jueves, 23 de agosto de 2012

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.

    Medication Guides are available for these products:
*biologic or drug/biologic combination
  • Abilify4 (aripiprazole) [2012 version] 
  • Absorica5 (isotrentinoin) [2012 version]
  • Abstral6 (fentanyl) [2011]
  • Accutane7 (isotretinoin) [2010 version]
  • Updated Actemra8* (tocilizumab) [2012 version]
  • Actiq9 (fentanyl citrate) [2011 version]
  • Actonel10 (risedronate sodium) [2011 version]
  • Actonel with Calcium11 (risedronate sodium and calcium carbonate) [2011 version]
  • Actoplus Met12 (metformin hydrochloride and pioglitazone hydrochloride) [2012 version]
  • Actoplus Met XR13 (metformin hydrochloride and pioglitazone hydrochloride) [2011 version]
  • Actos14 (pioglitazone hydrchloride) [2011 version]
  • Adderall XR15 (dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate) [2011 version]
  • Advair Diskus16 (fluticasone propionate and salmeterol xinafoate) [2011 version]
  • Advair HFA17 (fluticasone propionate and salmeterol xinafoate) [2011 version]
  • Ambien18 (zolpidem tartrate) [2010 version]
  • Ambien CR19 (zolpidem tartrate) [2010 version]
  • Amevive20* (alefacept) [2012 version]
  • Ampyra21 (dalfampridine) [2012 version] 
  • Anafranil22 (clomipramine hydrochloride) [2007 version]
  • Anaprox23 (naproxen sodium) [2008 version]
  • Androgel24 (testosterone) [2011 version]
  • Androgel25 (1.62%) (testosterone) [2011 version]
  • Ansaid26 (flurbiprofen) [2010 version]
  • Updated Aplenzin27 (bupropion hydrobromide [2012 version]
  • Aranesp28* (darbepoetin alfa) [2012 version)
  • Arcapta29 (indacaterol maleate) [2011 version]
  • Arthrotec30 (diclofenac sodium) [2010 version]
  • Updated Atelvia31 (risedronate sodium) [2012 version]
  • Avandamet32 (metformin hydrochloride and rosiglitazone maleate) [2011 version]
  • Avandaryl33 (glimepiride and rosiglitazone maleate) [2011 version]
  • Avandia34 (rosiglitazone maleate) [2011 version]
  • Avelox35 (moxifloxacin) [2011 version]
  • Avinza36 (morphine sulfate) [2012 version]
  • Avonex37* (interferon beta-1a) [2012 version]
  • Axiron38 (testosterone) [2011 version]
  • Banzel39 (rufinamide) [2011 version]
  • Benlysta40 (belimumab) [2012 version]
  • Betaseron41*(interferon beta-1b) [2009 version]
  • Boniva42 (ibandronate sodium) Injection [2011 version]
  • Boniva43 (ibandronate sodium) Tablets [2011 version]
  • Botox44* (onabotulinumtoxinA) [2011 version]
  • Brilinta45 (ticagrelor) [2011 version]
  • Brovana46 (arformoterol tartrate) [2011 version]
  • Butrans47 (buprenorphine) [2012 version]
  • Bydureon48 (exenatide) [2012 version]
  • Byetta49 (exenatide) [2011 version]
  • Cambia50 (diclofenac) [2009 version]
  • Carbatrol 51(carbamazepine) [2010 version]
  • Cataflam52 (diclofenac potassium) [2011 version]
  • Celebrex53 (celecoxib) [2011 version]
  • Celexa54 (citalopram hydrobromide) [2012 version]
  • Cellcept55 (mycophenolate mofetil) [2012 version]
  • Celontin56 (methsuximide) [2010 version]
  • Chantix57 (varenicline tartrate) [2011 version]
