List of withdrawn drugs

Drugs or medicines may be withdrawn from commercial markets because of risks to patients, but also because of commercial reasons (e.g. lack of demand and relatively high production costs) or because it turns out that they are less effective in clinical practice than premarketing efficacy trials suggested. When risks or harms are the cause, withdrawals will usually have been prompted by unexpected adverse effects that were not detected during the early, premaketing, clinical trials, i.e. they became apparent only from postmarketing surveillance data collected from the wider community during routine use over longer periods of time.

This list is not limited to drugs that were ever approved by specific jurisdictions. Some of them (lumiracoxib, rimonabant, tolrestat, ximelagatran, and zimeldine, for example) received marketing approval in Europe but had not yet been approved for marketing in the USA when adverse effects became clear and they were withdrawn from the market. Some drugs in this list (e.g. LSD) were never approved for marketing in the USA or Europe.

Significant withdrawals

Drug name (INNs where available)	Withdrawn	Country	Remarks
Amfetamine - mixture of four salts (Adderall XR)	2005	Canada	Withdrawn after reports of increased risk of stroke; reinstated after increased risk not found[1]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Alpidem (Ananxyl)	1995	Worldwide	Not approved in the USA; withdrawn in France in 1994[4] and the rest of the world in 1995 because of rare but serious hepatotoxicity[3][5]
Alosetron (Lotronex)	2000	USA	Serious gastrointestinal adverse events; ischaemic colitis; severe constipation;[2] reintroduced in 2002 with restricted indications and new controls[6]
Alphaxolone/Alphadolone (Althesin)	1984	France, Germany, UK	Anaphylaxis, possibly due to the carrier oil (Cremophor EL)[3]
Amineptine (Survector)	1999	France, USA	Hepatotoxicity, dermatological adverse effects, and abuse potential[7]
Aminophenazone (aminopyrine)	1999	France, Thailand	Risk of agranulocytosis and severe acne[3]
Amobarbital	1980	Norway	Risk of barbiturate toxicity[3]
Amoproxan	1970	France	Dermatological and ophthalmic toxicity[3]
Anagestone acetate	1969	Germany	Animal carcinogenicity[3]
Antrafenine	1984	France	Unspecific experimental toxicity[3]
Aprotinin (Trasylol)	2008	USA	Increased risk of death[2]
Ardeparin (Normiflo)	2001	USA	Withdrawn at the request of the NDA originator, "not for reason of safety or efficacy"[8][9]
Astemizole (Hismanal)	1999	USA, Malaysia, several nonspecified markets	Fatal arrhythmia[2][3]
Azaribine	1976	USA	Thromboembolism[3]
Bendazac	1993	Spain	Hepatotoxicity[3]
Benoxaprofen (Oraflex, Opren)	1982	Germany, Spain, UK, USA	Liver and kidney failure; gastrointestinal bleeding; ulcers[2][3]
Benzarone	1992	Germany	Hepatitis[3]
Benziodarone	1964	France, UK	Jaundice[3]
Beta-ethoxy-acetanilanide	1986	Germany	Renal toxicity, animal carcinogenicity[3]
Bezitramide	2004	Netherlands	Risk of fatal overdose[10]
Bithionol	1967	USA	Dermatological toxicity[3]
Brotizolam	1989	UK	Animal carcinogenicity[3]
Bromfenac	1998	USA	Severe hepatitis and liver failure (requiring transplantation)[2]
Bucetin	1986	Germany	Kidney damage[3]
Buformin	1978	Germany	Metabolic toxicity[3]
Bunamiodyl	1963	Canada, UK, USA	Nephropathy[11]
Butamben (Efocaine)(Butoforme)	1964	USA	Dermatological toxicity; psychiatric reactions[3]
Canrenone	1986	Germany	Animal carcinogenicity[3]
