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
Medication Guides are available for these products:
*biologic or drug/biologic combination
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- Mobic (meloxicam) [2011 version]
- Morphine Sulfate (morphine sulfate oral solution) [2011 version]
- Motrin (ibuprofen) [2007 version]
- Moviprep (polyethylene glycol 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid) [2013 version]
- MS Contin (morphine sulfate) [2014 version]
- Multaq (dronedarone) [2014 version]
- Myfortic (mycophenolic acid) [2013 version]
- Myobloc* (rimabotulinumtoxinB) [2009 version]
- Mysoline (primidone) [2010 version]
- Nalfon (fenoprofen calcium) [2009 version]
- Naprelan (naproxen sodium) [2011 version]
- Naprosyn (naproxen) [2013 version]
- Nardil (phenelzine sulfate) [2007 version]
- Natpara (parathyroid hormone) for injection [1/2015 version]
- Nesina (alogliptin) [2013 version]
- Neurontin (gabapentin) [2013 version]
- Nexium (esomeprazole magnesium) [3/2014 version]
- Nizoral (ketoconazole) [2014 version]
- Nolvadex (tamoxifen) [2006 version]
- Noroxin (norfloxacin) [2013 version]
- Norpramin (desipramine hydrochloride) [2014 version]
- Novantrone (mitoXantrone) [2012 version]
- Nplate* (romiplostim) [2014 version]
- NSAID (Nonsteroidal Anti-inflammatory Drugs) [2014 version]
- Nucynta (tapentadol hydrochloride) [11/2014 version]
- Nucynta ER (tapentadol) [2014 version]
- Nulojix* (belatacept) [4/2014 version]
- NuLytely (polyethylene glycol 3500, potassium chloride, sodium bicarbonate, and sodium chloride) [2013 version]
- Nuvigil (armodafinil) [4/2015 version]
- Oleptro (trazodone hydrochloride) [2014 version]
- Omontys (peginesatide) [2012 version]
- Onfi (clobazam) [2013 version]
- Onglyza (saxagliptin hydrochloride) [2013 version]
- Onsolis (fentanyl buccal soluble film) [2011 version]
- Opana ER (oxymorphone hydrochloride) [2014 version]
- Opdivo (nivolumab) [3/2015 version]
- Opsumit (macitentan) [4/2015 version]
- Oseni (alogliptin and pioglitazone) [2013 version]
- Osmoprep (sodium phosphate dibasic anhydrous and sodium phosphate monobasic monohydrate) [2012 version]
- Oxtellar XR (oxcarbazepine) [2012 version]
- Oxycodone Hydrochloride Oral Solution [2013 version]
- OxyContin (oxycodone hydrochloride) [2015 version]
- Pacerone (amiodarone hydrochloride) [2008 version]
- Palladone (hydromorphone hydrochloride) [2004 version]
- Pamelor (nortriptyline hydrochloride) [2012 version]
- Pancreaze (pancrelipase) [2014 version]
- Parnate (tranylcypromine sulfate) [2008 version]
- Paxil (paroxetine hydrochloride) [2014 version]
- Paxil CR (paroxetine hydrochloride) [2014 version]
- Peganone (ethotoin) [2010 version]
- Pegasys* (peginterferon alfa-2a) [2014 version]
- Pegintron* (peginterferon alfa-2b) [2013 version]
- PegIntron*/Rebetol Combo Pack (peginterferon alfa-2b and ribavirin) [2008 version]
- Pennsaid (diclofenac sodium) [2014 version]
- Perforomist (formoterol fumarate) [2012 version]
- Pertzye (pancrelipase) [2012 version]
- Pexeva (paroxetine mesylate) [2012 version]
- Plavix (clopidogrel bisulfate) [7/2015 version]
- Pomalyst (pomalidomide) [2014 version]
- Ponstel (mefenamic acid) [2008 version]
- Potiga (ezogabine) [2013 version]
- Pradaxa (dabigatran etexilate mesylate) [2015 version]
- Prepopik (sodium picosulfate, magnesium oxide and citric acid) [2012 version]
- Prevacid (lansoprazole [2012 version]
- Prevacid NapraPac (lansoprazole and naproxen) [2009 version]
- Priftin (rifapentine) Tablets [11/2014 version]
- Prilosec (omeprazole [3/2014 version]
- Pristiq (desvenlafaxine succinate) [2014 version]
- Procrit* (epoetin alfa) [2012 version]
- Prolia* (denosumab) [2/2015 version]
- Propylthiouracil [2010 version]
