Drug Safety and Availability > Medication Guides 1

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. 

Information Update (3/2017)

Medication Guides are updated as they appear in new drug labeling.  Please note that we link directly into the drug label to the first page of the medication guide. 

Medication Guides may or may not be at the end of the label.  Before printing check the number of pages of the Medication Guide.

The newest labeling may contain a Medication Guide, but this is not necessarily reflective of the date of the label.

Medication Guides are available for these products:

*biologic or drug/biologic combination

• Nalfon (fenoprofen calcium) [5/2016 version]
• Naprelan (naproxen sodium) [2011 version]
• Naprosyn (naproxen) [3/2017 version]
• Nardil (phenelzine sulfate) [2007 version]
• Natpara (parathyroid hormone) for injection [12/2015 version]
• Nesina (alogliptin) [4/2016 version]
• Neurontin (gabapentin) [9/2015 version]
• Nexium (esomeprazole magnesium) [3/2014 version] 
• Nizoral (ketoconazole) [2014 version]
• Noctiva (desmopressin acetate) [3/2017 version]
• Nolvadex (tamoxifen) [2006 version]
• Noroxin (norfloxacin) [2016 version]
• Norpramin (desipramine hydrochloride) [2014 version]
• Novantrone (mitoXantrone) [2012 version]
• Nplate* (romiplostim) [4/2016 version]
• NSAID (Nonsteroidal Anti-inflammatory Drugs) [3/2017version]
• Nucynta (tapentadol hydrochloride) [11/2016 version]
• Nucynta ER (tapentadol) [2014 version]
• Nulojix (belatacept) [2014 version]
• NuLytely (polyethylene glycol 3500, potassium chloride, sodium bicarbonate, and sodium chloride) [2013 version]
• Nuvigil (armodafinil) [4/2015 version]
• Ocrevus (ocrelizumab) [3/2017 version]
• Obredon (hydrocodone bitartrate and guaifenesin) [2017 version]
• Odomzo (sonidegib) [2015]
• Oleptro (trazodone hydrochloride) [2014 version]
• Omontys (peginesatide) [2012 version]
• Onfi (clobazam) [2016 version]
• Onglyza (saxagliptin hydrochloride) [2/2017 version]
• Onsolis (fentanyl buccal soluble film) [2016 version]
• Opana ER (oxymorphone hydrochloride) [2016 version]
• Opdivo (nivolumab) [4/2017 version]
• Opsumit (macitentan) [3/2017 version]
• Oseni (alogliptin and pioglitazone) [12/2016 version] 
• Osmoprep (sodium phosphate dibasic anhydrous and sodium phosphate monobasic monohydrate) [2012 version]
• OXAYDO (oxycodone HCl) [2016 version]
• Oxtellar XR (oxcarbazepine) [2012 version]
• Oxycodone Hydrochloride Capsules [2016 version]
• Oxycodone Hydrochloride Oral Solution [2013 version]
• OxyContin (oxycodone hydrochloride) [2015 version]
• Oxymorphone Hydrochloride [1/2015 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) [5/2017 version] 
• PegIntron*/Rebetol Combo Pack (peginterferon alfa-2b and ribavirin) [2008 version]
• Pennsaid (diclofenac sodium) [5/2016 version]
• Percodan (ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE) [2016 version]
• Perforomist (formoterol fumarate) [2012 version]
• Pertzye (pancrelipase) [7/2017 version] 
• Pexeva (paroxetine mesylate) [2017 version]
• Plavix (clopidogrel bisulfate) [7/2017 version] 
• Plegridy (peginterferon beta-1a) [7/2016 version]
• Pomalyst (pomalidomide) [4/2015 version]
• Ponstel (mefenamic acid) [5/2016 version]
• Potiga (ezogabine) [5/2016 version]
• Pradaxa (dabigatran etexilate mesylate) [2015 version] 
