Drug Safety and Availability > Medication Guides

Drug Safety and Availability > Medication Guides



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.

Related Information

• Guidance for Industry: Medication Guides - Distribution Requirements and Inclusion in REMS (PDF - 91KB)³⁷³
  Final version (11/17/2011)
  
• Questions and Answers on Draft Guidance for Industry: Medication Guides - Distribution Requirements and Inclusion in REMS³⁷⁴
  3/29/2011

Medication Guides are available for these products:

*biologic or drug/biologic combination

Abilify4 (aripiprazole) [2012 version] Absorica5 (isotrentinoin) [2012 version] Abstral6 (fentanyl) [2011] Aciphex7 (rabeprazole sodium) [2012 version] Accutane8 (isotretinoin) [2010 version] Actemra9* (tocilizumab) [2012 version] Actiq10 (fentanyl citrate) [2011 version] Actonel11 (risedronate sodium) [2011 version] Actonel with Calcium12 (risedronate sodium and calcium carbonate) [2011 version] Actoplus Met13 (metformin hydrochloride and pioglitazone hydrochloride) [2012 version] Actoplus Met XR14 (metformin hydrochloride and pioglitazone hydrochloride) [2011 version] Actos15 (pioglitazone hydrchloride) [2011 version] Adasuve16 (loxapine) [2012 version] Adderall XR17 (dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate) [2011 version] Advair Diskus18 (fluticasone propionate and salmeterol xinafoate) [2011 version] Advair HFA19 (fluticasone propionate and salmeterol xinafoate) [2012 version] Ambien20 (zolpidem tartrate) [2010 version] Ambien CR21 (zolpidem tartrate) [2010 version] Amevive22* (alefacept) [2012 version] Ampyra23 (dalfampridine) [2012 version] Anafranil24 (clomipramine hydrochloride) [2012 version] Anaprox25 (naproxen sodium) [2008 version] Androgel26 (testosterone) [2012 version] Androgel27 (1.62%) (testosterone) [2012 version] Ansaid28 (flurbiprofen) [2010 version] Aplenzin29 (bupropion hydrobromide [2012 version] Aranesp30* (darbepoetin alfa) [2012 version) Arcapta31 (indacaterol maleate) [2012 version] Arthrotec32 (diclofenac sodium) [2010 version] Atelvia33 (risedronate sodium) [2012 version] Aubagio34 (teriflunomide) [2012 version] Avandamet35 (metformin hydrochloride and rosiglitazone maleate) [2011 version] Avandaryl36 (glimepiride and rosiglitazone maleate) [2011 version] Avandia37 (rosiglitazone maleate) [2011 version] Avelox38 (moxifloxacin) [2012 version] Avinza39 (morphine sulfate) [2012 version] Avonex40* (interferon beta-1a) [2012 version] Axiron41 (testosterone) [2011 version] Banzel42 (rufinamide) [2011 version] Benlysta43 (belimumab) [2012 version] Betaseron44*(interferon beta-1b) [2012 version] Binosto45 (alendronate sodium) [2012 version] Boniva46 (ibandronate sodium) Injection [2011 version] Boniva47 (ibandronate sodium) Tablets [2011 version] Botox48* (onabotulinumtoxinA) [2012 version] Brilinta49 (ticagrelor) [2011 version] Brovana50 (arformoterol tartrate) [2011 version] Butrans51 (buprenorphine) [2012 version] Bydureon52 (exenatide) [2012 version] Byetta53 (exenatide) [2011 version] Cambia54 (diclofenac) [2009 version] Caprelsa55 (vandetanib) [2012 version] Carbatrol 56(carbamazepine) [2010 version] Cataflam57 (diclofenac potassium) [2011 version] Celebrex58 (celecoxib) [2011 version] Celexa59 (citalopram hydrobromide) [2012 version] Cellcept60 (mycophenolate mofetil) [2012 version] Celontin61 (methsuximide) [2010 version] Chantix62 (varenicline tartrate) [2012 version] Cimzia63* (certolizumab pegol) [2012 version] Cipro64 (ciprofloxacin) [2011 version] Clinoril65 (sulindac) [2010 version] Codeine Sulfate66 oral solution [2012 version] Colcrys67 (colchicine) [2011 version] Combunox68 (oxycodone hydrochloride and ibuprofen) [2010 version] Concerta69 (methylphenidate