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
- Abarelix
- AbobotulinumtoxinA
- Acetylcysteine*
- Acitretin
- Adalimumab
- Adefovir
- Aldesleukin
- Alemtuzumab
- Alglucosidase alfa
- Aliskiren
- Alosetron
- Alprostadil
- Altretamine
- Alvimopan
- Ambrisentan
- Amikacin (parenteral)
- Amiloride
- Aminoglycosides (parenteral)
- Amiodarone (oral)
- Amitriptyline
- Amoxapine
- Amphetamines
- Amphotericin (nonliposomal)
- Amprenavir (Oral solution) (manufacturer discontinued Feb 2008)
- Anabolic steroids
- Angiotensin Converting Enzyme (ACE) Inhibitors
- Angiotensin II Antagonists
- Anti-thymocyte Globulin (equine)
- Anti-thymocyte Globulin (rabbit)
- Aprotinin (U.S. Marketing Suspension: May 2008)
- Arformoterol
- Aripiprazole
- Arsenic trioxide
- Asenapine
- Asparaginase (black box removed upon last labeling revision)
- Atenolol (Oral)
- Atomoxetine
- Auranofin
- Azathioprine
B
- Bacitracin (injection)
- Baclofen(Intrathecal)
- Basiliximab
- BCG (Live)
- Becaplermin
- Benazepril
- Beta Blockers (Oral)
- Bevacizumab
- Bexarotene
- Bleomycin
- Bosentan
- Botulinum Toxins
- Bumetanide
- Buprenorphine (Transdermal)
- Bupropion
- Bupivacaine
- Busulfan
C
- Cabazitaxel
- Candesartan
- Capecitabine
- Capreomycin
- Captopril
- Carbamazepine
- Carbidopa*
- Carbonyl Iron (Oral)
- Carboplatin
- Carmustine
- Celecoxib
- Certolizumab Pegol
- Cetuximab
- Chlorambucil
- Chloramphenicol
- Chloroquine Phosphate
- Chlorpromazine
- Cidofovir
- Cilostazol
- Ciprofloxacin (Oral, Injectable)
- Cisapride
- Cisplatin
- Citalopram
- Cladribine
- Clindamycin(injection and oral)
- Clomipramine
- Clonidine(epidural)
- Clopidogrel
- Clozapine
- Coagulation Factor VIIa Recombinant
- Conjugated Estrogens(Oral, Injection, Vaginal)
- Conjugated Estrogens A, Synthetic (Vaginal, Oral)
- Conjugated Estrogens B, Synthetic (Oral)
- Conjugated Estrogens/Medroxyprogesterone Acetate(Oral)
- Contraceptives, Estrogen Containing (Oral, Transdermal, Vaginal)
- Cyclosporine
- Cytarabine (Conventional)
- Cytarabine (Liposomal)
D
- Dacarbazine
- Daclizumab
- Dactinomycin
- Dalteparin
- Danazol
- Dantrolene
- Darbepoetin alfa
- Daunorubicin (Conventional)
- Daunorubicin (Liposomal)
- Deferasirox
- Denileukin diftitox
- Desipramine
- Desirudin
- Desogestrel/Ethinyl Estradiol(Oral)
- Desvenlafaxine
- Dexmethylphenidate
- Dextroamphetamine
- Diatrizoate Meglumine
- Diatrizoate Sodium
- Diclofenac epolamine
- Diclofenac potassium
- Diclofenac sodium
- Didanosine
- Dienogest/Estradiol Valerate (Oral)
- Diflunisal
- Dihydroergotamine
- Dinoprostone (vaginal suppository)
- Disopyramide
- Disulfiram
- Divalproex Sodium
- Docetaxel
- Dofetilide
- Dopamine
- Doxacurium*
- Doxepin (Oral)
- Doxorubicin (Conventional)
- Doxorubicin (Liposomal)
- Dronedarone
- Droperidol
- Drospirenone/Estradiol (Oral)
- Drospirenone/Ethinyl Estradiol (Oral)
- Duloxetine
E
