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) [2011 version]
Actonel⁸ (risedronate sodium) [2011 version]
Actonel with Calcium⁹ (risedronate sodium and calcium carbonate) [2011 version]
Actoplus Met¹⁰ (metformin hydrochloride and pioglitazone hydrochloride) [2011 version]
Actoplus Met XR¹¹ (metformin hydrochloride and pioglitazone hydrochloride) [2011 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) [2011 version)
Arcapta²⁶ (indacaterol maleate) [2011 version]
Arthrotec²⁷ (diclofenac sodium) [2007 version]
Atelvia²⁸ (risedronate sodium) [2011 version]
Avandamet²⁹ (metformin hydrochloride and rosiglitazone maleate) [2011 version]
Avandaryl³⁰ (glimepiride and rosiglitazone maleate) [2011 version]
Avandia³¹ (rosiglitazone maleate) [2011 version]
Avelox³² (moxifloxacin) [2011 version]
Avonex³³* (interferon beta-1a) [2006 version]
Axiron³⁴ (testosterone) [2011 version]
Banzel³⁵ (rufinamide) [2011 version]
Benlysta³⁶ (belimumab) [2011 version]
Betaseron³⁷*(interferon beta-1b) [2009 version]
Boniva³⁸ (ibandronate sodium) Injection [2011 version]
Boniva³⁹ (ibandronate sodium) Tablets [2011 version]
Botox⁴⁰* (onabotulinumtoxinA) [2011 version]
Brilinta⁴¹ (ticagrelor) [2011 version]
Brovana⁴² (arformoterol tartrate) [2011 version]
Butrans⁴³ (buprenorphine) [2010 version]
Byetta⁴⁴ (exenatide) [2009 version]
Cambia⁴⁵ (diclofenac) [2009 version]
Carbatrol ⁴⁶(carbamazepine) [2010 version]
Cataflam⁴⁷ (diclofenac potassium) [2011 version]
Celebrex⁴⁸ (celecoxib) [2011 version]
Celexa⁴⁹ (citalopram hydrobromide) [2011 version]
Cellcept⁵⁰ (mycophenolate mofetil) [2009 version]
Celontin⁵¹ (methsuximide) [2010 version]
Chantix⁵² (varenicline tartrate) [2011 version]
Cimzia⁵³* (certolizumab pegol) [2009 version]
Cipro⁵⁴ (ciprofloxacin) [2011 version]
Clinoril⁵⁵ (sulindac) [2010 version]
Colcrys⁵⁶ (colchicine) [2011 version]
Combunox⁵⁷ (oxycodone hydrochloride and ibuprofen) [2010 version]
Concerta⁵⁸ (methylphenidate hydrochloride) [2010 version]
Copegus⁵⁹ (ribavirin) [2011 version]
Cordarone⁶⁰ (amiodarone hydrochloride) [2011 version]
Coumadin⁶¹ (warfarin sodium) [2010 version]
Creon⁶² (pancrelipase) [2011 version]
Cymbalta⁶³ (duloxetine hydrochloride) [2008 version)]
Dalmane⁶⁴ (flurazepam hydrochloride) [2009 version]
Darvocet⁶⁵ (acetaminophen and propoxyphene napsylate) [2009 version]
Darvon⁶⁶ (propoxyphene hydrochloride) [2009 version]
Daypro Alta⁶⁷ (oxaprozin potassium) [2007 version]
Daytrana⁶⁸ (methylphenidate) [2010 version]
Desoxyn⁶⁹ (methamphetamine hydrochloride) [2007 version]
Dexedrine⁷⁰ (dextroamphetamine sulfate) [2008 version]
Dilantin⁷¹ (phenytoin) [2011 version]
Doral⁷² (quazepam) [2007 version]
Duetact⁷³ (glimepiride and pioglitazone) [2011 version]
Duexis⁷⁴ (ibuprofen and famotidine) [2011 version]
Dulera⁷⁵ (mometasone furoate and formoterol fumarate) [2010 version]
Duragesic⁷⁶ (fentanyl) [2009 version]
Dysport⁷⁷* (abobotulinumtoxinA) [2009 version]
