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Medication Guides

This web page may not contain a complete listing of all available medication guides.  To see if a drug has a Medication Guide, please view the labeling found in Drugs@FDA.

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.

Note: This page links to PDF files which require the free Adobe Acrobat Reader.

Medication Guides are available for these products:

*biologic or drug/biologic combination

  • Abilify (aripiprazole) [2008 version]
  • Accutane (isotretinoin) [2007 version]
  • Actiq (fentanyl citrate) [2006 version]
  • Adderall XR (dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate) [2007 version]
  • Advair Diskus (fluticasone propionate and salmeterol xinafoate) [2008 version]
  • Advair HFA (fluticasone propionate and salmeterol xinafoate) [2008 version]
  • Ambien (zolpidem tartrate) [2008 version]
  • Ambien CR (zolpidem tartrate) [2007 version]
  • Anafranil (clomipramine hydrochloride) [2007 version]
  • Anaprox (naproxen sodium) [2008 version]
  • Ansaid (flurbiprofen) [2007 version]
  • Aplenzin (buproprion hydrobromide [2008 version]
  • Aranesp* (darbepoetin alfa) [2008 version]
  • Arthrotec (diclofenac sodium) [2007 version]
  • Avandamet (metformin hydrochloride and rosiglitazone maleate) [2008 version]
  • Avandaryl (glimepiride and rosiglitazone maleate) [2008 version]
  • Avandia (rosiglitazone maleate) [2008 version]
  • Avelox (moxifloxacin) [2008 version]
  • Avonex* (interferon beta-1a) [2005 version]
  • Banzel (rufinamide) [2008 version]
  • Betaseron*(interferon beta-1b) [2006 version]
  • Brovana (arformoterol tartrate) [2006 version]
  • Cataflam (diclofenac potassium) [2008 version]
  • Celebrex (celecoxib) [2007 version]
  • Celexa (citalopram hydrobromide) [2008 version]
  • Chantix (varenicline tartrate) [2008 version]
  • Cimzia (certolizumab pegol) [2008 version]
  • Cipro (ciprofloxacin) [2008 version]
  • Clinoril (sulindac) [2007 version]
  • Combunox (oxycodone hydrochloride and ibuprofen) [2007 version]
  • Concerta (methylphenidate hydrochloride) [2007 version]
  • Copegus (ribavirin) [2007 version]
  • Cordarone (amiodarone hydrochloride) [2005 version]
  • Coumadin (warfarin sodium) [2007 version]
  • Cymbalta (duloxetine hydrochloride) [2007 version)]
  • Dalmane (flurazepam hydrochloride) [2009 version]
  • Daypro Alta (oxaprozin potassium) [2007 version]
  • Daytrana (methylphenidate) [2007 version]
  • Desoxyn (methamphetamine hydrochloride) [2007 version]
  • Dexedrine (dextroamphetamine sulfate) [2007 version]
  • Duragesic (fentanyl) [2005 version]
  • EC-Naprosyn (naproxen) [2008 version]
  • Edluar (zolpidem tartrate) [2009 version]
  • Effexor (venlafaxine hydrochloride) [2008 version]
  • Elidel Cream (pimecrolimus) [2006 version]
  • Emsam (selegeline transdermal system) [2007 version]
  • Enbrel (etanercept) [2008 version]
  • Epogen* (epoeten alfa) [2008 version]
  • Epzicom (abacavir sulfate and lamivudine) [2006 version]
  • Evista (raloxifene hydrochloride) [2007 version]
  • Extraneal (icodextrin) [2009 version]
  • Exubera (insulin recombinant human) [2008 version]
  • Factive (gemifloxacin) [2008 version]
  • Feldene (piroxicam) [2007 version]
  • Fentora (fentanyl citrate) [2007 version]
  • Flector (diclofenac epolamine) [2005 version]
  • Floxin (ofloxacin) [2008 version]
  • Focalin (dexmethylphenidate hydrochloride) [2007 version]
  • Focalin XR (dexmethylphenidate hydrochloride) [2007 version]
  • Foradil Aerolizer (formoterol fumarate inhalation powder) [2006 version]
  • Foradil Certihaler (formoterol fumarate inhalation powder) [2006 version]
  • Forteo (teriparatide) [2008 version]
  • Halcion (triazolam) [2008 version]
  • Humira (adalimumab) [2008 version]
  • Indocin (indomethacin) [2007 version]
  • Infergen* (interferon alfacon-1) [2008 version]
  • Intron A* (interferon alfa-2b) [2008 version]
  • Kaletra (lopinavir and ritonavir) [2009 version]
  • Ketek (telithromycin) [2007 version]
  • Lariam (mefloquine hydrochloride) [2008 version]
  • Letairis (ambrisentan) [2007 version]
  • Levaquin (levofloxacin) [2008 version]
  • Lexapro (escitalopram oxalate) [2008 version]
  • Limbitrol (chlordiazepoxide and amitriptyline) [2007 version]
  • Lindane Lotion (lindane) [2003 version]
  • Lindane Shampoo (lindane) [2003 version]
  • Lotronex (alosetron hydrochloride) [2008 version]
  • Lunesta (eszopiclone) [2008 version]
  • Luvox CR (fluvoxamine mealeate) [2008 version]
  • Marplan (isocarboxazid) [2008 version]