- Ecallantide
- Eculizumab
- Edetate calcium disodium
- Efalizumab
- Eltrombopag Olamine
- Emtricitabine
- Enalapril/Enalaprilat
- Enoxaparin
- Entecavir
- Epirubicin
- Epoetin alfa
- Epoetin-beta, methoxy polyethylene glycol
- Eprosartan
- Ergotamine
- Escitalopram
- Esterified Estrogens (Oral)
- Esterified Estrogens/Methyltestosterone (Oral)
- Estradiol (Oral)
- Estradiol (Topical)
- Estradiol (Transdermal)
- Estradiol (Transdermal Spray)
- Estradiol (Vaginal Cream, Tablets)
- Estradiol (Vaginal Ring)
- Estradiol/Drospirenone (Oral)
- Estradiol/Levonorgestrel (Transdermal)
- Estradiol/Norethindrone Acetate(Oral)
- Estradiol/Norethindrone Acetate(Transdermal)
- Estradiol/Norgestimate (Oral)
- Estradiol Acetate (Oral)
- Estradiol Acetate (Vaginal Ring)
- Estradiol Cypionate(Injection)
- Estradiol Valerate (Injection)
- Estradiol Valerate/Dienogest (Oral)
- Estrogens, Conjugated (Oral, Injection)
- Estrogens A, Conjugated Synthetic (Vaginal, Oral)
- Estrogens B, Conjugated Synthetic (Oral)
- Estrogens, Conjugated/Medroxyprogesterone Acetate(Oral)
- Estrogens, Esterified (Oral)
- Estrogens, Esterified/Methyltestosterone (Oral)
- Estropipate (Oral)
- Etanercept
- Ethacrynate Sodium*
- Ethacrynic Acid*
- Ethinyl Estradiol/Desogestrel (Oral)
- Ethinyl Estradiol/Drospirenone (Oral)
- Ethinyl Estradiol/Ethinynodiol Diacetate (Oral)
- Ethinyl Estradiol/Etonogestrel (Vaginal Ring)
- Ethinyl Estradiol/Levonorgestrel (Oral)
- Ethinyl Estradiol/Norelgestromin (Transdermal)
- Ethinyl Estradiol/Norethindrone (Oral)
- Ethinyl Estradiol/Norethindrone Acetate (Oral Contraceptive)
- Ethinyl Estradiol/Norethindrone Acetate(Oral Postmenopausal Replacement)
- Ethinyl Estradiol/Norgestimate (Oral)
- Ethinyl Estradiol/Norgestrel (Oral)
- Ethynodiol Diacetate/Ethinyl Estradiol (Oral)
- Etodolac
- Etonogestrel (Implant)
- Etonogestrel/Ethinyl Estradiol (Vaginal)
- Etoposide
- Everolimus
F
- Factor VIIa, Recombinant
- Fat Emulsions (intravenous)
- Felbamate
- Fenoprofen
- Fentanyl (Buccal)
- Fentanyl (Transdermal)
- Fentanyl (Transmucosal)
- Ferrous Fumarate
- Flecainide
- Floxuridine
- Flucytosine
- Fludarabine
- Flumazenil
- Fluorouracil
- Fluoxetine
- Fluphenazine
- Flurbiprofen
- Flutamide
- Fluvoxamine
- Fondaparinux sodium
- Formoterol fumarate
- Foscarnet
- Fosinopril
- Furosemide*
G
- Gadobenate
- Gadodiamide
- Gadolinium based contrast agents
- Gadopentetate
- Gadoteridol
- Gadoversetamide
- Gadoxetate Disodium
- Gallium Nitrate
- Ganciclovir
- Gemifloxacin (Oral)
- Gemtuzumab
- Gentamicin (parenteral)
- Gold Sodium Thiomalate
- Golimumab
H
- Haloperidol
- Hemin for Injection
- Hematological Agents
- Heparinoids (low molecular weight)
- Hydralazine/hydrochlorothiazide
- Hydromorphone Hydrochloride (High Potency Injection)*
- Hydromorphone Hydrochloride (Oral: Extended release)
- Hydromorphone Hydrochloride (Oral: Liquid and Tablets)*