EC-Naprosyn⁷⁸ (naproxen) [2008 version]
Edluar⁷⁹ (zolpidem tartrate) [2009 version]
Effexor⁸⁰ (venlafaxine hydrochloride) [2008 version]
Effexor XR⁸¹ (venlafaxine hydrochloride) [2008 version]
Effient⁸² (prasugrel) [2011 version]
Elidel Cream ⁸³(pimecrolimus) [2010 version]
Embeda⁸⁴ (morphine sulfate and naltrexone hydrochloride) [2009 version]
Emsam⁸⁵ (selegeline transdermal system) [2007 version]
Enbrel⁸⁶* (etanercept) [2010 version]
Epogen⁸⁷* (epoeten alfa) [2011 version]
Epzicom⁸⁸ (abacavir sulfate and lamivudine) [2011 version]
Evista⁸⁹ (raloxifene hydrochloride) [2007 version]
Exalgo⁹⁰ (hydromorphone hydrochloride) [2010 version]
Extavia⁹¹* (interferon beta-1b) [2009 version]
Extraneal⁹² (icodextrin) [2010 version]
Exubera⁹³ (insulin recombinant human) [2008 version]
Factive⁹⁴ (gemifloxacin) [2011 version]
Felbatol⁹⁵ (felbamate) [2011 version]
Feldene⁹⁶ (piroxicam) [2010 version]
Fentora⁹⁷ (fentanyl citrate) [2011 version]
Flector⁹⁸ (diclofenac epolamine) [2010 version]
Floxin⁹⁹ (ofloxacin) [2011 version]
Focalin¹⁰⁰ (dexmethylphenidate hydrochloride) [2010 version]
Focalin XR¹⁰¹ (dexmethylphenidate hydrochloride) [2010 version]
Foradil Aerolizer¹⁰² (formoterol fumarate inhalation powder) [2011 version]
Foradil Certihaler¹⁰³ (formoterol fumarate inhalation powder) [2010 version]
Forfivo XL¹⁰⁴ (bupropion hydrochloride) [2011 version]
Forteo¹⁰⁵ (teriparatide) [2009 version]
Fortesta¹⁰⁶ (testosterone) [2010 version]
Fosamax¹⁰⁷ (alendronate sodium) [2011 version]
Fosamax Plus D¹⁰⁸ (alendronate sodium and cholecalciferol) [2011 version]
Fosrenol¹⁰⁹ (lanthanum carbonate) [2011 version]
Gabitril¹¹⁰ (tiagabine) [2010 version]
Gilenya¹¹¹ (fingolimid) [2010 version]
Gralise¹¹² (gabapentin) [2011 version]
Halcion¹¹³ (triazolam) [2008 version]
HalfLytely and Bisacodyl Bowel Prep Kit¹¹⁴ (bisacodyl, polyethylene glycol 3500, potassium chloride, sodium bicarbonate, sodium chloride) [2010 version]
Horizant¹¹⁵ (gabapentin enacarbil) [2011 version]
H.P. Acthar Gel¹¹⁶ (repository corticotropin) [2010 version]
Humira¹¹⁷* (adalimumab) [2011 version]
Incivek¹¹⁸ (telaprevir) [2011 version]
Indocin¹¹⁹ (indomethacin) [2008 version]
Infergen¹²⁰* (interferon alfacon-1) [2010 version]
Intron A¹²¹* (interferon alfa-2b) [2008 version]
Invirase¹²² (saquinavir mesylate) [2010 version]
Janumet¹²³ (metformin hydrochloride and sitagliptin phosphate) [2011 version]
Januvia¹²⁴ (sitagliptin phosphate) [2011 version]
Juvisync¹²⁵ (sitagliptin and simvastatin) [2011 version]
Kalbitor¹²⁶* (ecallantide) [2009 version]
Kaletra¹²⁷ (lopinavir and ritonavir) [2011 version]
Keppra¹²⁸ (levetiracetam) [2009 version]
Ketek¹²⁹ (telithromycin) [2010 version]
Klonopin¹³⁰ (clonazepam) [2010 version]
Kombiglyze XR¹³¹ (metformin hydrochloride and saxagliptin) [2011 version]
Krystexxa¹³²* (pegloticase) [2010 version]
Lamictal¹³³ (lamotrigine) [2011 version]
Lamictal XR¹³⁴ (lamotrigine) [2011 version]
