CIENCIASMEDICASNEWS: Drug Safety and Availability

Drug Safety and Availability > 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

Abilify (aripiprazole) [2012 version]
Abstral (fentanyl) [2011]
Accutane (isotretinoin) [2010 version]
Actemra* (tocilizumab) [2011 version]
Actiq (fentanyl citrate) [2011 version]
Actonel (risedronate sodium) [2011 version]
Actonel with Calcium (risedronate sodium and calcium carbonate) [2011 version]
Actoplus Met (metformin hydrochloride and pioglitazone hydrochloride) [2011 version]
Actoplus Met XR (metformin hydrochloride and pioglitazone hydrochloride) [2011 version]
Actos (pioglitazone hydrchloride) [2011 version]
Adderall XR (dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate) [2011 version]
Advair Diskus (fluticasone propionate and salmeterol xinafoate) [2011 version]
Advair HFA (fluticasone propionate and salmeterol xinafoate) [2011 version]
Ambien (zolpidem tartrate) [2010 version]
Ambien CR (zolpidem tartrate) [2010 version]
Ampyra (dalfampridine) [2010 version]
Anafranil (clomipramine hydrochloride) [2007 version]
Anaprox (naproxen sodium) [2008 version]
Androgel (testosterone) [2011 version]
Androgel (1.62%) (testosterone) [2011 version]
Ansaid (flurbiprofen) [2010 version]
Aplenzin (bupropion hydrobromide [2011 version]
Aranesp* (darbepoetin alfa) [2011 version)
Arcapta (indacaterol maleate) [2011 version]
Arthrotec (diclofenac sodium) [2007 version]
Atelvia (risedronate sodium) [2011 version]
Avandamet (metformin hydrochloride and rosiglitazone maleate) [2011 version]
Avandaryl (glimepiride and rosiglitazone maleate) [2011 version]
Avandia (rosiglitazone maleate) [2011 version]
Avelox (moxifloxacin) [2011 version]
Avonex* (interferon beta-1a) [2012 version]
Axiron (testosterone) [2011 version]
Banzel (rufinamide) [2011 version]
Benlysta (belimumab) [2012 version]
Betaseron*(interferon beta-1b) [2009 version]
Boniva (ibandronate sodium) Injection [2011 version]
Boniva (ibandronate sodium) Tablets [2011 version]
Botox* (onabotulinumtoxinA) [2011 version]
Brilinta (ticagrelor) [2011 version]
Brovana (arformoterol tartrate) [2011 version]
Butrans (buprenorphine) [2010 version]
Bydureon (exenatide) [2012 version]
Byetta (exenatide) [2009 version]
Cambia (diclofenac) [2009 version]
Carbatrol (carbamazepine) [2010 version]
Cataflam (diclofenac potassium) [2011 version]
Celebrex (celecoxib) [2011 version]
Celexa (citalopram hydrobromide) [2012 version]
Cellcept (mycophenolate mofetil) [2009 version]
Celontin (methsuximide) [2010 version]
Chantix (varenicline tartrate) [2011 version]
Cimzia* (certolizumab pegol) [2011 version]
Cipro (ciprofloxacin) [2011 version]
Clinoril (sulindac) [2010 version]
Codeine Sulfate oral solution [2012 version]
Colcrys (colchicine) [2011 version]
Combunox (oxycodone hydrochloride and ibuprofen) [2010 version]
Concerta (methylphenidate hydrochloride) [2010 version]
Copegus (ribavirin) [2011 version]
Cordarone (amiodarone hydrochloride) [2011 version]
Coumadin (warfarin sodium) [2010 version]
Creon (pancrelipase) [2011 version]
Cymbalta (duloxetine hydrochloride) [2008 version)]
Daliresp (roflumilast) [2011 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) [2010 version]
Desoxyn (methamphetamine hydrochloride) [2007 version]
Dexedrine (dextroamphetamine sulfate) [2008 version]
Dilantin (phenytoin) [2011 version]
Dilantin-125 (phenytoin) [2011 version]
Doral (quazepam) [2007 version]
Duetact (glimepiride and pioglitazone) [2011 version]
Duexis (ibuprofen and famotidine) [2011 version]
Dulera (mometasone furoate and formoterol fumarate) [2010 version]
Duragesic (fentanyl) [2009 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) [2011 version]
Elidel Cream (pimecrolimus) [2010 version]
