CIENCIASMEDICASNEWS: Drug Safety and Availability

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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.

Please note: All links in the table below go to documents in PDF format.

Medication Guides are available for these products:

*biologic or drug/biologic combination

Abilify⁴ (aripiprazole) [2012 version]
Absorica⁵ (isotrentinoin) [2012 version]
Abstral⁶ (fentanyl) [2011]
Accutane⁷ (isotretinoin) [2010 version]
Actemra⁸* (tocilizumab) [2011 version]
Actiq⁹ (fentanyl citrate) [2011 version]
Actonel¹⁰ (risedronate sodium) [2011 version]
Actonel with Calcium¹¹ (risedronate sodium and calcium carbonate) [2011 version]
Actoplus Met¹² (metformin hydrochloride and pioglitazone hydrochloride) [2012 version]
Actoplus Met XR¹³ (metformin hydrochloride and pioglitazone hydrochloride) [2011 version]
Actos¹⁴ (pioglitazone hydrchloride) [2011 version]
Adderall XR¹⁵ (dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate) [2011 version]
Advair Diskus¹⁶ (fluticasone propionate and salmeterol xinafoate) [2011 version]
Advair HFA¹⁷ (fluticasone propionate and salmeterol xinafoate) [2011 version]
Ambien¹⁸ (zolpidem tartrate) [2010 version]
Ambien CR¹⁹ (zolpidem tartrate) [2010 version]
Amevive²⁰* (alefacept) [2012 version]
Ampyra²¹ (dalfampridine) [2010 version]
Anafranil²² (clomipramine hydrochloride) [2007 version]
Anaprox²³ (naproxen sodium) [2008 version]
Androgel²⁴ (testosterone) [2011 version]
Androgel²⁵ (1.62%) (testosterone) [2011 version]
Ansaid²⁶ (flurbiprofen) [2010 version]
Aplenzin²⁷ (bupropion hydrobromide [2011 version]
Aranesp²⁸* (darbepoetin alfa) [2011 version)
Arcapta²⁹ (indacaterol maleate) [2011 version]
Arthrotec³⁰ (diclofenac sodium) [2007 version]
Atelvia³¹ (risedronate sodium) [2011 version]
Avandamet³² (metformin hydrochloride and rosiglitazone maleate) [2011 version]
Avandaryl³³ (glimepiride and rosiglitazone maleate) [2011 version]
Avandia³⁴ (rosiglitazone maleate) [2011 version]
Avelox³⁵ (moxifloxacin) [2011 version]
Avonex³⁶* (interferon beta-1a) [2012 version]
Axiron³⁷ (testosterone) [2011 version]
Banzel³⁸ (rufinamide) [2011 version]
Benlysta³⁹ (belimumab) [2012 version]
Betaseron⁴⁰*(interferon beta-1b) [2009 version]
Boniva⁴¹ (ibandronate sodium) Injection [2011 version]
Boniva⁴² (ibandronate sodium) Tablets [2011 version]
Botox⁴³* (onabotulinumtoxinA) [2011 version]
Brilinta⁴⁴ (ticagrelor) [2011 version]
Brovana⁴⁵ (arformoterol tartrate) [2011 version]
Butrans⁴⁶ (buprenorphine) [2010 version]
Bydureon⁴⁷ (exenatide) [2012 version]
Byetta⁴⁸ (exenatide) [2009 version]
Cambia⁴⁹ (diclofenac) [2009 version]
Carbatrol ⁵⁰(carbamazepine) [2010 version]
Cataflam⁵¹ (diclofenac potassium) [2011 version]
Celebrex⁵² (celecoxib) [2011 version]
Celexa⁵³ (citalopram hydrobromide) [2012 version]
