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:
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) [2012 version]
- Absorica (isotrentinoin) [2012 version]
- Abstral (fentanyl) [2011]
- Accutane (isotretinoin) [2010 version]
- Actemra* (tocilizumab) [2011 version]
- Actiq (fentanyl citrate) [2011 version]
- Actonel (risedronate sodium) [2011 version]
- Actonel with Calcium (risedronate sodium and calcium carbonate) [2011 version]
- Actoplus Met (metformin hydrochloride and pioglitazone hydrochloride) [2012 version]
- Actoplus Met XR (metformin hydrochloride and pioglitazone hydrochloride) [2011 version]
- Actos (pioglitazone hydrchloride) [2011 version]
- Adderall XR (dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate) [2011 version]
- Advair Diskus (fluticasone propionate and salmeterol xinafoate) [2011 version]
- Advair HFA (fluticasone propionate and salmeterol xinafoate) [2011 version]
- Ambien (zolpidem tartrate) [2010 version]
- Ambien CR (zolpidem tartrate) [2010 version]
- Amevive* (alefacept) [2012 version]
- Ampyra (dalfampridine) [2010 version]
- Anafranil (clomipramine hydrochloride) [2007 version]
- Anaprox (naproxen sodium) [2008 version]
- Androgel (testosterone) [2011 version]
- Androgel (1.62%) (testosterone) [2011 version]
- Ansaid (flurbiprofen) [2010 version]
- Aplenzin (bupropion hydrobromide [2011 version]
- Aranesp* (darbepoetin alfa) [2012 version)
- Arcapta (indacaterol maleate) [2011 version]
- Arthrotec (diclofenac sodium) [2010 version]
- Atelvia (risedronate sodium) [2011 version]
- Avandamet (metformin hydrochloride and rosiglitazone maleate) [2011 version]
- Avandaryl (glimepiride and rosiglitazone maleate) [2011 version]
- Avandia (rosiglitazone maleate) [2011 version]
- Avelox (moxifloxacin) [2011 version]
- Avonex* (interferon beta-1a) [2012 version]
- Axiron (testosterone) [2011 version]
- Banzel (rufinamide) [2011 version]
- Benlysta (belimumab) [2012 version]
- Betaseron*(interferon beta-1b) [2009 version]
- Boniva (ibandronate sodium) Injection [2011 version]
- Boniva (ibandronate sodium) Tablets [2011 version]
- Botox* (onabotulinumtoxinA) [2011 version]
- Brilinta (ticagrelor) [2011 version]
- Brovana (arformoterol tartrate) [2011 version]
- Butrans (buprenorphine) [2010 version]
- Bydureon (exenatide) [2012 version]
- Byetta (exenatide) [2011 version]
- Cambia (diclofenac) [2009 version]
- Carbatrol (carbamazepine) [2010 version]
- Cataflam (diclofenac potassium) [2011 version]
- Celebrex (celecoxib) [2011 version]
- Celexa (citalopram hydrobromide) [2012 version]
Cellcept (mycophenolate mofetil) [2012 version]
- Celontin (methsuximide) [2010 version]
- Chantix (varenicline tartrate) [2011 version]
- Cimzia* (certolizumab pegol) [2011 version]
- Cipro (ciprofloxacin) [2011 version]
- Clinoril (sulindac) [2010 version]
- Codeine Sulfate oral solution [2012 version]
- Colcrys (colchicine) [2011 version]
- Combunox (oxycodone hydrochloride and ibuprofen) [2010 version]
- Concerta (methylphenidate hydrochloride) [2010 version]
- Copegus (ribavirin) [2011 version]
- Cordarone (amiodarone hydrochloride) [2011 version]
- Coumadin (warfarin sodium) [2010 version]
- Creon (pancrelipase) [2011 version]
- Cymbalta (duloxetine hydrochloride) [2008 version)]
- Daliresp (roflumilast) [2011 version]
- Dalmane (flurazepam hydrochloride) [2009 version]
- Darvocet (acetaminophen and propoxyphene napsylate) [2009 version]
- Darvon (propoxyphene hydrochloride) [2009 version]
- Daypro Alta (oxaprozin potassium) [2007 version]
- Daytrana (methylphenidate) [2010 version]
- Desoxyn (methamphetamine hydrochloride) [2007 version]
- Dexedrine (dextroamphetamine sulfate) [2008 version]
- Dilantin (phenytoin) [2011 version]
- Dilantin-125 (phenytoin) [2011 version]
- Doral (quazepam) [2007 version]
- Duetact (glimepiride and pioglitazone) [2011 version]
- Duexis (ibuprofen and famotidine) [2011 version]
- Dulera (mometasone furoate and formoterol fumarate) [2010 version]
- Duragesic (fentanyl) [2009 version]
- Dysport* (abobotulinumtoxinA) [2012 version]
