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Some drugs have been withdrawn from the market subsequently to their introduction due to risks for the patients. Usually this has been due to unexpected adverse effects that were not detected during Phase III clinical trials and were only apparent from post-marketing surveillance data from the wider patient community.

• Thalidomide (1950s-1960s) - withdrawn due to risk of teratogenicity; returned to market as an anti-neoplastic drug under FDA orphan drug rules
• Diethylstilbestrol (1970s) - withdrawn due to risk of teratogenicity
• phenformin and buformin - withdrawn due to risk of lactic acidosis
• ticrynafen (1982) - withdrawn due to risk of hepatitis
• methaqualone (1984) - withdrawn due to risk of addiction and overdose.
• triazolam (1991) - withdrawn in the United Kingdom due to risk of psychiatric adverse drug reactions
• Fen-phen - popular combination of fenfluramine and phentermine; phentermine remains on the market, dexfenfluramine & fenfluramine (1997) later withdrawn
• lysergic acid diethylamide (LSD) (1950s-1960s), marketed as a psychiatric cure-all; withdrawn after it became widely used recreationally by hippies
• terfenadine (1998) - withdrawn due to risk of cardiac arrhythmias; superseded by fexofenadine
• mibefradil (1998) - withdrawn due to dangerous interactions with other drugs
• troglitazone (2000) - withdrawn due to risk of hepatotoxicity; superseded by pioglitazone and rosiglitazone
• alosetron (2000) - withdrawn due to risk of fatal complications of constipation; reintroduced 2002 on a restricted basis
• cisapride (2000s) - withdrawn in many countries due to risk of cardiac arrhythmias
• cerivastatin (2001) - withdrawn due to risk of rhabdomyolysis
• rapacuronium (2001) - withdrawn in many countries due to risk of fatal bronchospasm
• rofecoxib (Bextra) (2004) - withdrawn due to risk of myocardial infarction