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.
Medication Guides are available for these products:
*biologic or drug/biologic combination
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- Mobic193 (meloxicam) [2011 version]
- Morphine Sulfate194 (morphine sulfate oral solution) [2011 version]
- Motrin195 (ibuprofen) [2007 version]
- Moviprep196 (propylene glycol 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid) [2012 version]
- MS Contin197 (morphine sulfate) [2012 version]
- Multaq198 (dronedarone) [2013 version]
- Myfortic199 (mycophenolic acid) [2012 version]
- Myobloc200* (rimabotulinumtoxinB) [2009 version]
- Mysoline201 (primidone) [2010 version]
- Nalfon202 (fenoprofen calcium) [2009 version]
- Naprelan203 (naproxen sodium) [2011 version]
- Naprosyn204 (naproxen) [2013 version]
- Nardil205 (phenelzine sulfate) [2007 version]
- Nesina206 (alogliptin) [2013 version]
- Neurontin207 (gabapentin) [2011 version]
- Nexium208 (esomeprazole magnesium) [2012 version]
- Nolvadex209 (tamoxifen) [2006 version]
- Noroxin210 (norfloxacin) [2012 version]
- Norpramin211 (desipramine hydrochloride) [2012 version]
- Novantrone212 (mitoXantrone) [2012 version]
- Nplate213* (romiplostim) [2012 version]
- Nucynta214 (tapentadol hydrochloride) [2012 version]
- Nucynta ER215 (tapentadol) [2012 version]
- Nulojix216* (belatacept) [2011 version]
- Nuvigil217 (armodafinil) [2010 version]
- Oleptro218 (trazodone hydrochloride) [2012 version]
- Omontys219 (peginesatide) [2012 version]
- Onfi220 (clobazam) [2013 version]
- Onglyza221 (saxagliptin hydrochloride) [2011 version]
- Onsolis222 (fentanyl buccal soluble film) [2011 version]
- Opana ER223 (oxymorphone hydrochloride) [2012 version]
- Oseni 224(alogliptin and pioglitazone) [2013 version]
- Osmoprep225 (sodium phosphate dibasic anhydrous and sodium phosphate monobasic monohydrate) [2012 version]
- Oxtellar XR226 (oxcarbazepine) [2012 version]
- Oxycodone Hydrochloride Oral Solution227 [2012 version]
- OxyContin228 (oxycodone hydrochloride) [2012 version]
- Pacerone229 (amiodarone hydrochloride) [2008 version]
- Palladone230 (hydromorphone hydrochloride) [2004 version]
- Pamelor231 (nortriptyline hydrochloride) [2012 version]
- Pancreaze232 (pancrelipase) [2010 version]
- Parnate233 (tranylcypromine sulfate) [2008 version]
- Paxil234 (paroxetine hydrochloride) [2012 version]
- Paxil CR235 (paroxetine hydrochloride) [2012 version]
- Peganone236 (ethotoin) [2010 version]
- Pegasys237* (peginterferon alfa-2a) [2011 version]
- Pegintron238* (peginterferon alfa-2b) [2012 version]
- PegIntron*/Rebetol Combo Pack239 (peginterferon alfa-2b and ribavirin) [2008 version]
- Pennsaid240 (diclofenac sodium) [2010 version]
- Perforomist241 (formoterol fumarate) [2012 version]
- Pertzye242 (pancrelipase) [2012 version]
- Pexeva243 (paroxetine mesylate) [2012 version]
- Plavix244 (clopidogrel bisulfate) [2011 version]
- Pomalyst 245(pomalidomide) [2013 version]
- Ponstel246 (mefenamic acid) [2008 version]
- Potiga247 (ezogabine) [2012 version]
- Pradaxa 248(dabigatran etexilate mesylate) [2012 version]
- Prepopik 249(sodium picosulfate, magnesium oxide and citric acid) [2012 version]
- Prevacid250 (lansoprazole [2012 version]
- Prevacid NapraPac251 (lansoprazole and naproxen) [2009 version]
- Prilosec 252(omeprazole [2012 version]
- Pristiq253 (desvenlafaxine succinate) [2013 version]
- Procrit254* (epoetin alfa) [2012 version]
- Prolia255* (denosumab) [2012 version]
