Drug Safety and Availability > Medication Guides 2

Drug Safety and Availability > Medication Guides

The FDA Medication Guides Page has been updated to include: 

• Axiron
• Blincyto
• Pertzye
• Plavix
• Promacta
• Protonix
• Reclast
• Tremfya
• Vimovo

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

• Abilify (aripiprazole) [8/2016 version]  
• Abilify Maintena (aripiprazole) [1/2016 version]
• Absorica (isotrentinoin) [2014 version]
• Abstral (fentanyl) [2016 version]
• Aciphex (rabeprazole sodium) [4/2016 version]
• Aciphex DR (rabeprazole sodium) [4/2016 version]
• Accutane (isotretinoin) [2010 version]
• Actemra (tocilizumab) [5/2017 version] 
• Actiq (fentanyl citrate) [2016 version]
• Actonel (risedronate sodium) [2015 version]
• Actonel with Calcium (risedronate sodium and calcium carbonate) [2015 version]
• Actoplus Met (metformin hydrochloride and pioglitazone hydrochloride) [2014 version] 
• Actoplus Met XR (metformin hydrochloride and pioglitazone hydrochloride) [2016 version]
• Actos (pioglitazone hydrchloride) [2016 version]
• Adasuve (loxapine) [2016 version]
• Adderall (Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets) [2015 version]
• Adderall XR (dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate) [2015 version]
• Addyi (flibanserin) [2015 version]
• Adempas (riociguat) [2017 version]
• Adlyxin (lixisenatide) {2016 version]
• Advair Diskus (fluticasone propionate and salmeterol xinafoate) [2/2017 version] 
• Advair HFA (fluticasone propionate and salmeterol xinafoate) [2/2017 version]
• Afrezza (insulin human) [2015 version]
• Ambien (zolpidem tartrate) [2014 version]
• Ambien CR (zolpidem tartrate) [2014 version]
• Amevive* (alefacept) [2012 version]
• Amjevita (adalimumab-atto) [9/2016 version]  
• Ampyra (dalfampridine) [2016 version]  
• Anafranil (clomipramine hydrochloride) [2014 version]
• Anaprox (naproxen sodium) [8/2016 version]
• Androgel (1%) (testosterone) [2014 version] 
• Androgel (1.62%) (testosterone) [2015 version]
• Anoro Ellipta (Umeclidinium; Vilanterol) [3/2017 version]
• Ansaid (flurbiprofen) [5/2016 version]
• Aplenzin (bupropion hydrobromide [5/2017 version]
• Aptryxol( desvenlafaxine ) extended Release Tablets  [2017 version]
• Aranesp* (darbepoetin alfa) [4/2017 version)
• Arcapta (indacaterol maleate) [2012 version]
• Aristada (aripiprazole lauroxil) [6/2017 version] 
• Arthrotec (diclofenac sodium) [5/2016 version]
• Arymo ER (morphine sulfate)  [2017 version]
• Astagraf XL (tacrolimus) [2014 version]
• Atelvia (risedronate sodium) [2015 version]
• Ativan (lorazepam) [2016 version]
• Aubagio (teriflunomide) [2016 version]
• Austedo (deutetrabenazine ) [4/2017 version]
• Avandamet (metformin hydrochloride and rosiglitazone maleate) [4/2017 version]
• Avandaryl (glimepiride and rosiglitazone maleate) [3/2015 version]
• Avandia (rosiglitazone maleate) [5/2014 version]
• Aveed (testosterone undecanoate) [5/2015 version]
• Avelox (moxifloxacin) [7/2016 version] 
• Avinza (morphine sulfate) [2014 version]
• Avonex* (interferon beta-1a) [2014 version]
• Axiron (testosterone) [7/2017 version] 
• Banzel (rufinamide) [2015 version]
• Bavencio (avelumab) [5/2017 version]
• Baxdela ( delafloxacin) [6/2017 version] 
• Belbuca (buprenorphine) [12/2016 version]
• Belsomra  (suvorexant) [2014 version]
• Benlysta (belimumab) [2016 version] 
• Betaseron*(interferon beta-1b) [2016 version]
• Bevespi Aerosphere (glycopyrrolate and formoterol fumarate) [4/2016 version]
• Bevyxxa (betrixaban) [6/2017 version] 
• Binosto (alendronate sodium) [2/2015 version]