• Prepopik (sodium picosulfate, magnesium oxide and citric acid) [2012 version]
• Prevacid (lansoprazole [12/2015 version]
• Prevacid NapraPac (lansoprazole and naproxen) [5/2019 version]
• Priftin (rifapentine) Tablets [11/2014 version]
• Prilosec (omeprazole [2016 version]
• Pristiq (desvenlafaxine succinate) [2017 version]
• Procrit (epoetin alfa) [4/2017 version]
• Prolia (denosumab) [5/2017 version] 
• Promethazine HCl and Codeine Phosphate (2017 version)
• Promethazine Hydrochloride, Phenylephrine Hydrochloride and Codeine Phosphate (2017 version)
• Propylthiouracil [2010 version]
• Promacta (eltrombopag) [7/2017version] 
• Propulsid (cisapride) [2006 version]
• Proquin XR (ciprofloxacin hydrochloride) [2011 version]
• Protonix (pantoprazole sodium) 7/[2017 version]
• Protopic Ointment (tacrolimus) [2011 version]
• Provigil (modafinil) [2015 version]
• Prozac (fluoxetine hydrochloride) [2017 version]
• Qsymia (phentermine and topiramate) [9/2014 version]
• Qtern (dapagliflozin and saxagliptin) [2/2017 version]
• Qualaquin (quinine sulfate) [2014 version]
• Qudexy XR (topiramate) [2017? version]
• QuilliChew ER (methylphenidate Hydorchloride) [3/2017 version]
• Quillivant XR (methylphenidate) [2015 version] 
• Rapamune (sirolimus) [5/2015 version]
• Ravicti (glycerol phenylbutyrate) [4/2017 version]
• Rebetol (ribavirin) [2013 version]
• Rebif* (interferon beta-1a) [4/2014 version]
• Reclast (zoledronic acid) [7/2017 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) [10/2015 version]
• Renflexis (infliximab-abda) [4/2017 version]
• Restoril (temazepam) [2016 version]
• Revlimid (lenalidomide) [2017 version]
• Rexulti  (brexpiprazole) [8/2015 version] 
• Rezira ( hydrocodone bitartrate and pseudoephedrine hydrochloride) [2017 version] 
• Ribasphere (ribavirin) [2008 version]
• Ritalin (methylphenidate hydrochloride) [2015 version]
• Ritalin LA (methylphenidate hydrochloride) [2017version]
• Ritalin-SR (methylphenidate hydrochloride) [2017 version]
• Rituxan* (rituximab) [2013 version]
• Rituxan Hycela (rituximab and hyaluronidase human) [6/2017 version] 
• Roferon-A* (interferon alfa-2a recombinant) [2008 version]
• Roxocodone (oxycodone hydrochloride ) [12/2016 version]
• Roxybond (oxycodone hydrochloride) [4/2017 version]
• Rozerem (ramelteon) [2010 version]
• Sabril (vigabatrin) [4/2017 version] 
• Samsca (tolvaptan) [2/2014 version]
• Sarafem (fluoxetine hydrochloride) [2017 version]
• Savaysa (edoxaban) tablets [2015 version]
• Savella (milnacipran hydrochloride) [8/2016 version]
• Saxenda (liraglutide) injection [9/2016 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]
• Siliq (brodalumab) [2017version]
• Simponi (golimumab) [1/2016 version]
• Simponi Aria (golimumab) [2016 version]
• Sinequan (doxepin hydrochloride) [2007 version]
• Sirturo (bedaquiline) [2013 version] 
• Sodium Oxybate [2016 version]
• Solaraze (diclofenac sodium) Gel, 3% [5/2016 version]
• Soliqua (insulin glargine and lixisenatide) [2016 version]
• Soliris* (eculizumab) [2017 version]
• Soltamox (tamoxifen citrate) [2005 version]
• Sonata (zaleplon) [2013 version]
• Soriatane (acitretin) [2014 version]
• Sotret (isotretinoin) [2006 version]
• SPRIX (ketorolac tromethamine) Nasal Spray [5/2016 version]
• Spritam (levetiracetam) tablets [6/2017 version] 
• Stavzor (valproic acid) [2013 version]
• Stelara* (ustekinumab) [9/2016 version]
