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  1. Postmarket Drug Safety Information for Patients and Providers

Index to Drug-Specific Information

Note: This Index does not include all FDA approved drugs. Please use Drugs@FDA to search for information on a drug not found in the Index. You may also find Information for specific drugs on the Drug Safety Communications, Medication Guides, Drug Alerts and Statements, and Information by Drug Class pages.
 

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Abacavir sulfate 
Abilify (aripiprazole)
Abstral (fentanyl sublingual tablets)
Abuse-Deterrent Opioid Analgesics
Acetaminophen
Accupril  (quinapril) 
Accutane  (isotretinoin)
Aceon  (perindopril) 
Acetaminophen 
Actiq (fentanyl submucosal lozenge)
Actoplus Met  (pioglitazone)
Adalimumab
Adcetris (brentuximab vedotin)
Adenoscan (adenosine)
Adenosine
Ado-trastuzumab emtansine
Adderall  (amphetamine salts)
Adrenalin (epinephrine)
Aducanumab
Aduhelm (aducanumab)
Aleve  (naproxen sodium)
Aliskiren 
Alogliptin
Alosetron hydrochloride 
Altace (ramipril)
Ambien (zolpidem tartrate)
Amiodarone
Amnesteem  (isotretinoin)
Amphetamine salts
Ampyra  (dalfampridine)
Amturnide  (aliskiren/amlodipine/hydrochlorothiazide)
Anaprox  (naproxen sodium)
AndroGel 1% 
Aprotinin
Aranesp (darbepoetin alfa) 
Aripiprazole
Arzerra (ofatumumab)
Aspirin
Atacand  (candesartan)
Atomoxetine
Avalide  (irbesartan/hydrochlorothiazide)
Avapro  (irbesartan)
Avastin  (bevacizumab)
Avelox  (moxifloxacin)
Azithromycin
Azor  (olmesartan/amlodipine)

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B
Becaplermin
Benazepril
Bevacizumab
Bextra  (valdecoxib)
Biaxin  (clarithromycin)
Boceprevir
Bortezomib
Botulinium Type A and B
Brentuximab vedotin
Buprenorphine  
Bupropion
Butisol sodium 
Bydureon (exenatide)
Byetta (exenatide) 

   
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C

Candesartan
Capoten  (captopril)
Captopril
Carbamazepine
Carbatrol  (carbamazepine)
Carbrital (pentobarbital and carbromal)
Cefepime
Celebrex  (celecoxib)
Celecoxib 
Celexa
CellCept (mycophenolate mofetil)
Cerezyme (imiglucerase)
Certolizumab pergol
Cetuximab
Chantix
Cialis (tadalafil)
Cimzia (certolizumab pergol)
Cinacalcet
Cipro (ciprofloxacin)
Cipro XR (ciprofloxacin extended release)
Ciprofloxacin
Ciprofloxacin Extended Release
Citalopram
Claravis  (isotretinoin)
Clarithromycin
Clobazam
Clozapine
Clozaril (clozapine)
Codeine
Colchicine  
Colcrys  (colchicine)
Concerta (methylphenidate)
Cordarone (amiodarone)
Cozaar  (losartan)
Crestor  (rosuvastatin calcium)
Cyclosporine  
Cymbalta  (duloxetine)
Cytotec  (misoprostol)

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D
Dalfampridine
Dalmane (flurazepam)
Darunavir
Daytrana (methylphenidate)
Deferasirox
Definity  (perflutren lipid microspheres)
Depacon  (valproate)
Depakene  (valproic acid)
Depakote  (divalproex sodium)
Desoxyn (methamphetamine)
Dexedrine (dextroamphetamine sulfate)
Dexmethylphenidate
Dextroamphetamine
Dextrostat (dextroamphetatimine)
Didanosine
Diflucan (fluconazole)
Dimethyl fumarate
Diovan  (valsartan)
Diprivan (propofol)
Divalproex sodium
Doral (quazepam)
Drospirenone
Duetact (pioglitazone/glimepiride)
Duloxetine
Duract (bromfenac)
Duragesic  (fentanyl transdermal system)
Dysport   (abobotulinumtoxinA)

 
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E
Edetate disodium
Efalizumab
Effexor (venlafaxine)
Effient (prasugrel) 
Elidel  (pimecrolimus)
Eloxatin (oxaliplatin)
Enalapril/Enalaprilat
Enbrel  (etanercept)
Endrate (edetate disodium)
Enoxaparin
Epinephrine
Epogen/Procrit (Epoetin alfa)
Eprex  (epoetin alfa)
Equetro  (carbamazepine)
Erbitux (cetuximab)
Erythromycin
Escitalopram 
Estradiol
Estazolam
Eszopiclone
Etanercept
Ethchlorvynol
Evamist  (estradiol)
Exenatide
Exforge  (valsartan/amlodipine)
Exjade  (deferasirox)
Ezetimibe
Ezetimibe/simvastatin
 