hydrochloride) [2010 version] Copegus70 (ribavirin) [2011 version] Cordarone71 (amiodarone hydrochloride) [2011 version] Coumadin72 (warfarin sodium) [2011 version] Creon73 (pancrelipase) [2011 version] Cymbalta74 (duloxetine hydrochloride) [2012 version)] Daliresp75 (roflumilast) [2011 version] Dalmane76 (flurazepam hydrochloride) [2009 version] Darvocet77 (acetaminophen and propoxyphene napsylate) [2009 version] Darvon78 (propoxyphene hydrochloride) [2009 version] Daypro Alta79 (oxaprozin potassium) [2007 version] Daytrana80 (methylphenidate) [2010 version] Desoxyn81 (methamphetamine hydrochloride) [2007 version] Dexedrine82 (dextroamphetamine sulfate) [2008 version] Dexilant83 (dexlansoprazole) [2012 version] Dilantin84 (phenytoin) [2011 version] Dilantin-12585 (phenytoin) [2011 version] Dolophine86 (methadone hydrochloride) [2012 version] Doral87 (quazepam) [2007 version] Duetact88 (glimepiride and pioglitazone) [2011 version] Duexis89 (ibuprofen and famotidine) [2011 version] Dulera90 (mometasone furoate and formoterol fumarate) [2012 version] Duragesic91 (fentanyl) [2012 version] Dysport92* (abobotulinumtoxinA) [2012 version] EC-Naprosyn93 (naproxen) [2008 version] Edluar94 (zolpidem tartrate) [2009 version] Effexor95 (venlafaxine hydrochloride) [2012 version] Effexor XR96 (venlafaxine hydrochloride) [2012 version] Effient97 (prasugrel) [2012 version] Elidel Cream 98(pimecrolimus) [2010 version] Eliquis 99(apixaban) [2012 version] Embeda100 (morphine sulfate and naltrexone hydrochloride) [2012 version] Emsam101 (selegeline transdermal system) [2007 version] Enbrel102* (etanercept) [2012 version] Epogen103* (epoetin alfa) [2012 version] Epzicom104 (abacavir sulfate and lamivudine) [2012 version] Equetro105 (carbamazepine) [2012 version] Erivedge106 (vismodegib) [2012 version] Evista107 (raloxifene hydrochloride) [2007 version] Exalgo108 (hydromorphone hydrochloride) [2012 version] Extavia109* (interferon beta-1b) [2012 version] Extraneal110 (icodextrin) [2010 version] Exubera111 (insulin recombinant human) [2008 version] Factive112 (gemifloxacin) [2011 version] Felbatol113 (felbamate) [2011 version] Feldene114 (piroxicam) [2010 version] Fentora115 (fentanyl citrate) [2011 version] Ferriprox 116(deferiprone) [2012 version] Flector117 (diclofenac epolamine) [2010 version] Floxin118 (ofloxacin) [2011 version] Focalin119 (dexmethylphenidate hydrochloride) [2012 version] Focalin XR120 (dexmethylphenidate hydrochloride) [2012 version] Foradil Aerolizer121 (formoterol fumarate inhalation powder) [2012 version] Foradil Certihaler122 (formoterol fumarate inhalation powder) [2010 version] Forfivo XL123 (bupropion hydrochloride) [2011 version] Forteo124 (teriparatide) [2009 version] Fortesta125 (testosterone) [2010 version] Fosamax126 (alendronate sodium) [2012 version] Fosamax Plus D127 (alendronate sodium and cholecalciferol) [2011 version] Fosrenol128 (lanthanum carbonate) [2012 version] Fycompa129 (perampanel) [2012 version] Gabitril130 (tiagabine) [2010 version] Gattex131 (teduglutide [rDNA origin]) [2012 version] Gilenya132 (fingolimid) [2012 version] Gralise133 (gabapentin) [2012 version] Halcion134 (triazolam) [2008 version] HalfLytely and Bisacodyl Bowel Prep Kit135 (bisacodyl, polyethylene glycol 3500, potassium chloride, sodium bicarbonate, sodium chloride) [2010 version] Horizant136 (gabapentin enacarbil) [2012 version] H.P. Acthar Gel137 (repository corticotropin) [2010 version] Humira138* (adalimumab) [2012 version] Incivek139 (telaprevir) [2012 version] Iclusig 140(ponatinib) [2012 version] Indocin141 (indomethacin) [2008 version] Infergen142* (interferon alfacon-1) [2010 version] Intermezzo143 (zolpidem tartrate) [2011 version] Intron