Medication Guides are paper handouts that come with many prescription medicines. The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events.
FDA requires that Medication Guides be issued with certain prescribed drugs and biological products when the Agency determines that:
- certain information is necessary to prevent serious adverse effects
- patient decision-making should be informed by information about a known serious side effect with a product, or
- patient adherence to directions for the use of a product are essential to its effectiveness.
Medication Guides are available for these products:
*biologic or drug/biologic combination
- Abilify (aripiprazole) [2012 version]
- Abilify Maintena (aripiprazole) [2013 version]
- Absorica (isotrentinoin) [2012 version]
- Abstral (fentanyl) [2011 version]
- Aciphex (rabeprazole sodium) [2012 version]
- Accutane (isotretinoin) [2010 version]
- Actemra* (tocilizumab) [2013 version]
- Actiq (fentanyl citrate) [2011 version]
- Actonel (risedronate sodium) [2013 version]
- Actonel with Calcium (risedronate sodium and calcium carbonate) [2013 version]
- Actoplus Met (metformin hydrochloride and pioglitazone hydrochloride) [2012 version]
- Actoplus Met XR (metformin hydrochloride and pioglitazone hydrochloride) [2011 version]
- Actos (pioglitazone hydrchloride) [2011 version]
- Adasuve (loxapine) [2012 version]
- Adderall XR (dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate) [2013 version]
- Advair Diskus (fluticasone propionate and salmeterol xinafoate) [2011 version]
- Advair HFA (fluticasone propionate and salmeterol xinafoate) [2012 version]
- Ambien (zolpidem tartrate) [2013 version]
- Ambien CR (zolpidem tartrate) [2013 version]
- Amevive* (alefacept) [2012 version]
- Ampyra (dalfampridine) [2013 version]
- Anafranil (clomipramine hydrochloride) [2012 version]
- Anaprox (naproxen sodium) [2013 version]
- Androgel (testosterone) [2012 version]
- Androgel (1.62%) (testosterone) [2012 version]
- Ansaid (flurbiprofen) [2010 version]
- Aplenzin (bupropion hydrobromide [2012 version]
- Aranesp* (darbepoetin alfa) [2012 version)
- Arcapta (indacaterol maleate) [2012 version]
- Arthrotec (diclofenac sodium) [2013 version]
- Atelvia (risedronate sodium) [2013 version]
- Aubagio (teriflunomide) [2012 version]
- Avandamet (metformin hydrochloride and rosiglitazone maleate) [2011 version]
- Avandaryl (glimepiride and rosiglitazone maleate) [2011 version]
- Avandia (rosiglitazone maleate) [2011 version]
- Avelox (moxifloxacin) [2012 version]
- Avinza (morphine sulfate) [2013 version]
- Avonex* (interferon beta-1a) [2012 version]
- Axiron (testosterone) [2011 version]
- Banzel (rufinamide) [2011 version]
- Benlysta (belimumab) [2012 version]
- Betaseron*(interferon beta-1b) [2012 version]
- Binosto (alendronate sodium) [2013 version]
- Boniva (ibandronate sodium) Injection [2013 version]
- Boniva (ibandronate sodium) Tablets [2013 version]
- Botox* (onabotulinumtoxinA) [2013 version]
Breo Ellipta (fluticasone furoate and vilanterol) [2013 version]
- Brilinta (ticagrelor) [2013 version]
- Brovana (arformoterol tartrate) [2011 version]
- Butrans (buprenorphine) [2012 version]
- Bydureon (exenatide) [2012 version]