Cerivastatin (Baycol, Lipobay)	2001	USA	Risk of rhabdomyolysis[2]
Chlormadinone (Chlormenadione)	1970	UK, USA	Animal carcinogenicity[3]
Chlormezanone (Trancopal)	1996	European Union, USA, South Africa, Japan	Hepatotoxicity and Stevens–Johnson Syndrome[3]
Chlorphentermine	1969	Germany	Cardiovascular toxicity[3]
Cianidanol	1985	France, Germany, Spain, Sweden	Haemolytic anaemia[3]
Cinepazide	1988	Spain	Agranulocytosis[12][13]
Cisapride (Propulsid)	2000	USA	Risk of fatal cardiac arrhythmias[2]
Clioquinol	1973	France, Germany, UK, USA	Neurotoxicity[3]
Clobutinol	2007	Germany	Ventricular arrhythmias, QT-interval prolongation[14]
Cloforex	1969	Germany	Cardiovascular toxicity[3]
Clomacron	1982	UK	Hepatotoxicity[3]
Clometacin	1987	France	Hepatotoxicity[3]
Co-proxamol (codeine + paracetamol; Distalgesic)	2004	UK	Risk of overdose
Cyclobarbital	1980	Norway	Risk of overdose[3]
Cyclofenil	1987	France	Hepatotoxicity[3]
Dantron	1963	Canada, UK, USA	Mutagenic;[15] withdrawn from general use in the UK but permitted in terminal patients
Dexfenfluramine	1997	European Union, UK, USA	Cardiotoxic[3]
Propoxyphene (Darvocet/Darvon)	2010	Worldwide	Increased risk of heart attacks and stroke[16]
Diacetoxydiphenolisatin	1971	Australia	Hepatotoxicity[3]
Diethylstilbestrol	1970s	USA	Carcinogen
Difemerine	1986	Germany	Multi-organ toxicities[3]
Dihydrostreptomycin	1970	USA	Neuropsychiatric reactions[3]
Dilevalol	1990	UK	Hepatotoxicity[3]
Dimazole (Diamthazole)	1972	France, USA	Neuropsychiatric reactions[3]
Dimethylamylamine (DMAA)	1983	USA	Voluntarily withdrawn from market by Lilly;[17]: 12  reintroduced as a dietary supplement in 2006;[17]: 13  in 2013 the FDA started work to ban it because of cardiovascular problems[18]
Dinoprostone	1990	UK	Uterine hypotonus, fetal distress[3]
Dipyrone (Metamizole)	1975	UK, USA, others	Agranulocytosis, anaphylactic reactions[3]
Dithiazanine iodide	1964	France, USA	Cardiovascular and metabolic reactions[3]
Dofetilide	2004	Germany	Drug-drug interactions, prolonged QT[14]
Drotrecogin alfa (Xigris)	2011	Worldwide	Lack of efficacy as shown in the PROWESS-SHOCK study[19][20][21]
Ebrotidine	1998	Spain	Hepatotoxicity[3]
Efalizumab (Raptiva)	2009	Germany	Increased risk of progressive multifocal leukoencephalopathy[14]
Encainide	1991	UK, USA	Ventricular arrhythmias[2][3]
Ethyl carbamate	1963	Canada, UK, USA	Carcinogen[22]
Etretinate	1989	France	Teratogen[2][3]
Exifone	1989	France	Hepatotoxicity[3]
Fen-phen (combination of fenfluramine + phentermine)	1997		Cardiotoxicity
Fenclofenac	1984	UK	Cutaneous reactions; animal carcinogenicity[3]
Fenclozic acid	1970	UK, USA	Hepatotoxicity[3]
Fenfluramine	1997	European Union, UK, USA, India, South Africa, others	Cardiac valvular disease, pulmonary hypertension, cardiac fibrosis;[3][23] re-approved in June 2020 for treatment of seizures associated with Dravet syndrome, under FDA orphan drug rules
Fenoterol	1990	New Zealand	Increased asthma mortality[3]
Feprazone	1984	Germany, UK	Cutaneous reactions, multiorgan toxicity[3]
Fipexide	1991	France	Hepatotoxicity[3]
Flosequinan (Manoplax)	1993	UK, USA	Increased mortality at higher doses; increased hospitalizations[2][3]
Flunitrazepam	1991	France	Abuse[3]
Flupirtine	2018	European Union	Liver toxicity[24]
Gatifloxacin	2006	USA	Increased risk of dysglycaemia[2]
Gemtuzumab ozogamicin (Mylotarg)	2010	USA	No improvement in clinical benefit; risk for death;[2] returned to market in 2017[25]
Glafenine	1984	France, Germany	Anaphylaxis[3]
