Ursodiol (Page 3 of 4)

Pregnancy

Teratogenic Effects. Pregnancy Category B

Reproduction studies have been performed in rats and rabbits with ursodiol doses up to 200-fold the therapeutic dose and have revealed no evidence of impaired fertility or harm to the fetus at doses of 20- to 100-fold the human dose in rats and at 5-fold the human dose (highest dose tested) in rabbits. Studies employing 100- to 200-fold the human dose in rats have shown some reduction in fertility rate and litter size. There have been no adequate and well controlled studies of the use of ursodiol in pregnant women, but inadvertent exposure of four women to therapeutic doses of the drug in the first trimester of pregnancy during the ursodiol trials led to no evidence of effects on the fetus or newborn baby. Although it seems unlikely, the possibility that ursodiol can cause fetal harm cannot be ruled out; hence, the drug is not recommended for use during pregnancy.

Nursing Mothers

It is not known whether ursodiol is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when ursodiol is administered to a nursing mother.

Pediatric Use

The safety and effectiveness of ursodiol in pediatric patients have not been established.

Geriatric Use

In worldwide clinical studies of ursodiol, approximately 14% of subjects were over 65 years of age (approximately 3% were over 75 years old). In a subgroup analysis of existing clinical trials, patients greater than 56 years of age did not exhibit statistically significantly different complete dissolution rates from the younger population. No age-related differences in safety and effectiveness were found. Other reported clinical experience has not identified differences in response in elderly and younger patients. However, small differences in efficacy and greater sensitivity of some elderly individuals taking ursodiol cannot be ruled out. Therefore, it is recommended that dosing proceed with caution in this population.

ADVERSE REACTIONS

The nature and frequency of adverse experiences were similar across all groups.

The following tables provide comprehensive listings of the adverse experiences reported that occurred with a 5% incidence level:

GALLSTONE DISSOLUTION

Ursodiol
8 to 10 mg/kg/day

Placebo

(N = 155)

(N = 159)

N

(%)

N

(%)

Body as a Whole

Allergy

8

(5.2)

7

(4.4)

Chest Pain

5

(3.2)

10

(6.3)

Fatigue

7

(4.5)

8

(5)

Infection Viral

30

(19.4)

41

(25.8)

Digestive System

Abdominal Pain

67

(43.2)

70

(44)

Cholecystitis

8

(5.2)

7

(4.4)

Constipation

15

(9.7)

14

(8.8)

Diarrhea

42

(27.1)

34

(21.4)

Dyspepsia

26

(16.8)

18

(11.3)

Flatulence

12

(7.7)

12

(7.5)

Gastrointestinal Disorder

6

(3.9)

8

(5)

Nausea

22

(14.2)

27

(17)

Vomiting

15

(9.7)

11

(6.9)

Musculoskeletal System

Arthralgia

12

(7.7)

24

(15.1)

Arthritis

9

(5.8)

4

(2.5)

Back Pain

11

(7.1)

18

(11.3)

Myalgia

9

(5.8)

9

(5.7)

Nervous System

Headache

28

(18.1)

34

(21.4)

Insomnia

3

(1.9)

8

(5)

Respiratory System

Bronchitis

10

(6.5)

6

(3.8)

Coughing

11

(7.1)

7

(4.4)

Pharyngitis

13

(8.4)

5

(3.1)

Rhinitis

8

(5.2)

11

(6.9)

Sinusitis

17

(11)

18

(11.3)

Upper Respiratory Tract Infection

24

(15.5)

21

(13.2)

Urogenital System

Urinary Tract Infection

10

(6.5)

7

(4.4)

GALLSTONE PREVENTION

Ursodiol

Placebo

600 mg

(N = 322)

(N = 325)

N

(%)

N

(%)

Body as a Whole

Fatigue

25

(7.8)

33

(10.2)

Infection Viral

29

(9)

29

(8.9)

Influenza-like Symptoms

21

(6.5)

19

(5.8)

Digestive System

Abdominal Pain

20

(6.2)

39

(12)

Constipation

85

(26.4)

72

(22.2)

Diarrhea

81

(25.2)

68

(20.9)

Flatulence

15

(4.7)

24

(7.4)

Nausea

56

(17.4)

43

(13.2)

Vomiting

44

(13.7)

44

(13.5)

Musculoskeletal System

Back Pain

38

(11.8)

21

(6.5)

Musculoskeletal Pain

19

(5.9)

15

(4.6)

Nervous System

Dizziness

53

(16.5)

42

(12.9)

Headache

80

(24.8)

78

(24)

Respiratory System

Pharyngitis

10

(3.1)

19

(5.8)

Sinusitis

17

(5.3)

18

(5.5)

Upper Respiratory Tract Infection

40

(12.4)

35

(10.8)

Skin and Appendages

Alopecia

17

(5.3)

8

(2.5)

Urogenital System

Dysmenorrhea

18

(5.6)

19

(5.8)

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