The summary view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. The “quick view” table below provides the drug name and sections modified. Click on the drug name to go to the detailed view. The detailed view includes sections and subsections modified, a description of new or modified safety information in the BOXED WARNING, CONTRAINDICATIONS, or WARNINGS sections, and a link to the revised prescribing information.
Drug Safety Labeling Changes
The summary view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. The “quick view” table below provides the drug name and sections modified. Click on the drug name to go to the detailed view. The detailed view includes sections and subsections modified, a description of new or modified safety information in the BOXED WARNING, CONTRAINDICATIONS, or WARNINGS sections, and a link to the revised prescribing information.
Key to Label Section Acronyms:
BW=BOXED WARNING, C=CONTRAINDICATIONS, W=WARNINGS, P=PRECAUTIONS
AR=ADVERSE REACTIONS, PPI/MG=PATIENT PACKAGE INSERT/MEDICATION GUIDE
BW
C
W
P
AR
BW
C
W
P
AR
BW
C
W
P
AR
Amturnide (aliskiren/amlodipine/hydrochlorothiazide) Tablets
*Amlodipine/Simvsatin Interaction
Combivir (lamivudine/zidovudine) Tablets
*Immune Reconstitution Syndrome
Emtriva (emtricitabine) Capsules and Oral Solution
*Immune Reconstitution Syndrome
Epivir (lamivudine) Tablets and Oral Solution
*Immune Reconstitution Syndrome
Epzicom (abacavir sulfate and lamivudine) Tablets
*Immune Reconstitution Syndrome
Retrovir (zidovudine) IV Infusion, Capsules, Tablets, and Syrup
*Immune Reconstitution Syndrome
Tekamlo (aliskiren/amlodipine) Tablets
*Amlodipine/Simvsatin Interaction
Tribenzor (olmesartan medoxomil, amlodipine, hydrochlorothiazide) Tablets
*Amlodipine/Simvsatin Interaction
Trizivir (abacavir sulfate, lamivudine, and zidovudine) Tablets
*Immune Reconstitution Syndrome
Twynsta (telmisartan/amlodipine)
*Amlodipine/Simvsatin Interaction
Videx (didanosine) Pediatric Powder Oral Solution
*Immune Reconstitution Syndrome
Videx EC (didanosine, USP) Capsules
*Immune Reconstitution Syndrome
Viread (tenofovir disoproxil fumarate) Tablets
*Immune Reconstitution Syndrome
Zerit (stavudine) Capsules and Oral Solution
*Immune Reconstitution Syndrome
Ziagen (abacavir sulfate) Tablets and Oral Solution
*Immune Reconstitution Syndrome
BW
C
W
P
AR
Calan (verapamil hydrochloride) Intravenous Injection and Calan (verapamil hydrochloride) Intravenous Injection Syringe
*Verapamil/HMG-CoA Reductase Inhibitors Interaction
Covera HS (verapamil hydrochloride) Extended Release Tablets
*Verapamil/HMG-CoA Reductase Inhibitors Interaction
Tarka (trandolapril/verapamil hydrochloride) Tablets
*Verapamil/HMG-CoA Reductase Inhibitors Interaction
Verelan PM (verapamil hydrochloride) Extended-Release Capsules
Verelan (verapamil hydrochloride) Sustained-Release Capsules
*Verapamil/HMG-CoA Reductase Inhibitors Interaction
BW
C
W
P
AR
BW
C
W
P
AR