Embeda (morphine sulfate and naltrexone hydrochloride) [2009 version]
Emsam (selegeline transdermal system) [2007 version]
Enbrel* (etanercept) [2010 version]
Epogen* (epoeten alfa) [2011 version]
Epzicom (abacavir sulfate and lamivudine) [2012 version]
Erivedge (vismodegib) [2012 version]
Evista (raloxifene hydrochloride) [2007 version]
Exalgo (hydromorphone hydrochloride) [2010 version]
Extavia* (interferon beta-1b) [2012 version]
Extraneal (icodextrin) [2010 version]
Exubera (insulin recombinant human) [2008 version]
Factive (gemifloxacin) [2011 version]
Felbatol (felbamate) [2011 version]
Feldene (piroxicam) [2010 version]
Fentora (fentanyl citrate) [2011 version]
Ferriprox (deferiprone) [2012 version]
Flector (diclofenac epolamine) [2010 version]
Floxin (ofloxacin) [2011 version]
Focalin (dexmethylphenidate hydrochloride) [2010 version]
Focalin XR (dexmethylphenidate hydrochloride) [2010 version]
Foradil Aerolizer (formoterol fumarate inhalation powder) [2012 version]
Foradil Certihaler (formoterol fumarate inhalation powder) [2010 version]
Forfivo XL (bupropion hydrochloride) [2011 version]
Forteo (teriparatide) [2009 version]
Fortesta (testosterone) [2010 version]
Fosamax (alendronate sodium) [2011 version]
Fosamax Plus D (alendronate sodium and cholecalciferol) [2011 version]
Fosrenol (lanthanum carbonate) [2011 version]
Gabitril (tiagabine) [2010 version]
Gilenya (fingolimid) [2012 version]
Gralise (gabapentin) [2011 version]
Halcion (triazolam) [2008 version]
HalfLytely and Bisacodyl Bowel Prep Kit (bisacodyl, polyethylene glycol 3500, potassium chloride, sodium bicarbonate, sodium chloride) [2010 version]
Horizant (gabapentin enacarbil) [2011 version]
H.P. Acthar Gel (repository corticotropin) [2010 version]
Humira* (adalimumab) [2011 version]
Incivek (telaprevir) [2012 version]
Indocin (indomethacin) [2008 version]
Infergen* (interferon alfacon-1) [2010 version]
Intermezzo (zolpidem tartrate) [2011 version]
Intron A* (interferon alfa-2b) [2008 version]
Invirase (saquinavir mesylate) [2012 version]
Janumet (metformin hydrochloride and sitagliptin phosphate) [2012 version]
Janumet XR (sitagliptin and metformin hydrochloride) [2012 version]
Januvia (sitagliptin phosphate) [2012 version]
Juvisync (sitagliptin and simvastatin) [2011 version]
Kalbitor* (ecallantide) [2009 version]
Kaletra (lopinavir and ritonavir) [2012 version]
Keppra (levetiracetam) [2011 version]
Ketek (telithromycin) [2010 version]
Klonopin (clonazepam) [2010 version]
Kombiglyze XR (metformin hydrochloride and saxagliptin) [2012 version]
Korlym (mifepristone) [2012 version]
Krystexxa* (pegloticase) [2010 version]
Lamictal (lamotrigine) [2011 version]
Lamictal XR (lamotrigine) [2011 version]
Lariam (mefloquine hydrochloride) [2009 version]
Lazanda (fentanyl citrate) [2011 version]
Letairis (ambrisentan) [2012 version]
Levaquin (levofloxacin) [2011 version]
Lexapro (escitalopram oxalate) [2011 version]
Limbitrol (chlordiazepoxide and amitriptyline) [2007 version]
Lindane Lotion (lindane) [2007 version]
Lindane Shampoo (lindane) [2007 version]
Lotronex (alosetron hydrochloride) [2010 version]
Lunesta (eszopiclone) [2008 version]
Luvox (fluvoxamine maleate) [2011 version]
Luvox CR (fluvoxamine maleate) [2011 version]
Lyrica (pregabalin) [2011 version]
Marplan (isocarboxazid) [2008 version]
Meridia (sibutramine hydrochloride) [2010 version]
Metadate CD (methylphenidate hydrochloride) [2009 version]
Methylin (methylphenidate)
- chewable tablets [2010 version]
- oral solution [2010 version]
Metoclopramide Oral Solution [2009 version]
Metozolv ODT (metoclopramide hydrochloride) [2011 version]
Mifeprex (mifepristone) [2009 version]
Mircera* (methoxy polyethylene glycol-epoetin beta) [2007 version]

Mobic (meloxicam) [2011 version]
Morphine Sulfate (morphine sulfate oral solution) [2010 version]