Lariam¹³⁵ (mefloquine hydrochloride) [2009 version]
Lazanda¹³⁶ (fentanyl citrate) [2011 version]
Letairis¹³⁷ (ambrisentan) [2011 version]
Levaquin¹³⁸ (levofloxacin) [2011 version]
Lexapro¹³⁹ (escitalopram oxalate) [2011 version]
Limbitrol¹⁴⁰ (chlordiazepoxide and amitriptyline) [2007 version]
Lindane Lotion¹⁴¹ (lindane) [2007 version]
Lindane Shampoo¹⁴² (lindane) [2007 version]
Lotronex¹⁴³ (alosetron hydrochloride) [2010 version]
Lunesta¹⁴⁴ (eszopiclone) [2008 version]
Luvox¹⁴⁵ (fluvoxamine maleate) [2011 version]
Luvox CR¹⁴⁶ (fluvoxamine maleate) [2011 version]
Lyrica¹⁴⁷ (pregabalin) [2011 version]
Marplan¹⁴⁸ (isocarboxazid) [2008 version]
Meridia¹⁴⁹ (sibutramine hydrochloride) [2010 version]
Metadate CD¹⁵⁰ (methylphenidate hydrochloride) [2009 version]
Methylin (methylphenidate)
- chewable tablets¹⁵¹ [2010 version]
- oral solution¹⁵² [2010 version]
Metoclopramide Oral Solution¹⁵³ [2009 version]
Metozolv ODT¹⁵⁴ (metoclopramide hydrochloride) [2011 version]
Mifeprex¹⁵⁵ (mifepristone) [2009 version]
Mircera¹⁵⁶* (methoxy polyethylene glycol-epoetin beta) [2007 version]

Mobic¹⁵⁷ (meloxicam) [2010 version]
Morphine Sulfate¹⁵⁸ (morphine sulfate oral solution) [2010 version]
Motrin¹⁵⁹ (ibuprofen) [2007 version]
Moviprep¹⁶⁰ (propylene glycol 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid) [2011 version]
Multaq¹⁶¹ (dronedarone) [2011 version]
Myfortic¹⁶² (mycophenolic acid) [2009 version]
Myobloc¹⁶³* (rimabotulinumtoxinB) [2009 version]
Mysoline¹⁶⁴ (primidone) [2010 version]
Nalfon¹⁶⁵ (fenoprofen calcium) [2009 version]
Naprelan¹⁶⁶ (naproxen sodium) [2011 version]
Naprosyn¹⁶⁷ (naproxen) [2008 version]
Nardil¹⁶⁸ (phenelzine sulfate) [2007 version]
Neurontin¹⁶⁹ (gabapentin) [2011 version]
Nolvadex¹⁷⁰ (tamoxifen) [2006 version]
Noroxin¹⁷¹ (norfloxacin) [2011 version]
Norpramin¹⁷² (desipramine hydrochloride) [2009 version]
Nplate¹⁷³ (romiplostim) [2011 version]
Nucynta¹⁷⁴ (tapentadol hydrochloride) [2010 version]
Nucynta ER¹⁷⁵ (tapentadol) [2011 version]
Nulojix¹⁷⁶ (belatacept) [2011 version]
Nuvigil¹⁷⁷ (armodafinil) [2010 version]
Oleptro¹⁷⁸ (trazadone hydrochloride) [2010 version]
Onfi¹⁷⁹ (clobazam) [2011 version]
Onglyza¹⁸⁰ (saxagliptin hydrochloride) [2011 version]
Onsolis¹⁸¹ (fentanyl buccal soluble film) [2009 version]
Osmoprep¹⁸² (sodium phosphate dibasic anhydrous and sodium phosphate monobasic monohydrate) [2009 version]
OxyContin¹⁸³ (oxycodone hydrochloride) [2010 version]
Pacerone¹⁸⁴ (amiodarone hydrochloride) [2008 version]
Palladone¹⁸⁵ (hydromorphone hydrochloride) [2004 version]
Pamelor¹⁸⁶ (nortriptyline hydrochloride) [2007 version]
Pancreaze¹⁸⁷ (pancrelipase) [2010 version]
Parnate¹⁸⁸ (tranylcypromine sulfate) [2008 version]
Paxil¹⁸⁹ (paroxetine hydrochloride) [2011 version]
Paxil CR¹⁹⁰ (paroxetine hydrochloride) [2011 version]
Peganone¹⁹¹ (ethotoin) [2010 version]
Pegasys¹⁹²* (peginterferon alfa-2a) [2011 version]
Pegintron¹⁹³* (peginterferon alfa-2b) [2009 version]