• Stiolto Respimat (tiotropium bromide and olodaterol) [2016 version]
• Strattera (atomoxetine hydrochloride) [2014 version] 
• Striverdi respimat (olodaterol) [2016 version]
• Suboxone (buprenorphine and naloxone) [12/2016 version] 
• Subsys (fentanyl) [2016 version]
• Subutex (buprenorphine) [2016 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]
• Supprelin LA (histrelin acetate) [5/2017 version]
• Surmontil (trimipramine) [2014 version]
• Sustol ( granisetron) [8/2016 version] 
• Sutent (sunitimib malate) [2013 version]
• Sylatron (peginterferon alfa-2b) [5/2015 version]
• Symbicort (budesonide and formoterol fumarate dihydrate) [2017 version]
• Symbyax (fluoxetine hydrochloride and olanzapine) [2017 version]
• Symlin (pramlintide acetate) [2007 version]
• Synalgos-DC (aspirin, caffeine, and dihydrocodeine bitartrate) [2016 version]
• Synarel (nafarelin acetate) [2017 version]
• Synjardy (empagliflozin and metformin hydrochloride) [2016]
• Synjardy XR (empagliflozin and metformin Hydrochloride Extended Release) [2016 version]
• Synribo (omacetaxine mepesuccinate) [4/2014 version]
• Tafinlar (dabrafenib) [6/2017 version] 
• Taltz (ixekizumab) [3/2016]
• Tanzeum (albiglutide) [3/2015 version]
• Tapentadol see Nucynta 
• Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended-release tablets) [2016 version]
• Tasigna (nilotinib) [2/2017 version] 
• Tecentriq (atezolizumab) [4/2017version] 
• Technivie (ombitasvir, paritaprevir and ritonavir tablets) [3/2017 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) [2017 version]
• Tikosyn (dofetilide) [2013 version]
• Tivorbex  (indomethacin) [5/2016 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) [12/2015 version]
• Tradjenta (linagliptin) [3/2017 version]
• Tranxene (clorazepate dipotassium) [2016 version]
• Trazodone (Trazodone Hydrochloride) [2014 version]
• Tremfya (guselkumab) [7/2017 version] 
• Treximet (naproxen sodium and sumatriptan succinate) [5/2016 version]
• Tridione (trimethadione) [2012 version]
• Trileptal (oxcarbazepine) [2011 version]
• Trilipix (choline fenofibrate) [2012 version]
• Trintellix (vortioxetine) [4/2017 version]
• Triptodur (triptorelin) [6/2017 version] 
• Triumeq (abacavir, dolutegravir, and lamivudine) tablets [3/2017version]
• Trizivir (abacavir sulfate, lamivudine and zidovudine) [3/2017 version]
• Troxyca (oxycodone hydrochloride and naltrexone hydrochloride) [2016 version]
• Trokendi XR (topiramate) [4/2017 version]
• Trulicity (dulaglutide) [2017 version]
• Truvada (emtricitabine and tenofovir disoproxil fumarate) [4/2017 version]
• Tussionex (hydrocodone polistirex and chlorpheniramine polistirex) [2017 version]
• Tuxarin ER ( codeine phosphate and chlorpheniramine maleate ) [2017 verion]
• Tuzistra XR  (codeine polistirex and chlorpheniramine polistirex) [2017 version]
• Tysabri (natalizumab) [5/2015 version]
• Tyzeka (telbivudine) [2013 version]
• Ultracet ( tramadol  hydrochloride/acetaminophen) [2016 version] 
• Ultresa (pancrelipase) [2012 version]
• Ultram(tramadol hydrochloride) 2[016 version]
• Ultram ER (tramadol hydrochloride extended-release tablets [2016 version]
• Valchlor (mechlorethamine) [2013 version]
• Valium (diazepam) [2016 version]
• Vandetanib see Caprelsa
• Vantrela ER ( hydrocodone bitartrate) [2017 version]
• Venclexta (venetoclax) [4/2016 version]
