List of withdrawn drugs

Drugs or medicines may be withdrawn from commercial markets because of risks to patients, but also because of commercial reasons (e.g. lack of demand and relatively high production costs). Where risks or harms is the reason for withdrawal, this will usually have been prompted by unexpected adverse effects that were not detected during Phase III clinical trials, i.e. they were only made apparent from postmarketing surveillance data collected from the wider community over longer periods of time.

This list is not limited to drugs that were ever approved by the FDA. Some of them (lumiracoxib, rimonabant, tolrestat, ximelagatran and ximelidine, for example) were approved to be marketed in Europe but had not yet been approved for marketing in the US, when side effects became clear and their developers pulled them from the market. Some drugs in this list (e.g. LSD) were never approved for marketing in the US or Europe.

Significant withdrawals

Drug name	Withdrawn	Country	Remarks
Amphetamine Mix (Adderall XR)	2005	Canada	Withdrawn over reports of increased risk of stroke, reinstated after increased risk not found.[1]
Alatrofloxacin	2006	Worldwide	Serious hepatotoxicity leading to liver transplant or death.[2]
Alclofenac	1979	UK	Vasculitis[3]
Alpidem (Ananxyl)	1995	Worldwide	Not approved in the US, withdrawn in France in 1994[4] and the rest of the market in 1995 because of rare but serious hepatotoxicity.[3][5]
Alosetron (Lotronex)	2000	US	Serious gastrointestinal adverse events; ischemic colitis; severe constipation.[2] Reintroduced 2002 with restricted indication and new controls.[6]
Alphaxolone/Alphadolone (Althesin)	1984	France, Germany, UK	Anaphylaxis, possibly due to carrier oil (Cremophor EL).[3]
Amineptine (Survector)	1999	France, US	Hepatotoxicity, dermatological side effects, and abuse potential.[7]
Aminopyrine	1999	France, Thailand	Risk of agranulocytosis and severe acne.[3]
Amobarbital	1980	Norway	Risk of barbiturate toxicity.[3]
Amoproxan	1970	France	Dermatologic and ophthalmic toxicity.[3]
Anagestone acetate	1969	Germany	Animal carcinogenicity.[3]
Antrafenine	1984	France	Unspecific experimental toxicity.[3]
Aprotinin (Trasylol)	2008	US	Increased risk of death.[2]
Ardeparin (Normiflo)	2001	US	Withdrawn at request of NDA originator, "not for reason of safety or efficacy."[8][9]
Astemizole (Hismanal)	1999	US, Malaysia, Multiple Nonspecified Markets	Fatal arrhythmia[2][3]
Azaribine	1976	US	Thromboembolism.[3]
Bendazac	1993	Spain	Hepatotoxicity.[3]
Benoxaprofen (Oraflex, Opren)	1982	Germany, Spain, UK, US	Liver and kidney failure; gastrointestinal bleeding; ulcers.[2][3]
Benzarone	1992	Germany	Hepatitis.[3]
Benziodarone	1964	France, UK	Jaundice.[3]
Beta-ethoxy-lacetanilanide	1986	Germany	Renal toxicity, animal carcinogenicity.[3]
Bezitramide	2004	Netherlands	Risk of fatal overdose[10]
Bithionol	1967	US	Dermatologic toxicity.[3]
Brotizolam	1989	UK	Animal carcinogenicity.[3]
Bromfenac	1998	US	Severe hepatitis and liver failure (requiring transplantation).[2]
Bucetin	1986	Germany	Kidney damage[3]
Buformin	1978	Germany	Metabolic toxicity.[3]
Bunamiodyl	1963	Canada, UK, US	Nephropathy.[11]
