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Table 2: Reports submitted to Health Canada of suspected
hepatobiliary adverse reactions (ARs) associated with antidepressants
exerting an effect on serotonergic neurotransmission from date marketed to July 24, 2002*
Drug; no. of reports
| Hepatobiliary reaction |
Citalopram |
Fluoxetine |
Fluvoxamine |
Mirtazapine |
Nefazodone |
Paroxetine |
Sertraline |
Trazodone |
Venlafaxine |
| Gallbladder disorder† |
- |
6 |
- |
1 |
- |
2 |
1 |
- |
- |
| Hepatic function abnormal |
- |
3 |
1 |
2 |
4 |
2 |
4 |
2 |
2 |
| Increased hepatic enzyme levels‡ |
1 |
31 |
16 |
5 |
69 |
23 |
18 |
5 |
14 |
| Hepatic failure |
- |
- |
- |
- |
4 |
- |
- |
- |
- |
| Hepatitis viral |
- |
- |
- |
- |
- |
- |
- |
- |
1 |
| Hepatic necrosis |
- |
- |
- |
- |
1 |
- |
- |
- |
2 |
| Hepatitis |
- |
1 |
- |
2 |
10 |
1 |
5 |
- |
1 |
| Hepatitis cholestatic |
- |
1 |
1 |
- |
2 |
- |
- |
- |
- |
| Hepatocellular damage |
- |
1 |
- |
- |
1 |
1 |
1 |
- |
1 |
| Fatty liver |
- |
1 |
- |
- |
- |
- |
- |
- |
- |
| Bilirubinemia |
- |
2 |
3 |
- |
15 |
4 |
2 |
- |
4 |
| Jaundice |
- |
1 |
3 |
- |
15 |
5 |
2 |
- |
3 |
| Other§ |
- |
1 |
- |
- |
2 |
1 |
3 |
- |
- |
| Total |
1 |
48 |
24 |
10 |
123 |
39 |
36 |
8 |
27 |
*These data cannot be used to determine the incidence of ARs or to make
quantitative drug safety comparisons between the products because ARs are under reported and neither
patient exposure nor the amount of time the drug was on the market has been taken into consideration. Several
reaction terms may be listed per AR report. Reaction terms are based on the "preferred term" of the World Health
Organization (WHO) Adverse Reaction Dictionary (WHOART).
†Includes cholecystitis and cholelithiasis.
‡Includes aspartate amino transferase, alanine aminotransferase and gamma glutamyl transferase.
§Includes hepatomegaly and porphyria.
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