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. 2005 Jan 24;2005(1):CD004096. doi: 10.1002/14651858.CD004096.pub2
Adverse events Orlistat Sibutramine Fluoxetine
Gastrointestinal Minor 
 GI events: range 65% to 80% I, 27% to 62% C , most mild to 
 moderate, transient (Hollander 1998, Lindgarde 2000, Kelley 2002, 
 Miles 2002, Shi 2001, Halpern 2003, Hanefeld 2002, Kelley 2004) 
 34% GI effects (Allie 2004) Minor 
 Constipation: 9% to 55% I, 6% to 8% C(Gokcel 2001, Fujioka 2000, Serrano‐Rios 2002, 
 Chaisson 1989); 4% (Tankova 2003) Minor 
 Various: NSD between I and C(Connolly 1995) 
 Nausea: range 15% to 35% I, 6% to 20% C(Daubresse 1996, Kutnowski 1992, Chaisson 1989) 
 Diarrhea: 6% I, 2% C (p>0.05)(Daubresse 1996); 8% I, 4% C (p>0.05)(Gray 1992) 
 Anorexia: 12% I, 3% C (p<0.05)(Chaisson 1989) 
 Nausea, vomiting, diarrhea: 66% I, 60% C(O'Kane 1994)
Cardiovascular   Major 
 Rhythm disturbances: NSD between groups(Finer 1994) 
 Chest pain not suggestive of angina: 7% (2/27)(Sircar 2001) 
 Palpitations (moderate to severe): 41% I, 29% C(Serrano‐rios 2002) 
 Minor 
 Increased pulse rate: mean 2.4 beats/minute I (p>0.05)(Serrano‐Rios 2002); 
 mean 6 beats/minute I (p<0.01) (McNulty 2003) 
 Increased systolic blood pressure (4 mmHg) and diastolic blood pressure (3 mmHg) in 15mg 
 qd group; systolic blood pressure >=10 mmHG higher at endpont than baseline in 36% and 
 29% of patients receiving 15 and 20 mg (MuNulty 2003) 
 Palpitations: 7.4% I(Chaisson 1989)  
Neurologic   Minor 
 Headache: 22% to 32% I, 40% C(Finer 2000, Sircir 2001) 
 Dizziness: 9 to 14% I, 5% to 13% C(Finer 2000, Sircir 2001) 
 Anxiety: 9% I, 0% C(Serrano‐Rios 2002) 
 Sleeplessness: 7% (Tankova 2003) Minor 
 Tremor: 5% to 15% I, 0% to 3% C(Daubresse 1996, Kutnowski 1992, Chaisson 1989, Wise 1989) 
 Somnolence: 11% to 22% I, 4% to 7% C(Daubresse 1996, Chaisson 1989) 
 Headache: 13% I, 8% C(Gray 1992) 
 Asthenia: 37% I, 20% C (p>0.05)(Chaisson 1989) 
 Sweating: 28% I, 11% C (p<0.05)(Chaisson 1989) 
 Abnormal dreams: 12% I, 4% C (p<0.05)(Chaisson 1989) 
 Sweating, somnolence, nausea, tremor, anorexia: I > C(no statistics) 
 (Goldstein 1992)
Withdrawal due to 
 adverse effects Minor 
 Various: 13% I, 8% C (Kelley 2002); 10% I, 5% C (p<0.05)(Miles 2002) 
 Deterioration in glycemic control: 15% I, 28% C(Kelley 2002) 
 GI: 4.3% I, 1.2% C(Hollander 1998); 2.6% I, 0.5% C(Lindgarde 2000); 
 4.7% I, 2.9% C(Halpern 2003); 0.3% I(Shi 2001); 13% I, NR for C (Kelley 2004) 
 22% I (Allie 2004) Major 
 Palpitations: 3% I, 0% C(Serrano‐Rios 2002) 
 Hypertension: 3% (one patient) developed (Gokcel 2001) 
 
 Minor 
 Insomnia, nervousness: 6% (Redmon 2003) 
 Dizziness, insomnia, or diarrhea: 7% I(Finer 2000) 
 Chest pain not suggestive of angina: 4% I(Sircar 2001) 
 Dizziness, hyperglycemia, nausea: 3% I(Fukuika 2000) Major 
 Chest pain: 8% I, 0% C (p>0.05)(Gray 1992) 
 
 Minor 
 GI: 22%(O'Kane 1994) 
 Nausea, lethargy, or excessive sweating: 20%(Connolly 1995) 
 Unspecified: 1% to 9% I, 1% to 2% C (Daubresse 1996, Kutnowski 1992) 
 Connolly 1995)
Other Minor 
 Hypoglycemia: 7% to 17% I, 3% to 10% C(Kelley 2002, Miles 2002, Hanfeld 2002) 
 No gallstones, no renal stones(Hollander 1998) 
 Normal plasma concentrations vitamin A,D,E, beta‐carotene(Hollander 1998) 
 Decrease in vitamin E and beta‐carotene concentrations in I vs C (p<0.001)(Hollander 1998) 
 No significant difference in adverse events I and C (p=0.75)(Serrano‐rios 2001) Major 
 Serious AE: 6% I, 1% C (1/ 5 in I possibly drug‐related (somnolence, dizziness, confusion)) 
 (Fujioka 2000) 
 Minor 
 Dry mouth: 38% I, NR C(Gokcel 2001); 23% I, 11% C(Finer 2000); "common"(McNulty 2003); 
 reported in Redmon 2003 (no data); 6% (Tankova 2003) 
 Infection (not specified): 18% to 26% I, 2% to 24% C(Finer 2000, Fujioka 2000) 
 Increased platelet count and increased serum sodium in I (Serrano‐Rios 2002) 
 AE unspecified: 61% I, 52% C(Serrano‐Rios 2002) Minor 
 Infections: 50% I, 55% C(Breum 1995); NSD between groups(Connolly 1995) 
 Decreased libido: 13% I, 0% C (p=0.07)(Gray 1992)