A144* (interferon alfa-2b) [2012 version] Invirase145 (saquinavir mesylate) [2012 version] Janumet146 (metformin hydrochloride and sitagliptin phosphate) [2012 version] Janumet XR147 (sitagliptin and metformin hydrochloride) [2012 version] Januvia148 (sitagliptin phosphate) [2012 version] Juvisync149 (sitagliptin and simvastatin) [2012 version] Juxtapid150 (lomitapide) [2012 version] Kadian151 (morphine sulfate) [2012 version] Kalbitor152* (ecallantide) [2009 version] Kaletra 153Capsules (lopinavir and ritonavir) [2012 version] Kaletra 154Tablets and Oral Solution (lopinavir and ritonavir) [2012 version] Keppra155 (levetiracetam) [2011 version] Keppra XR156 (levetiracetam) [2009 version] Ketek157 (telithromycin) [2010 version] Klonopin158 (clonazepam) [2010 version] Kombiglyze XR159 (metformin hydrochloride and saxagliptin) [2012 version] Korlym160 (mifepristone) [2012 version] Krystexxa161* (pegloticase) [2012 version] Lamictal162 (lamotrigine) [2012 version] Lamictal XR163 (lamotrigine) [2012 version] Lariam164 (mefloquine hydrochloride) [2009 version] Lazanda165 (fentanyl citrate) [2011 version] Letairis166 (ambrisentan) [2012 version] Levaquin167 (levofloxacin) [2011 version] Lexapro168 (escitalopram oxalate) [2012 version] Limbitrol169 (chlordiazepoxide and amitriptyline) [2007 version] Lindane Lotion170 (lindane) [2007 version] Lindane Shampoo171 (lindane) [2007 version] Linzess172 (linaclotide) [2012 version] Lotronex173 (alosetron hydrochloride) [2010 version] Lunesta174 (eszopiclone) [2012 version] Luvox175 (fluvoxamine maleate) [2012 version] Luvox CR176 (fluvoxamine maleate) [2012 version] Lyrica177 (pregabalin) [2012 version] Marplan178 (isocarboxazid) [2008 version] Meridia179 (sibutramine hydrochloride) [2010 version] Metadate CD180 (methylphenidate hydrochloride) [2009 version] Methylin (methylphenidate) chewable tablets181 [2010 version] oral solution182 [2010 version] Metoclopramide Oral Solution183 [2009 version] Metozolv ODT184 (metoclopramide hydrochloride) [2011 version] Mifeprex185 (mifepristone) [2009 version] Mircera186* (methoxy polyethylene glycol-epoetin beta) [2007 version] Mobic187 (meloxicam) [2011 version] Morphine Sulfate188 (morphine sulfate oral solution) [2011 version] Motrin189 (ibuprofen) [2007 version] Moviprep190 (propylene glycol 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid) [2012 version] MS Contin191 (morphine sulfate) [2012 version] Multaq192 (dronedarone) [2012 version] Myfortic193 (mycophenolic acid) [2012 version] Myobloc194* (rimabotulinumtoxinB) [2009 version] Mysoline195 (primidone) [2010 version] Nalfon196 (fenoprofen calcium) [2009 version] Naprelan197 (naproxen sodium) [2011 version] Naprosyn198 (naproxen) [2008 version] Nardil199 (phenelzine sulfate) [2007 version] Neurontin200 (gabapentin) [2011 version] Nexium201 (esomeprazole magnesium) [2012 version] Nolvadex202 (tamoxifen) [2006 version] Noroxin203 (norfloxacin) [2012 version] Norpramin204 (desipramine hydrochloride) [2012 version] Novantrone205 (mitoXantrone) [2012 version] Nplate206* (romiplostim) [2012 version] Nucynta207 (tapentadol hydrochloride) [2012 version] Nucynta ER208 (tapentadol) [2012 version] Nulojix209* (belatacept) [2011 version] Nuvigil210 (armodafinil) [2010 version] Oleptro211 (trazodone hydrochloride) [2012 version] Omontys212 (peginesatide) [2012 version] Onfi213 (clobazam) [2012 version] Onglyza214 (saxagliptin hydrochloride) [2011 version] Onsolis215 (fentanyl buccal soluble film) [2011 version] Opana ER216 (oxymorphone hydrochloride) [2012 version] Osmoprep217 (sodium phosphate dibasic anhydrous and sodium phosphate monobasic monohydrate) [2012 version] Oxtellar XR218 (oxcarbazepine) [2012 version] Oxycodone