 
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F
Factive  (gemifloxacin)
Fentanyl buccal soluble film
Fentanyl buccal tablets
Fentanyl nasal spray
Fentanyl sublingual tablets
Fentanyl submucosal lozenge
Fentanyl transdermal system
Fentora  (fentanyl buccal tablets)
Feraheme (ferumoxytol)
ferumoxytol
Fingolimod
Fleet Accu-Prep  (sodium phosphate)
Fleet Phospho-Soda  (sodium phosphate)
Floxin  (ofloxacin)
Fluconazole
Fluoxetine 
Flurazepam
Fluvoxamine
Focalin  (dexmethylphenidate)
Fosinopril 
 

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G
Gabitril  (tiagabine)
Gadobenate Dimeglumine
Gadodiamide
Gadolinium
Gadopentetate Dimeglumine
Gadoteridol
Gasoversetamide
Galantamine
Gatifloxacin
Gefitinib
Gemifloxacin
Geodon (ziprasidone)
Gilenya
Gleevec (imatinib mesylate)
Golimumab  

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H
Halcion (triazolam)
Haldol  (haloperidol)
Haloperidol
Harvoni (ledipasvir/sofosbuvir)
Humira  (adalimumab)
Hydromorphone
Hyzaar  (losartan/hydrochlorothiazide)

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I
Ibuprofen
Iclusig (ponatinib)
Imatinib mesylate
Iplex
Incivek 
Infliximab
Insulin Glargine 
Intermezzo (zolpidem tartrate)
Irbesartan
Iressa  (gefitinib)
Isotretinoin
 

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J
Janumet (sitagliptin/metformin)
Januvia (sitagliptin)
Jentadueto (linagliptin/metformin)
Juvisync (sitagliptin/simvastatin)

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K
 

Kadcyla (ado-trastuzumab emtansine)
Kazano (alogliptin/metformin)
Kepivance (palifermin)
Ketoconazole
Kombiglyze XR (saxagliptin/metformin)

L
Lantus (insulin glargine)
Lazanda (fentanyl nasal spray)
ledipasvir/sofosbuvir
Lenalidomide
Levaquin  (levofloxacin)
Levitra (vardenafil)
Levofloxacin
Levonorgestrel
Levothyroxine sodium 
Lexapro  (escitalopram)
Lexiscan (regadenoson)
Linagliptin
Lindane
Liraglutide
Lisdexamfetamine dimesylate
Lisinopril
Loperamide (Imodium A-D)
Losartan
Lotensin  (benazepril)
Lotronex (alosetron hydrochloride)
Lovenox (enoxaparin)
Lunesta  (eszopiclone)
Luvox  (fluvoxamine)

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M
Magnevist (gadopentetate dimeglumine)
Magnesium sulfate
Mavik  (trandolapril)
Maxipime (cefepime)
Mecasermin rinfabate recombinant  
Metadate (methylphenidate)
Metformin
Methadone
Methamphetamine
Methylin (methylphenidate)
Methylphenidate
Metoclopramide
Miacalcin (calcitonin-salmon)
Micardis  (telmisartan)
Midodrine
Mifeprex  (mifepristone)
Mifepristone
Mirapex  (pramipexole)
Mirtazapine
Misoprostol
Mitoxantrone hydrochloride
Moexipril
Monopril  (fosinopril)
Moxifloxacin
Multihance (gadobenate dimeglumine)
Mycophenolate acid
Mycophenolate mofetil
Myfortic (mycophenolate acid) 
 

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N
Naloxone
Naltrexone
Naprosyn  (naproxen)
Naproxen
Natalizumab
Neoral  (cyclosporine)
Nesina (alogliptin)
NeutroSpec (technetium-99m)
Nizoral (ketoconazole)
Norelgestromin
Norfloxacin
Noroxin  (norfloxacin)
Novantrone  (mitoxantrone hydrochloride)

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O
Ofatumumab
Ofloxacin
Olanzapine pamoate
Olanzapine/fluoxetine
Omalizumab
Omniscan (gadodiamide)
Ondansetron
Onfi (clobazam)
Onglyza (saxagliptin)
Onsolis (fentanyl buccal soluble film)
OptimarkM (gasoversetamide)
Optison  (perflutren protein-type A microspheres)
Ortho Evra (norelgestromin; ethinyl estradiol)
Oseni (alogliptin/pioglitazone)
Osmoprep  (sodium phosphate)
Oxaliplatin
Oxymorphone

