FDA Medication Guides 2009

Medication Guides
Drugs@FDA and DailyMed 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

Abilify (aripiprazole) [2009 version]
Accutane (isotretinoin) [2008 version]
Actiq (fentanyl citrate) [2009 version]
Actoplus Met (metformin hydrochloride and pioglitazone hydrochloride) [2009 version]
Actoplus Met XR (metformin hydrochloride and pioglitazone hydrochloride) [2009 version]
Actos (pioglitazone hydrchloride) [2009 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]
Androgel (testosterone) [2009 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) [2009 version]
Avandia (rosiglitazone maleate) [2008 version]
Avelox (moxifloxacin) [2008 version]
Avonex* (interferon beta-1a) [2006 version]
Banzel (rufinamide) [2008 version]
Betaseron*(interferon beta-1b) [2006 version]
Botox* (onabotulinumtoxinA) [2009 version]
Brovana (arformoterol tartrate) [2006 version]
Byetta (exenatide) [2009 version]
Cambia (diclofenac) [2009 version]
Cataflam (diclofenac potassium) [2008 version]
Celebrex (celecoxib) [2007 version]
Celexa (citalopram hydrobromide) [2009 version]
Cellcept (mycophenolate mofetil) [2009 version]
Chantix (varenicline tartrate) [2009 version]
Cimzia* (certolizumab pegol) [2009 version]
Cipro (ciprofloxacin) [2008 version]
Clinoril (sulindac) [2007 version]
Colcrys (colchicine) [2009 version]
Combunox (oxycodone hydrochloride and ibuprofen) [2007 version]
Concerta (methylphenidate hydrochloride) [2008 version]
Copegus (ribavirin) [2009 version]
Cordarone (amiodarone hydrochloride) [2009 version]
Coumadin (warfarin sodium) [2007 version]
Creon (pancrelipase) [2009 version]
Cymbalta (duloxetine hydrochloride) [2007 version)]
Dalmane (flurazepam hydrochloride) [2009 version]
Darvocet (acetaminophen and propoxyphene napsylate) [2009 version]
Darvon (propoxyphene hydrochloride) [2009 version]
Daypro Alta (oxaprozin potassium) [2007 version]
Daytrana (methylphenidate) [2007 version]
Desoxyn (methamphetamine hydrochloride) [2007 version]
Dexedrine (dextroamphetamine sulfate) [2007 version]
Doral (quazepam) [2007 version]
Duragesic (fentanyl) [2005 version]
Dysport* (abobotulinumtoxinA) [2009 version]
EC-Naprosyn (naproxen) [2008 version]
Edluar (zolpidem tartrate) [2009 version]
Effexor (venlafaxine hydrochloride) [2008 version]
Effexor XR (venlafaxine hydrochloride) [2008 version]
Effient (prasugrel) [2009 version]
Elidel Cream (pimecrolimus) [2006 version]
Embeda (morphine sulfate and naltrexone hydrochloride) [2009 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]
Extavia* (interferon beta-1b) [2009 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) [2009 version]
Foradil Aerolizer (formoterol fumarate inhalation powder) [2006 version]
Foradil Certihaler (formoterol fumarate inhalation powder) [2006 version]
Forteo (teriparatide) [2009 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]
Kalbitor* (ecallantide) [2009 version]
Kaletra (lopinavir and ritonavir) [2009 version]
Keppra (levetiracetam) [2009 version]
Ketek (telithromycin) [2007 version]
Lamictal (lamotrigine) [2009 version]
Lamictal XR (lamotrigine) [2009 version]
Lariam (mefloquine hydrochloride) [2009 version]
Letairis (ambrisentan) [2009 version]
Levaquin (levofloxacin) [2008 version]
Lexapro (escitalopram oxalate) [2008 version]
Limbitrol (chlordiazepoxide and amitriptyline) [2007 version]
Lindane Lotion (lindane) [2007 version]
Lindane Shampoo (lindane) [2007 version]
Lotronex (alosetron hydrochloride) [2008 version]
Lunesta (eszopiclone) [2008 version]
Luvox CR (fluvoxamine mealeate) [2008 version]
Lyrica (pregabalin) [2009 version]
Marplan (isocarboxazid) [2008 version]
Metadate CD (methylphenidate hydrochloride) [2007 version]
Metozolv ODT (metoclopramide hydrochloride) [2009 version]
Methylin (methylphenidate)
chewable tablets [2007 version]
oral solution [2007 version]
Mifeprex (mifepristone) [2005 version]
Mircera* (methoxy polyethylene glycol-epoetin beta) [2007 version]