  • Updated Cimzia58* (certolizumab pegol) [2012 version]
  • Cipro59 (ciprofloxacin) [2011 version]
  • Clinoril60 (sulindac) [2010 version]
  • Codeine Sulfate61 oral solution [2012 version]
  • Colcrys62 (colchicine) [2011 version]
  • Combunox63 (oxycodone hydrochloride and ibuprofen) [2010 version]
  • Concerta64 (methylphenidate hydrochloride) [2010 version]
  • Copegus65 (ribavirin) [2011 version]
  • Cordarone66 (amiodarone hydrochloride) [2011 version]
  • Coumadin67 (warfarin sodium) [2010 version]
  • Creon68 (pancrelipase) [2011 version]
  • Cymbalta69 (duloxetine hydrochloride) [2008 version)]
  • Daliresp70 (roflumilast) [2011 version]
  • Dalmane71 (flurazepam hydrochloride) [2009 version]
  • Darvocet72 (acetaminophen and propoxyphene napsylate) [2009 version]
  • Darvon73 (propoxyphene hydrochloride) [2009 version]
  • Daypro Alta74 (oxaprozin potassium) [2007 version]
  • Daytrana75 (methylphenidate) [2010 version]
  • Desoxyn76 (methamphetamine hydrochloride) [2007 version]
  • Dexedrine77 (dextroamphetamine sulfate) [2008 version]
  • Dilantin78 (phenytoin) [2011 version]
  • Dilantin-12579 (phenytoin) [2011 version]
  • Dolophine80 (methadone hydrochloride) [2012 version]
  • Doral81 (quazepam) [2007 version]
  • Duetact82 (glimepiride and pioglitazone) [2011 version]
  • Duexis83 (ibuprofen and famotidine) [2011 version]
  • Dulera84 (mometasone furoate and formoterol fumarate) [2010 version]
  • Duragesic85 (fentanyl) [2012 version]
  • Dysport86* (abobotulinumtoxinA) [2012 version]
  • EC-Naprosyn87 (naproxen) [2008 version]
  • Edluar88 (zolpidem tartrate) [2009 version]
  • Effexor89 (venlafaxine hydrochloride) [2012 version]
  • Effexor XR90 (venlafaxine hydrochloride) [2012 version]
  • Effient91 (prasugrel) [2011 version]
  • Elidel Cream 92(pimecrolimus) [2010 version]
  • Embeda93 (morphine sulfate and naltrexone hydrochloride) [2012 version]
  • Emsam94 (selegeline transdermal system) [2007 version]
  • Enbrel95* (etanercept) [2010 version]
  • Epogen96* (epoetin alfa) [2012 version]
  • Epzicom97 (abacavir sulfate and lamivudine) [2012 version]
  • Erivedge98 (vismodegib) [2012 version]
  • Evista99 (raloxifene hydrochloride) [2007 version]
  • Exalgo100 (hydromorphone hydrochloride) [2012 version]
  • Extavia101* (interferon beta-1b) [2012 version]
  • Extraneal102 (icodextrin) [2010 version]
  • Exubera103 (insulin recombinant human) [2008 version]
  • Factive104 (gemifloxacin) [2011 version]
  • Felbatol105 (felbamate) [2011 version]
  • Feldene106 (piroxicam) [2010 version]
  • Fentora107 (fentanyl citrate) [2011 version]
  • Ferriprox 108(deferiprone) [2012 version]
  • Flector109 (diclofenac epolamine) [2010 version]
  • Floxin110 (ofloxacin) [2011 version]
  • Focalin111 (dexmethylphenidate hydrochloride) [2012 version]
  • Focalin XR112 (dexmethylphenidate hydrochloride) [2012 version]
  • Foradil Aerolizer113 (formoterol fumarate inhalation powder) [2012 version]
  • Foradil Certihaler114 (formoterol fumarate inhalation powder) [2010 version]
  • Forfivo XL115 (bupropion hydrochloride) [2011 version]