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P
Pacerone (amiodarone)
Palifermin
Pallodone (hydromorphone)
Paroxetine
Paxil  (paroxetine)
Pentobarbital and carbromal
Peramivir 
Perflutren lipid microspheres   
Pergolide
Permax (pergolide)
Perindopril
Phenergan  (promethazine)
Pimecrolimus
Placidyl (ethchlorvynol)
Plan B (levonorgestrel)
Ponatinib
Potiga (ezogabine)
Pramipexole
Prasugrel
Prezista  (darunavir)
Prinivil  (lisinopril)
Proglycem (diazoxide)
Prohance (gadoteridol)
Promethazine
Propofol  
Proquin XR  (ciprofloxacin extended release)
Prosom (estazolam)
Protopic (tacrolimus)
Prozac  (fluoxetine)
 

Q
Quazepam
Quetiapine
Quinapril

 

R
Ramelteon
Ramipril
Raptiva (efalizumab)
Razadyne  (galantamine)
Rapamune  (sirolimus)
Regadenoson
Reglan (metoclopramide)
Regranex (becaplermin)
Relenza (zanamivir)
Remeron  (mirtazapine)
Remicade  (infliximab)
Requip (ropinirole)
Restoril (temazepam)
Revatio  (sildenafil)
Revlimid
Risperdal (risperidone)
Risperidone
Ritalin (methylphenidate)
Rituxan
Rituximab 
Rofecoxib
Rolapitant
Ropinirole
Rosuvastatin
Rozerem (ramelteon)



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S
Sabril (vigabatrin)
Samsca (tolvaptan)
Sandimmune  (cyclosporine)
Sarafem  (fluoxetine)
Saxagliptin
Seconal (secobarbital)
Secobarbital
Sensipar (cinacalcet)
Seroquel (quetiapine)
Sertraline
Sildenafil citrate
Simponi  (golimumab) 
Simvastatin
Sirolimus  
Sitagliptin
Sodium phosphates
Sonata (zaleplon)
Sotret  (isotretinoin)
Spiriva (tiotropium bromide)
Stalevo (entacapone/carbidopa/levodopa)
Stavzor  (valproic acid)
Strattera  (atomoxetine)
Symbyax  (olanzapine/fluoxetine)



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T
Tacrolimus
Tadalafil
Tecfidera (dimethyl fumarate)
Tagaserod maleate
Tegretol  (carbamazepine)
Tekamlo  (aliskiren/amlodipine)
Tekturna  (aliskiren)
Temazepam
Tequin  (gatifloxacin)
Testim 1%
Testosterone
Teveten  (eprosartan)
Thalidomide
Thalomid (thalidomide)
Tiagabine
Tikosyn (dofetilide)
Tiotropium bromide
Tolvaptan
Tradjenta (linagliptin)
Tramadol
Trandolapril
Trasylol (aprotinin)
Trilafon  (perphenazine)
Triazolam
Trifluoperazine 
Tussionex  (hydrocodone)
Twynsta  (telmisartan/amlodipine)
Tygacil
Tylenol
Tysabri

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U
Unithroid (levothyroxine sodium)
Univasc  (moexipril)

V
Valdecoxib
Valproate
Valproic acid
Valturna  (valsartan/aliskiren)
Vardenafil
Varenicline
Varubi (rolapitant)
Vasotec  (enalapril/enalaprilat)
Velcade (bortezomib)
Venlafaxine
Viagra (sildenafil citrate)
Victoza (liraglutide)
Victrelis (boceprevir)
Videx
Vioxx (rofecoxib)
Visicol  (sodium phosphate)
Vytorin  (ezetimibe/simvastatin)
Vyvanse (lisdexamfetamine dimesylate)

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W
Wellbutrin  (bupropion)

X
Xolair  (omalizumab)
Xyrem  (sodium oxybate)

Y

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Z
Zaleplon
Zanamivir
Zestril  (lisinopril)
Zetia (ezetimibe)
Ziagen  (abacavir sulfate)
Ziprasidone
Zithromax (azithromycin)
Zmax (azithromycin)
Zocor
Zofran
Zolpidem tartrate
Zolpimist (zolidem tartrate)
Zoloft  (sertraline)
Zonegran  (zonisamide)
Zonisamide
Zyban   (bupropion hydrochloride)
Zyprexa (olanzapine)

 
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