Butamben (Efocaine)(Butoforme)	1964	US	Dermatologic toxicity; psychiatric reactions.[3]
Canrenone	1986	Germany	Animal Carcinogenicity.[3]
Cerivastatin (Baycol, Lipobay)	2001	US	Risk of rhabdomyolysis[2]
Chlormadinone (Chlormenadione)	1970	UK, US	Animal Carcinogenicity.[3]
Chlormezanone (Trancopal)	1996	European Union, US, South Africa, Japan	Hepatotoxicity and Stevens–Johnson Syndrome[3]
Chlorphentermine	1969	Germany	Cardiovascular Toxicity.[3]
Cianidanol	1985	France, Germany, Spain, Sweden	Hemolytic Anemia.[3]
Cinepazide	1988	Spain	Agranulocytosis.[12][13]
Cisapride (Propulsid)	2000	US	Risk of fatal cardiac arrhythmias[2]
Clioquinol	1973	France, Germany, UK, US	Neurotoxicity.[3]
Clobutinol	2007	Germany	Ventricular arrhythmia, QT-prolongation.[14]
Cloforex	1969	Germany	Cardiovascular toxicity.[3]
Clomacron	1982	UK	Hepatotoxicity.[3]
Clometacin	1987	France	Hepatotoxicity.[3]
Co-proxamol (Distalgesic)	2004	UK	Risk of overdose
Cyclobarbital	1980	Norway	Risk of overdose[3]
Cyclofenil	1987	France	Hepatotoxicity.[3]
Dantron	1963	Canada, UK, US	Mutagenic.[15] withdrawn from general use in UK but permitted in terminal patients
Dexfenfluramine	1997	European Union, UK, US	Cardiotoxic[3]
Propoxyphene (Darvocet/Darvon)	2010	Worldwide	Increased risk of heart attacks and stroke.[16]
Diacetoxydiphenolisatin	1971	Australia	Hepatotoxicity.[3]
Diethylstilbestrol	1970s	US	Carcinogen
Difemerine	1986	Germany	Multi-Organ toxicities.[3]
Dihydrostreptomycin	1970	US	Neuropsychiatric reaction.[3]
Dilevalol	1990	UK	Hepatotoxicity.[3]
Dimazole (Diamthazole)	1972	France, US	Neuropsychiatric reaction.[3]
Dimethylamylamine (DMAA)	1983	US	Voluntarily withdrawn from market by Lily.[17]: 12  Reintroduced as a dietary supplement in 2006;[17]: 13  in 2013 the FDA started work to ban it due to cardiovascular problems[18]
Dinoprostone	1990	UK	Uterine hypotonus, fetal distress.[3]
Dipyrone (Metamizole)	1975	UK, US, Others	Agranulocytosis, anaphylactic reactions.[3]
Dithiazanine iodide	1964	France, US	Cardiovascular and metabolic reaction.[3]
Dofetilide	2004	Germany	Drug interactions, prolonged QT.[14]
Drotrecogin alfa (Xigris)	2011	Worldwide	Lack of efficacy as shown by PROWESS-SHOCK study[19][20][21]
Ebrotidine	1998	Spain	Hepatotoxicity.[3]
Efalizumab (Raptiva)	2009	Germany	Withdrawn because of increased risk of progressive multifocal leukoencephalopathy[14]
Encainide	1991	UK, US	Ventricular arrhythmias.[2][3]
Ethyl carbamate	1963	Canada, UK, US	Carcinogen.[22]
Etretinate	1989	France	Teratogen.[2][3]
Exifone	1989	France	Hepatotoxicity.[3]
Fen-phen (popular combination of fenfluramine and phentermine)	1997		Cardiotoxicity
Fenclofenac	1984	UK	Cutaneous reactions; animal carcinogenicity.[3]
Fenclozic acid	1970	UK, US	Hepatotoxicity.[3]
Fenfluramine	1997	European Union, UK, US, India, South Africa, others	Cardiac valvular disease, pulmonary hypertension, cardiac fibrosis;[3][23] re-approved in June 2020 for the treatment of seizures associated with Dravet syndrome, under FDA orphan drug rules.
Fenoterol	1990	New Zealand	Asthma mortality.[3]
Feprazone	1984	Germany, UK	Cutaneous reaction, multiorgan toxicity.[3]
Fipexide	1991	France	Hepatotoxicity.[3]