- Byetta (exenatide) [2011 version]
- Cambia (diclofenac) [2009 version]
- Caprelsa (vandetanib) [2012 version]
- Carbatrol (carbamazepine) [2010 version]
- Cataflam (diclofenac potassium) [2011 version]
- Celebrex (celecoxib) [2011 version]
- Celexa (citalopram hydrobromide) [2012 version]
- Cellcept (mycophenolate mofetil) [2012 version]
- Celontin (methsuximide) [2010 version]
- Chantix (varenicline tartrate) [2012 version]
- Cimzia* (certolizumab pegol) [2012 version]
- Cipro (ciprofloxacin) [2013 version]
- Clinoril (sulindac) [2010 version]
Codeine Sulfate oral solution [2013 version]
- Colcrys (colchicine) [2011 version]
- Combunox (oxycodone hydrochloride and ibuprofen) [2010 version]
- Copegus (ribavirin) [2011 version]
- Cordarone (amiodarone hydrochloride) [2011 version]
- Coumadin (warfarin sodium) [2011 version]
- Creon (pancrelipase) [2012 version]
- Cymbalta (duloxetine hydrochloride) [2012 version)]
- Daliresp (roflumilast) [2011 version]
- Dalmane (flurazepam hydrochloride) [2009 version]
- Darvocet (acetaminophen and propoxyphene napsylate) [2009 version]
- Darvon (propoxyphene hydrochloride) [2009 version]
- Daypro Alta (oxaprozin potassium) [2007 version]
- Daytrana (methylphenidate) [2010 version]
- Depakene (valproic acid) [2013 version]
- Depakote (divalproex sodium) [2013 version]
- Desoxyn (methamphetamine hydrochloride) [2007 version]
- Dexedrine (dextroamphetamine sulfate) [2008 version]
- Dexilant (dexlansoprazole) [2012 version]
- Dilantin (phenytoin) [2011 version]
- Dilantin-125 (phenytoin) [2013 version]
- Dolophine (methadone hydrochloride) [2013 version]
- Doral (quazepam) [2013 version]
- Duetact (glimepiride and pioglitazone) [2011 version]
- Duexis (ibuprofen and famotidine) [2011 version]
- Dulera (mometasone furoate and formoterol fumarate) [2013 version]
- Duragesic (fentanyl) [2012 version]
- Dysport* (abobotulinumtoxinA) [2012 version]
- EC-Naprosyn (naproxen) [2013 version]
- Edluar (zolpidem tartrate) [2013 version]
- Effexor (venlafaxine hydrochloride) [2012 version]
- Effexor XR (venlafaxine hydrochloride) [2012 version]
- Effient (prasugrel) [2012 version]
- Elidel Cream (pimecrolimus) [2010 version]
- Eliquis (apixaban) [2012 version]
- Embeda (morphine sulfate and naltrexone hydrochloride) [2012 version]
- Emsam (selegeline transdermal system) [2007 version]
- Enbrel* (etanercept) [2012 version]
- Epogen* (epoetin alfa) [2012 version]
- Epzicom (abacavir sulfate and lamivudine) [2012 version]
- Equetro (carbamazepine) [2012 version]
- Erivedge (vismodegib) [2012 version]
- Evista (raloxifene hydrochloride) [2007 version]
- Exalgo (hydromorphone hydrochloride) [2013 version]
- Extavia* (interferon beta-1b) [2012 version]
- Extraneal (icodextrin) [2010 version]
- Exubera (insulin recombinant human) [2008 version]
- Factive (gemifloxacin) [2011 version]
- Felbatol (felbamate) [2011 version]
- Feldene (piroxicam) [2010 version]
- Fentora (fentanyl citrate) [2013 version]
- Ferriprox (deferiprone) [2012 version]
- Flector (diclofenac epolamine) [2010 version]
- Floxin (ofloxacin) [2011 version]
- Focalin (dexmethylphenidate hydrochloride) [2012 version]
- Focalin XR (dexmethylphenidate hydrochloride) [2012 version]