Cellcept⁵⁴ (mycophenolate mofetil) [2009 version]
Celontin⁵⁵ (methsuximide) [2010 version]
Chantix⁵⁶ (varenicline tartrate) [2011 version]
Cimzia⁵⁷* (certolizumab pegol) [2011 version]
Cipro⁵⁸ (ciprofloxacin) [2011 version]
Clinoril⁵⁹ (sulindac) [2010 version]
Codeine Sulfate⁶⁰ oral solution [2012 version]
Colcrys⁶¹ (colchicine) [2011 version]
Combunox⁶² (oxycodone hydrochloride and ibuprofen) [2010 version]
Concerta⁶³ (methylphenidate hydrochloride) [2010 version]
Copegus⁶⁴ (ribavirin) [2011 version]
Cordarone⁶⁵ (amiodarone hydrochloride) [2011 version]
Coumadin⁶⁶ (warfarin sodium) [2010 version]
Creon⁶⁷ (pancrelipase) [2011 version]
Cymbalta⁶⁸ (duloxetine hydrochloride) [2008 version)]
Daliresp⁶⁹ (roflumilast) [2011 version]
Dalmane⁷⁰ (flurazepam hydrochloride) [2009 version]
Darvocet⁷¹ (acetaminophen and propoxyphene napsylate) [2009 version]
Darvon⁷² (propoxyphene hydrochloride) [2009 version]
Daypro Alta⁷³ (oxaprozin potassium) [2007 version]
Daytrana⁷⁴ (methylphenidate) [2010 version]
Desoxyn⁷⁵ (methamphetamine hydrochloride) [2007 version]
Dexedrine⁷⁶ (dextroamphetamine sulfate) [2008 version]
Dilantin⁷⁷ (phenytoin) [2011 version]
Dilantin-125⁷⁸ (phenytoin) [2011 version]
Doral⁷⁹ (quazepam) [2007 version]
Duetact⁸⁰ (glimepiride and pioglitazone) [2011 version]
Duexis⁸¹ (ibuprofen and famotidine) [2011 version]
Dulera⁸² (mometasone furoate and formoterol fumarate) [2010 version]
Duragesic⁸³ (fentanyl) [2009 version]
Dysport⁸⁴* (abobotulinumtoxinA) [2012 version]
EC-Naprosyn⁸⁵ (naproxen) [2008 version]
Edluar⁸⁶ (zolpidem tartrate) [2009 version]
Effexor⁸⁷ (venlafaxine hydrochloride) [2012 version]
Effexor XR⁸⁸ (venlafaxine hydrochloride) [2012 version]
Effient⁸⁹ (prasugrel) [2011 version]
Elidel Cream ⁹⁰(pimecrolimus) [2010 version]
Embeda⁹¹ (morphine sulfate and naltrexone hydrochloride) [2009 version]
Emsam⁹² (selegeline transdermal system) [2007 version]
Enbrel⁹³* (etanercept) [2010 version]
Epogen⁹⁴* (epoeten alfa) [2011 version]
Epzicom⁹⁵ (abacavir sulfate and lamivudine) [2012 version]
Erivedge⁹⁶ (vismodegib) [2012 version]
Evista⁹⁷ (raloxifene hydrochloride) [2007 version]
Exalgo⁹⁸ (hydromorphone hydrochloride) [2010 version]
Extavia⁹⁹* (interferon beta-1b) [2012 version]
Extraneal¹⁰⁰ (icodextrin) [2010 version]
Exubera¹⁰¹ (insulin recombinant human) [2008 version]
Factive¹⁰² (gemifloxacin) [2011 version]
Felbatol¹⁰³ (felbamate) [2011 version]
Feldene¹⁰⁴ (piroxicam) [2010 version]
Fentora¹⁰⁵ (fentanyl citrate) [2011 version]
Ferriprox ¹⁰⁶(deferiprone) [2012 version]
Flector¹⁰⁷ (diclofenac epolamine) [2010 version]
Floxin¹⁰⁸ (ofloxacin) [2011 version]
Focalin¹⁰⁹ (dexmethylphenidate hydrochloride) [2012 version]
Focalin XR¹¹⁰ (dexmethylphenidate hydrochloride) [2012 version]