- Hydroxychloroquine
- Hydroxyurea
I
- Ibritumomab tiuxetan
- Ibuprofen
- Ibutilide
- Icodextrin
- Idarubicin
- Idursulfase
- Ifosfamide
- Iloperidone
- Imipiramine Hydrochloride
- Imipiramine Pamoate
- Immune Globulins (Intravenous)
- Immune Globulin, RHo D (Intravenous)
- Indomethacin
- Infliximab
- Interferons(alpha)
- Iodixanol
- Iopamidol
- Irbesartan
- Iron containing vitamins/products
- Iron dextran (injection)
- Irinotecan
- Isocarboxazid
- Isoniazid
- Isotretinoin
- Itraconazole
- Ixabepilone
K
- Kanamycin(parenteral)
- Ketamine
- Ketoconazole (oral)
- Ketoprofen
- Ketorolac (Oral, Injection)
- Ketorolac (Nasal)
L
- Lamivudine
- Lamotrigine
- Lapatinib
- Laronidase
- Leflunomide
- Lenalidomide
- Levofloxacin (Oral, Injectable)
- Levomethadyl
- Levonorgesterol (Releasing Intrauterine System)*
- Levonorgestrel/Estradiol(Transdermal)
- Levonorgestrel/Ethinyl Estradiol(Oral)
- Levothyroxine
- Lincomycin
- Lindane
- Liothyronine Sodium
- Liotrix
- Lisdexamfetamine dimesylate
- Lisinopril
- Liraglutide
- Lithium
- Lomustine
- Losartan
- Low Molecular Weight Heparins
- Loxapine
- Lymphocyte Immune Globulin (equine)
M
- Maprotiline
- Maraviroc
- Mechlorethamine
- Medroxyprogesterone Acetate (Depo-Contraceptive Injection)
- Medroxyprogesterone Acetate/Conjugated Estrogens (Oral)
- Mefenamic Acid
- Meloxicam
- Melphalan
- Mercaptopurine*
- Mesoridazine
- Mestranol/Norethindrone(Oral)
- Metformin
- Methacholine
- Methadone
- Methamphetamine
- Methohexital
- Methotrexate
- Methoxsalen (Injection)
- Methoxsalen (Oral)
- Methoxsalen (Topical)*
- Methoxy polyethylene Glycol-epoetin beta
- Methyldopa/thiazide Combinations
- Methylphenidate
- Methyltestosterone/Esterified Estrogens (Oral)
- Metoclopramide
- Metolazone*
- Metoprolol (Oral)
- Metronidazole (Oral and injection)
- Mexiletine
- Midazolam
- Midodrine
- Mifepristone
- Milnacipran
- Minoxidil
- Mirtazapine
- Misoprostol
- Mitomycin
- Mitotane
- Mitoxantrone
- Moexipril
- Molindone
- Moricizine
- Morphine Injection (Preservative Free)
- Morphine Sulfate (Controlled Release Tablets/Extended Release Capsules)
- Morphine Sulfate/Naltrexone(Oral, Extended Release Capsules)
- Moxifloxacin (Oral, Injectable)
- Muromonab
- Mycophenolate mofetil
- Mycophenolate sodium
N
- Nabumetone
- Nadolol (oral)
- Naltrexone
- Naltrexone/Morphine Sulfate(Oral, Extended Release Capsules)
- Nandrolone Decanoate
- Naproxen
- Natalizumab
- Nefazodone
- Nelarabine
- Neomycin (oral solution)
- Nevirapine
- Nilotinib
- Nilutamide
- Nimodipine
- Nitroprusside
- Nonsteroidal Anti-inflammatory Agents (NSAIDs)
- Norelgestromin/Ethinyl Estradiol(Transdermal)
- Norepinephrine Bitarate (Injection)
- Norethindrone(Oral)
- Norethindrone/Estradiol(Oral)
- Norethindrone/Ethinyl Estradiol(Oral)
- Norethindrone Acetate/Estradiol(Transdermal)
- Norethindrone Acetate/Ethinyl Estradiol(Oral Contraceptive)
