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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- Mobic174 (meloxicam) [2011 version]
- Morphine Sulfate175 (morphine sulfate oral solution) [2010 version]
- Motrin176 (ibuprofen) [2007 version]
- Moviprep177 (propylene glycol 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid) [2011 version]
- MS Contin178 (morphine sulfate) [2012 version]
- Multaq179 (dronedarone) [2012 version]
- Myfortic180 (mycophenolic acid) [2012 version]
- Myobloc181* (rimabotulinumtoxinB) [2009 version]
- Mysoline182 (primidone) [2010 version]
- Nalfon183 (fenoprofen calcium) [2009 version]
- Naprelan184 (naproxen sodium) [2011 version]
- Naprosyn185 (naproxen) [2008 version]
- Nardil186 (phenelzine sulfate) [2007 version]
- Neurontin187 (gabapentin) [2011 version]
- Nolvadex188 (tamoxifen) [2006 version]
- Noroxin189 (norfloxacin) [2012 version]
- Norpramin190 (desipramine hydrochloride) [2009 version]
- Novantrone191 (mitoXantrone) [2012 version]
- Nplate192* (romiplostim) [2011 version]
- Nucynta193 (tapentadol hydrochloride) [2010 version]
- Nucynta ER194 (tapentadol) [2012 version]
- Nulojix195* (belatacept) [2011 version]
- Nuvigil196 (armodafinil) [2010 version]
- Oleptro197 (trazodone hydrochloride) [2010 version]
- Omontys198 (peginesatide) [2012 version]
- Onfi199 (clobazam) [2011 version]
- Onglyza200 (saxagliptin hydrochloride) [2011 version]
- Onsolis201 (fentanyl buccal soluble film) [2011 version]
- Opana ER202 (oxymorphone hydrochloride) [2012 version]
- Osmoprep203 (sodium phosphate dibasic anhydrous and sodium phosphate monobasic monohydrate) [2009 version]
- Oxycodone Hydrochloride Oral Solution204 [2012 version]
- OxyContin205 (oxycodone hydrochloride) [2012 version]
- Pacerone206 (amiodarone hydrochloride) [2008 version]
- Palladone207 (hydromorphone hydrochloride) [2004 version]
- Pamelor208 (nortriptyline hydrochloride) [2007 version]
- Pancreaze209 (pancrelipase) [2010 version]
- Parnate210 (tranylcypromine sulfate) [2008 version]
- Paxil211 (paroxetine hydrochloride) [2011 version]
- Paxil CR212 (paroxetine hydrochloride) [2011 version]
- Peganone213 (ethotoin) [2010 version]
- Pegasys214* (peginterferon alfa-2a) [2011 version]
- Pegintron215* (peginterferon alfa-2b) [2012 version]
- PegIntron*/Rebetol Combo Pack216 (peginterferon alfa-2b and ribavirin) [2008 version]
- Pennsaid217 (diclofenac sodium) [2010 version]
- Perforomist218 (formoterol fumarate) [2012 version]
- Pertzye219 (pancrelipase) [2012 version]
- Pexeva220 (paroxetine mesylate) [2011 version]
- Plavix221 (clopidogrel bisulfate) [2011 version]
- Ponstel222 (mefenamic acid) [2008 version]
- Potiga223 (ezogabine) [2012 version]
- Pradaxa 224(dabigatran etexilate mesylate) [2012 version]
- Prepopik 225(sodium picosulfate, magnesium oxide and citric acid) [2012 version]
- Prevacid NapraPac226 (lansoprazole and naproxen) [2009 version]
- Pristiq227 (desvenlafaxine succinate) [2011 version]
- Procrit228* (epoetin alfa) [2012 version]
- Prolia229* (denosumab) [2012 version]
- Propylthiouracil230 [2010 version]
- Promacta231 (eltrombopag) [2011 version]