- EC-Naprosyn (naproxen) [2008 version]
- Edluar (zolpidem tartrate) [2009 version]
- Effexor (venlafaxine hydrochloride) [2012 version]
- Effexor XR (venlafaxine hydrochloride) [2012 version]
- Effient (prasugrel) [2011 version]
- Elidel Cream (pimecrolimus) [2010 version]
- Embeda (morphine sulfate and naltrexone hydrochloride) [2009 version]
- Emsam (selegeline transdermal system) [2007 version]
- Enbrel* (etanercept) [2010 version]
- Epogen* (epoetin alfa) [2012 version]
- Epzicom (abacavir sulfate and lamivudine) [2012 version]
- Erivedge (vismodegib) [2012 version]
- Evista (raloxifene hydrochloride) [2007 version]
- Exalgo (hydromorphone hydrochloride) [2010 version]
- Extavia* (interferon beta-1b) [2012 version]
- Extraneal (icodextrin) [2010 version]
- Exubera (insulin recombinant human) [2008 version]
- Factive (gemifloxacin) [2011 version]
- Felbatol (felbamate) [2011 version]
- Feldene (piroxicam) [2010 version]
- Fentora (fentanyl citrate) [2011 version]
- Ferriprox (deferiprone) [2012 version]
- Flector (diclofenac epolamine) [2010 version]
- Floxin (ofloxacin) [2011 version]
- Focalin (dexmethylphenidate hydrochloride) [2012 version]
- Focalin XR (dexmethylphenidate hydrochloride) [2012 version]
- Foradil Aerolizer (formoterol fumarate inhalation powder) [2012 version]
- Foradil Certihaler (formoterol fumarate inhalation powder) [2010 version]
- Forfivo XL (bupropion hydrochloride) [2011 version]
- Forteo (teriparatide) [2009 version]
- Fortesta (testosterone) [2010 version]
- Fosamax Plus D (alendronate sodium and cholecalciferol) [2011 version]
- Fosrenol (lanthanum carbonate) [2011 version]
- Gabitril (tiagabine) [2010 version]
- Gilenya (fingolimid) [2012 version]
- Gralise (gabapentin) [2011 version]
- Halcion (triazolam) [2008 version]
- HalfLytely and Bisacodyl Bowel Prep Kit (bisacodyl, polyethylene glycol 3500, potassium chloride, sodium bicarbonate, sodium chloride) [2010 version]
- Horizant (gabapentin enacarbil) [2012 version]
- H.P. Acthar Gel (repository corticotropin) [2010 version]
- Humira* (adalimumab) [2011 version]
- Indocin (indomethacin) [2008 version]
- Infergen* (interferon alfacon-1) [2010 version]
- Intermezzo (zolpidem tartrate) [2011 version]
- Invirase (saquinavir mesylate) [2012 version]
- Janumet (metformin hydrochloride and sitagliptin phosphate) [2012 version]
- Janumet XR (sitagliptin and metformin hydrochloride) [2012 version]
- Januvia (sitagliptin phosphate) [2012 version]
- Juvisync (sitagliptin and simvastatin) [2011 version]
- Kalbitor* (ecallantide) [2009 version]
- Kaletra Tablets and Oral Solution (lopinavir and ritonavir) [2012 version]
- Keppra (levetiracetam) [2011 version]
- Ketek (telithromycin) [2010 version]
- Klonopin (clonazepam) [2010 version]
- Kombiglyze XR (metformin hydrochloride and saxagliptin) [2012 version]
- Korlym (mifepristone) [2012 version]
- Lamictal (lamotrigine) [2011 version]
- Lamictal XR (lamotrigine) [2011 version]
- Lariam (mefloquine hydrochloride) [2009 version]
- Lazanda (fentanyl citrate) [2011 version]
- Letairis (ambrisentan) [2012 version]
- Levaquin (levofloxacin) [2011 version]
- Lexapro (escitalopram oxalate) [2011 version]
- Limbitrol (chlordiazepoxide and amitriptyline) [2007 version]
- Lindane Lotion (lindane) [2007 version]
- Lindane Shampoo (lindane) [2007 version]
- Lotronex (alosetron hydrochloride) [2010 version]
- Lunesta (eszopiclone) [2008 version]
- Luvox (fluvoxamine maleate) [2011 version]
- Luvox CR (fluvoxamine maleate) [2011 version]
- Marplan (isocarboxazid) [2008 version]
- Meridia (sibutramine hydrochloride) [2010 version]
- Metadate CD (methylphenidate hydrochloride) [2009 version]
- Methylin (methylphenidate)
- chewable tablets [2010 version]
- oral solution [2010 version]
- Metoclopramide Oral Solution [2009 version]
- Metozolv ODT (metoclopramide hydrochloride) [2011 version]
- Mifeprex (mifepristone) [2009 version]
- Mircera* (methoxy polyethylene glycol-epoetin beta) [2007 version]
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