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.
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
*APAP class change
*APAP class change
*APAP class change
Avalide (irbesartan/hydrochlorothiazide) tablets
Ditropan XL (oxybutynin chloride) tablets
Exforge HCT (amlodipine/valsartan/hydrochlorothiazide) tablets
*eye problems
Photofrin (porfimer sodium) for injection
Prilosec (omeprazole magnesium) for delayed-release oral suspension and delayed-release capsules
Prozac Pulvules (fluoxetine hydrochloride) capsules for oral use and Prozac Weekly (fluoxetine hydrochloride) delayed-release capsules
Tekturna HCT (aliskiren/hydrochlorothiazide) tablets
*eye problems
Venofer (iron sucrose) injection
Atacand (candesartan cilexetil) tablets and Atacand HCT (candesartan/cilexetil hydrochlorothiazide) tablets
*NSAID interaction
Benicar (olmesartan medoxomil) tablets
*NSAID interaction
Calan (verapamil hydrochloride) tablets
Diovan (valsartan) tablets
*NSAID interaction
Lotensin HCT (benazepril HCl and hydrochlorothiazide) tablets
*NSAID interaction
Lotrel (amlodipine besylate and benazepril hydrochloride) tablets
*NSAID interaction
Pepcid (famotidine) tablets
Propecia (finasteride) 1 mg tablet
Twynsta (telmisartan/amlodipine) tablets
*NSAID interaction
Busulfex (busulfan) injection