Motrin (ibuprofen) [2007 version]
Moviprep (propylene glycol 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid) [2011 version]
Multaq (dronedarone) [2011 version]
Myfortic (mycophenolic acid) [2009 version]
Myobloc* (rimabotulinumtoxinB) [2009 version]
Mysoline (primidone) [2010 version]
Nalfon (fenoprofen calcium) [2009 version]
Naprelan (naproxen sodium) [2011 version]
Naprosyn (naproxen) [2008 version]
Nardil (phenelzine sulfate) [2007 version]
Neurontin (gabapentin) [2011 version]
Nolvadex (tamoxifen) [2006 version]
Noroxin (norfloxacin) [2011 version]
Norpramin (desipramine hydrochloride) [2009 version]
Novantrone (mitoXantrone) [2012 version]
Nplate* (romiplostim) [2011 version]
Nucynta (tapentadol hydrochloride) [2010 version]
Nucynta ER (tapentadol) [2011 version]
Nulojix* (belatacept) [2011 version]
Nuvigil (armodafinil) [2010 version]
Oleptro (trazadone hydrochloride) [2010 version]
Omontys (peginesatide) [2012 version]
Onfi (clobazam) [2011 version]
Onglyza (saxagliptin hydrochloride) [2011 version]
Onsolis (fentanyl buccal soluble film) [2011 version]
Opana ER (oxymorphone hydrochloride) [2011 version]
Osmoprep (sodium phosphate dibasic anhydrous and sodium phosphate monobasic monohydrate) [2009 version]
Oxycodone Hydrochloride Oral Solution [2012 version]
OxyContin (oxycodone hydrochloride) [2010 version]
Pacerone (amiodarone hydrochloride) [2008 version]
Palladone (hydromorphone hydrochloride) [2004 version]
Pamelor (nortriptyline hydrochloride) [2007 version]
Pancreaze (pancrelipase) [2010 version]
Parnate (tranylcypromine sulfate) [2008 version]
Paxil (paroxetine hydrochloride) [2011 version]
Paxil CR (paroxetine hydrochloride) [2011 version]
Peganone (ethotoin) [2010 version]
Pegasys* (peginterferon alfa-2a) [2011 version]
Pegintron* (peginterferon alfa-2b) [2011 version]
PegIntron*/Rebetol Combo Pack (peginterferon alfa-2b and ribavirin) [2008 version]
Pennsaid (diclofenac sodium) [2009 version]
Perforomist (formoterol fumarate) [2010 version]
Pexeva (paroxetine mesylate) [2010 version]
Plavix (clopidogrel bisulfate) [2011 version]
Ponstel (mefenamic acid) [2008 version]
Potiga (ezogabine) [2011 version]
Pradaxa (dabigatran etexilate mesylate) [2012 version]
Prevacid NapraPac (lansoprazole and naproxen) [2009 version]
Pristiq (desvenlafaxine succinate) [2011 version]
Procrit* (epoetin alfa) [2011 version]
Prolia* (denosumab) [2011 version]
Propylthiouracil [2010 version]
Promacta (eltrombopag) [2011 version]
Propulsid (cisapride) [2006 version]
Proquin XR (ciprofloxacin hydrochloride) [2011 version]
Protopic Ointment (tacrolimus) [2006 version]
Provigil (modafinil) [2010 version]
Prozac (fluoxetine hydrochloride) [2009 version]
Qualaquin (quinine sulfate) [2011 version]
Rapamune (sirolimus) [2010 version]
Rebetol (ribavirin) [2010 version]
Rebif* (interferon beta-1a) [2002 version]
Reclast (zoledronic acid) [2011 version]
Reglan (metoclopramide hydrochloride) injection [2009 version]
Reglan (metoclopramide hydrochloride) tablets [2011 version]
Reglan ODT (metoclopramide hydrochloride) [2011 version]
Remeron (mirtazapine) [2011 version]
Remeron SolTabs (mirtazapine) [2011 version]
Remicade* (infliximab) [2011 version]
Restoril (temazepam) [2010 version]
Revlimid (lenalidomide) [2011 version]
Ribasphere (ribavirin) [2008 version]
Ritalin (methylphenidate hydrochloride) [2010 version]
Ritalin LA (methylphenidate hydrochloride) [2010 version]
Ritalin-SR (methylphenidate hydrochloride) [2010 version]
Rituxan* (rituximab) [2012 version]
Roferon-A* (interferon alfa-2a recombinant) [2008 version]
Rozerem (ramelteon) [2010 version]
Sabril (vigabatrin) [2010 version]
Samsca (tolvaptan) [2012 version]
Sarafem (fluoxetine hydrochloride) [2009 version]
