Drug Safety and Availability > Medication Guides

Medication Guides
Drugs@FDA1 and DailyMed2 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

Abilify3 (aripiprazole) [2011 version]
Abstral4 (fentanyl) [2011]
Accutane5 (isotretinoin) [2010 version]
Actemra6* (tocilizumab) [2011 version]
Actiq7 (fentanyl citrate) [2009 version]
Actonel8 (risedronate sodium) [2011 version]
Actonel with Calcium9 (risedronate sodium and calcium carbonate) [2011 version]
Actoplus Met10 (metformin hydrochloride and pioglitazone hydrochloride) [2009 version]
Actoplus Met XR11 (metformin hydrochloride and pioglitazone hydrochloride) [2010 version]
Actos12 (pioglitazone hydrchloride) [2011 version]
Adderall XR13 (dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate) [2010 version]
Advair Diskus14 (fluticasone propionate and salmeterol xinafoate) [2011 version]
Advair HFA15 (fluticasone propionate and salmeterol xinafoate) [2011 version]
Ambien16 (zolpidem tartrate) [2010 version]
Ambien CR17 (zolpidem tartrate) [2010 version]
Ampyra18 (dalfampridine) [2010 version]
Anafranil19 (clomipramine hydrochloride) [2007 version]
Anaprox20 (naproxen sodium) [2008 version]
Androgel21 (testosterone) [2011 version]
Androgel22 (1.62%) (testosterone) [2011 version]
Ansaid23 (flurbiprofen) [2010 version]
Aplenzin24 (bupropion hydrobromide [2011 version]
Aranesp25* (darbepoetin alfa) [2010 version)
Arthrotec26 (diclofenac sodium) [2007 version]
Atelvia27 (risedronate sodium) [2011 version]
Avandamet28 (metformin hydrochloride and rosiglitazone maleate) [2011 version]
Avandaryl29 (glimepiride and rosiglitazone maleate) [2011 version]
Avandia30 (rosiglitazone maleate) [2011 version]
Avelox31 (moxifloxacin) [2011 version]
Avonex32* (interferon beta-1a) [2006 version]
Axiron33 (testosterone) [2011 version]
Banzel34 (rufinamide) [2011 version]
Benlysta35 (belimumab) [2011 version]
Betaseron36*(interferon beta-1b) [2009 version]
Boniva37 (ibandronate sodium) Injection [2011 version]
Boniva38 (ibandronate sodium) Tablets [2011 version]
Botox39* (onabotulinumtoxinA) [2010 version]
Brovana40 (arformoterol tartrate) [2011 version]
Butrans41 (buprenorphine) [2010 version]
Byetta42 (exenatide) [2009 version]
Cambia43 (diclofenac) [2009 version]
Carbatrol 44(carbamazepine) [2010 version]
Cataflam45 (diclofenac potassium) [2011 version]
Celebrex46 (celecoxib) [2011 version]
Celexa47 (citalopram hydrobromide) [2009 version]
Cellcept48 (mycophenolate mofetil) [2009 version]
Celontin49 (methsuximide) [2010 version]
Chantix50 (varenicline tartrate) [2010 version]
Cimzia51* (certolizumab pegol) [2009 version]
Cipro52 (ciprofloxacin) [2011 version]
Clinoril53 (sulindac) [2010 version]
Colcrys54 (colchicine) [2009 version]
Combunox55 (oxycodone hydrochloride and ibuprofen) [2010 version]
Concerta56 (methylphenidate hydrochloride) [2010 version]
Copegus57 (ribavirin) [2010 version]
Cordarone58 (amiodarone hydrochloride) [2009 version]
Coumadin59 (warfarin sodium) [2010 version]
Creon60 (pancrelipase) [2010 version]
Cymbalta61 (duloxetine hydrochloride) [2008 version)]
Dalmane62 (flurazepam hydrochloride) [2009 version]
Darvocet63 (acetaminophen and propoxyphene napsylate) [2009 version]
Darvon64 (propoxyphene hydrochloride) [2009 version]
Daypro Alta65 (oxaprozin potassium) [2007 version]
Daytrana66 (methylphenidate) [2010 version]
Desoxyn67 (methamphetamine hydrochloride) [2007 version]
Dexedrine68 (dextroamphetamine sulfate) [2008 version]
Dilantin69 (phenytoin) [2011 version]
Doral70 (quazepam) [2007 version]
Duetact71 (glimepiride and pioglitazone) [2009 version]
Duexis72 (ibuprofen and famotidine) [2011 version]
Dulera73 (mometasone furoate and formoterol fumarate) [2010 version]
Duragesic74 (fentanyl) [2009 version]
Dysport75* (abobotulinumtoxinA) [2009 version]
EC-Naprosyn76 (naproxen) [2008 version]
