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Drug Safety Labeling Changes - March 2014

Food and Drug Administration (FDA) announces important safety label changes for prescription drugs almost every month. By implementing the label changes the FDA warns a physician of new side- effects, adverse reactions, contra-indications and precautions necessary for a drug. This information is important for safe practice of medicine.

Key to Label Sections

  • C - Contraindications
  • W - Warnings
  • P - Precautions
  • AR - Adverse Reactions
Drug Name Sections Modified
C W P AR
Esomeprazole - for Intravenous Injection, Delayed-Release Capsules, and Delayed-Release Oral Suspension
Maraviroc - Tablets
Sildenafil - Tablets, Injection and Oral Suspension
Valproic Acid - Delayed Release Capsules
Valsartan and Hydrochlorothiazide - Tablets
Cabazitaxel - Injection
Econazole - Cream 
Estradiol - transdermal spray
Finasteride - Tablets
Fluconazole - Injection and Powder for Oral Suspension
Levetiracetam - Tablets, Extended Release Tablets, Oral Solution and Injection
Omeprazole - Delayed-Release Capsules and Oral Suspension
Rifaximin - Tablets
Rivaroxaban - Tablets, 10 mg
Sulfasalazine - tablets, USP
Sulfasalazine - delayed release tablets, USP
Tofacitinib - Tablets
Trastuzumab
Valsartan - Tablets and Capsules

2016 - Monthly Summary Report for Drug Label Changes

2015 - Monthly Summary Report for Drug Label Changes

2014 - Monthly Summary Report for Drug Label Changes

2013 - Monthly Summary Report for Drug Label Changes

2012 - Monthly Summary Report for Drug Label Changes

Drugs A-Z
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
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