  • Forteo116 (teriparatide) [2009 version]
  • Fortesta117 (testosterone) [2010 version]
  • Fosamax118 (alendronate sodium) [2012 version]
  • Fosamax Plus D119 (alendronate sodium and cholecalciferol) [2011 version]
  • Fosrenol120 (lanthanum carbonate) [2011 version]
  • Gabitril121 (tiagabine) [2010 version]
  • Gilenya122 (fingolimid) [2012 version]
  • Updated Gralise123 (gabapentin) [2012 version]
  • Halcion124 (triazolam) [2008 version]
  • HalfLytely and Bisacodyl Bowel Prep Kit125 (bisacodyl, polyethylene glycol 3500, potassium chloride, sodium bicarbonate, sodium chloride) [2010 version]
  • Horizant126 (gabapentin enacarbil) [2012 version]
  • H.P. Acthar Gel127 (repository corticotropin) [2010 version]
  • Humira128* (adalimumab) [2011 version]
  • Incivek129 (telaprevir) [2012 version]
  • Indocin130 (indomethacin) [2008 version]
  • Infergen131* (interferon alfacon-1) [2010 version]
  • Intermezzo132 (zolpidem tartrate) [2011 version]
  • Intron A133* (interferon alfa-2b) [2012 version]
  • Invirase134 (saquinavir mesylate) [2012 version] 
  • Janumet135 (metformin hydrochloride and sitagliptin phosphate) [2012 version]
  • Janumet XR136 (sitagliptin and metformin hydrochloride) [2012 version]
  • Januvia137 (sitagliptin phosphate) [2012 version]
  • Juvisync138 (sitagliptin and simvastatin) [2011 version]
  • Kadian139 (morphine sulfate) [2012 version]
  • Kalbitor140* (ecallantide) [2009 version]
  • Kaletra 141Capsules (lopinavir and ritonavir) [2012 version]
  • Kaletra 142Tablets and Oral Solution (lopinavir and ritonavir) [2012 version] 
  • Keppra143 (levetiracetam) [2011 version]
  • Keppra XR144 (levetiracetam) [2009 version]
  • Ketek145 (telithromycin) [2010 version]
  • Klonopin146 (clonazepam) [2010 version]
  • Kombiglyze XR147 (metformin hydrochloride and saxagliptin) [2012 version] 
  • Korlym148 (mifepristone) [2012 version]
  • Krystexxa149* (pegloticase) [2012 version]
  • Lamictal150 (lamotrigine) [2012 version]
  • Lamictal XR151 (lamotrigine) [2012 version]
  • Lariam152 (mefloquine hydrochloride) [2009 version]
  • Lazanda153 (fentanyl citrate) [2011 version]
  • Letairis154 (ambrisentan) [2012 version]
  • Levaquin155 (levofloxacin) [2011 version]
  • Lexapro156 (escitalopram oxalate) [2011 version]
  • Limbitrol157 (chlordiazepoxide and amitriptyline) [2007 version]
  • Lindane Lotion158 (lindane) [2007 version]
  • Lindane Shampoo159 (lindane) [2007 version]
  • Lotronex160 (alosetron hydrochloride) [2010 version]
  • Lunesta161 (eszopiclone) [2008 version]
  • Luvox162 (fluvoxamine maleate) [2011 version]
  • Luvox CR163 (fluvoxamine maleate) [2011 version]
  • Lyrica164 (pregabalin) [2012 version]
  • Marplan165 (isocarboxazid) [2008 version]
  • Meridia166 (sibutramine hydrochloride) [2010 version]
  • Metadate CD167 (methylphenidate hydrochloride) [2009 version]
  • Methylin (methylphenidate)
  • Metoclopramide Oral Solution170 [2009 version]
  • Metozolv ODT171 (metoclopramide hydrochloride) [2011 version]
  • Mifeprex172 (mifepristone) [2009 version]
  • Mircera173* (methoxy polyethylene glycol-epoetin beta) [2007 version]