- Propylthiouracil256 [2010 version]
- Promacta257 (eltrombopag) [2012 version]
- Propulsid258 (cisapride) [2006 version]
- Proquin XR259 (ciprofloxacin hydrochloride) [2011 version]
- Protonix260 (pantoprazole sodium) [2012 version]
- Protopic Ointment261 (tacrolimus) [2011 version]
- Provigil262 (modafinil) [2010 version]
- Prozac263 (fluoxetine hydrochloride) [2013 version]
- Qsymia264 (phentermine and topiramate) [2012 version]
- Qualaquin265 (quinine sulfate) [2013 version]
- Quillivant XR266 (methylphenidate) [2012 version]
- Rapamune267 (sirolimus) [2013 version]
- Ravicti 268(glycerol phenylbutyrate) [2013 version]
- Rebetol269 (ribavirin) [2013 version]
- Rebif270* (interferon beta-1a) [2002 version]
- Reclast271 (zoledronic acid) [2011 version]
- Reglan272 (metoclopramide hydrochloride) injection [2009 version]
- Reglan273 (metoclopramide hydrochloride) tablets [2011 version]
- Reglan ODT274 (metoclopramide hydrochloride) [2011 version]
- Remeron275 (mirtazapine) [2012 version]
- Remeron SolTab276 (mirtazapine) [2012 version]
- Remicade277* (infliximab) [2013 version]
- Revlimid279 (lenalidomide) [2013 version]
- Ribasphere280 (ribavirin) [2008 version]
- Ritalin281 (methylphenidate hydrochloride) [2010 version]
- Ritalin LA282 (methylphenidate hydrochloride) [2010 version]
- Ritalin-SR283 (methylphenidate hydrochloride) [2010 version]
- Rituxan284* (rituximab) [2012 version]
- Roferon-A285* (interferon alfa-2a recombinant) [2008 version]
- Rozerem286 (ramelteon) [2010 version]
- Sabril287 (vigabatrin) [2012 version]
- Samsca288 (tolvaptan) [2012 version]
- Sarafem289 (fluoxetine hydrochloride) [2009 version]
- Savella290 (milnacipran hydrochloride) [2012 version]
- Selzentry291 (maraviroc) [2013 version]
- Serevent Diskus292 (salmeterol xinafoate) [2010 version]
- Seroquel293 (quetiapine fumarate) [2011 version]
- Seroquel XR294 (quetiapine fumarate) [2011 version]
- Signifor295 (pasireotide diaspartate) [2012 version]
- Silenor296 (doxepin) [2010 version]
- Simponi297* (golimumab) [2012 version]
- Sinequan298 (doxepin hydrochloride) [2007 version]
- Sirturo299 (bedaquiline) [2012 versuib]
- Soliris300* (eculizumab) [2009 version]
- Soltamox301 (tamoxifen citrate) [2005 version]
- Soriatane302 (acitretin) [2011 version]
- Sotret303 (isotretinoin) [2006 version]
- Stavzor304 (valproic acid) [2013 version]
- Stelara305* (ustekinumab) [2013 version]
- Strattera306 (atomoxetine hydrochloride) [2012 version]
- Suboxone307 (buprenorphine and naloxone) [2012 version]
- Subsys308 (fentanyl) [2012 version]
- Subutex309 (buprenorphine) [2011 version]
- Suclear 310(sodium sulfate, potassium sulfate, magnesium sulfate, sodium chloride, sodium bicarbonate and potassium chloride) [2013 version]
- Suprep311 (sodium sulfate, potassium sulfate and magnesium sulfate) [2010 version]
- Surmontil 312(trimipramine) [2012 version]
- Sutent313 (sunitimib malate) [2012 version]
- Sylatron314 (peginterferon alfa-2b) [2012 version]
- Symbicort315 (budesonide and formoterol fumarate dihydrate) [2010 version]
- Symbyax316 (fluoxetine hydrochloride and olanzapine) [2013 version]
- Symlin317 (pramlintide acetate) [2007 version]
- Tapentadol318 see Nucynta
- Tasigna319 (nilotinib) [2011 version]
- Tegretol320 (carbamazepine) [2013 version]
- Testim321 (testosterone) [2011 version]
- Testosterone Gel322 [2012 version]
- Thalomid323 (thalidomide) [2013 version]
- Tikosyn324 (dofetilide) [2011 version]
- Tofranil325 (imipramine hydrochloride) [2007 version]
