Medication Guides

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:

Abilify3 (aripiprazole) [2009 version]
Accutane4 (isotretinoin) [2010 version]
Actemra5 * (tocilizumab) [2009 version]
Actiq6 (fentanyl citrate) [2009 version]
Actoplus Met7 (metformin hydrochloride and pioglitazone hydrochloride) [2009 version]
Actoplus Met XR8 (metformin hydrochloride and pioglitazone hydrochloride) [2009 version]
Actos9 (pioglitazone hydrchloride) [2009 version]
Adderall XR10 (dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate) [2007 version]
Advair Diskus11 (fluticasone propionate and salmeterol xinafoate) [2008 version]
Advair HFA12 (fluticasone propionate and salmeterol xinafoate) [2008 version]
Ambien13 (zolpidem tartrate) [2008 version]
Ambien CR14 (zolpidem tartrate) [2007 version]
Ampyra15 (dalfampridine) [2010 version]
Anafranil16 (clomipramine hydrochloride) [2007 version]
Anaprox17 (naproxen sodium) [2008 version]
Androgel18 (testosterone) [2009 version]
Ansaid19 (flurbiprofen) [2007 version]
Aplenzin20 (buproprion hydrobromide [2008 version]
Aranesp21* (darbepoetin alfa) [2010 version]
Arthrotec22 (diclofenac sodium) [2007 version]
Avandamet23 (metformin hydrochloride and rosiglitazone maleate) [2008 version]
Avandaryl24 (glimepiride and rosiglitazone maleate) [2009 version]
Avandia25 (rosiglitazone maleate) [2008 version]
Avelox26 (moxifloxacin) [2008 version]
Avonex27* (interferon beta-1a) [2006 version]
Banzel28 (rufinamide) [2008 version]
Betaseron29*(interferon beta-1b) [2009 version]
Botox30* (onabotulinumtoxinA) [2010 version]
Brovana31 (arformoterol tartrate) [2006 version]
Byetta32 (exenatide) [2009 version]
Cambia33 (diclofenac) [2009 version]
Cataflam34 (diclofenac potassium) [2008 version]
Celebrex35 (celecoxib) [2007 version]
Celexa36 (citalopram hydrobromide) [2009 version]
Cellcept37 (mycophenolate mofetil) [2009 version]
Chantix38 (varenicline tartrate) [2009 version]
Cimzia39* (certolizumab pegol) [2009 version]
Cipro40 (ciprofloxacin) [2008 version]
Clinoril41 (sulindac) [2007 version]
Colcrys42 (colchicine) [2009 version]
Combunox43 (oxycodone hydrochloride and ibuprofen) [2007 version]
Concerta44 (methylphenidate hydrochloride) [2008 version]
Copegus45 (ribavirin) [2009 version]
Cordarone46 (amiodarone hydrochloride) [2009 version]
Coumadin47 (warfarin sodium) [2010 version]
Creon48 (pancrelipase) [2009 version]
Cymbalta49 (duloxetine hydrochloride) [2007 version)]
Dalmane50 (flurazepam hydrochloride) [2009 version]
Darvocet51 (acetaminophen and propoxyphene napsylate) [2009 version]
Darvon52 (propoxyphene hydrochloride) [2009 version]
Daypro Alta53 (oxaprozin potassium) [2007 version]
Daytrana54 (methylphenidate) [2009 version]
Desoxyn55 (methamphetamine hydrochloride) [2007 version]
Dexedrine56 (dextroamphetamine sulfate) [2008 version]
Doral57 (quazepam) [2007 version]
Duragesic58 (fentanyl) [2005 version]
Dysport59* (abobotulinumtoxinA) [2009 version]
EC-Naprosyn60 (naproxen) [2008 version]
Edluar61 (zolpidem tartrate) [2009 version]
Effexor62 (venlafaxine hydrochloride) [2008 version]
Effexor XR63 (venlafaxine hydrochloride) [2008 version]
Effient64 (prasugrel) [2009 version]
Elidel Cream 65(pimecrolimus) [2006 version]
Embeda66 (morphine sulfate and naltrexone hydrochloride) [2009 version]
Emsam67 (selegeline transdermal system) [2007 version]
Enbrel68* (etanercept) [2008 version]
Epogen69* (epoeten alfa) [2010 version]
Epzicom70 (abacavir sulfate and lamivudine) [2006 version]
Evista71 (raloxifene hydrochloride) [2007 version]
Exalgo72 (hydromorphone hydrochloride) [2010 version]
Extavia73* (interferon beta-1b) [2009 version]
Extraneal74 (icodextrin) [2009 version]
Exubera75 (insulin recombinant human) [2008 version]
Factive76 (gemifloxacin) [2008 version]
Feldene77 (piroxicam) [2007 version]
Fentora78 (fentanyl citrate) [2009 version]