Flosequinan (Manoplax)	1993	UK, US	Increased mortality at higher doses; increased hospitalizations.[2][3]
Flunitrazepam	1991	France	Abuse.[3]
Flupirtine	2018	European Union	Liver toxicity.[24]
Gatifloxacin	2006	US	Increased risk of dysglycemia.[2]
Gemtuzumab ozogamicin (Mylotarg)	2010	US	No improvement in clinical benefit; risk for death.[2] Returned to market in 2017.[25]
Glafenine	1984	France, Germany	Anaphylaxis.[3]
Grepafloxacin (Raxar)	1999	Withdrawn Germany, UK, US others	Cardiac repolarization; QT interval prolongation.[2]
Hydromorphone (Palladone, extended release version)	2005		High risk of accidental overdose when extended release version (Palladone) administered with alcohol. Standard hydromorphone is sold in most of the world including the US
Ibufenac	1968	UK	Hepatotoxicity, jaundice.[3]
Indalpine	1985	France	Agranulocytosis.[3]
Indoprofen	1983	Germany, Spain, UK	Animal carcinogenicity, gastrointestinal toxicity.[3]
Ingenol mebutate gel	2020	Suspended in Europe	Increased risk of skin cancers.[26][27]
Iodinated casein strophantin	1964	US	Metabolic reaction.[3]
Iproniazid	1964	Canada	Interactions with food products containing tyrosine.[28]
Isaxonine phosphate	1984	France	Hepatotoxicity.[3]
Isoxicam	1983	France, Germany, Spain, others	Stevens–Johnson syndrome.[3]
Kava Kava	2002	Germany	Hepatotoxicity.[14]
Ketorolac	1993	France, Germany, others	Hemorrhage, Kidney Failure.[3]
L-tryptophan	1989	Germany, UK	Eosinophilic myalgia syndrome.[3] Still sold in the US
Levamisole (Ergamisol)	1999	US	Still used as veterinary drug and as a human antihelminthic in many markets; listed on the WHO List of Essential Medicines. In humans, it was used to treat melanoma before it was withdrawn for agranulocytosis.[29][30][31]
Levomethadyl acetate	2003	US	Cardiac arrhythmias and cardiac arrest.[2]
Lorcaserin (Belviq)	2020	US	Increased risk of cancer.[32]
Lumiracoxib (Prexige)	2007–2008	Worldwide	Liver damage
Lysergic acid diethylamide (LSD)	1950s–1960s		Marketed as a psychiatric drug; withdrawn after it became widely used recreationally. Now illegal in most of the world.
Mebanazine	1975	UK	Hepatotoxicity, drug intereaction.[3]
Methandrostenolone	1982	France, Germany, UK, US, others	Off-label abuse.[3]
Methapyrilene	1979	Germany, UK, US	Animal carcinogenicity.[3]
Methaqualone	1984	South Africa (1971), India (1984), United Nations (1971–1988)	Withdrawn because of risk of addiction and overdose[33][34]
Metipranolol	1990	UK, others	Uveitis.[3]
Metofoline	1965	US	Unspecific experimental toxicity.[3]
Mibefradil	1998	European Union, Malaysia, US, others	Fatal arrhythmia, drug interactions.[2][3]
Minaprine	1996	France	Convulsions.[3]
Moxisylyte	1993	France	Necrotic hepatitis.[3]
Muzolimine	1987	France, Germany, European Union	Polyneuropathy.[3]
Natalizumab (Tysabri)	2005–2006	US	Voluntarily withdrawn from US market because of risk of Progressive multifocal leukoencephalopathy (PML). Returned to market July 2006.
Nefazodone	2004	Europe, Australia, New Zealand and Canada[35][36][37]	Branded version withdrawn by originator in several countries in 2007 for hepatotoxicity. Generic versions available. Still available in US market.
Nialamide	1974	UK, US	Hepatotoxicity, drug intereaction.[3]
