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Drug Safety Labeling Changes - July 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
Azilsartan Medoxomil - Tablets
Desvenlafaxine - Extended-Release Tablets
Fluoxetine - Pulvules
Paroxetine - Tablets, Oral Suspension and Controlled-Release Tablets
Boceprevir - Capsules
Bupropion - Extended-Release Tablets
Bupropion - Sustained-Release Tablets
Citalopram - Tablets
Clarithromycin - tablets, USP
Clarithromycin - for Oral Suspension USP)
Clarithromycin - extended release tablets
Clomipramine - Capsules
Desipramine -Tablets USP
Desvenlafaxine - Extended-Release Tablets
Desvenlafaxine - Extended-Release Tablets
Desvenlafaxine - Extended-Release Tablets
Docetaxel - Injection
Doxepin - Capsules and Oral Concentrate
Duloxetine - Capsules
Eprosartan
Escitalopram -Tablets and Oral Solution
Everolimus - Tablets for Oral Administration
Everolimus - Tablets for Oral Suspension
Fluoxetine - Delayed Release Capsules
Fluoxetine - Tablets
Fluvoxamine - Extended-Release Capsules
Fluvoxamine -Tablets
Fondaparinux - Solution for Injection
Histrelin Acetate - Subcutaneous Implant
Hydrocortisone - Injection and Sterile Powder for Injection
Imipramine - Capsules
Indinavir
Leuprolide - Injection
Linaclotide - Capsules
Memantine - Extended-Release Capsules
Methylprednisolone - Injectable Suspension, USP
MethylPrednisolone - Sterile Powder for Injection
Mirtazapine - Tablets Orally Disintegrating Tablets
Nicardipine - Injection
Nortriptyline - Solution
Nortriptyline Capsules
Olanzapine and Fluoxetine - Capsules
Oxcarbazepine - Film-Coated Tablets and Oral Suspension for Oral Administration
Paroxetine - Tablets
Rosuvastatin - Tablets
Ruxolitinib - Tablets
Selegiline - Orally Disintegrating Tablets
Sertraline - Tablets and Oral Concentrate
Tamsulosin - Capsules
Trazodone - Extended-Release Tablets
Trazodone - Tablets
Triamcinolone - USP Injectable Suspension
Triamcinolone Hexacetonide - Injection Suspension
Triptorelin - for Injectable Suspension Intramuscular use
Venlafaxine -Extended-Release Tablets
Venlafaxine - Extended-Release Capsules
Venlafaxine - Extended-Release Tablets
Vortioxetine - Tablets

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
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