Grepafloxacin (Raxar)	1999	Germany, UK, USA, 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 USA
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	USA	Metabolic reactions[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 (Piper methysticum)	2002	Germany	Hepatotoxicity[14]
Ketorolac	1993	France, Germany, others	Haemorrhage, Kidney Failure[3]
L-tryptophan	1989	Germany, UK	Eosinophilic myalgia syndrome;[3] still sold in the USA
Levamisole (Ergamisol)	1999	USA	Still used as veterinary drug and as a human antihelminthic in many markets; listed on the WHO's List of Essential Medicines; in humans, it was used to treat melanoma before it was withdrawn because of agranulocytosis[29][30][31]
Levomethadyl acetate	2003	USA	Cardiac arrhythmias and cardiac arrest[2]
Lorcaserin (Belviq)	2020	USA	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-drug interactions[3]
Methandrostenolone	1982	France, Germany, UK, USA, others	Off-label abuse[3]
Methapyrilene	1979	Germany, UK, USA	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	USA	Unspecific experimental toxicity[3]
Mibefradil	1998	European Union, Malaysia, USA, others	Fatal arrhythmias, drug-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	USA	Voluntarily withdrawn from the US market because of a risk of Progressive multifocal leukoencephalopathy (PML); returned to the market in July 2006
Nefazodone	2004	Europe, Australia, New Zealand, Canada[35][36][37]	Branded version withdrawn by the originator in several countries in 2007 because of hepatotoxicity; generic versions available; still available in the USA
Nialamide	1974	UK, USA	Hepatotoxicity, drug -drug interactions[3]
Nikethamide	1988	Multiple markets	CNS stimulation[3]
Nitrefazole	1984	Germany	Hepatic and haematological toxicity[3]
Nomifensine	1981–1986	France, Germany, Spain, UK, USA, others	Haemolytic anaemia, hepatotoxicity, serious hypersensitivity reactions[2][3]
Oxeladin	1976	Canada, UK, USA (1976)	Carcinogen[38]
Oxyphenbutazone	1984–1985	UK, USA, Germany, France, Canada	Bone marrow suppression, Stevens–Johnson syndrome[3][39][40]
Oxyphenisatin (Phenisatin)	1970s	Australia, France, Germany, UK, USA	Hepatotoxicity[3]
Ozogamicin	2010	USA	No improvement in clinical benefit; risk of death; veno-occlusive disease[2]
Pemoline (Cylert)	1997	Canada, UK	Withdrawn in the USA in 2005 because of hepatotoxicity[41][3]
Pentobarbital	1980	Norway	Risk of fatal overdose[3]
Pentylenetetrazol	1982	USA	Withdrawn because of inability to produce effective convulsive therapy, and because it caused seizures
Pergolide (Permax)	2007	USA	Risk of heart valve damage[2]
Perhexiline	1985	UK, Spain	Neurological and hepatic toxicity[3]
Phenacetin	1975	Canada	An ingredient in "APC" tablets (aspirin + phenacetin + caffeine); withdrawn because of risks of cancer and kidney disease[42] in Germany, Denmark, UK, USA, and in others because of nephropathy[3]
Phenformin and Buformin	1977	France, Germany, USA	Severe lactic acidosis[3]
Phenolphthalein	1997	USA	Possible carcinogen[43]
Phenoxypropazine	1966	UK	Hepatotoxicity, drug-drug intereactions[3]
Phenylbutazone	1985	Germany	Off-label abuse, haematological toxicity[3]
Phenylpropanolamine (Propagest, Dexatrim)	2000	Canada, USA	Haemorrhagic stroke[44][45]
Pifoxime (=Pixifenide)	1976	France	Neuropsychiatric reactions[3]
Pirprofen	1990	France, Germany, Spain	Liver toxicity.[3][12]: 223
Prenylamine	1988	Canada, France, Germany, UK, USA, others	Cardiac arrhythmias[46] and death[3]