Foradil Aerolizer¹¹¹ (formoterol fumarate inhalation powder) [2012 version]
Foradil Certihaler¹¹² (formoterol fumarate inhalation powder) [2010 version]
Forfivo XL¹¹³ (bupropion hydrochloride) [2011 version]
Forteo¹¹⁴ (teriparatide) [2009 version]
Fortesta¹¹⁵ (testosterone) [2010 version]
Fosamax¹¹⁶ (alendronate sodium) [2011 version]
Fosamax Plus D¹¹⁷ (alendronate sodium and cholecalciferol) [2011 version]
Fosrenol¹¹⁸ (lanthanum carbonate) [2011 version]
Gabitril¹¹⁹ (tiagabine) [2010 version]
Gilenya¹²⁰ (fingolimid) [2012 version]
Gralise¹²¹ (gabapentin) [2011 version]
Halcion¹²² (triazolam) [2008 version]
HalfLytely and Bisacodyl Bowel Prep Kit¹²³ (bisacodyl, polyethylene glycol 3500, potassium chloride, sodium bicarbonate, sodium chloride) [2010 version]
Horizant¹²⁴ (gabapentin enacarbil) [2011 version]
H.P. Acthar Gel¹²⁵ (repository corticotropin) [2010 version]
Humira¹²⁶* (adalimumab) [2011 version]
Incivek¹²⁷ (telaprevir) [2012 version]
Indocin¹²⁸ (indomethacin) [2008 version]
Infergen¹²⁹* (interferon alfacon-1) [2010 version]
Intermezzo¹³⁰ (zolpidem tartrate) [2011 version]
Intron A¹³¹* (interferon alfa-2b) [2008 version]
Invirase¹³² (saquinavir mesylate) [2012 version]
Janumet¹³³ (metformin hydrochloride and sitagliptin phosphate) [2012 version]
Janumet XR¹³⁴ (sitagliptin and metformin hydrochloride) [2012 version]
Januvia¹³⁵ (sitagliptin phosphate) [2012 version]
Juvisync¹³⁶ (sitagliptin and simvastatin) [2011 version]
Kalbitor¹³⁷* (ecallantide) [2009 version]
Kaletra¹³⁸ (lopinavir and ritonavir) [2012 version]
Keppra¹³⁹ (levetiracetam) [2011 version]
Ketek¹⁴⁰ (telithromycin) [2010 version]
Klonopin¹⁴¹ (clonazepam) [2010 version]
Kombiglyze XR¹⁴² (metformin hydrochloride and saxagliptin) [2012 version]
Korlym¹⁴³ (mifepristone) [2012 version]
Krystexxa¹⁴⁴* (pegloticase) [2010 version]
Lamictal¹⁴⁵ (lamotrigine) [2011 version]
Lamictal XR¹⁴⁶ (lamotrigine) [2011 version]
Lariam¹⁴⁷ (mefloquine hydrochloride) [2009 version]
Lazanda¹⁴⁸ (fentanyl citrate) [2011 version]
Letairis¹⁴⁹ (ambrisentan) [2012 version]
Levaquin¹⁵⁰ (levofloxacin) [2011 version]
Lexapro¹⁵¹ (escitalopram oxalate) [2011 version]
Limbitrol¹⁵² (chlordiazepoxide and amitriptyline) [2007 version]
Lindane Lotion¹⁵³ (lindane) [2007 version]
Lindane Shampoo¹⁵⁴ (lindane) [2007 version]
Lotronex¹⁵⁵ (alosetron hydrochloride) [2010 version]
Lunesta¹⁵⁶ (eszopiclone) [2008 version]
Luvox¹⁵⁷ (fluvoxamine maleate) [2011 version]
Luvox CR¹⁵⁸ (fluvoxamine maleate) [2011 version]
Lyrica¹⁵⁹ (pregabalin) [2011 version]
Marplan¹⁶⁰ (isocarboxazid) [2008 version]
Meridia¹⁶¹ (sibutramine hydrochloride) [2010 version]
Metadate CD¹⁶² (methylphenidate hydrochloride) [2009 version]
Methylin (methylphenidate)
- chewable tablets¹⁶³ [2010 version]
- oral solution¹⁶⁴ [2010 version]
Metoclopramide Oral Solution¹⁶⁵ [2009 version]
