Drug Safety and Availability > Medication Guides

Medication Guides

Drugs@FDA and DailyMed also contain medication guides as part of drug labeling.

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.

Please note: All links in the table below go to documents in PDF format.

Medication Guides are available for these products:

*biologic or drug/biologic combination

Abilify (aripiprazole) [2013 version]
Abilify Maintena (aripiprazole) [2013 version]
Absorica (isotrentinoin) [2012 version]
Abstral (fentanyl) [2013 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) [2013 version]
Androgel (1.62%) (testosterone) [2013 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]
Astagraf XL (tacrolimus) [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]
Brisdelle (paroxetine) [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) [2013 version]
Carbatrol (carbamazepine) [2013 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]
Concerta (methylphenidate hydrochloride) [2013 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) [2013 version]
Depakene (valproic acid) [2013 version]
Depakote (divalproex sodium) [2013 version]
Desoxyn (methamphetamine hydrochloride) [2007 version]
Dexedrine (dextroamphetamine sulfate) [2013 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]
Estazolam [2008 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) [2013 version]
Focalin XR (dexmethylphenidate hydrochloride) [2013 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]
Horizant (gabapentin enacarbil) [2013 version]
H.P. Acthar Gel (repository corticotropin) [2010 version]
Humira* (adalimumab) [2013 version]
Incivek (telaprevir) [2013 version]
Iclusig (ponatinib) [2012 version]
Ilaris* (canakinumab) [2013 version]
Indocin (indomethacin) [2008 version]
Infergen* (interferon alfacon-1) [2013 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]
Jentadueto (linagliptin and metformin hydrochloride) [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) [2013 version]
Keppra XR (levetiracetam) [2013 version]
Ketek (telithromycin) [2010 version]
Khedezla (desvenlafaxine) [2013 version]
Klonopin (clonazepam) [2010 version]
Kombiglyze XR (metformin hydrochloride and saxagliptin) [2013 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]
Latuda (lurasidone hydrochloride) [2013 versin]
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) [2013 version]
Methylin (methylphenidate)
- chewable tablets [2013 version]
- oral solution [2013 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]
Myfortic (mycophenolic acid) [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]
Neurontin (gabapentin) [2013 version]
Nexium (esomeprazole magnesium) [2012 version]
Nizoral (ketoconazole) [2013 version]
Nolvadex (tamoxifen) [2006 version]
Noroxin (norfloxacin) [2012 version]
Norpramin (desipramine hydrochloride) [2012 version]
Novantrone (mitoXantrone) [2012 version]
Nplate* (romiplostim) [2013 version]
Nucynta (tapentadol hydrochloride) [2012 version]
Nucynta ER (tapentadol) [2012 version]
Nulojix* (belatacept) [2013 version]
Nuvigil (armodafinil) [2013 version]
Oleptro (trazodone hydrochloride) [2012 version]
Omontys (peginesatide) [2012 version]
Onfi (clobazam) [2013 version]
Onglyza (saxagliptin hydrochloride) [2013 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) [2013 version]
Pegintron* (peginterferon alfa-2b) [2013 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) [2013 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 [2013 version]
Pristiq (desvenlafaxine succinate) [2013 version]
Procrit* (epoetin alfa) [2012 version]
Prolia* (denosumab) [2013 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) [2013 version]
Ritalin LA (methylphenidate hydrochloride) [2013 version]
Ritalin-SR (methylphenidate hydrochloride) [2013 version]
Rituxan* (rituximab) [2012 version]
Roferon-A* (interferon alfa-2a recombinant) [2008 version]
Rozerem (ramelteon) [2010 version]
Sabril (vigabatrin) [2012 version] Samsca (tolvaptan) [2013 version]
Sarafem (fluoxetine hydrochloride) [2013 version]
Savella (milnacipran hydrochloride) [2012 version]
Selzentry (maraviroc) [2013 version]
Serevent Diskus (salmeterol xinafoate) [2010 version]
Seroquel (quetiapine fumarate) [2013 version]
Seroquel XR (quetiapine fumarate) [2013 version]
Signifor (pasireotide diaspartate) [2012 version]
Silenor (doxepin) [2010 version]
Simponi* (golimumab) [2013 version]
Simponi Aria* (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]
Stelara* (ustekinumab) [2013 version]
Strattera (atomoxetine hydrochloride) [2013 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]
Tafinlar (dabrafenib) [2013 version]
Tapentadol see Nucynta Tasigna (nilotinib) [2013 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]
Tradjenta (linagliptin) [2013 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) [2013 version]
Tysabri* (natalizumab) [2013 version]
Tyzeka (telbivudine) [2013 version]
Ultresa (pancrelipase) [2012 version]
Vandetanib see Caprelsa
Vibativ (telavancin) [2013 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) [2013 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) [2013 version]
Zarontin (ethosuximide) [2012 version]
Zegerid (omeprazole and sodium bicarbonate) [2012 version]
Zelboraf (vemurafenib) [2013 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]
Zubsolv (buprenorphine and naloxone) [2013 version]
Zyban (bupropion hydrochloride) [2012 version]
Zyprexa (olanzapine) [2013 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