- Foradil Aerolizer (formoterol fumarate inhalation powder) [2012 version]
- Foradil Certihaler (formoterol fumarate inhalation powder) [2010 version]
- Forfivo XL (bupropion hydrochloride) [2011 version]
- Forteo (teriparatide) [2009 version]
- Fortesta (testosterone) [2010 version]
- Fosamax (alendronate sodium) [2013 version]
- Fosamax Plus D (alendronate sodium and cholecalciferol) [2013 version]
- Fosrenol (lanthanum carbonate) [2012 version]
- Fycompa (perampanel) [2012 version]
- Gabitril (tiagabine) [2010 version]
- Gattex (teduglutide [rDNA origin]) [2012 version]
- Gilenya (fingolimid) [2012 version]
- Gralise (gabapentin) [2012 version]
- Halcion (triazolam) [2008 version]
- HalfLytely and Bisacodyl Bowel Prep Kit (bisacodyl, polyethylene glycol 3500, potassium chloride, sodium bicarbonate, sodium chloride) [2010 version]
- H.P. Acthar Gel (repository corticotropin) [2010 version]
- Humira* (adalimumab) [2012 version]
- Incivek (telaprevir) [2013 version]
- Iclusig (ponatinib) [2012 version]
- Indocin (indomethacin) [2008 version]
- Infergen* (interferon alfacon-1) [2010 version]
- Intermezzo (zolpidem tartrate) [2013 version]
- Intron A* (interferon alfa-2b) [2012 version]
- Invirase (saquinavir mesylate) [2012 version]
- Invokana (canagliflozin) [2013 version]
- Janumet (metformin hydrochloride and sitagliptin phosphate) [2013 version]
- Janumet XR (sitagliptin and metformin hydrochloride) [2013 version]
- Januvia (sitagliptin phosphate) [2013 version]
- Juvisync (sitagliptin and simvastatin) [2013 version]
- Juxtapid (lomitapide) [2012 version]
- Kadian (morphine sulfate) [2012 version]
- Kalbitor* (ecallantide) [2009 version]
- Kaletra Capsules (lopinavir and ritonavir) [2013 version]
- Kaletra Tablets and Oral Solution (lopinavir and ritonavir) [2013 version]
- Kazano (alogliptin and metformin hydrochloride) [2013 version]
- Keppra (levetiracetam) [2011 version]
- Keppra XR (levetiracetam) [2009 version]
- Ketek (telithromycin) [2010 version]
- Klonopin (clonazepam) [2010 version]
- Kombiglyze XR (metformin hydrochloride and saxagliptin) [2012 version]
- Korlym (mifepristone) [2012 version]
- Krystexxa* (pegloticase) [2012 version]
- Kynamro (mipomersen sodium) [2013 version]
- Lamictal (lamotrigine) [2012 version]
- Lamictal XR (lamotrigine) [2012 version]
- Lariam (mefloquine hydrochloride) [2009 version]
- Lazanda (fentanyl citrate) [2011 version]
- Letairis (ambrisentan) [2012 version]
- Levaquin (levofloxacin) [2011 version]
- Lexapro (escitalopram oxalate) [2012 version]
- Limbitrol (chlordiazepoxide and amitriptyline) [2007 version]
- Lindane Lotion (lindane) [2007 version]
- Lindane Shampoo (lindane) [2007 version]
- Linzess (linaclotide) [2012 version]
- Lotronex (alosetron hydrochloride) [2010 version]
- Lunesta (eszopiclone) [2012 version]
- Luvox (fluvoxamine maleate) [2012 version]
- Luvox CR (fluvoxamine maleate) [2012 version]
- Lyrica (pregabalin) [2012 version]
- Marplan (isocarboxazid) [2008 version]
- Meridia (sibutramine hydrochloride) [2010 version]
- Metadate CD (methylphenidate hydrochloride) [2009 version]
- Methylin (methylphenidate)
- chewable tablets [2010 version]
- oral solution [2010 version]
- Metoclopramide Oral Solution [2009 version]
