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Drug Safety Labeling Changes - September 2012

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
Abiraterone acetate
Albuterol (Salbutamol)
Amlodipine and Olmesartan
Amlodipine and Valsartan
Amlodipine, Valsartan and Hydrochlorothiazide
Benazepril
Benazepril HCl and Hydrochlorothiazide
Cefepime
Clobetasol Propinate
Deferasirox
Denosumab
Dexlansoprazole
Doxorubicin
Dronedarone
Enalapril
Enalapril and Hydrochlorothiazide
Eprosartan
Eprosartan Mesylate Hydrochlorothiazide
Esomeprazole
Fenofibric Acid
Formoterol
Indacaterol
Irbesartan
Lansoprazole
Levalbuterol HCl
Levocetirizine
Linagliptin
Losartan
Miglitol
Moexipril HCl Hydrochlorothiazide Tablets
Montelukast
Naproxen and Esomeprazole Magnesium
Olmesartan
Omeprazole
Paclitaxel
Pantoprazole
Quinapril
Quinapril HC- Hydrochlorothiazide Tablets
Rotavirus vaccine
Simvastatin and Sitagliptin
Telmisartan
Testosterone Fortesta
Trandolapril
Trandolapril- Verapamil
Zolmitriptan

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

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