Metozolv ODT¹⁶⁶ (metoclopramide hydrochloride) [2011 version]
Mifeprex¹⁶⁷ (mifepristone) [2009 version]
Mircera¹⁶⁸* (methoxy polyethylene glycol-epoetin beta) [2007 version]

Mobic¹⁶⁹ (meloxicam) [2011 version]
Morphine Sulfate¹⁷⁰ (morphine sulfate oral solution) [2010 version]
Motrin¹⁷¹ (ibuprofen) [2007 version]
Moviprep¹⁷² (propylene glycol 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid) [2011 version]
Multaq¹⁷³ (dronedarone) [2011 version]
Myfortic¹⁷⁴ (mycophenolic acid) [2009 version]
Myobloc¹⁷⁵* (rimabotulinumtoxinB) [2009 version]
Mysoline¹⁷⁶ (primidone) [2010 version]
Nalfon¹⁷⁷ (fenoprofen calcium) [2009 version]
Naprelan¹⁷⁸ (naproxen sodium) [2011 version]
Naprosyn¹⁷⁹ (naproxen) [2008 version]
Nardil¹⁸⁰ (phenelzine sulfate) [2007 version]
Neurontin¹⁸¹ (gabapentin) [2011 version]
Nolvadex¹⁸² (tamoxifen) [2006 version]
Noroxin¹⁸³ (norfloxacin) [2011 version]
Norpramin¹⁸⁴ (desipramine hydrochloride) [2009 version]
Novantrone¹⁸⁵ (mitoXantrone) [2012 version]
Nplate¹⁸⁶* (romiplostim) [2011 version]
Nucynta¹⁸⁷ (tapentadol hydrochloride) [2010 version]
Nucynta ER¹⁸⁸ (tapentadol) [2011 version]
Nulojix¹⁸⁹* (belatacept) [2011 version]
Nuvigil¹⁹⁰ (armodafinil) [2010 version]
Oleptro¹⁹¹ (trazodone hydrochloride) [2010 version]
Omontys¹⁹² (peginesatide) [2012 version]
Onfi¹⁹³ (clobazam) [2011 version]
Onglyza¹⁹⁴ (saxagliptin hydrochloride) [2011 version]
Onsolis¹⁹⁵ (fentanyl buccal soluble film) [2011 version]
Opana ER¹⁹⁶ (oxymorphone hydrochloride) [2011 version]
Osmoprep¹⁹⁷ (sodium phosphate dibasic anhydrous and sodium phosphate monobasic monohydrate) [2009 version]
Oxycodone Hydrochloride Oral Solution¹⁹⁸ [2012 version]
OxyContin¹⁹⁹ (oxycodone hydrochloride) [2010 version]
Pacerone²⁰⁰ (amiodarone hydrochloride) [2008 version]
Palladone²⁰¹ (hydromorphone hydrochloride) [2004 version]
Pamelor²⁰² (nortriptyline hydrochloride) [2007 version]
Pancreaze²⁰³ (pancrelipase) [2010 version]
Parnate²⁰⁴ (tranylcypromine sulfate) [2008 version]
Paxil²⁰⁵ (paroxetine hydrochloride) [2011 version]
Paxil CR²⁰⁶ (paroxetine hydrochloride) [2011 version]
Peganone²⁰⁷ (ethotoin) [2010 version]
Pegasys²⁰⁸* (peginterferon alfa-2a) [2011 version]
Pegintron²⁰⁹* (peginterferon alfa-2b) [2011 version]
PegIntron*/Rebetol Combo Pack²¹⁰ (peginterferon alfa-2b and ribavirin) [2008 version]
Pennsaid²¹¹ (diclofenac sodium) [2009 version]
Perforomist²¹² (formoterol fumarate) [2010 version]
Pertzye²¹³ (pancrelipase) [2012 version]
Pexeva²¹⁴ (paroxetine mesylate) [2010 version]
Plavix²¹⁵ (clopidogrel bisulfate) [2011 version]
Ponstel²¹⁶ (mefenamic acid) [2008 version]
Potiga²¹⁷ (ezogabine) [2011 version]
Pradaxa ²¹⁸(dabigatran etexilate mesylate) [2012 version]
Prevacid NapraPac²¹⁹ (lansoprazole and naproxen) [2009 version]
