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

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) [2009 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]
Forteo¹⁰⁴ (teriparatide) [2009 version]
Fortesta¹⁰⁵ (testosterone) [2010 version]
Fosamax¹⁰⁶ (alendronate sodium) [2011 version]
Fosamax Plus D¹⁰⁷ (alendronate sodium and cholecalciferol) [2011 version]
Fosrenol¹⁰⁸ (lanthanum carbonate) [2011 version]
Gabitril¹⁰⁹ (tiagabine) [2010 version]
Gilenya¹¹⁰ (fingolimid) [2010 version]
Gralise¹¹¹ (gabapentin) [2011 version]
Halcion¹¹² (triazolam) [2008 version]
HalfLytely and Bisacodyl Bowel Prep Kit¹¹³ (bisacodyl, polyethylene glycol 3500, potassium chloride, sodium bicarbonate, sodium chloride) [2010 version]
Horizant¹¹⁴ (gabapentin enacarbil) [2011 version]
H.P. Acthar Gel¹¹⁵ (repository corticotropin) [2010 version]
Humira¹¹⁶* (adalimumab) [2011 version]
Incivek¹¹⁷ (telaprevir) [2011 version]
Indocin¹¹⁸ (indomethacin) [2008 version]
Infergen¹¹⁹* (interferon alfacon-1) [2010 version]
Intron A¹²⁰* (interferon alfa-2b) [2008 version]
Invirase¹²¹ (saquinavir mesylate) [2010 version]
Janumet¹²² (metformin hydrochloride and sitagliptin phosphate) [2011 version]
Januvia¹²³ (sitagliptin phosphate) [2011 version]
Kalbitor¹²⁴* (ecallantide) [2009 version]
Kaletra¹²⁵ (lopinavir and ritonavir) [2011 version]
Keppra¹²⁶ (levetiracetam) [2009 version]
Ketek¹²⁷ (telithromycin) [2010 version]
Klonopin¹²⁸ (clonazepam) [2010 version]
Krystexxa¹²⁹* (pegloticase) [2010 version]
Lamictal¹³⁰ (lamotrigine) [2011 version]
Lamictal XR¹³¹ (lamotrigine) [2011 version]
Lariam¹³² (mefloquine hydrochloride) [2009 version]
Lazanda¹³³ (fentanyl citrate) [2011 version]
Letairis¹³⁴ (ambrisentan) [2011 version]
Levaquin¹³⁵ (levofloxacin) [2011 version]
Lexapro¹³⁶ (escitalopram oxalate) [2011 version]
Limbitrol¹³⁷ (chlordiazepoxide and amitriptyline) [2007 version]
Lindane Lotion¹³⁸ (lindane) [2007 version]
Lindane Shampoo¹³⁹ (lindane) [2007 version]
Lotronex¹⁴⁰ (alosetron hydrochloride) [2010 version]
Lunesta¹⁴¹ (eszopiclone) [2008 version]
Luvox¹⁴² (fluvoxamine maleate) [2011 version]
Luvox CR¹⁴³ (fluvoxamine maleate) [2011 version]
Lyrica¹⁴⁴ (pregabalin) [2011 version]
Marplan¹⁴⁵ (isocarboxazid) [2008 version]
Meridia¹⁴⁶ (sibutramine hydrochloride) [2010 version]
Metadate CD¹⁴⁷ (methylphenidate hydrochloride) [2009 version]
Methylin (methylphenidate)
- chewable tablets¹⁴⁸ [2010 version]
- oral solution¹⁴⁹ [2010 version]
Metoclopramide Oral Solution¹⁵⁰ [2009 version]
Metozolv ODT¹⁵¹ (metoclopramide hydrochloride) [2011 version]