Savella (milnacipran hydrochloride) [2010 version]
Selzentry (maraviroc) [2011 version]
Serevent Diskus (salmeterol xinafoate) [2010 version]
Seroquel (quetiapine fumarate) [2011 version]
Seroquel XR (quetiapine fumarate) [2011 version]
Silenor (doxepin) [2010 version]
Simponi* (golimumab) [2010 version]
Sinequan (doxepin hydrochloride) [2007 version]
Soliris* (eculizumab) [2009 version]
Soltamox (tamoxifen citrate) [2005 version]
Soriatane (acitretin) [2011 version]
Sotret (isotretinoin) [2006 version]
Stelara* (ustekinumab) [2010 version]
Strattera (atomoxetine hydrochloride) [2011 version]
Suboxone (buprenorphine and naloxone) [2011 version]
Subsys (fentanyl) [2012 version]
Subutex (buprenorphine) [2011 version]
Suprep (sodium sulfate, potassium sulfate and magnesium sulfate) [2010 version]
Sutent (sunitimib malate) [2012 version]
Sylatron (peginterferon alfa-2b) [2011 version]
Symbicort (budesonide and formoterol fumarate dihydrate) [2010 version]
Symbyax (fluoxetine hydrochloride and olanzapine) [2011 version]
Symlin (pramlintide acetate) [2007 version]
Tapentadol see Nucynta
Tasigna (nilotinib) [2011 version]
Tegretol (carbamazepine) [2011 version]
Testim (testosterone) [2011 version]
Testosterone Gel [2012 version]
Thalomid (thalidomide) [2012 version]
Tikosyn (dofetilide) [2011 version]
Tofranil (imipramine hydrochloride) [2007 version]
Tolectin (tolmetin sodium) [2008 version]
Topamax (topiramate) [2011 version]
Toradol (ketorolac tromethamine) [2007 version]
Tracleer (bosentan) [2009 version]
Tranxene (clorazepate dipotassium) [2010 version]
Treximet (naproxen sodium and sumatriptan succinate) [2012 version]
Trileptal (oxcarbazepine) [2011 version]
Trilipix (choline fenofibrate) [2011 version]
Trizivir (abacavir sulfate, lamivudine and zidovudine) [2011 version]
Tysabri* (natalizumab) [2012 version]
Tyzeka (telbivudine) [2011 version]
Ultresa (pancrelipase) [2012 version]
Vandetanib (vandetanib) [2011 version]
Vibativ (telavancin) [2009 version]
Vicoprofen (vicoprofen and ibuprofen) [2008 version]
Victoza (liraglutide) [2012 version]
Victrelis (boceprevir) [2012 version]
Videx (didanosine) [2011 version]
Videx EC (didanosine) [2011 version]
Viibryd (vilazodone hydrochloride) [2011 version]
Vimovo (esomeprazole magnesium and naproxen) [2012 version]
Vimpat (lacosamide) [2009 version]
Viokace (pancrelipase) [2012 version]
Viramune (nevirapine) [2011 version]
Visicol (sodium phosphate dybasic anhydrous and sodium phosphate monobasic monohydrate) [2009 version]
Vivactil (protriptyline hydrochloride) [2007 version]
Vivitrol (naltrexone) [2010 version]
Voltaren (diclofenac sodium) [2011 version]
Votrient (pazopanib hydrochloride) [2012 version]
Vyvanse (lisdexamfetamine dimesylate) [2012 version]
Wellbutrin (bupropion hydrochloride) [2010 version]
Wellbutrin SR (bupropion hydrochloride) [2010 version]
Wellbutrin XL (buproprion hydrochloride) [2011 version]
Xarelto (rivaroxaban) [2011 version]
Xenazine (tetrabenazine) [2011 version]
Xeomin* (incobotulinumtoxinA) [2011 version]
Xiaflex* (collagenase clostridium histolyticum) [2011 version]
Xolair* (omalizumab) [2010 version]
Xyrem (sodium oxybate) [2005 version]
Yervoy* (ipilimumab) [2011 version]
Zarontin (ethosuximide) [2010 version]
Zelboraf (vemurafenib) [2011 version]
Zenpep (pancrelipase) [2011 version]
Zerit (stavudine) [2011 version]
Ziagen (abacavir sulfate) [2012 version]
Zipsor (diclofenac potassium) [2009 version]
Zoloft (sertraline hydrochloride) [2008 version]
Zolpidem (zolpidem tartrate) [2008 version]
Zolpimist (zolpidem tartrate) [2008 version]
Zonegran (zonisamide) [2012 version]
Zortress (everolimus) [2012 version]
Zyban (bupropion hydrochloride) [2010 version]
Zyprexa (olanzapine) [2010 version]
Zyprexa Relprevv (olanzapine) [2010 version]