Drugs or medicines may be withdrawn from commercial markets because of risks to patients, but also because of commercial reasons (e.g. lack of demand and relatively high production costs) or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Europe but had not yet been approved for marketing in the United States when adverse effects became clear and they were withdrawn from the market.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 United States or Europe.
Significant withdrawals
{| class="wikitable sortable"
!Drug name (INNs where available)
!Withdrawn
!Country
!class="unsortable"|Remarks
|-
|Amphetamine - mixture of four salts (Adderall XR)
|2005
|Canada
|Withdrawn after reports of increased risk of stroke; reinstated after increased risk not found
|-
|Alatrofloxacin
|2006
|Worldwide
|Serious hepatotoxicity leading to liver transplant or death
|-
|Alpidem (Ananxyl)
|1995
|Worldwide
|Not approved in the US; withdrawn in France in 1994 and the rest of the world in 1995 because of rare but serious hepatotoxicity
|-
|Alosetron (Lotronex)
|2000
|US
|Serious gastrointestinal adverse events; ischaemic colitis; severe constipation;
|-
|Alphaxolone/Alphadolone
(Althesin)
|1984
|France, Germany, UK
|Anaphylaxis, possibly due to the carrier oil
(Cremophor EL)
|-
|Aminophenazone (aminopyrine)
|1999
|France, Thailand
|Risk of agranulocytosis and severe acne
|-
|Astemizole (Hismanal)
|1999
|US, Malaysia, several nonspecified markets
|Fatal arrhythmia
|-
|Bendazac
|1993
|Spain
|Hepatotoxicity
|-
|Benziodarone
|1964
|France, UK
|Jaundice
|-
|Bithionol
|1967
|US
|Dermatological toxicity
|-
|Butamben (Efocaine)(Butoforme)
|1964
|US
|Dermatological toxicity; psychiatric reactions
|-
|Cisapride (Propulsid)
|2000
|US
|Risk of fatal cardiac arrhythmias
|-
|Cloforex
|1969
|Germany
|Cardiovascular toxicity withdrawn from general use in the UK but permitted in terminal patients
|-
|Dexfenfluramine
|1997
|European Union, UK, US
|Cardiotoxic
|-
|Diacetoxydiphenolisatin
|1971
|Australia
|Hepatotoxicity reintroduced as a dietary supplement in 2006;
|-
|Dinoprostone
|1990
|UK
|Uterine hypotonus, fetal distress
|-
|Ebrotidine
|1998
|Spain
|Hepatotoxicity
|-
|Etretinate
|1989
|France
| Teratogen 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
|-
|Gatifloxacin
|2006
|US
|Increased risk of dysglycaemia
|-
|Glafenine
|1984
|France, Germany
|Anaphylaxis
|-
|Iodinated casein strophantin
|1964
|US
|Metabolic reactions
|-
|Isaxonine phosphate
|1984
|France
|Hepatotoxicity
|-
|Levomethadyl acetate
|2003
|US
|Cardiac arrhythmias and cardiac arrest
|-
|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
|-
|Metipranolol
|1990
|UK, others
|Uveitis
|Branded version withdrawn by the originator in several countries in 2007 because of hepatotoxicity; generic versions available; still available in the US
|-
|Nialamide
|1974
|UK, US
|Hepatotoxicity, drug -drug interactions
|-
|Oxyphenbutazone
|1984–1985
|UK, US, Germany, France, Canada
|Bone marrow suppression, Stevens–Johnson syndrome
|-
|Oxyphenisatin (Phenisatin)
|1970s
|Australia, France, Germany, UK, US
|Hepatotoxicity in Germany, Denmark, UK, US, and in others because of nephropathy
|-
|Phenoxypropazine
|1966
|UK
|Hepatotoxicity, drug-drug interactions
|-
|Pifoxime (=Pixifenide)
|1976
|France
|Neuropsychiatric reactions and death
|-
|Rimonabant (Acomplia)
|2008
|Worldwide
|Risk of severe depression and suicide
|-
|Sibutramine (Reductil/Meridia)
|2010
|Australia, Canada, China, the European Union (EU), Hong Kong, India, Mexico, New Zealand, the Philippines, Thailand, the United Kingdom, US
|Increased risk of heart attack and stroke
|-
|Sparfloxacin
|2001
|US
|QT interval prolongation and phototoxicity
|-
|Thalidomide
|1961
|Germany
|Withdrawn because of risk of teratogenicity; returned to the market for use in leprosy and multiple myeloma under FDA orphan drug rules
|-
|Thenalidine
|1963
|Canada, UK, US
|Neutropenia
|-
|Thiobutabarbital
|1993
|Germany
|Kidney damage still available in Russia
|-
|Ticrynafen (Tienilic acid)
|1980
|Germany, France, UK, US, others
|Liver toxicity and death
|-
|Triparanol
|1962
|France, US
|Cataracts, alopecia, ichthyosis banned worldwide.
|-
|Zomepirac
|1983
|UK, Germany, Spain, US
|Anaphylactic reactions and non-fatal allergic reactions; kidney failure