies in humans but potential benefits may indicate use of the drug in pregnant women despite potential risks
Category B
Animal reproduction studies indicate no risk to the fetus, however there are no
well-controlled studies in pregnant women.
Category A
Adequate and well-controlled studies indicate no risk to the fetus in the first trimester of pregnancy or later