Flector79 (diclofenac epolamine) [2009 version]
Floxin80 (ofloxacin) [2008 version]
Focalin81 (dexmethylphenidate hydrochloride) [2007 version]
Focalin XR82 (dexmethylphenidate hydrochloride) [2009 version]
Foradil Aerolizer83 (formoterol fumarate inhalation powder) [2006 version]
Foradil Certihaler84 (formoterol fumarate inhalation powder) [2006 version]
Forteo85 (teriparatide) [2009 version]
Halcion86 (triazolam) [2008 version]
Humira87* (adalimumab) [2009 version]
Indocin88 (indomethacin) [2007 version]
Infergen89* (interferon alfacon-1) [2008 version]
Intron A90* (interferon alfa-2b) [2008 version]
Janumet91 (metformin hydrochloride and sitagliptin phosphate) [2010 version]
Januvia92 (sitagliptin phosphate) [2010 version]
Kalbitor93* (ecallantide) [2009 version]
Kaletra94 (lopinavir and ritonavir) [2010 version]
Keppra95 (levetiracetam) [2009 version]
Ketek96 (telithromycin) [2007 version]
Lamictal97 (lamotrigine) [2009 version]
Lamictal XR98 (lamotrigine) [2010 version]
Lariam99 (mefloquine hydrochloride) [2009 version]
Letairis100 (ambrisentan) [2009 version]
Levaquin101 (levofloxacin) [2008 version]
Lexapro102 (escitalopram oxalate) [2008 version]
Limbitrol103 (chlordiazepoxide and amitriptyline) [2007 version]
Lindane Lotion104 (lindane) [2007 version]
Lindane Shampoo105 (lindane) [2007 version]
Lotronex106 (alosetron hydrochloride) [2008 version]
Lunesta107 (eszopiclone) [2008 version]
Luvox CR108 (fluvoxamine mealeate) [2008 version]
Lyrica109 (pregabalin) [2009 version]
Marplan110 (isocarboxazid) [2008 version]
Metadate CD111 (methylphenidate hydrochloride) [2007 version]
Metozolv ODT112 (metoclopramide hydrochloride) [2009 version]
Methylin (methylphenidate)
chewable tablets113 [2007 version]
oral solution114 [2007 version]
Mifeprex115 (mifepristone) [2005 version]
Mircera116* (methoxy polyethylene glycol-epoetin beta) [2007 version]

Mobic117 (meloxicam) [2008 version]
Morphine Sulfate118 (morphine sulfate oral solution) [2010 version]
Motrin119 (ibuprofen) [2007 version]
Multaq120 (dronedarone) [2009 version]
Myfortic121 (mycophenolic acid) [2009 version]
Myobloc122* (rimabotulinumtoxinB) [2009 version]
Nalfon123 (fenoprofen calcium) [2007 version]
Naprosyn124 (naproxen) [2008 version]
Nardil125 (phenelzine sulfate) [2007 version]
Nolvadex126 (tamoxifen) [2006 version]
Noroxin127 (norfloxacin) [2008 version]
Norpramin128 (desipramine hydrochloride) [2009 version]
Nplate129 (romiplostim) [2008 version]
Nucynta130 (tapentadol hydrochloride) [2009 version]
Oleptro131 (trazadone hydrochloride) [2010 version]
Onsolis132 (fentanyl buccal soluble film) [2009 version]
Osmoprep133 (sodium phosphate dibasic anhydrous and sodium phosphate monobasic monohydrate) [2009 version]
OxyContin134 (oxycodone hydrochloride) [2010 version]
Pacerone135 (amiodarone hydrochloride) [2008 version]
Palladone136 (hydromorphone hydrochloride) [2004 version]
Pamelor137 (nortriptyline hydrochloride) [2007 version]
Pancreaze138 (pancrelipase) [2010 version]
Parnate139 (tranylcypromine sulfate) [2008 version]
Paxil140 (paroxetine hydrochloride) [2008 version]
Pegasys141* (peginterferon alfa-2a) [2008 version]
Pegintron142* (peginterferon alfa-2b) [2009 version]
PegIntron*/Rebetol Combo Pack143 (peginterferon alfa-2b and ribavirin) [2008 version]
Pennsaid144 (diclofenac sodium) [2009 version]
Pexeva145 (paroxetine mesylate) [2008 version]
Ponstel146 (mefenamic acid) [2008 version]
Prevacid NapraPac147 (lansoprazole and naproxen) [2009 version]
Pristiq148 (desvenlafaxine succinate) [2009 version]
Procrit149* (epoetin alfa) [2010 version]
Propylthiouracil150 [2010 version]
Promacta151 (eltrombopag) [2010 version]
Propulsid152 (cisapride) [2006 version]
Proquin XR153 (ciprofloxacin hydrochloride) [2008 version]
Protopic Ointment154 (tacrolimus) [2006 version]
Prozac155 (fluoxetine hydrochloride) [2009 version]