- Promacta (eltrombopag) [8/2014 version]
- Propulsid (cisapride) [2006 version]
- Proquin XR (ciprofloxacin hydrochloride) [2011 version]
- Protonix (pantoprazole sodium) [2013 version]
- Protopic Ointment (tacrolimus) [2011 version]
- Provigil (modafinil) [2015 version]
- Prozac (fluoxetine hydrochloride) [2013 version]
- Qsymia (phentermine and topiramate) [9/2014 version]
- Qualaquin (quinine sulfate) [2014 version]
- Qudexy XR (topiramate) [2014 version]
- Quillivant XR (methylphenidate) [2/2015 version]
- Rapamune (sirolimus) [2013 version]
- Ravicti (glycerol phenylbutyrate) [2013 version]
- Rebetol (ribavirin) [2013 version]
- Rebif* (interferon beta-1a) [4/2014 version]
- Reclast (zoledronic acid) [1/2015 version]
- Reglan (metoclopramide hydrochloride) injection [2009 version]
- Reglan (metoclopramide hydrochloride) tablets [2011 version]
- Reglan ODT (metoclopramide hydrochloride) [2011 version]
- Relistor (methylnaltrexone bromide) [9/2014 version]
- Remeron (mirtazapine) [2014 version]
- Remeron SolTab (mirtazapine) [2014 version]
- Remicade* (infliximab) [2013 version]
- Restoril (temazepam) [2010 version]
- Revlimid (lenalidomide) [2014 version]
- Ribasphere (ribavirin) [2008 version]
- Ritalin (methylphenidate hydrochloride) [2015 version]
- Ritalin LA(methylphenidate hydrochloride) [2013 version]
- Ritalin-SR (methylphenidate hydrochloride) [2015 version]
- Rituxan* (rituximab) [2013 version]
- Roferon-A* (interferon alfa-2a recombinant) [2008 version]
- Rozerem (ramelteon) [2010 version]
- Sabril (vigabatrin) [2013 version]
- Samsca (tolvaptan) [2014 version]
- Sarafem (fluoxetine hydrochloride) [10/2014 version]
- Savella (milnacipran hydrochloride) [1/2015 version]
- Selzentry (maraviroc) [3/2014 version]
- Serevent Diskus (salmeterol xinafoate) [4/2014 version]
- Seroquel (quetiapine fumarate) [2013 version]
- Seroquel XR (quetiapine fumarate) [2013 version]
- Signifor (pasireotide diaspartate) [3/2015 version]
- Silenor (doxepin) [2010 version]
- Simponi* (golimumab) [2014 version]
- Simponi Aria* (golimumab) [2014 version]
- Sinequan (doxepin hydrochloride) [2007 version]
- Sirturo (bedaquiline) [2013 version]
- Soliris* (eculizumab) [4/2014 version]
- Soltamox (tamoxifen citrate) [2005 version]
- Sonata (zaleplon) [2013 version]
- Soriatane (acitretin) [2014 version]
- Sotret (isotretinoin) [2006 version]
- Stavzor (valproic acid) [2013 version]
- Stelara* (ustekinumab) [2014 version]
- Strattera (atomoxetine hydrochloride) [2014 version]
- Suboxone (buprenorphine and naloxone) [4/2014 version]
- Subsys (fentanyl) [2012 version]
- Subutex (buprenorphine) [2011 version]
- Suclear (sodium sulfate, potassium sulfate, magnesium sulfate, sodium chloride, sodium bicarbonate, and potassium chloride) [2013 version]
- Suprep (sodium sulfate, potassium sulfate and magnesium sulfate) [2010 version]
- Surmontil (trimipramine) [2014 version]
- Sutent (sunitimib malate) [2013 version]
- Sylatron (peginterferon alfa-2b) [5/2015 version]
- Symbicort (budesonide and formoterol fumarate dihydrate) [2010 version]
- Symbyax (fluoxetine hydrochloride and olanzapine) [2014 version]
- Symlin (pramlintide acetate) [2007 version]
- Synribo (omacetaxine mepesuccinate) [4/2014 version]
- Tafinlar (dabrafenib) [2013 version]
- Tanzeum (albiglutide) [3/2015 version]
- Tapentadol see Nucynta
- Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended-release tablets) [2014 version]
- Tasigna (nilotinib) [1/2015 version]
- Tegretol and Tegretol XR (carbamazepine) [2014 version]
- Testim (testosterone) [5/2015 version]
- Testosterone Gel (Perrigo) [5/2015 version]
- Testosterone Gel (Teva) [5/2015 version]
- Thalomid (thalidomide) [2014 version]
- Tikosyn (dofetilide) [2013 version]