• Blincyto (blinatumomab) injection [7/2017 version] 
• Boniva (ibandronate sodium) Injection [2016 version]
• Boniva (ibandronate sodium) Tablets [2016  version]
• Botox* (onabotulinumtoxinA) [1/2016 version]
• Breo Ellipta (fluticasone furoate and vilanterol) [5/2017 version]
• Brilinta (ticagrelor) [9/2016 version]
• Brintellix (vortioxetine) [2014 version] 
• Brisdelle (paroxetine) [4/2017 version]
• Briviact ((brivaracetam) [2/2016 version]
• Brovana (arformoterol tartrate) [2014 version]
• Bunavail (Buprenorphine and naloxone) Buccal Film (2016)
• Butrans (buprenorphine) [2016 version] 
• Bydureon (exenatide) [32015 version]
• Byetta (exenatide) [2/2015 version]
• Cambia (diclofenac) [3/2017 version]
• Caprelsa (vandetanib) [3/2014 version]
• Carbatrol (carbamazepine) [2013 version]
• Cataflam (diclofenac potassium) [5/2016 version]
• Celebrex (celecoxib) [5/2016 version]
• Celexa (citalopram hydrobromide) [2017version]
• Cellcept (mycophenolate mofetil) [2013 version] 
• Celontin (methsuximide) [2010 version]
• Cerdelga (eliglustat) [2014 version]
• Chantix (varenicline tartrate) [2016 version]
• Cimzia* (certolizumab pegol) [2016 version]
• Cipro (ciprofloxacin) [2016 version]
• Clinoril (sulindac) [2010 version]
• Codeine Sulfate oral solution [2016 version]
• Codeine Sulfate tablets [2016 version]
• Colcrys (colchicine) [2012 version]
• Combunox (oxycodone hydrochloride and ibuprofen) [2010 version]
• Concerta (methylphenidate hydrochloride) [2013 version]
• Contrave(naltrexone HCl and bupropion HCl) ER [5/2017 version]
• Copegus (ribavirin) [2015 version]
• Cordarone (amiodarone hydrochloride) [3/2015 version]
• Corlanor (ivabradine) [2017 version]
• Cosentyx (secukinumab) [2015 version]
• Cotempla XR-ODT (methylphenidate) [6/2017 version] 
• Coumadin (warfarin sodium) [5/2017 version] 
• Creon (pancrelipase) [2012 version]
• Cymbalta (duloxetine hydrochloride) [2017 version)]
• Daliresp (roflumilast) [2015 version]
• Dalmane (flurazepam hydrochloride) [2009 version]
• Darvocet (acetaminophen and propoxyphene napsylate) [2009 version]
• Darvon (propoxyphene hydrochloride) [2009 version]
• Daypro (oxaprozin potassium) [5/2016 version]
• Daypro Alta (oxaprozin potassium) [5/2016 version]
• Daytrana (methylphenidate) [2017 version] 
• Depakene (valproic acid) [3/2017 version] 
• Depakote ER(divalproex sodium) [3/2017 version]
• Desoxyn (methamphetamine hydrochloride) [2015 version]
• Desvenlafaxine Extended Release Tablet(desvenlafaxine fumarate) [2017version] 
• Desyrel (trazodone hydrochloride) [6/2017 version] 
• Dexedrine (dextroamphetamine sulfate) [2013 version]
• Dexilant (dexlansoprazole) [2016 version]
• Dilantin (phenytoin) Chewable/ER [2015 version]
• Dilantin-125 (phenytoin) [2016 version]
• Dolophine (methadone hydrochloride) [2016 version]
• Doral (quazepam) [2016 version]
• Duetact (glimepiride and pioglitazone) [3/2015 version]
• Duexis (ibuprofen and famotidine) [6/2017 version] 
• Dulera (mometasone furoate and formoterol fumarate) [4/2015 version] 
• Duragesic (fentanyl) [2016 version]
• Dyanavel XR (amphetamine) [5/2017 version]
• Dysport  (abobotulinumtoxinA) [6/2017 version] 
• EC-Naprosyn (naproxen) [8/2016 version]
• Edluar (zolpidem tartrate) [2013 version]
• Effexor (venlafaxine hydrochloride) [2012 version]
• Effexor XR (venlafaxine hydrochloride) [1/2017 version
• Effient (prasugrel) [1/2016 version]
• Elidel Cream (pimecrolimus) [3/2014 version]
• Eliquis (apixaban) [6/2015 version]
• Embeda (morphine sulfate and naltrexone hydrochloride) [2014 version]