- Tofranil-PM326 (imipramine pamoate) [2012 version]
- Tolectin327 (tolmetin sodium) [2008 version]
- Topamax328 (topiramate) [2012 version]
- Toradol329 (ketorolac tromethamine) [2013 version]
- Tracleer330 (bosentan) [2012 version]
- Tranxene331 (clorazepate dipotassium) [2010 version]
- Treximet332 (naproxen sodium and sumatriptan succinate) [2012 version]
- Tridione333 (trimethadione) [2012 version]
- Trileptal334 (oxcarbazepine) [2011 version]
- Trilipix335 (choline fenofibrate) [2012 version]
- Trizivir336 (abacavir sulfate, lamivudine and zidovudine) [2012 version]
- Truvada337 (emtricitabine and tenofovir disoproxil fumarate) [2012 version]
- Tysabri338* (natalizumab) [2012 version]
- Tyzeka339 (telbivudine) [2013 version]
- Ultresa340 (pancrelipase) [2012 version]
- Vandetanib341 see Caprelsa
- Vibativ342 (telavancin) [2009 version]
- Vicoprofen343 (vicoprofen and ibuprofen) [2008 version]
- Victoza344 (liraglutide) [2012 version]
- Victrelis345 (boceprevir) [2013 version]
- Videx346 (didanosine) [2011 version]
- Videx EC347 (didanosine) [2011 version]
- Viibryd348 (vilazodone hydrochloride) [2012 version]
- Vimovo349 (esomeprazole magnesium and naproxen) [2012 version]
- Vimpat350 (lacosamide) [2013 version]
- Viokace351 (pancrelipase) [2012 version]
- Viramune352 (nevirapine) [2012 version]
- Visicol353 (sodium phosphate dybasic anhydrous and sodium phosphate monobasic monohydrate) [2013 version]
- Vivactil354 (protriptyline hydrochloride) [2007 version]
- Vivitrol355 (naltrexone) [2010 version]
- Voltaren356 (diclofenac sodium) [2011 version]
- Votrient357 (pazopanib hydrochloride) [2012 version]
- Vyvanse358 (lisdexamfetamine dimesylate) [2012 version]
- Wellbutrin359 (bupropion hydrochloride) [2013 version]
- Wellbutrin SR360 (bupropion hydrochloride) [2013 version]
- Wellbutrin XL361 (buproprion hydrochloride) [2011 version]
- Xarelto362 (rivaroxaban) [2013 version]
- Xeljanz363 (tofacitinib) [2012 version]
- Xenazine364 (tetrabenazine) [2011 version]
- Xeomin365* (incobotulinumtoxinA) [2011 version]
- Xiaflex366* (collagenase clostridium histolyticum) [2011 version]
- Xolair367* (omalizumab) [2010 version]
- Xyrem368 (sodium oxybate) [2012 version]
- Yervoy369* (ipilimumab) [2012 version]
- Zarontin370 (ethosuximide) [2012 version]
- Zegerid371 (omeprazole and sodium bicarbonate) [2012 version]
- Zelboraf372 (vemurafenib) [2011 version]
- Zenpep373 (pancrelipase) [2011 version]
- Zerit374 (stavudine) [2011 version]
- Ziagen375 (abacavir sulfate) [2012 version]
- Zipsor376 (diclofenac potassium) [2009 version]
- Zoloft377 (sertraline hydrochloride) [2012 version]
- Zolpidem378 (zolpidem tartrate) [2008 version]
- Zolpimist379 (zolpidem tartrate) [2008 version]
- Zonegran380 (zonisamide) [2012 version]
- Zortress381 (everolimus) [2013 version]
- Zyban382 (bupropion hydrochloride) [2012 version]
- Zyprexa383 (olanzapine) [2010 version]
- Zyprexa Relprevv384 (olanzapine) [2012 version]
Related Information
Medication Guides for Certain Prescription Products 385
Consumer Update article
- Guidance for Industry: Medication Guides - Distribution Requirements and Inclusion in REMS (PDF - 91KB)386
Final version (11/17/2011)
- Questions and Answers on Draft Guidance for Industry: Medication Guides - Distribution Requirements and Inclusion in REMS387
3/29/2011
Public Hearing on Use of Medication Guides to Distribute Drug Risk Information to Patients June 12-13, 2007 388
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