Table 2 Safety data on hydrophilic bile acids arising from the available human studies
From: Tauroursodeoxycholic acid: a potential therapeutic tool in neurodegenerative diseases
Intervention(s) | Condition | Dose | Duration | Number of participants | Age | Safety findings | References |
|---|---|---|---|---|---|---|---|
UDCA | Gallstones | 12 mg/kg per day | 3 months | 34 | 18–80 years | Well tolerated. No side effects were reported | [72] |
UDCA | Gallstones | 300 or 600 mg/day | 13 months | 20 |  > 18 years | Well tolerated. The most common adverse events were nausea and skin rash | [73] |
UDCA + CDCA, UDCA | Gallstones | 10 mg/kg per day | 24 months | 596 |  > 20 years | Both interventions were well tolerated. The most common adverse events were diarrhoea, abdominal pain, nausea, vomiting, dizziness and asthenia | [74] |
UDCA | Primary biliary cirrhosis | 300 mg/day | 3 months | 24 | 18–75 years | Well tolerated. Two patients had severe diarrhoea, and terminated the trial prematurely | [75] |
UDCA | Primary biliary cirrhosis | 250 or 500 mg/day | 3 months | 199 | 18–70 years | Well tolerated. The most common adverse events were abdominal pain, eructation, abdominal distension, nausea, and vomiting | [76] |
UDCA | Primary biliary cirrhosis | 15 mg/kg per day | 24 months | 184 |  > 19 years | Well tolerated. The most common adverse events were abdominal pain, flatulence and diarrhoea | [77] |
TUDCA | Primary biliary cirrhosis | 500, 1000 or 1500 mg/day | 6 months | 159 | 18–75 years | Well tolerated. Three patients had severe diarrhoea, and terminated the trial prematurely | [78] |
UDCA, TUDCA | Primary biliary cirrhosis | 750 mg/day | 6 months | 154 |  > 18 years | Both interventions were well tolerated. The most common adverse events were diarrhoea, pruritus, rash and dysmenorrhoeal in the TUDCA group, rash and nausea in the UDCA group | [79] |
UDCA, TUDCA | Primary biliary cirrhosis | 500 mg/day | 6 months | 192 | 18–72 years | Both interventions were well tolerated. No side effects were reported | [80] |
UDCA | Primary sclerosing cholangitis | 20 mg/kg per day | 5 years | 30 |  > 18 years | The most common adverse events were diarrhoea, loose stools, pruritus, anorexia and flatulence | [81] |
norUDCA | Primary sclerosing cholangitis | 500, 1000 or 1500 mg/day | 3 months | 219 | 18–70 years | Well tolerated at all doses, except by two patients in the 1000 mg group | [82] |
UDCA | Chronic hepatitis C | 150, 600 or 900 mg/day | 6 months | 65 |  > 18 years | Well tolerated. The most common adverse events were diarrhoea | [83] |
UDCA, TUDCA | Liver cirrhosis | 750 mg/day | 6 months | 625 |  > 18 years | Well tolerated. No side effects were reported | [84] |
UDCA | Polycystic liver disease | 20 mg/kg per day | 6 months | 23 | 18–75 years | The most common adverse events were frequent stools or diarrhoea | [85] |
UDCA | Intrahepatic cholestasis of pregnancy | 450 mg/day | 14 days | 23 | 18–70 years | No adverse events during or after the treatment | [86] |
UDCA | Fatigue in chronic liver disease | Not reported | Not reported | 20 | Not reported | Well tolerated. No side effects were reported | [87] |
UDCA | ALS | 15, 30, or 50 mg/kg per day | 1 month | 30 |  > 18 years | Well tolerated. The most common adverse events were gastrointestinal | [10] |
UDCA | ALS | 3.5 g/140 mL per day | 3 months | 65 |  > 18 years | Well tolerated. The most common adverse events were gastrointestinal | [88] |
TUDCA | ALS | 2 g/day | 13.5 months | 20 | Not reported | Well tolerated. The most common adverse events were mild diarrhoea and anorexia | [89] |
TUDCA + NaPB | ALS | 2 g/day TUDCA + 6 g/day NaPB | 4 months | 23 | 18–75 years | Well tolerated. The most common adverse events were nausea, diarrhoea, and abdominal pain | [90] |