Pristiq²²⁰ (desvenlafaxine succinate) [2011 version]
Procrit²²¹* (epoetin alfa) [2011 version]
Prolia²²²* (denosumab) [2012 version]
Propylthiouracil²²³ [2010 version]
Promacta²²⁴ (eltrombopag) [2011 version]
Propulsid²²⁵ (cisapride) [2006 version]
Proquin XR²²⁶ (ciprofloxacin hydrochloride) [2011 version]
Protopic Ointment²²⁷ (tacrolimus) [2006 version]
Provigil²²⁸ (modafinil) [2010 version]
Prozac²²⁹ (fluoxetine hydrochloride) [2009 version]
Qualaquin²³⁰ (quinine sulfate) [2011 version]
Rapamune²³¹ (sirolimus) [2010 version]
Rebetol²³² (ribavirin) [2010 version]
Rebif²³³* (interferon beta-1a) [2002 version]
Reclast²³⁴ (zoledronic acid) [2011 version]
Reglan²³⁵ (metoclopramide hydrochloride) injection [2009 version]
Reglan²³⁶ (metoclopramide hydrochloride) tablets [2011 version]
Reglan ODT²³⁷ (metoclopramide hydrochloride) [2011 version]
Remeron²³⁸ (mirtazapine) [2011 version]
Remeron SolTabs²³⁹ (mirtazapine) [2011 version]
Remicade²⁴⁰* (infliximab) [2011 version]
Restoril²⁴¹ (temazepam) [2010 version]
Revlimid²⁴² (lenalidomide) [2012 version]
Ribasphere²⁴³ (ribavirin) [2008 version]
Ritalin²⁴⁴ (methylphenidate hydrochloride) [2010 version]
Ritalin LA²⁴⁵ (methylphenidate hydrochloride) [2010 version]
Ritalin-SR²⁴⁶ (methylphenidate hydrochloride) [2010 version]
Rituxan²⁴⁷* (rituximab) [2012 version]
Roferon-A²⁴⁸* (interferon alfa-2a recombinant) [2008 version]
Rozerem²⁴⁹ (ramelteon) [2010 version]
Sabril²⁵⁰ (vigabatrin) [2010 version]
Samsca²⁵¹ (tolvaptan) [2012 version]
Sarafem²⁵² (fluoxetine hydrochloride) [2009 version]
Savella²⁵³ (milnacipran hydrochloride) [2010 version]
Selzentry²⁵⁴ (maraviroc) [2011 version]
Serevent Diskus²⁵⁵ (salmeterol xinafoate) [2010 version]
Seroquel²⁵⁶ (quetiapine fumarate) [2011 version]
Seroquel XR²⁵⁷ (quetiapine fumarate) [2011 version]
Silenor²⁵⁸ (doxepin) [2010 version]
Simponi²⁵⁹* (golimumab) [2010 version]
Sinequan²⁶⁰ (doxepin hydrochloride) [2007 version]
Soliris²⁶¹* (eculizumab) [2009 version]
Soltamox²⁶² (tamoxifen citrate) [2005 version]
Soriatane²⁶³ (acitretin) [2011 version]
Sotret²⁶⁴ (isotretinoin) [2006 version]
Stelara²⁶⁵* (ustekinumab) [2010 version]
Strattera²⁶⁶ (atomoxetine hydrochloride) [2011 version]
Suboxone²⁶⁷ (buprenorphine and naloxone) [2011 version]
Subsys²⁶⁸ (fentanyl) [2012 version]
Subutex²⁶⁹ (buprenorphine) [2011 version]
Suprep²⁷⁰ (sodium sulfate, potassium sulfate and magnesium sulfate) [2010 version]
Sutent²⁷¹ (sunitimib malate) [2012 version]
Sylatron²⁷² (peginterferon alfa-2b) [2011 version]
Symbicort²⁷³ (budesonide and formoterol fumarate dihydrate) [2010 version]
Symbyax²⁷⁴ (fluoxetine hydrochloride and olanzapine) [2011 version]
Symlin²⁷⁵ (pramlintide acetate) [2007 version]
Tapentadol²⁷⁶ see Nucynta
Tasigna²⁷⁷ (nilotinib) [2011 version]
Tegretol²⁷⁸ (carbamazepine) [2011 version]