Mifeprex¹⁵² (mifepristone) [2009 version]
Mircera¹⁵³* (methoxy polyethylene glycol-epoetin beta) [2007 version]

Mobic¹⁵⁴ (meloxicam) [2010 version]
Morphine Sulfate¹⁵⁵ (morphine sulfate oral solution) [2010 version]
Motrin¹⁵⁶ (ibuprofen) [2007 version]
Moviprep¹⁵⁷ (propylene glycol 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid) [2011 version]
Multaq¹⁵⁸ (dronedarone) [2011 version]
Myfortic¹⁵⁹ (mycophenolic acid) [2009 version]
Myobloc¹⁶⁰* (rimabotulinumtoxinB) [2009 version]
Mysoline¹⁶¹ (primidone) [2010 version]
Nalfon¹⁶² (fenoprofen calcium) [2009 version]
Naprosyn¹⁶³ (naproxen) [2008 version]
Nardil¹⁶⁴ (phenelzine sulfate) [2007 version]
Neurontin¹⁶⁵ (gabapentin) [2011 version]
Nolvadex¹⁶⁶ (tamoxifen) [2006 version]
Noroxin¹⁶⁷ (norfloxacin) [2011 version]
Norpramin¹⁶⁸ (desipramine hydrochloride) [2009 version]
Nplate¹⁶⁹ (romiplostim) [2011 version]
Nucynta¹⁷⁰ (tapentadol hydrochloride) [2010 version]
Nucynta ER¹⁷¹ (tapentadol) [2011 version]
Nulojix¹⁷² (belatacept) [2011 version]
Nuvigil¹⁷³ (armodafinil) [2010 version]
Oleptro¹⁷⁴ (trazadone hydrochloride) [2010 version]
Onsolis¹⁷⁵ (fentanyl buccal soluble film) [2009 version]
Osmoprep¹⁷⁶ (sodium phosphate dibasic anhydrous and sodium phosphate monobasic monohydrate) [2009 version]
OxyContin¹⁷⁷ (oxycodone hydrochloride) [2010 version]
Pacerone¹⁷⁸ (amiodarone hydrochloride) [2008 version]
Palladone¹⁷⁹ (hydromorphone hydrochloride) [2004 version]
Pamelor¹⁸⁰ (nortriptyline hydrochloride) [2007 version]
Pancreaze¹⁸¹ (pancrelipase) [2010 version]
Parnate¹⁸² (tranylcypromine sulfate) [2008 version]
Paxil¹⁸³ (paroxetine hydrochloride) [2011 version]
Paxil CR¹⁸⁴ (paroxetine hydrochloride) [2011 version]
Peganone¹⁸⁵ (ethotoin) [2010 version]
Pegasys¹⁸⁶* (peginterferon alfa-2a) [2011 version]
Pegintron¹⁸⁷* (peginterferon alfa-2b) [2009 version]
PegIntron*/Rebetol Combo Pack¹⁸⁸ (peginterferon alfa-2b and ribavirin) [2008 version]
Pennsaid¹⁸⁹ (diclofenac sodium) [2009 version]
Perforomist¹⁹⁰ (formoterol fumarate) [2010 version]
Pexeva¹⁹¹ (paroxetine mesylate) [2010 version]
Plavix¹⁹² (clopidogrel bisulfate) [2011 version]
Ponstel¹⁹³ (mefenamic acid) [2008 version]
Potiga¹⁹⁴ (ezogabine) [2011 version]
Pradaxa ¹⁹⁵(dabigatran etexilate mesylate) [2011 version]
Prevacid NapraPac¹⁹⁶ (lansoprazole and naproxen) [2009 version]
Pristiq¹⁹⁷ (desvenlafaxine succinate) [2011 version]
Procrit¹⁹⁸* (epoetin alfa) [2011 version]
Prolia¹⁹⁹* (denosumab) [2011 version]
Propylthiouracil²⁰⁰ [2010 version]
Promacta²⁰¹ (eltrombopag) [2011 version]