- Norethindrone Acetate/Ethinyl Estradiol(Oral Postmenopausal Replacement)
- Norethindrone/Mestranol(Oral)
- Norfloxacin (Oral)
- Norgestimate/Estradiol (Oral)
- Norgestimate/Ethinyl Estradiol (Oral)
- Norgestrel/Ethinyl Estradiol (Oral)
- Nortriptyline
O
- Ofloxacin (Oral, Injectable)
- Olanzapine
- Olmesartan
- Omalizumab
- OnabotulinumtoxinA
- Oprelvekin
- Oxaliplatin
- Oxandrolone
- Oxaprozin
- Oxaprozin Potassium
- Oxybate, Sodium
- Oxycodone (Controlled Release)
- Oxymetholone
- Oxymorphone (Extended Release)
- Oxytocin
P
- Paclitaxel
- Paclitaxel: Protein-Bound Particles (PBP)
- Paliperidone
- Pancuronium
- Panitumumab
- Paroxetine
- Pazopanib
- Peginterferon
- Pemoline (US Market withdrawal Oct 2005)
- Penicillamine
- Penicillin G Benzathine/Penicillin G Procaine
- Pentazocine/naloxone
- Pentostatin
- Perflutren Microsphere
- Pergolide (Withdrawn from US Market-March 2007)
- Perindopril
- Perphenazine
- Phenelzine
- Phenylephrine (Injection)
- Phytonadione (injection)
- Pimecrolimus (topical)
- Pimozide
- Pioglitazone
- Piroxicam
- Polymixin B (Parenteral)
- Pooled Plasma (human) SD Treated (Plas+SD)
- Pramlintide
- Prasugrel
- Prazosin/Polythiazide
- Primaquine Phosphate
- Procainamide
- Procarbazine
- Prochlorperazine
- Progesterone (oral)
- Promethazine
- Propafenone
- Propoxyphene
- Propylthiouracil
- Protamine Sulfate
- Propranolol (Oral)
- Protriptyline
Q
R
- Raloxifene
- Ramipril
- Rasburicase
- Ribavirin (inhalation)
- Ribavirin (Oral)
- Ribavirin /interferon
- RimabotulinumtoxinB
- Risperidone
- Ritonavir
- Rituximab
- Rocuronium*
- Rosiglitazone
S
- Salmeterol
- Salsalate*
- Saquinavir
- Selegiline (Transdermal)
- Sertraline
- Sirolimus
- Smallpox Vaccine
- Sodium Oxybate
- Sodium Phosphate (oral)
- Sotalol (Oral)
- Sotalol (Intravenous)
- Spironolactone
- Stavudine
- Streptomycin
- Streptozocin
- Succinyl Choline
- Sulfadoxine/Pyrimethamine
- Sulindac
T
- Tacrolimus (Oral, Injection)
- Tacrolimus (Topical)
- Tamoxifen
- Telavancin
- Telbivudine
- Telithromycin
- Telmisartan
- Teniposide
- Tenofovir
- Teriparatide
- Testosterone (gel)
- Tetrabenazine
- Thalidomide
- Thioridazine
- Thiothixene
- Thrombin (bovine)
- Thyroid
- Ticlopidine
- Timolol (Oral)
- Tinidazole
- Tinzaparin
- Tipranavir
- Tizanidine*
- Tobramycin(parenteral)
- Tocaininde
- Tocilizumab
- Tolcapone
- Tolmetin
- Tolvaptan
- Topotecan
- Tositumomomab and Iodine I 131 Tositumomab
- Trandolapril
- Tranylcypromine
- Trastuzumab
- Trazodone
- Tretinoin
- Triameterene Combination products
- Trifluoperazine
- Trimetrexate
- Trimipramine
- Trovafloxacin
V
- Vaccina Immune Globulins (Intravenous)
- Valdecoxib (Withdrawn from US Market-April 2005)
- Valganciclovir
- Valproate Sodium (Injection)
- Valproic Acid and derivatives
- Valsartan
- Varenicline
- Venlafaxine
- Vigabatrin
- Vinblastine
- Vincristine
- Vinorelbine