Testim²⁷⁹ (testosterone) [2011 version]
Testosterone Gel²⁸⁰ [2012 version]
Thalomid²⁸¹ (thalidomide) [2012 version]
Tikosyn²⁸² (dofetilide) [2011 version]
Tofranil²⁸³ (imipramine hydrochloride) [2007 version]
Tolectin²⁸⁴ (tolmetin sodium) [2008 version]
Topamax²⁸⁵ (topiramate) [2011 version]
Toradol²⁸⁶ (ketorolac tromethamine) [2007 version]
Tracleer²⁸⁷ (bosentan) [2009 version]
Tranxene²⁸⁸ (clorazepate dipotassium) [2010 version]
Treximet²⁸⁹ (naproxen sodium and sumatriptan succinate) [2012 version]
Trileptal²⁹⁰ (oxcarbazepine) [2011 version]
Trilipix²⁹¹ (choline fenofibrate) [2011 version]
Trizivir²⁹² (abacavir sulfate, lamivudine and zidovudine) [2012 version]
Tysabri²⁹³* (natalizumab) [2012 version]
Tyzeka²⁹⁴ (telbivudine) [2011 version]
Ultresa²⁹⁵ (pancrelipase) [2012 version]
Vandetanib²⁹⁶ (vandetanib) [2011 version]
Vibativ²⁹⁷ (telavancin) [2009 version]
Vicoprofen²⁹⁸ (vicoprofen and ibuprofen) [2008 version]
Victoza²⁹⁹ (liraglutide) [2012 version]
Victrelis³⁰⁰ (boceprevir) [2012 version]
Videx³⁰¹ (didanosine) [2011 version]
Videx EC³⁰² (didanosine) [2011 version]
Viibryd³⁰³ (vilazodone hydrochloride) [2011 version]
Vimovo³⁰⁴ (esomeprazole magnesium and naproxen) [2012 version]
Vimpat³⁰⁵ (lacosamide) [2009 version]
Viokace³⁰⁶ (pancrelipase) [2012 version]
Viramune³⁰⁷ (nevirapine) [2011 version]
Visicol³⁰⁸ (sodium phosphate dybasic anhydrous and sodium phosphate monobasic monohydrate) [2009 version]
Vivactil³⁰⁹ (protriptyline hydrochloride) [2007 version]
Vivitrol³¹⁰ (naltrexone) [2010 version]
Voltaren³¹¹ (diclofenac sodium) [2011 version]
Votrient³¹² (pazopanib hydrochloride) [2012 version]
Vyvanse³¹³ (lisdexamfetamine dimesylate) [2012 version]
Wellbutrin³¹⁴ (bupropion hydrochloride) [2010 version]
Wellbutrin SR³¹⁵ (bupropion hydrochloride) [2010 version]
Wellbutrin XL³¹⁶ (buproprion hydrochloride) [2011 version]
Xarelto³¹⁷ (rivaroxaban) [2011 version]
Xenazine³¹⁸ (tetrabenazine) [2011 version]
Xeomin³¹⁹* (incobotulinumtoxinA) [2011 version]
Xiaflex³²⁰* (collagenase clostridium histolyticum) [2011 version]
Xolair³²¹* (omalizumab) [2010 version]
Xyrem³²² (sodium oxybate) [2005 version]
Yervoy³²³* (ipilimumab) [2011 version]
Zarontin³²⁴ (ethosuximide) [2012 version]
Zelboraf³²⁵ (vemurafenib) [2011 version]
Zenpep³²⁶ (pancrelipase) [2011 version]
Zerit³²⁷ (stavudine) [2011 version]
Ziagen³²⁸ (abacavir sulfate) [2012 version]
Zipsor³²⁹ (diclofenac potassium) [2009 version]
Zoloft³³⁰ (sertraline hydrochloride) [2008 version]
Zolpidem³³¹ (zolpidem tartrate) [2008 version]
Zolpimist³³² (zolpidem tartrate) [2008 version]
Zonegran³³³ (zonisamide) [2012 version]
Zortress³³⁴ (everolimus) [2012 version]
Zyban³³⁵ (bupropion hydrochloride) [2010 version]
Zyprexa³³⁶ (olanzapine) [2010 version]
Zyprexa Relprevv³³⁷ (olanzapine) [2010 version]