Hydrochloride Oral Solution219 [2012 version] OxyContin220 (oxycodone hydrochloride) [2012 version] Pacerone221 (amiodarone hydrochloride) [2008 version] Palladone222 (hydromorphone hydrochloride) [2004 version] Pamelor223 (nortriptyline hydrochloride) [2012 version] Pancreaze224 (pancrelipase) [2010 version] Parnate225 (tranylcypromine sulfate) [2008 version] Paxil226 (paroxetine hydrochloride) [2012 version] Paxil CR227 (paroxetine hydrochloride) [2012 version] Peganone228 (ethotoin) [2010 version] Pegasys229* (peginterferon alfa-2a) [2011 version] Pegintron230* (peginterferon alfa-2b) [2012 version] PegIntron*/Rebetol Combo Pack231 (peginterferon alfa-2b and ribavirin) [2008 version] Pennsaid232 (diclofenac sodium) [2010 version] Perforomist233 (formoterol fumarate) [2012 version] Pertzye234 (pancrelipase) [2012 version] Pexeva235 (paroxetine mesylate) [2012 version] Plavix236 (clopidogrel bisulfate) [2011 version] Ponstel237 (mefenamic acid) [2008 version] Potiga238 (ezogabine) [2012 version] Pradaxa 239(dabigatran etexilate mesylate) [2012 version] Prepopik 240(sodium picosulfate, magnesium oxide and citric acid) [2012 version] Prevacid241 (lansoprazole [2012 version] Prevacid NapraPac242 (lansoprazole and naproxen) [2009 version] Prilosec 243(omeprazole [2012 version] Pristiq244 (desvenlafaxine succinate) [2012 version] Procrit245* (epoetin alfa) [2012 version] Prolia246* (denosumab) [2012 version] Propylthiouracil247 [2010 version] Promacta248 (eltrombopag) [2012 version] Propulsid249 (cisapride) [2006 version] Proquin XR250 (ciprofloxacin hydrochloride) [2011 version] Protonix251 (pantoprazole sodium) [2012 version] Protopic Ointment252 (tacrolimus) [2011 version] Provigil253 (modafinil) [2010 version] Prozac254 (fluoxetine hydrochloride) [2011 version] Qsymia255 (phentermine and topiramate) [2012 version] Qualaquin256 (quinine sulfate) [2011 version] Quillivant XR257 (methylphenidate) [2012 version] Rapamune258 (sirolimus) [2012 version] Rebetol259 (ribavirin) [2010 version] Rebif260* (interferon beta-1a) [2002 version] Reclast261 (zoledronic acid) [2011 version] Reglan262 (metoclopramide hydrochloride) injection [2009 version] Reglan263 (metoclopramide hydrochloride) tablets [2011 version] Reglan ODT264 (metoclopramide hydrochloride) [2011 version] Remeron265 (mirtazapine) [2012 version] Remeron SolTab266 (mirtazapine) [2012 version] Remicade267* (infliximab) [2011 version] Restoril268 (temazepam) [2010 version] Revlimid269 (lenalidomide) [2012 version] Ribasphere270 (ribavirin) [2008 version] Ritalin271 (methylphenidate hydrochloride) [2010 version] Ritalin LA272 (methylphenidate hydrochloride) [2010 version] Ritalin-SR273 (methylphenidate hydrochloride) [2010 version] Rituxan274* (rituximab) [2012 version] Roferon-A275* (interferon alfa-2a recombinant) [2008 version] Rozerem276 (ramelteon) [2010 version] Sabril277 (vigabatrin) [2012 version] Samsca278 (tolvaptan) [2012 version] Sarafem279 (fluoxetine hydrochloride) [2009 version] Savella280 (milnacipran hydrochloride) [2012 version] Selzentry281 (maraviroc) [2012 version] Serevent Diskus282 (salmeterol xinafoate) [2010 version] Seroquel283 (quetiapine fumarate) [2011 version] Seroquel XR284 (quetiapine fumarate) [2011 version] Signifor285 (pasireotide diaspartate) [2012 version] Silenor286 (doxepin) [2010 version] Simponi287* (golimumab) [2012 version] Sinequan288 (doxepin hydrochloride) [2007 version] Sirturo289 (bedaquiline) [2012 versuib] Soliris290* (eculizumab) [2009 version] Soltamox291 (tamoxifen citrate) [2005 version] Soriatane292 (acitretin) [2011 version] Sotret293 (isotretinoin) [2006 version] Stelara294* (ustekinumab) [2012 version] Strattera295 (atomoxetine