Propulsid²⁰² (cisapride) [2006 version]
Proquin XR²⁰³ (ciprofloxacin hydrochloride) [2011 version]
Protopic Ointment²⁰⁴ (tacrolimus) [2006 version]
Provigil²⁰⁵ (modafinil) [2010 version]
Prozac²⁰⁶ (fluoxetine hydrochloride) [2009 version]
Qualaquin²⁰⁷ (quinine sulfate) [2011 version]
Rapamune²⁰⁸ (sirolimus) [2010 version]
Rebetol²⁰⁹ (ribavirin) [2010 version]
Rebif²¹⁰* (interferon beta-1a) [2002 version]
Reclast²¹¹ (zoledronic acid) [2011 version]
Reglan²¹² (metoclopramide hydrochloride) injection [2009 version]
Reglan²¹³ (metoclopramide hydrochloride) tablets [2011 version]
Reglan ODT²¹⁴ (metoclopramide hydrochloride) [2010 version]
Remeron²¹⁵ (mirtazapine) [2010 version]
Remicade²¹⁶* (infliximab) [2011 version]
Restoril²¹⁷ (temazepam) [2010 version]
Revlimid²¹⁸ (lenalidomide) [2009 version]
Ribasphere²¹⁹ (ribavirin) [2008 version]
Ritalin²²⁰ (methylphenidate hydrochloride) [2010 version]
Ritalin LA²²¹ (methylphenidate hydrochloride) [2010 version]
Ritalin-SR²²² (methylphenidate hydrochloride) [2010 version]
Rituxan²²³* (rituximab) [2011 version]
Roferon-A²²⁴* (interferon alfa-2a recombinant) [2008 version]
Rozerem²²⁵ (ramelteon) [2010 version]
Sabril²²⁶ (vigabatrin) [2010 version]
Samsca²²⁷ (tolvaptan) [2009 version]
Sarafem²²⁸ (fluoxetine hydrochloride) [2009 version]
Savella²²⁹ (milnacipran hydrochloride) [2010 version]
Selzentry²³⁰ (maraviroc) [2010 version]
Serevent Diskus²³¹ (salmeterol xinafoate) [2010 version]
Seroquel²³² (quetiapine fumarate) [2011 version]
Seroquel XR²³³ (quetiapine fumarate) [2011 version]
Silenor²³⁴ (doxepin) [2010 version]
Simponi²³⁵* (golimumab) [2010 version]
Sinequan²³⁶ (doxepin hydrochloride) [2007 version]
Soliris²³⁷ (eculizumab) [2009 version]
Soltamox²³⁸ (tamoxifen citrate) [2005 version]
Soriatane²³⁹ (acitretin) [2007 version]
Sotret²⁴⁰ (isotretinoin) [2006 version]
Stelara²⁴¹* (ustekinumab) [2010 version]
Strattera²⁴² (atomoxetine hydrochloride) [2011 version]
Suboxone²⁴³ (buprenorphine and naloxone) [2010 version]
Suprep²⁴⁴ (sodium sulfate, potassium sulfate and magnesium sulfate) [2010 version]
Sutent²⁴⁵ (sunitimib malate) [2010 version]
Sylatron²⁴⁶ (peginterferon alfa-2b) [2011 version]
Symbicort²⁴⁷ (budesonide and formoterol fumarate dihydrate) [2010 version]
Symbyax²⁴⁸ (fluoxetine hydrochloride and olanzapine) [2009 version]
Symlin²⁴⁹ (pramlintide acetate) [2007 version]
Tapentadol²⁵⁰ see Nucynta
Tasigna²⁵¹ (nilotinib) [2011 version]
Tegretol²⁵² (carbamazepine) [2011 version]
Testim²⁵³ (testosterone) [2009 version]
Thalomid²⁵⁴ (thalidomide) [2009 version]