• Emsam (selegeline transdermal system) [2007 version]
• Enbrel* (etanercept) [2013 version]
• Entyvio (vedolizumab) [2014 version]  
• Epogen* (epoetin alfa) [2012 version] 
• Epzicom (abacavir sulfate and lamivudine) [3/2017 version]
• Equetro (carbamazepine) [9/2016 version]
• Erivedge (vismodegib) [2016 version] 
• Estazolam [2008 version]
• Evista (raloxifene hydrochloride) [2007 version]
• Exalgo (hydromorphone hydrochloride) [2014 version]
• Extavia (interferon beta-1b) [2016 version]
• Extraneal (icodextrin) [2010 version]
• Exubera (insulin recombinant human) [2008 version]
• Factive (gemifloxacin) [2016 version]
• Farxiga (dapagliflozin) [8/2016 version]
• Farydak (panobinostat) [2/2015 version]
• Felbatol (felbamate) [2011 version]
• Feldene (piroxicam) [5/2016 version]
• Fentora (fentanyl citrate) [12/2016 version]
• Ferriprox (deferiprone) [2012 version]
• Fetzima (levomilnacipran) [2017 version]
• FIORINAL with CODEINE (Butalbital, Aspirin, Caffeine, and Codeine Phosphate) [12/2016 version]
• Flector (diclofenac epolamine) [5/2016 version]
• Floxin (ofloxacin) [2011 version]
• Fluoxetine (Fluoxetine) [2017 version]
• Fluvoxamine Flluvoxamine Maleate)[2014 version]
• Focalin (dexmethylphenidate hydrochloride) [2017 version]
• Focalin XR (dexmethylphenidate hydrochloride) [2017 version]
• Foradil Aerolizer (formoterol fumarate inhalation powder) [2012 version]
• Foradil Certihaler (formoterol fumarate inhalation powder) [2010 version]
• Forfivo XL (bupropion hydrochloride) [5/2017 version]
• Forteo (teriparatide) [2013 version]
• Fortesta (testosterone) [5/2015 version]
• Fosamax (alendronate sodium) [2013 version]
• Fosamax Plus D (alendronate sodium and cholecalciferol) [2013 version]
• Fosrenol (lanthanum carbonate) [9/2014 version]
• Fycompa (perampanel) [4/2016 version] 
• Gabitril (tiagabine) [11/2015 version]
• Gattex (teduglutide [rDNA origin]) [2012 version] 
• Gilenya (fingolimid) [2/2016 version]
• Glyxambi (empagliflozin and linagliptin) Tablets [3/2017 version]
• GoLytely (polyethylene glycol 3500, potassium chloride, sodium bicarbonate, sodium chloride, and sodium sulfate anhydrous) [2013 version]
• Gralise (gabapentin) [2012 version]
• Halcion (triazolam) [2016 version]
• HalfLytely and Bisacodyl Bowel Prep Kit (bisacodyl, polyethylene glycol 3500, potassium chloride, sodium bicarbonate, and sodium chloride) [2010 version]
• Horizant (gabapentin enacarbil) [2013 version] 
• H.P. Acthar Gel (repository corticotropin) [2010 version]
• Humira (adalimumab) [4/2017 version]
• Hycodan ( hydrocodone bitartrate and homatropine methylbromide) [2017 version]
• Hydromorphone Hydrochloride ER [2014 version]
• Hysingla ER (Hydrocodone, Bitartrate) [2016 version]
• Iclusig (ponatinib) [2016 version]
• Ilaris* (canakinumab) [7/2016 version]
• Imfinzi (durvalumab) [4/2017 version]
• Impavido (miltefosine) [2014 version]
• Incivek (telaprevir) [2013 version]
• Indocin (indomethacin) [5/2016 version]
• Indocin SR (indomethacin) [5/2016 version]
• Inflectra (Infliximab-dyyb) [4/2016 version]
• Infergen* (interferon alfacon-1) [2013 version]
• Intermezzo (zolpidem tartrate) [2013 version]
•  Intron A* (interferon alfa-2b) [4/2014 version]
• Invirase (saquinavir mesylate) [12/2016 version] 
• Invokamet (canagliflozin and metformin hydrochloride) [2017]  
• Invokamet XR (canagliflozin and metformin hydrochloride extended-release) [2016 version]
• Invokana (canagliflozin) [2016 version]
• Janumet (metformin hydrochloride and sitagliptin phosphate) [2013 version]
• Janumet XR (sitagliptin and metformin hydrochloride) [2014 version]
