BlackBoxRX
 
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FDA may require the distribution of Medication Guides for selected drugs.
Bolded drug names on this list have Medication Guides which are available on the
FDA website.

A

Abacavir    
Abacavir/Dolutegravir/Lamivudine    
Abacavir/Lamivudine    
Abacavir/Lamivudine/Zidovudine    
Abaloparatide (Effective 12/2021, Box Warning has been removed)    
Abarelix (Discontinued manufacturer 5/2005)    
AbobotulinumtoxinA    
Acetaminophen    
Acetaminophen/Benzhydrocodone    
Acetaminophen/Butalbital/Caffeine/Codeine    
acetaminophen/caffeine/dihydrocodeine    
Acetaminophen/Codeine    
Acetaminophen/Codeine    
Acetaminophen/Hydrocodone    
Acetaminophen/Oxycodone    
Acetaminophen/Tramadol    
Acetylcysteine*    
Acitretin    
Adalimumab    
Adalimumab-adaz    
Adalimumab-adbm    
adalimumab-afzb    
Adalimumab-aqvh New Warning!  
Adalimumab-atto    
Adalimumab-bwwd    
Adalimumab-fkjp    
Adefovir    
Ado-Trastuzumab emtansine    
Albiglutide    
Aldesleukin    
Alemtuzumab    
Alfentanil    
Alglucosidase alfa    
Aliskiren    
Alogliptin/Metformin    
Alosetron    
alprazolam    
Alprostadil    
Altretamine    
Alvimopan    
Ambrisentan    
Amikacin (parenteral)    
Amikacin Liposome    
Amiloride    
Aminoglycosides (parenteral)    
Amiodarone (oral)    
Amitriptyline    
Amitriptyline/ Chlordiazepoxide    
Amitriptyline/Perphenazine    
Amlidipine/Olmesartan    
Amlodipine/Benazepril    
Amlodipine/Celecoxib    
Amlodipine/Hydrochlorothiazide/Olmesartan    
Amlodipine/Hydrochlorothiazide/Valsartan    
Amlodipine/Perindopril    
Amlodipine/Telmisartan    
Amlodipine/Valsartan    
Amoxapine    
Amphetamine    
Amphotericin (nonliposomal)    
Amprenavir (Oral solution) (manufacturer discontinued Feb 2008)    
Anabolic steroids    
Angiotensin Converting Enzyme (ACE) Inhibitors    
Angiotensin II Antagonists    
Anti-thymocyte Globulin (rabbit)    
Apixaban    
Aprotinin (U.S. Marketing Suspension: May 2008)    
Arformoterol    
Aripiprazole    
Arsenic trioxide    
Asenapine    
Asparaginase (black box removed upon last labeling revision)    
Aspirin/Caffeine/Dihydrocodeine    
Aspirin/Carisoprodol/Codeine    
Aspirin/Oxycodone    
Atenolol (Oral)    
Atomoxetine    
Auranofin    
Avalglusidase Alfa New Warning!  
Axicabtagene Ciloleucel    
Azathioprine    
Azilsartan