  • Mobic174 (meloxicam) [2011 version]
  • Morphine Sulfate175 (morphine sulfate oral solution) [2010 version]
  • Motrin176 (ibuprofen) [2007 version]
  • Moviprep177 (propylene glycol 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid) [2011 version]
  • MS Contin178 (morphine sulfate) [2012 version]
  • Multaq179 (dronedarone) [2012 version]
  • Myfortic180 (mycophenolic acid) [2012 version]
  • Myobloc181* (rimabotulinumtoxinB) [2009 version]
  • Mysoline182 (primidone) [2010 version]
  • Nalfon183 (fenoprofen calcium) [2009 version]
  • Naprelan184 (naproxen sodium) [2011 version]
  • Naprosyn185 (naproxen) [2008 version]
  • Nardil186 (phenelzine sulfate) [2007 version]
  • Neurontin187 (gabapentin) [2011 version]
  • Nolvadex188 (tamoxifen) [2006 version]
  • Noroxin189 (norfloxacin) [2012 version]
  • Norpramin190 (desipramine hydrochloride) [2009 version]
  • Novantrone191 (mitoXantrone) [2012 version]
  • Nplate192* (romiplostim) [2011 version]
  • Nucynta193 (tapentadol hydrochloride) [2010 version]
  • Nucynta ER194 (tapentadol) [2012 version]
  • Nulojix195* (belatacept) [2011 version]
  • Nuvigil196 (armodafinil) [2010 version]
  • Oleptro197 (trazodone hydrochloride) [2010 version]
  • Omontys198 (peginesatide) [2012 version]
  • Onfi199 (clobazam) [2011 version]
  • Onglyza200 (saxagliptin hydrochloride) [2011 version]
  • Onsolis201 (fentanyl buccal soluble film) [2011 version]
  • Opana ER202 (oxymorphone hydrochloride) [2012 version]
  • Osmoprep203 (sodium phosphate dibasic anhydrous and sodium phosphate monobasic monohydrate) [2009 version]
  • Oxycodone Hydrochloride Oral Solution204 [2012 version]
  • OxyContin205 (oxycodone hydrochloride) [2012 version]
  • Pacerone206 (amiodarone hydrochloride) [2008 version]
  • Palladone207 (hydromorphone hydrochloride) [2004 version]
  • Pamelor208 (nortriptyline hydrochloride) [2007 version]
  • Pancreaze209 (pancrelipase) [2010 version]
  • Parnate210 (tranylcypromine sulfate) [2008 version]
  • Paxil211 (paroxetine hydrochloride) [2011 version]
  • Paxil CR212 (paroxetine hydrochloride) [2011 version]
  • Peganone213 (ethotoin) [2010 version]
  • Pegasys214* (peginterferon alfa-2a) [2011 version]
  • Pegintron215* (peginterferon alfa-2b) [2012 version]
  • PegIntron*/Rebetol Combo Pack216 (peginterferon alfa-2b and ribavirin) [2008 version]
  • Pennsaid217 (diclofenac sodium) [2010 version]
  • Perforomist218 (formoterol fumarate) [2012 version]
  • Pertzye219 (pancrelipase) [2012 version]
  • Pexeva220 (paroxetine mesylate) [2011 version]
  • Plavix221 (clopidogrel bisulfate) [2011 version]
  • Ponstel222 (mefenamic acid) [2008 version]
  • Potiga223 (ezogabine) [2012 version]
  • Pradaxa 224(dabigatran etexilate mesylate) [2012 version]
  • Prepopik 225(sodium picosulfate, magnesium oxide and citric acid) [2012 version]
  • Prevacid NapraPac226 (lansoprazole and naproxen) [2009 version]
  • Pristiq227 (desvenlafaxine succinate) [2011 version]
  • Procrit228* (epoetin alfa) [2012 version]
  • Prolia229* (denosumab) [2012 version]