PegIntron*/Rebetol Combo Pack¹⁹⁴ (peginterferon alfa-2b and ribavirin) [2008 version]
Pennsaid¹⁹⁵ (diclofenac sodium) [2009 version]
Perforomist¹⁹⁶ (formoterol fumarate) [2010 version]
Pexeva¹⁹⁷ (paroxetine mesylate) [2010 version]
Plavix¹⁹⁸ (clopidogrel bisulfate) [2011 version]
Ponstel¹⁹⁹ (mefenamic acid) [2008 version]
Potiga²⁰⁰ (ezogabine) [2011 version]
Pradaxa ²⁰¹(dabigatran etexilate mesylate) [2011 version]
Prevacid NapraPac²⁰² (lansoprazole and naproxen) [2009 version]
Pristiq²⁰³ (desvenlafaxine succinate) [2011 version]
Procrit²⁰⁴* (epoetin alfa) [2011 version]
Prolia²⁰⁵* (denosumab) [2011 version]
Propylthiouracil²⁰⁶ [2010 version]
Promacta²⁰⁷ (eltrombopag) [2011 version]
Propulsid²⁰⁸ (cisapride) [2006 version]
Proquin XR²⁰⁹ (ciprofloxacin hydrochloride) [2011 version]
Protopic Ointment²¹⁰ (tacrolimus) [2006 version]
Provigil²¹¹ (modafinil) [2010 version]
Prozac²¹² (fluoxetine hydrochloride) [2009 version]
Qualaquin²¹³ (quinine sulfate) [2011 version]
Rapamune²¹⁴ (sirolimus) [2010 version]
Rebetol²¹⁵ (ribavirin) [2010 version]
Rebif²¹⁶* (interferon beta-1a) [2002 version]
Reclast²¹⁷ (zoledronic acid) [2011 version]
Reglan²¹⁸ (metoclopramide hydrochloride) injection [2009 version]
Reglan²¹⁹ (metoclopramide hydrochloride) tablets [2011 version]
Reglan ODT²²⁰ (metoclopramide hydrochloride) [2010 version]
Remeron²²¹ (mirtazapine) [2010 version]
Remicade²²²* (infliximab) [2011 version]
Restoril²²³ (temazepam) [2010 version]
Revlimid²²⁴ (lenalidomide) [2009 version]
Ribasphere²²⁵ (ribavirin) [2008 version]
Ritalin²²⁶ (methylphenidate hydrochloride) [2010 version]
Ritalin LA²²⁷ (methylphenidate hydrochloride) [2010 version]
Ritalin-SR²²⁸ (methylphenidate hydrochloride) [2010 version]
Rituxan²²⁹* (rituximab) [2011 version]
Roferon-A²³⁰* (interferon alfa-2a recombinant) [2008 version]
Rozerem²³¹ (ramelteon) [2010 version]
Sabril²³² (vigabatrin) [2010 version]
Samsca²³³ (tolvaptan) [2009 version]
Sarafem²³⁴ (fluoxetine hydrochloride) [2009 version]
Savella²³⁵ (milnacipran hydrochloride) [2010 version]
Selzentry²³⁶ (maraviroc) [2011 version]
Serevent Diskus²³⁷ (salmeterol xinafoate) [2010 version]
Seroquel²³⁸ (quetiapine fumarate) [2011 version]
Seroquel XR²³⁹ (quetiapine fumarate) [2011 version]
Silenor²⁴⁰ (doxepin) [2010 version]
Simponi²⁴¹* (golimumab) [2010 version]
Sinequan²⁴² (doxepin hydrochloride) [2007 version]
Soliris²⁴³ (eculizumab) [2009 version]
Soltamox²⁴⁴ (tamoxifen citrate) [2005 version]
Soriatane²⁴⁵ (acitretin) [2007 version]
Sotret²⁴⁶ (isotretinoin) [2006 version]
Stelara²⁴⁷* (ustekinumab) [2010 version]
Strattera²⁴⁸ (atomoxetine hydrochloride) [2011 version]
Suboxone²⁴⁹ (buprenorphine and naloxone) [2010 version]
Suprep²⁵⁰ (sodium sulfate, potassium sulfate and magnesium sulfate) [2010 version]
Sutent²⁵¹ (sunitimib malate) [2010 version]
Sylatron²⁵² (peginterferon alfa-2b) [2011 version]
Symbicort²⁵³ (budesonide and formoterol fumarate dihydrate) [2010 version]