  • Metadate CD (methylphenidate hydrochloride) [2007 version]
  • Methylin (methylphenidate)
  • Mifeprex (mifepristone) [2005 version]
  • Mircera* (methoxy polyethylene glycol-epoetin beta) [2007 version]
  • Mobic (meloxicam) [2008 version]
  • Motrin (ibuprofen) [2007 version]
  • Myfortic (mycophenolic acid) [2008 version]
  • Nalfon (fenoprofen calcium) [2007 version]
  • Naprosyn (naproxen) [2008 version]
  • Nardil (phenelzine sulfate) [2007 version]
  • Nolvadex (tamoxifen) [2006 version]
  • Noroxin (norfloxacin) [2008 version]
  • Norpramin (desipramine hydrochloride) [2007 version]
  • Nplate (romiplostim) [2008 version]
  • Osmoprep (sodium phosphate dibasic anhydrous and sodium phosphate monobasic monohydrate) [2009 version]
  • Pacerone (amiodarone hydrochloride) [2008 version]
  • Palladone (hydromorphone hydrochloride) [2004 version]
  • Pamelor (nortriptyline hydrochloride) [2007 version]
  • Parnate (tranylcypromine sulfate) [2007 version]
  • Paxil (paroxetine hydrochloride) [2008 version]
  • Pegasys* (peginterferon alfa-2a) [2008 version]
  • PegIntron* (peginterferon alfa-2b) [2006 version]
  • PegIntron*/Rebetol Combo Pack (peginterferon alfa-2b and ribavirin) [2008 version]
  • Pexeva (paroxetine mesylate) [2008 version]
  • Ponstel (mefenamic acid) [2008 version]
  • Prevacid NapraPac (lansoprazole and naproxen) [2007 version]
  • Pristiq (desvenlafaxine succinate) [2008 version]
  • Procrit* (epoetin alfa) [2008 version]
  • Promacta (eltrombopag) [2008 version]
  • Propulsid (cisapride) [2006 version]
  • Protopic Ointment (tacrolimus) [2006 version]
  • Prozac (fluoxetine hydrochloride) [2009 version]
  • Rebetol (ribavirin) [2007 version]
  • Rebif* (interferon beta-1a) [2002 version]
  • Remeron (mirtazapine) [2007 version]
  • Remicade (infliximab) [2007 version]
  • Revlimid (lenalidomide) [2009 version]
  • Ribasphere (ribavirin) [2008 version]
  • Ritalin (methylphenidate hydrochloride) [2007 version]
  • Ritalin LA (methylphenidate hydrochloride) [2007 version]
  • Ritalin-SR (methylphenidate hydrochloride) [2007 version]
  • Roferon-A* (interferon alfa-2a recombinant) [2008 version]
  • Rozerem (ramelteon) [2008 version]
  • Sarafem (fluoxetine hydrochloride) [2007 version]
  • Savella (milnacipran hydrochloride) [2009 version]
  • Selzentry (maraviroc) [2007 version]
  • Serevent Diskus (salmeterol xinafoate) [2006 version]
  • Seroquel (quetiapine fumarate) [2008 version]
  • Sinequan (doxepin hydrochloride) [2007 version]
  • Soliris (eculizumab) [2007 version]
  • Soltamox (tamoxifen citrate) [2005 version]
  • Soriatane (acitretin) [2007 version]
  • Sotret (isotretinoin) [2006 version]
  • Strattera (atomoxetine hydrochloride) [2007 version]
  • Symbicort (budesonide and formoterol fumarate dihydrate) [2008 version]
  • Symbyax (fluoxetine hydrochloride and olanzapine) [2009 version]
  • Symlin (pramlintide acetate) [2007 version]
  • Tapentadol (tapentadol) [2009 version]
  • Tasigna (nilotinib) [2007 version]
  • Tofranil (imipramine hydrochloride) [2007 version]
  • Tolectin (tolmetin sodium) [2008 version]
  • Toradol (ketorolac tromethamine) [2007 version]
  • Tracleer (bosentan) [2009 version]
  • Treximet (naproxen sodium and sumatriptan succinate) [2008 version]
  • Trilipix (choline fenofibrate) [2008 version]
  • Trizivir (abacavir sulfate, lamivudine and zidovudine) [2006 version]
  • Tyasbri (natalizumab) [2008 version]
  • Tyzeka (telbivudine) [2009 version]
  • Vicoprofen (vicoprofen and ibuprofen) [2008 version]
  • Vimpat (lacosamide) [2008 version]
  • Viramune (nevirapine) [2008 version]
  • Visicol (sodium phosphate dybasic anhydrous and sodium phosphate monobasic monohydrate) [2009 version]
  • Vivactil (protriptyline hydrochloride) [2007 version]
  • Voltaren (diclofenac sodium) [2007 version]
  • Vyvanse (lisdexamfetamine dimesylate) [2007 version]
  • Wellbutrin (bupropion hydrochloride) [2007 version]
  • Wellbutrin SR (bupropion hydrochloride) [2007 version]
  • Xenazine (tetrabenazine) [2008 version]
  • Xolair (omalizumab) [2007 version]
  • Xyrem (sodium oxybate) [2005 version]
  • Ziagen (abacavir sulfate) [2008 version]
  • Zoloft (sertraline hydrochloride) [2008 version]
  • Zolpidem (zolpidem tartrate) [2008 version]
  • Zolpimist (zolpidem tartrate) [2008 version]
  • Zyban (bupropion hydrochloride) [2007 version]
  • Zyprexa (olanzapine) [2009 version]

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Date created: May 30, 2006, updated April 29, 2009