Edluar77 (zolpidem tartrate) [2009 version]
Effexor78 (venlafaxine hydrochloride) [2008 version]
Effexor XR79 (venlafaxine hydrochloride) [2008 version]
Effient80 (prasugrel) [2010 version]
Elidel Cream 81(pimecrolimus) [2010 version]
Embeda82 (morphine sulfate and naltrexone hydrochloride) [2009 version]
Emsam83 (selegeline transdermal system) [2007 version]
Enbrel84* (etanercept) [2010 version]
Epogen85* (epoeten alfa) [2010 version]
Epzicom86 (abacavir sulfate and lamivudine) [2011 version]
Evista87 (raloxifene hydrochloride) [2007 version]
Exalgo88 (hydromorphone hydrochloride) [2010 version]
Extavia89* (interferon beta-1b) [2009 version]
Extraneal90 (icodextrin) [2010 version]
Exubera91 (insulin recombinant human) [2008 version]
Factive92 (gemifloxacin) [2011 version]
Feldene93 (piroxicam) [2010 version]
Fentora94 (fentanyl citrate) [2011 version]
Flector95 (diclofenac epolamine) [2010 version]
Floxin96 (ofloxacin) [2011 version]
Focalin97 (dexmethylphenidate hydrochloride) [2010 version]
Focalin XR98 (dexmethylphenidate hydrochloride) [2010 version]
Foradil Aerolizer99 (formoterol fumarate inhalation powder) [2011 version]
Foradil Certihaler100 (formoterol fumarate inhalation powder) [2010 version]
Forteo101 (teriparatide) [2009 version]
Fortesta102 (testosterone) [2010 version]
Fosamax103 (alendronate sodium) [2011 version]
Fosamax Plus D104 (alendronate sodium and cholecalciferol) [2011 version]
Gabitril105 (tiagabine) [2010 version]
Gilenya106 (fingolimid) [2010 version]
Gralise107 (gabapentin) [2011 version]
Halcion108 (triazolam) [2008 version]
HalfLytely and Bisacodyl Bowel Prep Kit109 (bisacodyl, polyethylene glycol 3500, potassium chloride, sodium bicarbonate, sodium chloride) [2010 version]
Horizant110 (gabapentin enacarbil) [2011 version]
H.P. Acthar Gel111 (repository corticotropin) [2010 version]
Humira112* (adalimumab) [2011 version]
Incivek113 (telaprevir) [2011 version]
Indocin114 (indomethacin) [2008 version]
Infergen115* (interferon alfacon-1) [2010 version]
Intron A116* (interferon alfa-2b) [2008 version]
Invirase117 (saquinavir mesylate) [2010 version]
Janumet118 (metformin hydrochloride and sitagliptin phosphate) [2011 version]
Januvia119 (sitagliptin phosphate) [2011 version]
Kalbitor120* (ecallantide) [2009 version]
Kaletra121 (lopinavir and ritonavir) [2011 version]
Keppra122 (levetiracetam) [2009 version]
Ketek123 (telithromycin) [2010 version]
Klonopin124 (clonazepam) [2010 version]
Krystexxa125* (pegloticase) [2010 version]
Lamictal126 (lamotrigine) [2010 version]
Lamictal XR127 (lamotrigine) [2011 version]
Lariam128 (mefloquine hydrochloride) [2009 version]
Letairis129 (ambrisentan) [2011 version]
Levaquin130 (levofloxacin) [2011 version]
Lexapro131 (escitalopram oxalate) [2009 version]
Limbitrol132 (chlordiazepoxide and amitriptyline) [2007 version]
Lindane Lotion133 (lindane) [2007 version]
Lindane Shampoo134 (lindane) [2007 version]
Lotronex135 (alosetron hydrochloride) [2010 version]
Lunesta136 (eszopiclone) [2008 version]
Luvox137 (fluvoxamine maleate) [2011 version]
Luvox CR138 (fluvoxamine maleate) [2011 version]
Lyrica139 (pregabalin) [2010 version]
Marplan140 (isocarboxazid) [2008 version]
Meridia141 (sibutramine hydrochloride) [2010 version]
Metadate CD142 (methylphenidate hydrochloride) [2009 version]
Methylin (methylphenidate)
chewable tablets143 [2010 version]
oral solution144 [2010 version]
Metoclopramide Oral Solution145 [2009 version]
Metozolv ODT146 (metoclopramide hydrochloride) [2009 version]
Mifeprex147 (mifepristone) [2009 version]
Mircera148* (methoxy polyethylene glycol-epoetin beta) [2007 version]
Mobic149 (meloxicam) [2010 version]
Morphine Sulfate150 (morphine sulfate oral solution) [2010 version]
Motrin151 (ibuprofen) [2007 version]