Nikethamide	1988	multiple markets	CNS Stimulation.[3]
Nitrefazole	1984	Germany	Hepatic and hematologic toxicity.[3]
Nomifensine	1981–1986	France, Germany, Spain, UK, US, others	Hemolytic Anemia, hepatotoxicity, serious hypersensitive reactions.[2][3]
Oxeladin	1976	Canada, UK, US (1976)	Carcinogen.[38]
Oxyphenbutazone	1984–1985	UK, US, Germany, France, Canada	Bone marrow suppression, Stevens–Johnson syndrome.[3][39][40]
Oxyphenisatin (Phenisatin)	1970s	Australia, France, Germany, UK, US	Hepatotoxicity.[3]
Ozogamicin	2010	US	No improvement in clinical benefit; risk for death; veno-occlusive disease.[2]
Pemoline (Cylert)	1997	Canada, UK	Withdrawn from US in 2005 due to hepatotoxicity.[41][3]
Pentobarbital	1980	Norway	Risk of fatal overdose.[3]
Pentylenetetrazol	1982	US	Withdrawn for inability to produce effective convulsive therapy, and for causing seizures.
Pergolide (Permax)	2007	US	Risk for heart valve damage.[2]
Perhexiline	1985	UK, Spain	Neurologic and hepatic toxicity.[3]
Phenacetin	1975	Canada	An ingredient in "A.P.C." tablet; withdrawn because of risk of cancer and kidney disease[42] Germany Denmark, UK, US, others Reason: nephropathy.[3]
Phenformin and Buformin	1977	France, Germany US	Severe lactic acidosis[3]
Phenolphthalein	1997	US	Possible carcinogen.[43]
Phenoxypropazine	1966	UK	Hepatotoxicity, drug intereaction.[3]
Phenylbutazone	1985	Germany	Off-label abuse, hematologic toxicity.[3]
Phenylpropanolamine (Propagest, Dexatrim)	2000	Canada, US	Hemorrhagic stroke.[44][45]
Pifoxime (=Pixifenide)	1976	France	Neuropsychiatric reaction.[3]
Pirprofen	1990	France, Germany, Spain	Liver toxicity.[3][12]: 223
Prenylamine	1988	Canada, France, Germany, UK, US, others	Cardiac arrhythmia[46] and death.[3]
Proglumide	1989	Germany	Respiratory reaction.[3]
Pronethalol	1965	UK	Animal carcinogenicity.[3]
Propanidid	1983	UK	Allergy.[3]
Proxibarbal	1998	Spain, France, Italy, Portugal, Turkey	Immunoallergic, thrombocytopenia.[3]
Pyrovalerone	1979	France	Abuse.[3]
Ranitidine (Zantac)	2020	Worldwide	Found to spontaneously break down into the carcinogen N-nitrosodimethylamine.
Rapacuronium (Raplon)	2001	US, multiple markets	Withdrawn in many countries because of risk of fatal bronchospasm.[2]
Remoxipride	1993	UK, others	Aplastic anemia.[3]
rhesus rotavirus vaccine-tetravalent (RotaShield)	1999	US	Withdrawn due to risk of intussusception.[47]
Rimonabant (Acomplia)	2008	Worldwide	Risk of severe depression and suicide.[14]
Rofecoxib (Vioxx)	2004	Worldwide	Withdrawn by Merck & Co. Risk of myocardial infarction and stroke.[2]
Rosiglitazone (Avandia)	2010	Europe	Risk of heart attacks and death. This drug continues to be available in the US
Secobarbital		France, Norway, others.	Risk of overdose[3]
Sertindole	1998	European Union	Arrhythmia and sudden cardiac death[3][48]
Sibutramine (Reductil/Meridia)	2010	Australia,[49] Canada,[50] China,[51] the European Union (EU),[52] Hong Kong,[53] India,[54] Mexico, New Zealand,[55] the Philippines,[56] Thailand,[57] the United Kingdom,[58] and the United States[59]	Increased risk of heart attack and stroke.[2]
Sitaxentan	2010	Germany	Hepatotoxicity.[14]
Sorivudine	1993	Japan	Drug interaction and deaths.[60]