Symbyax²⁵⁴ (fluoxetine hydrochloride and olanzapine) [2011 version]
Symlin²⁵⁵ (pramlintide acetate) [2007 version]
Tapentadol²⁵⁶ see Nucynta
Tasigna²⁵⁷ (nilotinib) [2011 version]
Tegretol²⁵⁸ (carbamazepine) [2011 version]
Testim²⁵⁹ (testosterone) [2009 version]
Thalomid²⁶⁰ (thalidomide) [2009 version]
Tikosyn²⁶¹ (dofetilide) [2011 version]
Tofranil²⁶² (imipramine hydrochloride) [2007 version]
Tolectin²⁶³ (tolmetin sodium) [2008 version]
Topamax²⁶⁴ (topiramate) [2011 version]
Toradol²⁶⁵ (ketorolac tromethamine) [2007 version]
Tracleer²⁶⁶ (bosentan) [2009 version]
Tranxene²⁶⁷ (clorazepate dipotassium) [2010 version]
Treximet²⁶⁸ (naproxen sodium and sumatriptan succinate) [2011 version]
Trileptal²⁶⁹ (oxcarbazepine) [2011 version]
Trilipix²⁷⁰ (choline fenofibrate) [2011 version]
Trizivir²⁷¹ (abacavir sulfate, lamivudine and zidovudine) [2011 version]
Tysabri²⁷²* (natalizumab) [2011 version]
Tyzeka²⁷³ (telbivudine) [2010 version]
Vandetanib²⁷⁴ (vandetanib) [2011 version]
Vibativ²⁷⁵ (telavancin) [2009 version]
Vicoprofen²⁷⁶ (vicoprofen and ibuprofen) [2008 version]
Victoza²⁷⁷ (liraglutide) [2010 version]
Victrelis²⁷⁸ (boceprevir) [2011 version]
Videx²⁷⁹ (didanosine) [2010 version]
Videx EC²⁸⁰ (didanosine) [2010 version]
Viibryd²⁸¹ (vilazodone hydrochloride) [2011 version]
Vimovo²⁸² (esomeprazole magnesium and naproxen) [2011 version]
Vimpat²⁸³ (lacosamide) [2009 version]
Viramune²⁸⁴ (nevirapine) [2011 version]
Visicol²⁸⁵ (sodium phosphate dybasic anhydrous and sodium phosphate monobasic monohydrate) [2009 version]
Vivactil²⁸⁶ (protriptyline hydrochloride) [2007 version]
Vivitrol²⁸⁷ (naltrexone) [2010 version]
Voltaren²⁸⁸ (diclofenac sodium) [2011 version]
Votrient²⁸⁹ (pazopanib hydrochloride) [2011 version]
Vyvanse²⁹⁰ (lisdexamfetamine dimesylate) [2011 version]
Wellbutrin²⁹¹ (bupropion hydrochloride) [2010 version]
Wellbutrin SR²⁹² (bupropion hydrochloride) [2010 version]
Wellbutrin XL²⁹³ (buproprion hydrochloride) [2011 version]
Xarelto²⁹⁴ (rivaroxaban) [2011 version]
Xenazine²⁹⁵ (tetrabenazine) [2011 version]
Xeomin²⁹⁶* (incobotulinumtoxinA) [2011 version]
Xiaflex²⁹⁷* (collagenase clostridium histolyticum) [2010 version]
Xolair²⁹⁸* (omalizumab) [2010 version]
Xyrem²⁹⁹ (sodium oxybate) [2005 version]
Yervoy ³⁰⁰(ipilimumab) [2011 version]
Zarontin³⁰¹ (ethosuximide) [2010 version]
Zelboraf³⁰² (vemurafenib) [2011 version]
Zenpep³⁰³ (pancrelipase) [2011 version]
Zerit³⁰⁴ (stavudine) [2010 version]
Ziagen³⁰⁵ (abacavir sulfate) [2008 version]
Zipsor³⁰⁶ (diclofenac potassium) [2009 version]
Zoloft³⁰⁷ (sertraline hydrochloride) [2008 version]
Zolpidem³⁰⁸ (zolpidem tartrate) [2008 version]
Zolpimist³⁰⁹ (zolpidem tartrate) [2008 version]
Zonegran³¹⁰ (zonisamide) [2011 version]
Zortress³¹¹ (everolimus) [2010 version]
Zyban³¹² (bupropion hydrochloride) [2010 version]
Zyprexa³¹³ (olanzapine) [2010 version]
Zyprexa Relprevv³¹⁴ (olanzapine) [2010 version]