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.
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) [2016 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) [2012 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) [2013 version]
Adlyxin (lixisenatide) {2016 version]
Advair Diskus (fluticasone propionate and salmeterol xinafoate) [4/2016 version]
Advair HFA (fluticasone propionate and salmeterol xinafoate) [2014 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) [2016 version]
Androgel (1%) (testosterone) [2014 version]
Androgel (1.62%) (testosterone) [2015 version]
Anoro Ellipta (Umeclidinium; Vilanterol) [2016 version]
Ansaid (flurbiprofen) [5/2016 version]
Aplenzin (bupropion hydrobromide [2016 version]
Aptryxol( desvenlafaxine ) extended Release Tablets [2017 version]
Aranesp* (darbepoetin alfa) [2012 version)
Arcapta (indacaterol maleate) [2012 version]
Aristada (aripiprazole lauroxil) [10/2015 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]
Avandamet (metformin hydrochloride and rosiglitazone maleate) [5/2014 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) [5/2015 version]
Banzel (rufinamide) [2015 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]
Binosto (alendronate sodium) [2/2015 version]
Blincyto (blinatumomab) injection [8/2016 version]
Boniva (ibandronate sodium) Injection [2016 version]
Boniva (ibandronate sodium) Tablets [2016 version]
Botox* (onabotulinumtoxinA) [1/2016 version]
Breo Ellipta (fluticasone furoate and vilanterol) [2015 version]
Brilinta (ticagrelor) [9/2016 version]
Brintellix (vortioxetine) [2014 version]
Brisdelle (paroxetine) [2016 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) [5/2016 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]
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]
Copegus (ribavirin) [2015 version]
Cordarone (amiodarone hydrochloride) [2015 version]
Corlanor (ivabradine) [2017 version]
Cosentyx (secukinumab) [2015 version]
Coumadin (warfarin sodium) [2016 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) [2/2016 version]
Depakote ER(divalproex sodium) [2/2016 version]
Desoxyn (methamphetamine hydrochloride) [2015 version]
Desvenlafaxine Extended Release Tablet(desvenlafaxine fumarate) [2017version]
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) [5/2016 version]
Dulera (mometasone furoate and formoterol fumarate) [4/2015 version]
Duragesic (fentanyl) [2016 version]
Dyanavel XR (amphetamine) [2017 version]
Dysport* (abobotulinumtoxinA) [2016 version]
EC-Naprosyn (naproxen) [2013 version]
Edluar (zolpidem tartrate) [2013 version]
Effexor (venlafaxine hydrochloride) [2012 version]
Effexor XR (venlafaxine hydrochloride) [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) [9/2015 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) [6/2016 version]
Farydak (panobinostat) [2/2015 version]
Felbatol (felbamate) [2011 version]
Feldene (piroxicam) [5/2016 version]
Fentora (fentanyl citrate) [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 (Fluvoxamine 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) [2014 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 [2016 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) [2013 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]
<a href="http://www.fda.gov/downloads/Drugs/DrugSafety/UCM390972.pdf" style="border-bo