- Metozolv ODT (metoclopramide hydrochloride) [2011 version]
- Mifeprex (mifepristone) [2009 version]
- Mircera* (methoxy polyethylene glycol-epoetin beta) [2007 version]
- Mobic (meloxicam) [2011 version]
- Morphine Sulfate (morphine sulfate oral solution) [2011 version]
- Motrin (ibuprofen) [2007 version]
- Moviprep (polyethylene glycol 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid) [2012 version]
- MS Contin (morphine sulfate) [2012 version]
- Multaq (dronedarone) [2013 version]
- Myobloc* (rimabotulinumtoxinB) [2009 version]
- Mysoline (primidone) [2010 version]
- Nalfon (fenoprofen calcium) [2009 version]
- Naprelan (naproxen sodium) [2011 version]
- Naprosyn (naproxen) [2013 version]
- Nardil (phenelzine sulfate) [2007 version]
- Nesina (alogliptin) [2013 version]
- Nexium (esomeprazole magnesium) [2012 version]
- Nolvadex (tamoxifen) [2006 version]
- Noroxin (norfloxacin) [2012 version]
- Norpramin (desipramine hydrochloride) [2012 version]
- Novantrone (mitoXantrone) [2012 version]
- Nplate* (romiplostim) [2012 version]
- Nucynta (tapentadol hydrochloride) [2012 version]
- Nucynta ER (tapentadol) [2012 version]
- Nulojix* (belatacept) [2013 version]
- Nuvigil (armodafinil) [2010 version]
- Oleptro (trazodone hydrochloride) [2012 version]
- Omontys (peginesatide) [2012 version]
- Onfi (clobazam) [2013 version]
- Onglyza (saxagliptin hydrochloride) [2011 version]
- Onsolis (fentanyl buccal soluble film) [2011 version]
- Opana ER (oxymorphone hydrochloride) [2013 version]
- Oseni (alogliptin and pioglitazone) [2013 version]
- Osmoprep (sodium phosphate dibasic anhydrous and sodium phosphate monobasic monohydrate) [2012 version]
- Oxtellar XR (oxcarbazepine) [2012 version]
- Oxycodone Hydrochloride Oral Solution [2012 version]
- OxyContin (oxycodone hydrochloride) [2012 version]
- Pacerone (amiodarone hydrochloride) [2008 version]
- Palladone (hydromorphone hydrochloride) [2004 version]
- Pamelor (nortriptyline hydrochloride) [2012 version]
- Pancreaze (pancrelipase) [2010 version]
- Parnate (tranylcypromine sulfate) [2008 version]
- Paxil (paroxetine hydrochloride) [2012 version]
- Paxil CR (paroxetine hydrochloride) [2012 version]
- Peganone (ethotoin) [2010 version]
- Pegasys* (peginterferon alfa-2a) [2011 version]
- Pegintron* (peginterferon alfa-2b) [2012 version]
- PegIntron*/Rebetol Combo Pack (peginterferon alfa-2b and ribavirin) [2008 version]
- Pennsaid (diclofenac sodium) [2010 version]
- Perforomist (formoterol fumarate) [2012 version]
- Pertzye (pancrelipase) [2012 version]
- Pexeva (paroxetine mesylate) [2012 version]
- Plavix (clopidogrel bisulfate) [2011 version]
- Pomalyst (pomalidomide) [2013 version]
- Ponstel (mefenamic acid) [2008 version]
- Potiga (ezogabine) [2012 version]
- Pradaxa (dabigatran etexilate mesylate) [2013 version]
- Prepopik (sodium picosulfate, magnesium oxide and citric acid) [2012 version]
- Prevacid (lansoprazole [2012 version]
- Prevacid NapraPac (lansoprazole and naproxen) [2009 version]
- Prilosec (omeprazole [2012 version]
- Pristiq (desvenlafaxine succinate) [2013 version]
- Procrit* (epoetin alfa) [2012 version]
- Prolia* (denosumab) [2012 version]
- Propylthiouracil [2010 version]