• Venlafaxine HCl ER (venlafaxine hydrochloride) [2017 version]
• Vibativ (telavancin) [12/2014 version]
• Viberzi  (eluxadoline) [4/2017 version]
• Vicoprofen (hydrocodone bitartrate and ibuprofen) [2016 version]
• Victoza (liraglutide) [5/2016 version]
• Victrelis (boceprevir) [2014 version]
• Videx (didanosine) [2011 version]
• Videx EC (didanosine) [2011 version]
• Viekira Pak ((ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) [3/2017 version]
• Viekira XR  (dasabuvir, ombitasvir, paritaprevir, and ritonavir) [3/2017 version] 
• Viibryd (vilazodone hydrochloride) [2017 version] 
• Vimovo (esomeprazole magnesium and naproxen) [7/2017 version]
• Vimpat (lacosamide) [8/2014 version] 
• Viokace (pancrelipase) [2012 version]  
• Viramune and Viramune XR (nevirapine) [3/2017 version] 
• Visicol (sodium phosphate dybasic anhydrous and sodium phosphate monobasic monohydrate) [2013 version]
• Vituz ( hydrocodone bitartrate and chlorpheniramine maleate) [2017 version]
• Vivactil (protriptyline hydrochloride) [2007 version]
• Vivitrol (naltrexone) [2013 version]
• Vogelxo (testosterone) gel [5/2015 version]
• Voltaren (diclofenac sodium) [5/2016 version]
• Voltaren XR (diclofenac sodium) [5/2016 version]
• Votrient (pazopanib hydrochloride) [5/2017 version] 
• Vyvanse (lisdexamfetamine dimesylate) [2017 version]
• Wellbutrin (bupropion hydrochloride) [5/2017 version]
• Wellbutrin SR (bupropion hydrochloride) [5/2017 version]
• Wellbutrin XL (buproprion hydrochloride) [5/2017 version] 
• Xanax (alprazolam) [2016 version]
• Xanax XR (alprazolam) [2016 version]
• Xarelto (rivaroxaban) [5/ 2016 version]
• Xartemis XR (oxycodone hydrochloride and acetaminophen) [12/2016 version]
• Xeljanz (tofacitinib) [3/2014 version]
• Xenazine (tetrabenazine) [6/2015 version]
• Xeomin* (incobotulinumtoxinA) [2011 version]
• Xiaflex* (collagenase clostridium histolyticum) [8/2016 version] 
• Xigduo XR ( Depagliflozin and Metformin HCL extended release ) [8/2016 version] 
• Xolair* (omalizumab) [7/2016 version]
• Xtampza ER (oxycodone) [2016 version]
• Xultophy (insulin degludec and liraglutide injection) [11/2016 version] 
• Xyrem (sodium oxybate) [2015 version]
• Yervoy* (ipilimumab) [12/2013 version]
• Yosprala (aspirin and omeprazole) [ 9/2016 version ] 
• Zarontin (ethosuximide) [2012 version]
• Zegerid (omeprazole and sodium bicarbonate) [2014 version]
• Zelboraf (vemurafenib) [8/2016 version] 
• Zenpep (pancrelipase) [2014 version]
• Zerit (stavudine) [2011 version]
• Ziagen (abacavir sulfate) [3/2017 version]
• Zinbryta (daclizumab) [5/2017 version] 
• Zipsor (diclofenac potassium) [5/2016 version]
• Zohydro ER (hydrocodone bitartrate) [2016 version]
• Zoloft (sertraline hydrochloride) [2016 version]
• Zolpidem (zolpidem tartrate) [2008 version] 
• Zolpimist (zolpidem tartrate) [2008 version]
• Zonegran (zonisamide) [4/2016 version]
• Zontivity (vorapaxar) [2013 version]
• Zortress (everolimus) [2013 version]
• Zorvolex (diclofenac) [5/2016 version]
• Zubsolv (buprenorphine and naloxone) [2013 version] 
• Zurampic (lesinurad) [2016 version]
• Zutripro ((hydrocodone bitartrate, chlorpheniramine maleate and pseudoephedrine hydrochloride ) [2017 version]
• Zyban (bupropion hydrochloride) [5/2017 version]
• Zydelig ( idelalisib) [9/2016 version] 
• Zyprexa (olanzapine) [2013 version]
• Zyprexa Relprevv (olanzapine) [2012 version]