  • Propylthiouracil230 [2010 version]
  • Promacta231 (eltrombopag) [2011 version]
  • Propulsid232 (cisapride) [2006 version]
  • Proquin XR233 (ciprofloxacin hydrochloride) [2011 version]
  • Protopic Ointment234 (tacrolimus) [2011 version]
  • Provigil235 (modafinil) [2010 version]
  • Prozac236 (fluoxetine hydrochloride) [2011 version]
  • Qsymia237 (phentermine and topiramate) [2012 version]
  • Qualaquin238 (quinine sulfate) [2011 version]
  • Rapamune239 (sirolimus) [2010 version]
  • Rebetol240 (ribavirin) [2010 version]
  • Rebif241* (interferon beta-1a) [2002 version]
  • Reclast242 (zoledronic acid) [2011 version]
  • Reglan243 (metoclopramide hydrochloride) injection [2009 version]
  • Reglan244 (metoclopramide hydrochloride) tablets [2011 version]
  • Reglan ODT245 (metoclopramide hydrochloride) [2011 version]
  • Remeron246 (mirtazapine) [2011 version]
  • Remeron SolTabs247 (mirtazapine) [2011 version]
  • Remicade248* (infliximab) [2011 version]
  • Restoril249 (temazepam) [2010 version]
  • Revlimid250 (lenalidomide) [2012 version] 
  • Ribasphere251 (ribavirin) [2008 version]
  • Ritalin252 (methylphenidate hydrochloride) [2010 version]
  • Ritalin LA253 (methylphenidate hydrochloride) [2010 version]
  • Ritalin-SR254 (methylphenidate hydrochloride) [2010 version]
  • Rituxan255* (rituximab) [2012 version]
  • Roferon-A256* (interferon alfa-2a recombinant) [2008 version]
  • Rozerem257 (ramelteon) [2010 version]
  • Sabril258 (vigabatrin) [2010 version]
  • Samsca259 (tolvaptan) [2012 version]
  • Sarafem260 (fluoxetine hydrochloride) [2009 version]
  • Savella261 (milnacipran hydrochloride) [2010 version]
  • Updated Selzentry262 (maraviroc) [2012 version]
  • Serevent Diskus263 (salmeterol xinafoate) [2010 version]
  • Seroquel264 (quetiapine fumarate) [2011 version]
  • Seroquel XR265 (quetiapine fumarate) [2011 version]
  • Silenor266 (doxepin) [2010 version]
  • Simponi267* (golimumab) [2010 version]
  • Sinequan268 (doxepin hydrochloride) [2007 version]
  • Soliris269* (eculizumab) [2009 version]
  • Soltamox270 (tamoxifen citrate) [2005 version]
  • Soriatane271 (acitretin) [2011 version]
  • Sotret272 (isotretinoin) [2006 version]
  • Stelara273* (ustekinumab) [2012 version]
  • Updated Strattera274 (atomoxetine hydrochloride) [2012 version]
  • Updated Suboxone275 (buprenorphine and naloxone) [2012 version]
  • Subsys276 (fentanyl) [2012 version]
  • Subutex277 (buprenorphine) [2011 version]
  • Suprep278 (sodium sulfate, potassium sulfate and magnesium sulfate) [2010 version]
  • Sutent279 (sunitimib malate) [2012 version]
  • Sylatron280 (peginterferon alfa-2b) [2012 version]
  • Symbicort281 (budesonide and formoterol fumarate dihydrate) [2010 version]
  • Updated Symbyax282 (fluoxetine hydrochloride and olanzapine) [2012 version]
  • Symlin283 (pramlintide acetate) [2007 version]
  • Tapentadol284 see Nucynta
  • Tasigna285 (nilotinib) [2011 version]
  • Tegretol286 (carbamazepine) [2011 version]
  • Testim287 (testosterone) [2011 version]
  • Testosterone Gel288 [2012 version]
  • Thalomid289 (thalidomide) [2012 version]