- Propulsid232 (cisapride) [2006 version]
- Proquin XR233 (ciprofloxacin hydrochloride) [2011 version]
- Protopic Ointment234 (tacrolimus) [2011 version]
- Provigil235 (modafinil) [2010 version]
- Prozac236 (fluoxetine hydrochloride) [2011 version]
- Qsymia237 (phentermine and topiramate) [2012 version]
- Qualaquin238 (quinine sulfate) [2011 version]
- Rapamune239 (sirolimus) [2010 version]
- Rebetol240 (ribavirin) [2010 version]
- Rebif241* (interferon beta-1a) [2002 version]
- Reclast242 (zoledronic acid) [2011 version]
- Reglan243 (metoclopramide hydrochloride) injection [2009 version]
- Reglan244 (metoclopramide hydrochloride) tablets [2011 version]
- Reglan ODT245 (metoclopramide hydrochloride) [2011 version]
- Remeron246 (mirtazapine) [2011 version]
- Remeron SolTabs247 (mirtazapine) [2011 version]
- Remicade248* (infliximab) [2011 version]
- Restoril249 (temazepam) [2010 version]
- Revlimid250 (lenalidomide) [2012 version]
- Ribasphere251 (ribavirin) [2008 version]
- Ritalin252 (methylphenidate hydrochloride) [2010 version]
- Ritalin LA253 (methylphenidate hydrochloride) [2010 version]
- Ritalin-SR254 (methylphenidate hydrochloride) [2010 version]
- Rituxan255* (rituximab) [2012 version]
- Roferon-A256* (interferon alfa-2a recombinant) [2008 version]
- Rozerem257 (ramelteon) [2010 version]
- Sabril258 (vigabatrin) [2010 version]
- Samsca259 (tolvaptan) [2012 version]
- Sarafem260 (fluoxetine hydrochloride) [2009 version]
- Savella261 (milnacipran hydrochloride) [2010 version]
- Selzentry262 (maraviroc) [2012 version]
- Serevent Diskus263 (salmeterol xinafoate) [2010 version]
- Seroquel264 (quetiapine fumarate) [2011 version]
- Seroquel XR265 (quetiapine fumarate) [2011 version]
- Silenor266 (doxepin) [2010 version]
- Simponi267* (golimumab) [2010 version]
- Sinequan268 (doxepin hydrochloride) [2007 version]
- Soliris269* (eculizumab) [2009 version]
- Soltamox270 (tamoxifen citrate) [2005 version]
- Soriatane271 (acitretin) [2011 version]
- Sotret272 (isotretinoin) [2006 version]
- Stelara273* (ustekinumab) [2012 version]
- Strattera274 (atomoxetine hydrochloride) [2012 version]
- Suboxone275 (buprenorphine and naloxone) [2012 version]
- Subsys276 (fentanyl) [2012 version]
- Subutex277 (buprenorphine) [2011 version]
- Suprep278 (sodium sulfate, potassium sulfate and magnesium sulfate) [2010 version]
- Sutent279 (sunitimib malate) [2012 version]
- Sylatron280 (peginterferon alfa-2b) [2012 version]
- Symbicort281 (budesonide and formoterol fumarate dihydrate) [2010 version]
- Symbyax282 (fluoxetine hydrochloride and olanzapine) [2012 version]
- Symlin283 (pramlintide acetate) [2007 version]
- Tapentadol284 see Nucynta
- Tasigna285 (nilotinib) [2011 version]
- Tegretol286 (carbamazepine) [2011 version]
- Testim287 (testosterone) [2011 version]
- Testosterone Gel288 [2012 version]
- Thalomid289 (thalidomide) [2012 version]
- Tikosyn290 (dofetilide) [2011 version]
- Tofranil291 (imipramine hydrochloride) [2007 version]
- Tolectin292 (tolmetin sodium) [2008 version]
- Topamax293 (topiramate) [2011 version]
- Toradol294 (ketorolac tromethamine) [2007 version]