• Januvia (sitagliptin phosphate) [2013 version]
• Jentadueto (linagliptin and metformin hydrochloride) [3/2017 version]
• Jentadueto XR (linagliptin and metformin hydrochloride) [7/2017 version] 
• Juvisync (sitagliptin and simvastatin) [2014 version]
• Juxtapid (lomitapide) [5/2016 version]   
• Kadian (morphine sulfate) [12/2016 version]
• Kalbitor* (ecallantide) [3/2014 version]
• Kaletra Capsules (lopinavir and ritonavir) [6/2017 version] 
• Kaletra Tablets and Oral Solution (lopinavir and ritonavir) [6/2017 version] 
• Kazano (alogliptin and metformin hydrochloride) [4/2016 version] 
• Keppra (levetiracetam) [4/2017 version]
• Keppra XR (levetiracetam) [4/2017 version
• Ketek (telithromycin) [2010 version]
• Kevzara injection (sarilumab) [5/2017 version]
• Keytruda (pembrolizumab) [5/2017 version] 
• Khedezla (desvenlafaxine) [2016 version]
• Klonopin (clonazepam) [2016 version] 
• Kombiglyze XR (metformin hydrochloride and saxagliptin) [2/2017 version]  
• Korlym (mifepristone) [5/2017 version]
• Krystexxa* (pegloticase) [12/2014 version]
• Kynamro (mipomersen sodium) [5/2016 version] 
• Lacosamide Tablets (lacosamide) [4/2016 version]
• Lacosamide Tablets CV (lacosamide) [4/2016 version]
• Lacosamide Oral Solution (lacosamide) [3/2016 version]
• Lamictal (lamotrigine) [2013 version] 
• Lamictal XR (lamotrigine) [2013 version]
• Lamisil (terbinafine hydrochloride) [8/2016 version]
• Lariam (mefloquine hydrochloride) [2009 version]
• Latuda (lurasidone hydrochloride) [2017 version]
• Lazanda (fentanyl citrate) [2016 version]
• Lemtrada (alemtuzumab) Injection [11/2014 version]
• Letairis (ambrisentan) [10/2015 version] 
• Levaquin (levofloxacin) [2016 version]
• Lexapro (escitalopram oxalate) [2017 version]
• Librax  ( chlordiazepoxide HCl and clidinium bromide ) [2017 version]
• Librium(chlordiazepoxide) [2016 version]
• Limbitrol (chlordiazepoxide and amitriptyline) [2016 version]
• Lindane Lotion (lindane) [2007 version]
• Lindane Shampoo (lindane) [2007 version]
• Linzess (linaclotide) [3/2017 version]
• Lotronex (alosetron hydrochloride) [/2016 version]
• Lunesta (eszopiclone) [2014 version]
• Lupron Injection (leuprolide acetate) [5/2017 version]
• Lupron Depot-Ped (leuprolide acetate for depot suspension) [5/2017 version]
• Luvox (fluvoxamine maleate) [2014 version] See: Fluvoxamine
• Luvox CR (fluvoxamine maleate) [2014 version]
• Lynparza (olaparib) [2014 version]
• Lyrica (pregabalin) [2013 version]
• Marplan (isocarboxazid) [2008 version]
• Mekinist (trametinib) [2015 version]
• Meridia (sibutramine hydrochloride) [2010 version]
• Metadate CD (methylphenidate hydrochloride) [2014 version]
• Methylin (methylphenidate)
  • chewable tablets [2013 version]
  • oral solution [2013 version]
• Metoclopramide Oral Solution [2009 version]
• Metozolv ODT (metoclopramide hydrochloride) [2011 version]
• Mifeprex (mifepristone) [2016 version]
• Mircera* (methoxy polyethylene glycol-epoetin beta) [4/2016 version]
• Mitigare (Colchicine) [9/2014 version]
• Mobic (meloxicam) [5/2016 version]
• Morphabond (morphine sulfate)extended release tablets [12/2016]
• 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]
• Moxifloxacin (moxifloxacin) [7/2016 version]
• MS Contin (morphine sulfate) [2014 version] 
• Multaq (dronedarone) [2014 version]
• Myalept (Metreleptin) [2015 version]
• Mydayis (mixed salts of a single-entity amphetamine product ) [6/2017 version] 
• Myfortic (mycophenolic acid) [2013 version]
• Myobloc* (rimabotulinumtoxinB) [2009 version]
• Mysoline (primidone) [2010 version]