Tikosyn²⁵⁵ (dofetilide) [2011 version]
Tofranil²⁵⁶ (imipramine hydrochloride) [2007 version]
Tolectin²⁵⁷ (tolmetin sodium) [2008 version]
Topamax²⁵⁸ (topiramate) [2011 version]
Toradol²⁵⁹ (ketorolac tromethamine) [2007 version]
Tracleer²⁶⁰ (bosentan) [2009 version]
Tranxene²⁶¹ (clorazepate dipotassium) [2010 version]
Treximet²⁶² (naproxen sodium and sumatriptan succinate) [2008 version]
Trileptal²⁶³ (oxcarbazepine) [2011 version]
Trilipix²⁶⁴ (choline fenofibrate) [2011 version]
Trizivir²⁶⁵ (abacavir sulfate, lamivudine and zidovudine) [2011 version]
Tysabri²⁶⁶* (natalizumab) [2011 version]
Tyzeka²⁶⁷ (telbivudine) [2010 version]
Vandetanib²⁶⁸ (vandetanib) [2011 version]
Vibativ²⁶⁹ (telavancin) [2009 version]
Vicoprofen²⁷⁰ (vicoprofen and ibuprofen) [2008 version]
Victoza²⁷¹ (liraglutide) [2010 version]
Victrelis²⁷² (boceprevir) [2011 version]
Videx²⁷³ (didanosine) [2010 version]
Videx EC²⁷⁴ (didanosine) [2010 version]
Viibryd²⁷⁵ (vilazodone hydrochloride) [2011 version]
Vimovo²⁷⁶ (esomeprazole magnesium and naproxen) [2011 version]
Vimpat²⁷⁷ (lacosamide) [2009 version]
Viramune²⁷⁸ (nevirapine) [2011 version]
Visicol²⁷⁹ (sodium phosphate dybasic anhydrous and sodium phosphate monobasic monohydrate) [2009 version]
Vivactil²⁸⁰ (protriptyline hydrochloride) [2007 version]
Vivitrol²⁸¹ (naltrexone) [2010 version]
Voltaren²⁸² (diclofenac sodium) [2011 version]
Votrient²⁸³ (pazopanib hydrochloride) [2010 version]
Vyvanse²⁸⁴ (lisdexamfetamine dimesylate) [2011 version]
Wellbutrin²⁸⁵ (bupropion hydrochloride) [2010 version]
Wellbutrin SR²⁸⁶ (bupropion hydrochloride) [2010 version]
Wellbutrin XL²⁸⁷ (buproprion hydrochloride) [2011 version]
Xenazine²⁸⁸ (tetrabenazine) [2011 version]
Xeomin²⁸⁹* (incobotulinumtoxinA) [2011 version]
Xiaflex²⁹⁰* (collagenase clostridium histolyticum) [2010 version]
Xolair²⁹¹* (omalizumab) [2010 version]
Xyrem²⁹² (sodium oxybate) [2005 version]
Yervoy ²⁹³(ipilimumab) [2011 version]
Zarontin²⁹⁴ (ethosuximide) [2010 version]
Zelboraf²⁹⁵ (vemurafenib) [2011 version]
Zenpep²⁹⁶ (pancrelipase) [2011 version]
Zerit²⁹⁷ (stavudine) [2010 version]
Ziagen²⁹⁸ (abacavir sulfate) [2008 version]
Zipsor²⁹⁹ (diclofenac potassium) [2009 version]
Zoloft³⁰⁰ (sertraline hydrochloride) [2008 version]
Zolpidem³⁰¹ (zolpidem tartrate) [2008 version]
Zolpimist³⁰² (zolpidem tartrate) [2008 version]
Zonegran³⁰³ (zonisamide) [2011 version]
Zortress³⁰⁴ (everolimus) [2010 version]
Zyban³⁰⁵ (bupropion hydrochloride) [2010 version]
Zyprexa³⁰⁶ (olanzapine) [2010 version]
Zyprexa Relprevv³⁰⁷ (olanzapine) [2010 version]