Qualaquin156 (quinine sulfate) [2009 version]
Rebetol157 (ribavirin) [2009 version]
Rebif158* (interferon beta-1a) [2002 version]
Reglan159 (metoclopramide hydrochloride) injection [2009 version]
Reglan160 (metoclopramide hydrochloride) tablets [2009 version]
Reglan ODT161 (metoclopramide hydrochloride) [2009 version]
Remeron162 (mirtazapine) [2007 version]
Remicade163* (infliximab) [2009 version]
Revlimid164 (lenalidomide) [2009 version]
Ribasphere165 (ribavirin) [2008 version]
Ritalin166 (methylphenidate hydrochloride) [2007 version]
Ritalin LA167 (methylphenidate hydrochloride) [2007 version]
Ritalin-SR168 (methylphenidate hydrochloride) [2007 version]
Rituxan169* (rituximab) [2009 version]
Roferon-A170* (interferon alfa-2a recombinant) [2008 version]
Rozerem171 (ramelteon) [2008 version]
Sabril172 (vigabatrin) [2009 version]
Sarafem173 (fluoxetine hydrochloride) [2007 version]
Savella174 (milnacipran hydrochloride) [2010 version]
Selzentry175 (maraviroc) [2009 version]
Serevent Diskus176 (salmeterol xinafoate) [2006 version]
Seroquel177 (quetiapine fumarate) [2009 version]
Seroquel XR178 (quetiapine fumarate) [2009 version]
Silenor179 (doxepin) [2010 version]
Simponi180* (golimumab) [2009 version]
Sinequan181 (doxepin hydrochloride) [2007 version]
Soliris182 (eculizumab) [2007 version]
Soltamox183 (tamoxifen citrate) [2005 version]
Soriatane184 (acitretin) [2007 version]
Sotret185 (isotretinoin) [2006 version]
Stelara186* (ustekinumab) [2009 version]
Strattera187 (atomoxetine hydrochloride) [2009 version]
Symbicort188 (budesonide and formoterol fumarate dihydrate) [2009 version]
Symbyax189 (fluoxetine hydrochloride and olanzapine) [2009 version]
Symlin190 (pramlintide acetate) [2007 version]
Tapentadol191 see Nucynta
Tasigna192 (nilotinib) [2009 version]
Testim193 (testosterone) [2009 version]
Tofranil194 (imipramine hydrochloride) [2007 version]
Tolectin195 (tolmetin sodium) [2008 version]
Topamax196 (topiramate) [2009 version]
Toradol197 (ketorolac tromethamine) [2007 version]
Tracleer198 (bosentan) [2009 version]
Treximet199 (naproxen sodium and sumatriptan succinate) [2008 version]
Trilipix200 (choline fenofibrate) [2008 version]
Trizivir201 (abacavir sulfate, lamivudine and zidovudine) [2009 version]
Tyasbri202 (natalizumab) [2008 version]
Tyzeka203 (telbivudine) [2010 version]
Vibativ204 (telavancin) [2009 version]
Vicoprofen205 (vicoprofen and ibuprofen) [2008 version]
Victoza206 (liraglutide) [2010 version]
Videx207 (didanosine) [2010 version]
Videx EC208 (didanosine) [2010 version]
Vimpat209 (lacosamide) [2009 version]
Viramune210 (nevirapine) [2010 version]
Visicol211 (sodium phosphate dybasic anhydrous and sodium phosphate monobasic monohydrate) [2009 version]
Vivactil212 (protriptyline hydrochloride) [2007 version]
Vivitrol213 (naltrexone) [2010 version]
Voltaren214 (diclofenac sodium) [2009 version]
Votrient215 (pazopanib hydrochloride) [2009 version]
Vyvanse216 (lisdexamfetamine dimesylate) [2010 version]
Wellbutrin217 (bupropion hydrochloride) [2010 version]
Wellbutrin SR218 (bupropion hydrochloride) [2010 version]
Wellbutrin XL219 (buproprion hydrochloride) [2010 version]
Xenazine220 (tetrabenazine) [2008 version]
Xiaflex221* (collagenase clostridium histolyticum) [2010 version]
Xolair222* (omalizumab) [2007 version]
Xyrem223 (sodium oxybate) [2005 version]
Zenpep224 (pancrelipase) [2009 version]
Ziagen225 (abacavir sulfate) [2008 version]
Zoloft226 (sertraline hydrochloride) [2008 version]
Zolpidem227 (zolpidem tartrate) [2008 version]
Zolpimist228 (zolpidem tartrate) [2008 version]
Zonegran229 (zonisamide) [2009 version]
Zyban230 (bupropion hydrochloride) [2009 version]
Zyprexa231 (olanzapine) [2010 version]
Zyprexa Relprevv232 (olanzapine) [2009 version]

open here to see the original document of FDA and opening each label:
Medication Guides