Sparfloxacin	2001	US	QT prolongation and phototoxicity.[2]
Sulfacarbamide	1988	Germany	Dermatologic, hematologic and hepatic reactions.[3]
Sulfamethoxydiazine	1988	Germany	Unknown.[3]
Sulfamethoxypyridazine	1986	UK	Dermatologic and hematologic reactions.[3]
Suloctidil	1985	Germany, France, Spain	Hepatotoxicity.[3]
Suprofen	1986–1987	UK, Spain, US	Kidney damage.[2][3]
Tegaserod (Zelnorm)	2007	US	Risk for heart attack, stroke, and unstable angina.[2] Was available through a restricted access program until April 2008; returned to market in 2019.
Temafloxacin	1992	Germany, UK, US, others	Low blood sugar; hemolytic anemia; kidney, liver dysfunction; allergic reactions[2][3]
Temafloxacin	1992	US	Allergic reactions and cases of hemolytic anemia, leading to three patient deaths.
Temazepam (Restoril, Euhypnos, Normison, Remestan, Tenox, Norkotral)	1999	Sweden, Norway	Diversion, abuse, and a relatively high rate of overdose deaths in comparison to other drugs of its group. This drug continues to be available in most of the world including the US, but under strict controls.
Terfenadine (Seldane, Triludan)	1997–1998	France, South Africa, Oman, others, US	Prolonged QT interval; ventricular tachycardia[2][3]
Terodiline (Micturin)	1991	Germany, UK, Spain, others	Prolonged QT interval, ventricular tachycardia and arrhythmia.[3]
Tetrazepam	2013	European Union	Serious cutaneous reactions.[61]
Thalidomide	1961	Germany	Withdrawn because of risk of teratogenicity;[62] returned to market for use in leprosy and multiple myeloma under FDA orphan drug rules
Thenalidine	1963	Canada, UK, US	Neutropenia[3][63]
Thiobutabarbitone	1993	Germany	Kidney injury.[3]
Thioridazine (Melleril)	2005	Germany, UK	Withdrawn worldwide due to severe cardiac arrhythmias[64][65] Continues to be available in Russia.
Ticrynafen (Tienilic acid)	1980	Germany, France, UK, US others	Liver toxicity and death.[3]
Tolcapone (Tasmar)	1998	European Union, Canada, Australia	Hepatotoxicity[3]
Tolrestat (Alredase)	1996	Argentina, Canada, Italy, others	Severe hepatotoxicity[3]
Triacetyldiphenolisatin	1971	Australia	Hepatotoxicity.[3]
Triazolam	1991	France, Netherlands, Finland, Argentina, UK others	Psychiatric adverse drug reactions, amnesia.[3][66]
Triparanol	1962	France, US	Cataracts, alopecia, ichthyosis.[3]
Troglitazone (Rezulin)	2000	US, Germany	Hepatotoxicity[2]
Trovafloxacin (Trovan)	1999–2001	European Union, US	Withdrawn because of risk of liver failure[2][3]
Valdecoxib (Bextra)	2004	US	Risk of heart attack and stroke.[2]
Vincamine	1987	Germany	Hematologic toxicity.[3]
Xenazoic acid	1965	France	Hepatotoxicity.[3]
Ximelagatran (Exanta)	2006	Germany	Hepatotoxicity[14]
Zimelidine	1983	Worldwide	Risk of Guillain–Barré syndrome, hypersensitivity reaction, hepatotoxicity[3][67][68] banned worldwide.[69]
Zomepirac	1983	UK, Germany, Spain, US	Anaphylactic reactions and non-fatal allergic reactions, kidney failure[2][3]

See also

• Adverse drug reaction
• Adverse events
• European Medicines Agency
• Food and Drug Administration

References

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External links

• CDER Report to the Nation: 2005 Has a list of US withdrawals through 2005.