Moviprep152 (propylene glycol 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid) [2011 version]

Multaq153 (dronedarone) [2011 version]
Myfortic154 (mycophenolic acid) [2009 version]
Myobloc155* (rimabotulinumtoxinB) [2009 version]
Mysoline156 (primidone) [2010 version]
Nalfon157 (fenoprofen calcium) [2009 version]
Naprosyn158 (naproxen) [2008 version]
Nardil159 (phenelzine sulfate) [2007 version]
Neurontin160 (gabapentin) [2011 version]
Nolvadex161 (tamoxifen) [2006 version]
Noroxin162 (norfloxacin) [2011 version]
Norpramin163 (desipramine hydrochloride) [2009 version]
Nplate164 (romiplostim) [2008 version]
Nucynta165 (tapentadol hydrochloride) [2010 version]
Nuvigil166 (armodafinil) [2010 version]
Oleptro167 (trazadone hydrochloride) [2010 version]
Onsolis168 (fentanyl buccal soluble film) [2009 version]
Osmoprep169 (sodium phosphate dibasic anhydrous and sodium phosphate monobasic monohydrate) [2009 version]
OxyContin170 (oxycodone hydrochloride) [2010 version]
Pacerone171 (amiodarone hydrochloride) [2008 version]
Palladone172 (hydromorphone hydrochloride) [2004 version]
Pamelor173 (nortriptyline hydrochloride) [2007 version]
Pancreaze174 (pancrelipase) [2010 version]
Parnate175 (tranylcypromine sulfate) [2008 version]
Paxil176 (paroxetine hydrochloride) [2010 version]
Paxil CR177 (paroxetine hydrochloride) [2010 version]
Peganone178 (ethotoin) [2010 version]
Pegasys179* (peginterferon alfa-2a) [2011 version]
Pegintron180* (peginterferon alfa-2b) [2009 version]
PegIntron*/Rebetol Combo Pack181 (peginterferon alfa-2b and ribavirin) [2008 version]
Pennsaid182 (diclofenac sodium) [2009 version]
Perforomist183 (formoterol fumarate) [2010 version]
Pexeva184 (paroxetine mesylate) [2010 version]
Plavix185 (clopidogrel bisulfate) [2011 version]
Ponstel186 (mefenamic acid) [2008 version]
Pradaxa 187(dabigatran etexilate mesylate) [2011 version]
Prevacid NapraPac188 (lansoprazole and naproxen) [2009 version]
Pristiq189 (desvenlafaxine succinate) [2011 version]
Procrit190* (epoetin alfa) [2010 version]
Prolia191* (denosumab) [2010 version]
Propylthiouracil192 [2010 version]
Promacta193 (eltrombopag) [2011 version]
Propulsid194 (cisapride) [2006 version]
Proquin XR195 (ciprofloxacin hydrochloride) [2011 version]
Protopic Ointment196 (tacrolimus) [2006 version]
Provigil197 (modafinil) [2010 version]
Prozac198 (fluoxetine hydrochloride) [2009 version]
Qualaquin199 (quinine sulfate) [2011 version]
Rapamune200 (sirolimus) [2010 version]
Rebetol201 (ribavirin) [2010 version]
Rebif202* (interferon beta-1a) [2002 version]
Reclast203 (zoledronic acid) [2011 version]
Reglan204 (metoclopramide hydrochloride) injection [2009 version]
Reglan205 (metoclopramide hydrochloride) tablets [2009 version]
Reglan ODT206 (metoclopramide hydrochloride) [2010 version]
Remeron207 (mirtazapine) [2010 version]
Remicade208* (infliximab) [2011 version]
Restoril209 (temazepam) [2010 version]
Revlimid210 (lenalidomide) [2009 version]
Ribasphere211 (ribavirin) [2008 version]
Ritalin212 (methylphenidate hydrochloride) [2010 version]
Ritalin LA213 (methylphenidate hydrochloride) [2010 version]
Ritalin-SR214 (methylphenidate hydrochloride) [2010 version]
Rituxan215* (rituximab) [2011 version]
Roferon-A216* (interferon alfa-2a recombinant) [2008 version]
Rozerem217 (ramelteon) [2010 version]
Sabril218 (vigabatrin) [2010 version]
Samsca219 (tolvaptan) [2009 version]
Sarafem220 (fluoxetine hydrochloride) [2009 version]
Savella221 (milnacipran hydrochloride) [2010 version]
Selzentry222 (maraviroc) [2010 version]
Serevent Diskus223 (salmeterol xinafoate) [2010 version]
224Seroquel225 (quetiapine fumarate) [2011 version]
226Seroquel XR227 (quetiapine fumarate) [2011 version]
Silenor228 (doxepin) [2010 version]
Simponi229* (golimumab) [2010 version]
Sinequan230 (doxepin hydrochloride) [2007 version]