Proglumide	1989	Germany	Respiratory reactions[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	USA, multiple markets	Withdrawn in many countries because of the risk of fatal bronchospasm[2]
Remoxipride	1993	UK, others	Aplastic anaemia[3]
Rhesus rotavirus vaccine-tetravalent (RotaShield)	1999	USA	Withdrawn because of a risk of intussusception[47]
Rimonabant (Acomplia)	2008	Worldwide	Risk of severe depression and suicide[14]
Rofecoxib (Vioxx)	2004	Worldwide	Withdrawn by Merck & Co. because of the risks of myocardial infarction and stroke[2]
Rosiglitazone (Avandia)	2010	Europe	Risk of heart attacks and death; still available in the USA
Secobarbital	1990	France, Norway, others[which?]	Risk of overdose[3]
Sertindole	1998	European Union	Arrhythmias 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] USA[59]	Increased risk of heart attack and stroke[2]
Sitaxentan	2010	Germany	Hepatotoxicity[14]
Sorivudine	1993	Japan	Drug-drug interactions and deaths[60]
Sparfloxacin	2001	USA	QT interval prolongation and phototoxicity[2]
Sulfacarbamide	1988	Germany	Dermatological, hematological, and hepatic reactions[3]
Sulfamethoxydiazine	1988	Germany	Dermatological reactions
Sulfamethoxypyridazine	1986	UK	Dermatological and haematological reactions[3]
Suloctidil	1985	Germany, France, Spain	Hepatotoxicity[3]
Suprofen	1986–1987	UK, Spain, USA	Kidney damage[2][3]
Tegaserod (Zelnorm)	2007	USA	Risks of heart attack, stroke, and unstable angina;[2] was available through a restricted access programme until April 2008; returned to the market in 2019
Temafloxacin	1992	Germany, UK, USA, others	Low blood sugar; haemolytic anaemia; kidney, liver dysfunction; allergic reactions[2][3]
Temafloxacin	1992	US	Allergic reactions and cases of haemolytic anaemia, leading to three deaths
Temazepam (Restoril, Euhypnos, Normison, Remestan, Tenox, Norkotral)	1999	Sweden, Norway	Diversion, abuse, and a relatively high rate of overdose deaths compared with other drugs of its group; it is still available in most of the world, including the USA, but under strict controls
Terfenadine (Seldane, Triludan)	1997–1998	France, South Africa, Oman, USA, others	Prolonged QT interval; ventricular tachycardia[2][3]
Terodiline (Micturin)	1991	Germany, UK, Spain, others	Prolonged QT interval, ventricular tachycardia, and other arrhythmias[3]
Tetrazepam	2013	European Union	Serious cutaneous reactions[61]
Thalidomide	1961	Germany	Withdrawn because of risk of teratogenicity;[62] returned to the market for use in leprosy and multiple myeloma under FDA orphan drug rules
Thenalidine	1963	Canada, UK, USA	Neutropenia[3][63]
Thiobutabarbital	1993	Germany	Kidney damage[3]
Thioridazine (Melleril)	2005	Germany, UK	Withdrawn worldwide because of severe cardiac arrhythmias;[64][65] still available in Russia
Ticrynafen (Tienilic acid)	1980	Germany, France, UK, USA, 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, USA	Cataracts, alopecia, ichthyosis[3]
Troglitazone (Rezulin)	2000	Germany, USA	Hepatotoxicity[2]
Trovafloxacin (Trovan)	1999–2001	European Union, USA	Withdrawn because of risk of liver failure[2][3]
Valdecoxib (Bextra)	2004	USA	Risk of heart attack and stroke[2]
Vincamine	1987	Germany	Haematological toxicity[3]
Xenazoic acid	1965	France	Hepatotoxicity[3]
Ximelagatran (Exanta)	2006	Germany	Hepatotoxicity[14]
Zimeldine	1983	Worldwide	Risk of Guillain–Barré syndrome, hypersensitivity reactions, hepatotoxicity;[3][67][68] banned worldwide.[69]
Zomepirac	1983	UK, Germany, Spain, USA	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