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Drug Safety Labeling Changes - April 2015

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
Methylphenidate - Extended-Release Capsules
Alendronate - Tablets and Oral Solution
Alendronate -Effervescent Tablets for Oral Solution
Atomoxetine - Capsules
Cetuximab
Dextroamphetamine - Spansule Sustained Release Capsules
Etidronate - Tablets
Ibandronate - Injection
Ibandronate - Tablets
Itraconazole - Capsules and Oral Solution
Lisdexamfetamine - Capsules
Maraviroc
Methadone - Tablets
Methamphetamine - Tablets
Methylphenidate - Chewable Tablets
Methylphenidate - Extended-Release Capsules
Methylphenidate - Extended-release Oral Suspension
Methylphenidate - Oral Solution
Methylphenidate - Sustained-Release Tablets
Methylphenidate - Tablets
Methylphenidate - transdermal system
Methylphenidate-Extended-release Tablets
Pazopanib -Tablets
Pomalidomide - Capsules
Primaquine - Tablets
Regorafenib - Tablets
Risedronate - Tablets
Risedronate - Delayed-Release Tablets
Risedronate -Tablets with Calcium Carbonate Tablets, USP
Saquinavir -Capsules and Tablets
Sildenafil - Tablets, Single Use Vials for Injection, and Oral Suspension
Simeprevir - Capsules
Sitagliptin - Tablets
Tadalafil - Tablets
Temozolomide - for Injection
Trastuzumab
Zoledronic Acid - Injection

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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