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Drug Safety Labeling Changes - March 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
Pazopanib - Tablets
Acarbose - Tablets
Aliskiren - Tablets
Alprostadil - for Injection
Amiodarone - Premixed Injection
Amiodarone - Tablets
Amlodipine - Besylate Tablets
Asenapine - Sublingual Tablets
Atazanavir - Capsules, Oral Powder
Atorvastatin - Tablets
Calcipotriene - Cream and Ointment
Canagliflozin - Tablets
Capecitabine - Tablets
Capecitabine - Tablets
Carfilzomib - for Injection
Cefotaxime - Injection
Cefotaxime - Sterile IM/IV
Cetuximab - Injection for Intravenous Infusion
Cyclosporine - Injection, Oral Solution, Soft Gelatin Capsules
Cyclosporine - Soft Gelatin Capsules, Oral Solution
Darunavir - Tablets, Oral Suspension
Diltiazem - Extended Release Tablets
Dulaglutide - Injection, for Subcutaneous Use
Efavirenz - Capsules, Tablets
Estradiol - Topical Emulsion
Etidronate - Tablets
Exenatide - Extended-Release for Injectable Suspension
Ferumoxytol - Injection
Indinavir - Capsules
Ivacaftor - Tablets
Lamotrigine - Tablets, Chewable Dispersible Tablets, Orally Disintegrating Tablets, Extended-release Tablets
Levetiracetam - Tablets, Oral Solution, Extended-release Tablets
Minocycline - Pellet-filled Capsules
Palifermin- Injection
Risedronate - Delayed-release Tablets
Risedronate -Tablets with Calcium Carbonate Tablets
Risedronate - Tablets
Ritonavir - Capsules, Oral Solution, Tablets
Ritonavir- Tablets, Oral Solution, Soft Gelatin Capsules
Saquinavir - Capsules, Tablets
Sirolimus -Oral Solution, Tablets
Sofosbuvir - Tablet
Ulipristal Acetate - 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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