- Tofranil (imipramine hydrochloride) [2007 version]
- Tofranil-PM (imipramine pamoate) [2012 version]
- Tolectin (tolmetin sodium) [2008 version]
- Topamax (topiramate) [3/2014 version]
- Toradol (ketorolac tromethamine) [2013 version]
- Tracleer (bosentan) [2012 version]
- Tradjenta (linagliptin) [2013 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) [2012 version]
- Trizivir (abacavir sulfate, lamivudine and zidovudine) [2012 version]
- Trokendi XR (topiramate) [2013 version]
- Truvada (emtricitabine and tenofovir disoproxil fumarate) [2013 version]
- Tysabri (natalizumab) [5/2015 version]
- Tyzeka (telbivudine) [2013 version]
- Ultresa (pancrelipase) [2012 version]
- Valchlor (mechlorethamine) [2013 version]
- Vandetanib see Caprelsa
- Venlafaxine HCl ER (venlafaxine hydrochloride) [2014 version]
- Vibativ (telavancin) [12/2014 version]
- Vicoprofen (vicoprofen and ibuprofen) [2008 version]
- Victoza (liraglutide) [2013 version]
- Victrelis (boceprevir) [2014 version]
- Videx (didanosine) [2011 version]
- Videx EC (didanosine) [2011 version]
- Viibryd (vilazodone hydrochloride) [3/2015 version]
- Vimovo (esomeprazole magnesium and naproxen) [3/2014 version]
- Vimpat (lacosamide) [2013 version]
- Viokace (pancrelipase) [2012 version]
- Viramune and Viramune XR (nevirapine) [2014 version]
- Visicol (sodium phosphate dybasic anhydrous and sodium phosphate monobasic monohydrate) [2013 version]
- Vivactil (protriptyline hydrochloride) [2007 version]
- Vivitrol (naltrexone) [2013 version]
- Vogelxo (testosterone) gel [5/2015 version]
- Voltaren (diclofenac sodium) [2011 version]
- Votrient (pazopanib hydrochloride) [3/2015 version]
- Vyvanse (lisdexamfetamine dimesylate) [1/2015 version]
- Wellbutrin (bupropion hydrochloride) [2014 version]
- Wellbutrin SR (bupropion hydrochloride) [2013 version]
- Wellbutrin XL (buproprion hydrochloride) [2011 version]
- Xarelto (rivaroxaban) [December 2014 version]
- Xartemis XR (oxycodone hydrochloride and acetaminophen) [3/2015 version]
- Xeljanz (tofacitinib) [3/2014 version]
- Xenazine (tetrabenazine) [6/2015 version]
- Xeomin* (incobotulinumtoxinA) [2011 version]
- Xiaflex* (collagenase clostridium histolyticum) [2013 version]
- Xolair* (omalizumab) [9/2014 version]
- Xyrem (sodium oxybate) [4/2015 version]
- Yervoy* (ipilimumab) [12/2013 version]
- Zarontin (ethosuximide) [2012 version]
- Zegerid (omeprazole and sodium bicarbonate) [2014 version]
- Zelboraf (vemurafenib) [11/2014 version]
- Zenpep (pancrelipase) [2014 version]
- Zerit (stavudine) [2011 version]
- Ziagen (abacavir sulfate) [2012 version]
- Zipsor (diclofenac potassium) [2009 version]
- Zohydro ER (hydrocodone bitartrate) [2014 version]
- Zoloft (sertraline hydrochloride) [2012 version]
- Zolpidem (zolpidem tartrate) [2008 version]
- Zolpimist (zolpidem tartrate) [2008 version]
- Zonegran (zonisamide) [2012 version]
- Zontivity (vorapaxar) [2013 version]
- Zortress (everolimus) [2013 version]
- Zorvolex (diclofenac) [2013 version]
- Zubsolv (buprenorphine and naloxone) [2013 version]
- Zyban (bupropion hydrochloride) [3/2014 version]
- Zyprexa (olanzapine) [2013 version]
- Zyprexa Relprevv (olanzapine) [2012 version]
Related Information
- Medication Guides for Certain Prescription Products [ARCHIVED]
Consumer Update article - Guidance for Industry: Medication Guides - Distribution Requirements and Inclusion in REMS (PDF - 91KB)
Final version (11/17/2011) - Questions and Answers on Draft Guidance for Industry: Medication Guides - Distribution Requirements and Inclusion in REMS
3/29/2011 - Public Hearing on Use of Medication Guides to Distribute Drug Risk Information to Patients June 12-13, 2007
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