  • Tikosyn290 (dofetilide) [2011 version]
  • Tofranil291 (imipramine hydrochloride) [2007 version]
  • Tolectin292 (tolmetin sodium) [2008 version]
  • Topamax293 (topiramate) [2011 version]
  • Toradol294 (ketorolac tromethamine) [2007 version]
  • Tracleer295 (bosentan) [2009 version]
  • Tranxene296 (clorazepate dipotassium) [2010 version]
  • Treximet297 (naproxen sodium and sumatriptan succinate) [2012 version]
  • Tridione298 (trimethadione) [2012 version]
  • Trileptal299 (oxcarbazepine) [2011 version]
  • Trilipix300 (choline fenofibrate) [2011 version]
  • Trizivir301 (abacavir sulfate, lamivudine and zidovudine) [2012 version]
  • Truvada302 (emtricitabine and tenofovir disoproxil fumarate) [2012 version]
  • Tysabri303* (natalizumab) [2012 version]
  • Tyzeka304 (telbivudine) [2011 version]
  • Ultresa305 (pancrelipase) [2012 version]
  • Vandetanib306 (vandetanib) [2011 version]
  • Vibativ307 (telavancin) [2009 version]
  • Vicoprofen308 (vicoprofen and ibuprofen) [2008 version]
  • Victoza309 (liraglutide) [2012 version]
  • Victrelis310 (boceprevir) [2012 version]
  • Videx311 (didanosine) [2011 version]
  • Videx EC312 (didanosine) [2011 version]
  • Viibryd313 (vilazodone hydrochloride) [2011 version]
  • Vimovo314 (esomeprazole magnesium and naproxen) [2012 version]
  • Vimpat315 (lacosamide) [2009 version]
  • Viokace316 (pancrelipase) [2012 version] 
  • Viramune317 (nevirapine) [2011 version]
  • Visicol318 (sodium phosphate dybasic anhydrous and sodium phosphate monobasic monohydrate) [2009 version]
  • Vivactil319 (protriptyline hydrochloride) [2007 version]
  • Vivitrol320 (naltrexone) [2010 version]
  • Voltaren321 (diclofenac sodium) [2011 version]
  • Votrient322 (pazopanib hydrochloride) [2012 version]
  • Vyvanse323 (lisdexamfetamine dimesylate) [2012 version]
  • Wellbutrin324 (bupropion hydrochloride) [2010 version]
  • Wellbutrin SR325 (bupropion hydrochloride) [2010 version]
  • Wellbutrin XL326 (buproprion hydrochloride) [2011 version]
  • Xarelto327 (rivaroxaban) [2011 version]
  • Xenazine328 (tetrabenazine) [2011 version]
  • Xeomin329* (incobotulinumtoxinA) [2011 version]
  • Xiaflex330* (collagenase clostridium histolyticum) [2011 version]
  • Xolair331* (omalizumab) [2010 version]
  • Xyrem332 (sodium oxybate) [2005 version]
  • Yervoy333* (ipilimumab) [2011 version]
  • Zarontin334 (ethosuximide) [2012 version]
  • Zelboraf335 (vemurafenib) [2011 version]
  • Zenpep336 (pancrelipase) [2011 version]
  • Zerit337 (stavudine) [2011 version]
  • Ziagen338 (abacavir sulfate) [2012 version]
  • Zipsor339 (diclofenac potassium) [2009 version]
  • Zoloft340 (sertraline hydrochloride) [2011 version]
  • Zolpidem341 (zolpidem tartrate) [2008 version]
  • Zolpimist342 (zolpidem tartrate) [2008 version]
  • Zonegran343 (zonisamide) [2012 version]
  • Zortress344 (everolimus) [2012 version]
  • Zyban345 (bupropion hydrochloride) [2012 version]
  • Zyprexa346 (olanzapine) [2010 version]
  • Updated Zyprexa Relprevv347 (olanzapine) [2012 version]



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