Mobic (meloxicam) [2008 version]
Motrin (ibuprofen) [2007 version]
Multaq (dronedarone) [2009 version]
Myfortic (mycophenolic acid) [2009 version]
Myobloc* (rimabotulinumtoxinB) [2009 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]
Nucynta (tapentadol hydrochloride) [2009 version]
Onsolis (fentanyl buccal soluble film) [2009 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) [2008 version]
Paxil (paroxetine hydrochloride) [2008 version]
Pegasys* (peginterferon alfa-2a) [2008 version]
PegIntron* (peginterferon alfa-2b) [2006 version]
powder
redipen
PegIntron*/Rebetol Combo Pack (peginterferon alfa-2b and ribavirin) [2008 version]
Pennsaid (diclofenac sodium) [2009 version]
Pexeva (paroxetine mesylate) [2008 version]
Ponstel (mefenamic acid) [2008 version]
Prevacid NapraPac (lansoprazole and naproxen) [2007 version]
Pristiq (desvenlafaxine succinate) [2009 version]
Procrit* (epoetin alfa) [2008 version]
Promacta (eltrombopag) [2008 version]
Propulsid (cisapride) [2006 version]
Proquin XR (ciprofloxacin hydrochloride) [2008 version]
Protopic Ointment (tacrolimus) [2006 version]
Prozac (fluoxetine hydrochloride) [2009 version]
Qualaquin (quinine sulfate) [2009 version]
Raptiva* (efalizumab) [2009 version]
Rebetol (ribavirin) [2009 version]
Rebif* (interferon beta-1a) [2002 version]
Reglan (metoclopramide hydrochloride) injection [2009 version]
Reglan (metoclopramide hydrochloride) tablets [2009 version]
Reglan ODT (metoclopramide hydrochloride) [2009 version]
Remeron (mirtazapine) [2007 version]
Remicade* (infliximab) [2009 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]
Rituxan* (rituximab) [2009 version]
Roferon-A* (interferon alfa-2a recombinant) [2008 version]
Rozerem (ramelteon) [2008 version]
Sabril (vigabatrin) [2009 version]
Sarafem (fluoxetine hydrochloride) [2007 version]
Savella (milnacipran hydrochloride) [2009 version]
Selzentry (maraviroc) [2009 version]
Serevent Diskus (salmeterol xinafoate) [2006 version]
Seroquel (quetiapine fumarate) [2009 version]
Seroquel XR (quetiapine fumarate) [2009 version]
Simponi* (golimumab) [2009 version]
Sinequan (doxepin hydrochloride) [2007 version]
Soliris (eculizumab) [2007 version]
Soltamox (tamoxifen citrate) [2005 version]
Soriatane (acitretin) [2007 version]
Sotret (isotretinoin) [2006 version]
Stelara* (ustekinumab) [2009 version]
Strattera (atomoxetine hydrochloride) [2009 version]
Symbicort (budesonide and formoterol fumarate dihydrate) [2009 version]
Symbyax (fluoxetine hydrochloride and olanzapine) [2009 version]
Symlin (pramlintide acetate) [2007 version]
Tapentadol see Nucynta
Tasigna (nilotinib) [2009 version]
Testim (testosterone) [2009 version]
Tofranil (imipramine hydrochloride) [2007 version]
Tolectin (tolmetin sodium) [2008 version]
Topamax (topiramate) [2009 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) [2009 version]
Tyasbri (natalizumab) [2008 version]
Tyzeka (telbivudine) [2009 version]
Vibativ (telavancin) [2009 version]
Vicoprofen (vicoprofen and ibuprofen) [2008 version]
Vimpat (lacosamide) [2009 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) [2009 version]
Votrient (pazopanib hydrochloride) [2009 version]
Vyvanse (lisdexamfetamine dimesylate) [2008 version]
Wellbutrin (bupropion hydrochloride) [2009 version]
Wellbutrin SR (bupropion hydrochloride) [2009 version]
Wellbutrin XL (buproprion hydrochloride) [2009 version]
Xenazine (tetrabenazine) [2008 version]
Xolair (omalizumab) [2007 version]
Xyrem (sodium oxybate) [2005 version]
Zenpep (pancrelipase) [2009 version]
Ziagen (abacavir sulfate) [2008 version]
Zoloft (sertraline hydrochloride) [2008 version]
Zolpidem (zolpidem tartrate) [2008 version]
Zolpimist (zolpidem tartrate) [2008 version]
Zonegran (zonisamide) [2009 version]
Zyban (bupropion hydrochloride) [2009 version]
Zyprexa (olanzapine) [2009 version]
Zyprexa Relprevv (olanzapine) [2009 version]

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Medication Guides