- Promacta (eltrombopag) [2012 version]
- Propulsid (cisapride) [2006 version]
- Proquin XR (ciprofloxacin hydrochloride) [2011 version]
- Protonix (pantoprazole sodium) [2012 version]
- Protopic Ointment (tacrolimus) [2011 version]
- Provigil (modafinil) [2010 version]
- Prozac (fluoxetine hydrochloride) [2013 version]
- Qsymia (phentermine and topiramate) [2013 version]
- Qualaquin (quinine sulfate) [2013 version]
- Quillivant XR (methylphenidate) [2012 version]
- Rapamune (sirolimus) [2013 version]
- Ravicti (glycerol phenylbutyrate) [2013 version]
- Rebetol (ribavirin) [2013 version]
- Rebif* (interferon beta-1a) [2013 version]
- Reclast (zoledronic acid) [2013 version]
- Reglan (metoclopramide hydrochloride) injection [2009 version]
- Reglan (metoclopramide hydrochloride) tablets [2011 version]
- Reglan ODT (metoclopramide hydrochloride) [2011 version]
- Remeron (mirtazapine) [2012 version]
- Remeron SolTab (mirtazapine) [2012 version]
- Remicade* (infliximab) [2013 version]
- Restoril (temazepam) [2010 version]
- Revlimid (lenalidomide) [2013 version]
- Ribasphere (ribavirin) [2008 version]
- Ritalin (methylphenidate hydrochloride) [2010 version]
- Ritalin LA (methylphenidate hydrochloride) [2010 version]
- Ritalin-SR (methylphenidate hydrochloride) [2010 version]
- Roferon-A* (interferon alfa-2a recombinant) [2008 version]
- Rozerem (ramelteon) [2010 version]
- Sabril (vigabatrin) [2012 version]
- Samsca (tolvaptan) [2013 version]
- Sarafem (fluoxetine hydrochloride) [2009 version]
- Savella (milnacipran hydrochloride) [2012 version]
- Selzentry (maraviroc) [2013 version]
- Serevent Diskus (salmeterol xinafoate) [2010 version]
- Signifor (pasireotide diaspartate) [2012 version]
- Silenor (doxepin) [2010 version]
- Simponi* (golimumab) [2013 version]
- Sinequan (doxepin hydrochloride) [2007 version]
- Sirturo (bedaquiline) [2012 versuib]
- Soliris* (eculizumab) [2009 version]
- Soltamox (tamoxifen citrate) [2005 version]
- Sonata (zaleplon) [2013 version]
- Soriatane (acitretin) [2011 version]
- Sotret (isotretinoin) [2006 version]
- Stavzor (valproic acid) [2013 version]
- Strattera (atomoxetine hydrochloride) [2012 version]
- Suboxone (buprenorphine and naloxone) [2012 version]
- Subsys (fentanyl) [2012 version]
- Subutex (buprenorphine) [2011 version]
- Suclear (sodium sulfate, potassium sulfate, magnesium sulfate, sodium chloride, sodium bicarbonate and potassium chloride) [2013 version]
- Suprep (sodium sulfate, potassium sulfate and magnesium sulfate) [2010 version]
- Surmontil (trimipramine) [2012 version]
- Sutent (sunitimib malate) [2012 version]
- Sylatron (peginterferon alfa-2b) [2012 version]
- Symbicort (budesonide and formoterol fumarate dihydrate) [2010 version]
- Symbyax (fluoxetine hydrochloride and olanzapine) [2013 version]
- Symlin (pramlintide acetate) [2007 version]
- Tapentadol see Nucynta
- Tasigna (nilotinib) [2011 version]
- Tegretol (carbamazepine) [2013 version]
- Testim (testosterone) [2011 version]
- Testosterone Gel [2012 version]
- Thalomid (thalidomide) [2013 version]
- Tikosyn (dofetilide) [2011 version]
- Tofranil (imipramine hydrochloride) [2007 version]
- Tofranil-PM (imipramine pamoate) [2012 version]
- Tolectin (tolmetin sodium) [2008 version]