Soliris231 (eculizumab) [2009 version]
Soltamox232 (tamoxifen citrate) [2005 version]
Soriatane233 (acitretin) [2007 version]
Sotret234 (isotretinoin) [2006 version]
Stelara235* (ustekinumab) [2010 version]
Strattera236 (atomoxetine hydrochloride) [2011 version]
Suboxone237 (buprenorphine and naloxone) [2010 version]
Suprep238 (sodium sulfate, potassium sulfate and magnesium sulfate) [2010 version]
Sutent239 (sunitimib malate) [2010 version]
Sylatron240 (peginterferon alfa-2b) [2011 version]
Symbicort241 (budesonide and formoterol fumarate dihydrate) [2010 version]
Symbyax242 (fluoxetine hydrochloride and olanzapine) [2009 version]
Symlin243 (pramlintide acetate) [2007 version]
Tapentadol244 see Nucynta
Tasigna245 (nilotinib) [2011 version]
Tegretol246 (carbamazepine) [2011 version]
Testim247 (testosterone) [2009 version]
Thalomid248 (thalidomide) [2009 version]
Tofranil249 (imipramine hydrochloride) [2007 version]
Tolectin250 (tolmetin sodium) [2008 version]
Topamax251 (topiramate) [2011 version]
Toradol252 (ketorolac tromethamine) [2007 version]
Tracleer253 (bosentan) [2009 version]
Tranxene254 (clorazepate dipotassium) [2010 version]
Treximet255 (naproxen sodium and sumatriptan succinate) [2008 version]
Trileptal256 (oxcarbazepine) [2011 version]
Trilipix257 (choline fenofibrate) [2010 version]
Trizivir258 (abacavir sulfate, lamivudine and zidovudine) [2011 version]
Tyasbri259* (natalizumab) [2011 version]
Tyzeka260 (telbivudine) [2010 version]
Vandetanib261 (vandetanib) [2011 version]
Vibativ262 (telavancin) [2009 version]
Vicoprofen263 (vicoprofen and ibuprofen) [2008 version]
Victoza264 (liraglutide) [2010 version]
Victrelis265 (boceprevir) [2011 version]

Videx266 (didanosine) [2010 version]
Videx EC267 (didanosine) [2010 version]
Viibryd268 (vilazodone hydrochloride) [2011 version]
269Vimovo270 (esomeprazole magnesium and naproxen) [2011 version]
Vimpat271 (lacosamide) [2009 version]
Viramune272 (nevirapine) [2011 version]
Visicol273 (sodium phosphate dybasic anhydrous and sodium phosphate monobasic monohydrate) [2009 version]
Vivactil274 (protriptyline hydrochloride) [2007 version]
Vivitrol275 (naltrexone) [2010 version]
Voltaren276 (diclofenac sodium) [2011 version]
Votrient277 (pazopanib hydrochloride) [2010 version]
Vyvanse278 (lisdexamfetamine dimesylate) [2011 version]
Wellbutrin279 (bupropion hydrochloride) [2010 version]
Wellbutrin SR280 (bupropion hydrochloride) [2010 version]
Wellbutrin XL281 (buproprion hydrochloride) [2010 version]
Xenazine282 (tetrabenazine) [2011 version]
Xeomin283* (incobotulinumtoxinA) [2010 version]
Xiaflex284* (collagenase clostridium histolyticum) [2010 version]
Xolair285* (omalizumab) [2010 version]
Xyrem286 (sodium oxybate) [2005 version]
Yervoy 287(ipilimumab) [2011 version]
Zarontin288 (ethosuximide) [2010 version]
Zenpep289 (pancrelipase) [2009 version]
Zerit290 (stavudine) [2010 version]
Ziagen291 (abacavir sulfate) [2008 version]
Zipsor292 (diclofenac potassium) [2009 version]
Zoloft293 (sertraline hydrochloride) [2008 version]
Zolpidem294 (zolpidem tartrate) [2008 version]
Zolpimist295 (zolpidem tartrate) [2008 version]
Zonegran296 (zonisamide) [2010 version]
Zortress297 (everolimus) [2010 version]
Zyban298 (bupropion hydrochloride) [2010 version]
Zyprexa299 (olanzapine) [2010 version]
Zyprexa Relprevv300 (olanzapine) [2010 version]




-Related Information
Questions and Answers on Guidance for Industry: Medication Guides - Distribution Requirements and Inclusion in REMS301
3/29/2011
Guidance for Industry: Medication Guides - Distribution Requirements and Inclusion in REMS (PDF - 96KB)302
2/25/2011
Public Hearing on Use of Medication Guides to Distribute Drug Risk Information to Patients June 12-13, 2007303

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Drug Safety and Availability > Medication Guides