CIENCIASMEDICASNEWS: Drug Safety and Availability

Drug Safety and Availability > Medication Guides

Electronic Common Technical Document (eCTD) Module 1: Public Meeting on Module 1 Updates. Meeting and registration information

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]
Absorica (isotrentinoin) [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) [2012 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]
Amevive* (alefacept) [2012 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) [2012 version)
Arcapta (indacaterol maleate) [2011 version]
Arthrotec (diclofenac sodium) [2010 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) [2011 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) [2012 version]
EC-Naprosyn (naproxen) [2008 version]
Edluar (zolpidem tartrate) [2009 version]
Effexor (venlafaxine hydrochloride) [2012 version]
Effexor XR (venlafaxine hydrochloride) [2012 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* (epoetin alfa) [2012 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) [2012 version]
Focalin XR (dexmethylphenidate hydrochloride) [2012 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) [2012 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 (trazodone 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) [2012 version]
PegIntron*/Rebetol Combo Pack (peginterferon alfa-2b and ribavirin) [2008 version]
Pennsaid (diclofenac sodium) [2010 version]
Perforomist (formoterol fumarate) [2012 version]
Pertzye (pancrelipase) [2012 version]
Pexeva (paroxetine mesylate) [2011 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) [2012 version]
Prolia* (denosumab) [2012 version]
Propylthiouracil [2010 version]
Promacta (eltrombopag) [2011 version]
Propulsid (cisapride) [2006 version]
Proquin XR (ciprofloxacin hydrochloride) [2011 version]
Protopic Ointment (tacrolimus) [2011 version]
Provigil (modafinil) [2010 version]
Prozac (fluoxetine hydrochloride) [2011 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) [2012 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) [2012 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]
Tridione (trimethadione) [2012 version]
Trileptal (oxcarbazepine) [2011 version]
Trilipix (choline fenofibrate) [2011 version]
Trizivir (abacavir sulfate, lamivudine and zidovudine) [2012 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) [2012 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) [2011 version]
Zolpidem (zolpidem tartrate) [2008 version]
Zolpimist (zolpidem tartrate) [2008 version]
Zonegran (zonisamide) [2012 version]
Zortress (everolimus) [2012 version]
Zyban (bupropion hydrochloride) [2012 version]
Zyprexa (olanzapine) [2010 version]
Zyprexa Relprevv (olanzapine) [2010 version]