- Topamax (topiramate) [2012 version]
- Toradol (ketorolac tromethamine) [2013 version]
- Tracleer (bosentan) [2012 version]
- Tranxene (clorazepate dipotassium) [2010 version]
- Treximet (naproxen sodium and sumatriptan succinate) [2012 version]
- Tridione (trimethadione) [2012 version]
- Trileptal (oxcarbazepine) [2011 version]
- Trilipix (choline fenofibrate) [2012 version]
- Trizivir (abacavir sulfate, lamivudine and zidovudine) [2012 version]
- Truvada (emtricitabine and tenofovir disoproxil fumarate) [2012 version]
- Tysabri* (natalizumab) [2012 version]
- Tyzeka (telbivudine) [2013 version]
- Ultresa (pancrelipase) [2012 version]
- Vandetanib see Caprelsa
- Vibativ (telavancin) [2009 version]
- Vicoprofen (vicoprofen and ibuprofen) [2008 version]
- Victoza (liraglutide) [2013 version]
- Victrelis (boceprevir) [2013 version]
- Videx (didanosine) [2011 version]
- Videx EC (didanosine) [2011 version]
- Viibryd (vilazodone hydrochloride) [2012 version]
- Vimovo (esomeprazole magnesium and naproxen) [2012 version]
- Vimpat (lacosamide) [2013 version]
- Viokace (pancrelipase) [2012 version]
- Viramune (nevirapine) [2012 version]
- Visicol (sodium phosphate dybasic anhydrous and sodium phosphate monobasic monohydrate) [2013 version]
- Vivactil (protriptyline hydrochloride) [2007 version]
- Vivitrol (naltrexone) [2010 version]
- Voltaren (diclofenac sodium) [2011 version]
- Votrient (pazopanib hydrochloride) [2012 version]
- Vyvanse (lisdexamfetamine dimesylate) [2013 version]
- Wellbutrin (bupropion hydrochloride) [2013 version]
- Wellbutrin SR (bupropion hydrochloride) [2013 version]
- Wellbutrin XL (buproprion hydrochloride) [2011 version]
- Xarelto (rivaroxaban) [2013 version]
- Xeljanz (tofacitinib) [2012 version]
- Xenazine (tetrabenazine) [2011 version]
- Xeomin* (incobotulinumtoxinA) [2011 version]
- Xiaflex* (collagenase clostridium histolyticum) [2011 version]
- Xolair* (omalizumab) [2010 version]
- Xyrem (sodium oxybate) [2012 version]
- Yervoy* (ipilimumab) [2012 version]
- Zarontin (ethosuximide) [2012 version]
- Zegerid (omeprazole and sodium bicarbonate) [2012 version]
- Zelboraf (vemurafenib) [2011 version]
- Zenpep (pancrelipase) [2013 version]
- Zerit (stavudine) [2011 version]
- Ziagen (abacavir sulfate) [2012 version]
- Zipsor (diclofenac potassium) [2009 version]
- Zoloft (sertraline hydrochloride) [2012 version]
- Zolpidem (zolpidem tartrate) [2008 version]
- Zolpimist (zolpidem tartrate) [2008 version]
- Zonegran (zonisamide) [2012 version]
- Zortress (everolimus) [2013 version]
- Zyban (bupropion hydrochloride) [2012 version]
- Zyprexa (olanzapine) [2010 version]
- Zyprexa Relprevv (olanzapine) [2012 version]
Related Information
- Medication Guides for Certain Prescription Products
Consumer Update article - Guidance for Industry: Medication Guides - Distribution Requirements and Inclusion in REMS (PDF - 91KB)
Final version (11/17/2011) - Questions and Answers on Draft Guidance for Industry: Medication Guides - Distribution Requirements and Inclusion in REMS
3/29/2011 - Public Hearing on Use of Medication Guides to Distribute Drug Risk Information to Patients June 12-13, 2007
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