hydrochloride) [2012 version] Suboxone296 (buprenorphine and naloxone) [2012 version] Subsys297 (fentanyl) [2012 version] Subutex298 (buprenorphine) [2011 version] Suprep299 (sodium sulfate, potassium sulfate and magnesium sulfate) [2010 version] Surmontil 300(trimipramine) [2012 version] Sutent301 (sunitimib malate) [2012 version] Sylatron302 (peginterferon alfa-2b) [2012 version] Symbicort303 (budesonide and formoterol fumarate dihydrate) [2010 version] Symbyax304 (fluoxetine hydrochloride and olanzapine) [2012 version] Symlin305 (pramlintide acetate) [2007 version] Tapentadol306 see Nucynta Tasigna307 (nilotinib) [2011 version] Tegretol308 (carbamazepine) [2012 version] Testim309 (testosterone) [2011 version] Testosterone Gel310 [2012 version] Thalomid311 (thalidomide) [2012 version] Tikosyn312 (dofetilide) [2011 version] Tofranil313 (imipramine hydrochloride) [2007 version] Tofranil-PM314 (imipramine pamoate) [2012 version] Tolectin315 (tolmetin sodium) [2008 version] Topamax316 (topiramate) [2012 version] Toradol317 (ketorolac tromethamine) [2007 version] Tracleer318 (bosentan) [2012 version] Tranxene319 (clorazepate dipotassium) [2010 version] Treximet320 (naproxen sodium and sumatriptan succinate) [2012 version] Tridione321 (trimethadione) [2012 version] Trileptal322 (oxcarbazepine) [2011 version] Trilipix323 (choline fenofibrate) [2012 version] Trizivir324 (abacavir sulfate, lamivudine and zidovudine) [2012 version] Truvada325 (emtricitabine and tenofovir disoproxil fumarate) [2012 version] Tysabri326* (natalizumab) [2012 version] Tyzeka327 (telbivudine) [2011 version] Ultresa328 (pancrelipase) [2012 version] Vandetanib329 see Caprelsa Vibativ330 (telavancin) [2009 version] Vicoprofen331 (vicoprofen and ibuprofen) [2008 version] Victoza332 (liraglutide) [2012 version] Victrelis333 (boceprevir) [2012 version] Videx334 (didanosine) [2011 version] Videx EC335 (didanosine) [2011 version] Viibryd336 (vilazodone hydrochloride) [2012 version] Vimovo337 (esomeprazole magnesium and naproxen) [2012 version] Vimpat338 (lacosamide) [2010 version] Viokace339 (pancrelipase) [2012 version] Viramune340 (nevirapine) [2012 version] Visicol341 (sodium phosphate dybasic anhydrous and sodium phosphate monobasic monohydrate) [2009 version] Vivactil342 (protriptyline hydrochloride) [2007 version] Vivitrol343 (naltrexone) [2010 version] Voltaren344 (diclofenac sodium) [2011 version] Votrient345 (pazopanib hydrochloride) [2012 version] Vyvanse346 (lisdexamfetamine dimesylate) [2012 version] Wellbutrin347 (bupropion hydrochloride) [2010 version] Wellbutrin SR348 (bupropion hydrochloride) [2010 version] Wellbutrin XL349 (buproprion hydrochloride) [2011 version] Xarelto350 (rivaroxaban) [2012 version] Xeljanz351 (tofacitinib) [2012 version] Xenazine352 (tetrabenazine) [2011 version] Xeomin353* (incobotulinumtoxinA) [2011 version] Xiaflex354* (collagenase clostridium histolyticum) [2011 version] Xolair355* (omalizumab) [2010 version] Xyrem356 (sodium oxybate) [2012 version] Yervoy357* (ipilimumab) [2012 version] Zarontin358 (ethosuximide) [2012 version] Zegerid359 (omeprazole and sodium bicarbonate) [2012 version] Zelboraf360 (vemurafenib) [2011 version] Zenpep361 (pancrelipase) [2011 version] Zerit362 (stavudine) [2011 version] Ziagen363 (abacavir sulfate) [2012 version] Zipsor364 (diclofenac potassium) [2009 version] Zoloft365 (sertraline hydrochloride) [2012 version] Zolpidem366 (zolpidem tartrate) [2008 version] Zolpimist367 (zolpidem tartrate) [2008 version] Zonegran368 (zonisamide) [2012 version] Zortress369 (everolimus) [2012 version] Zyban370 (bupropion hydrochloride) [2012 version] Zyprexa371 (olanzapine) [2010 version] Zyprexa Relprevv372 (olanzapine) [2012 version]