- Tracleer295 (bosentan) [2009 version]
- Tranxene296 (clorazepate dipotassium) [2010 version]
- Treximet297 (naproxen sodium and sumatriptan succinate) [2012 version]
- Tridione298 (trimethadione) [2012 version]
- Trileptal299 (oxcarbazepine) [2011 version]
- Trilipix300 (choline fenofibrate) [2011 version]
- Trizivir301 (abacavir sulfate, lamivudine and zidovudine) [2012 version]
- Truvada302 (emtricitabine and tenofovir disoproxil fumarate) [2012 version]
- Tysabri303* (natalizumab) [2012 version]
- Tyzeka304 (telbivudine) [2011 version]
- Ultresa305 (pancrelipase) [2012 version]
- Vandetanib306 (vandetanib) [2011 version]
- Vibativ307 (telavancin) [2009 version]
- Vicoprofen308 (vicoprofen and ibuprofen) [2008 version]
- Victoza309 (liraglutide) [2012 version]
- Victrelis310 (boceprevir) [2012 version]
- Videx311 (didanosine) [2011 version]
- Videx EC312 (didanosine) [2011 version]
- Viibryd313 (vilazodone hydrochloride) [2011 version]
- Vimovo314 (esomeprazole magnesium and naproxen) [2012 version]
- Vimpat315 (lacosamide) [2009 version]
- Viokace316 (pancrelipase) [2012 version]
- Viramune317 (nevirapine) [2011 version]
- Visicol318 (sodium phosphate dybasic anhydrous and sodium phosphate monobasic monohydrate) [2009 version]
- Vivactil319 (protriptyline hydrochloride) [2007 version]
- Vivitrol320 (naltrexone) [2010 version]
- Voltaren321 (diclofenac sodium) [2011 version]
- Votrient322 (pazopanib hydrochloride) [2012 version]
- Vyvanse323 (lisdexamfetamine dimesylate) [2012 version]
- Wellbutrin324 (bupropion hydrochloride) [2010 version]
- Wellbutrin SR325 (bupropion hydrochloride) [2010 version]
- Wellbutrin XL326 (buproprion hydrochloride) [2011 version]
- Xarelto327 (rivaroxaban) [2011 version]
- Xenazine328 (tetrabenazine) [2011 version]
- Xeomin329* (incobotulinumtoxinA) [2011 version]
- Xiaflex330* (collagenase clostridium histolyticum) [2011 version]
- Xolair331* (omalizumab) [2010 version]
- Xyrem332 (sodium oxybate) [2005 version]
- Yervoy333* (ipilimumab) [2011 version]
- Zarontin334 (ethosuximide) [2012 version]
- Zelboraf335 (vemurafenib) [2011 version]
- Zenpep336 (pancrelipase) [2011 version]
- Zerit337 (stavudine) [2011 version]
- Ziagen338 (abacavir sulfate) [2012 version]
- Zipsor339 (diclofenac potassium) [2009 version]
- Zoloft340 (sertraline hydrochloride) [2011 version]
- Zolpidem341 (zolpidem tartrate) [2008 version]
- Zolpimist342 (zolpidem tartrate) [2008 version]
- Zonegran343 (zonisamide) [2012 version]
- Zortress344 (everolimus) [2012 version]
- Zyban345 (bupropion hydrochloride) [2012 version]
- Zyprexa346 (olanzapine) [2010 version]
- Zyprexa Relprevv347 (olanzapine) [2012 version]
Related Information
- Guidance for Industry: Medication Guides - Distribution Requirements and Inclusion in REMS (PDF - 91KB)348
Final version (11/17/2011)
- Questions and Answers on Draft Guidance for Industry: Medication Guides - Distribution Requirements and Inclusion in REMS349
3/29/2011
Public Hearing on Use of Medication Guides to Distribute Drug Risk Information to Patients June 12-13, 2007 350
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