URSODIOL
Ursodiol Capsules, USP (300 mg) Rx only
fb317988-a4e3-9c9a-e053-6294a90a5990
HUMAN PRESCRIPTION DRUG LABEL
Sep 25, 2023
Golden State Medical Supply, Inc.
DUNS: 603184490
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ursodiol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (11)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL
NDC 51407-754-01
Ursodiol Capsules, USP 300 mg
100 Capsules
Rxonly
ADVERSE REACTIONS SECTION
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 |
Placebo | |||
|
8 - 10 mg/kg/day |
(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 |
(5.0) |
|
Infection Viral |
30 |
(19.4) |
41 |
(25.8) |
|
Digestive System | ||||
|
Abdominal Pain |
67 |
(43.2) |
70 |
(44.0) |
|
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 |
(5.0) |
|
Nausea |
22 |
(14.2) |
27 |
(17.0) |
|
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 |
(5.0) |
|
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 |
(11.0) |
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 = 325) | |||
|
N |
(%) |
N |
(%) | |
|
Body as a Whole | ||||
|
Fatigue |
25 |
(7.8) |
33 |
(10.2) |
|
Infection Viral |
29 |
(9.0) |
29 |
(8.9) |
|
Influenza-like Symptoms |
21 |
(6.5) |
19 |
(5.8) |
|
Digestive System | ||||
|
Abdominal Pain |
20 |
(6.2) |
39 |
(12.0) |
|
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 |
(24.0) |
|
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) |
Postmarketing Experience
The following adverse reactions, presented by system organ class in alphabetical order, have been identified during post-approval use of ursodiol. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Gastrointestinal disorders: enteroliths (bezoars)
To report SUSPECTED ADVERSE REACTIONS, contact Strides Pharma Inc. at 1-877-244-9825 or go towww.strides.comor FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
SPL UNCLASSIFIED SECTION
ALTERNATIVE THERAPIES
Watchful Waiting
Watchful waiting has the advantage that no therapy may ever be required. For patients with silent or minimally symptomatic stones, the rate of development of moderate-to-severe symptoms or gallstone complications is estimated to be between 2% and 6% per year, leading to a cumulative rate of 7% to 27% in 5 years. Presumably the rate is higher for patients already having symptoms.
Cholecystectomy
For patients with symptomatic gallstones, surgery offers the advantage of immediate and permanent stone removal, but carries a high risk in some patients. About 5% of cholecystectomized patients have residual symptoms or retained common duct stones. The spectrum of surgical risk varies as a function of age and the presence of disease other than cholelithiasis.
| |||
|
** With severe or extreme systemic disease. | |||
|
*** Includes both elective and emergency surgery. | |||
|
Mortality Rates for Cholecystectomy in the U.S. (National Halothane Study, JAMA 1966; 197:775-8) 27,600 Cholecystectomies (Smoothed Rates) Deaths/1000 Operations*** | |||
|
Age (Yrs) |
Cholecystectomy |
Cholecystectomy | |
|
Low Risk Patients* | |||
|
Women |
0 - 49 |
0.54 |
2.13 |
|
50 - 69 |
2.80 |
10.10 | |
|
Men |
0 - 49 |
1.04 |
4.12 |
|
50 - 69 |
5.41 |
19.23 | |
|
High Risk Patients** | |||
|
Women |
0 - 49 |
12.66 |
47.62 |
|
|
50 - 69 |
17.24 |
58.82 |
|
Men |
0 - 49 |
24.39 |
90.91 |
|
|
50 - 69 |
33.33 |
111.11 |
Women in good health or who have only moderate systemic disease and are under 49 years of age have the lowest surgical mortality rate (0.054); men in all categories have a surgical mortality rate twice that of women. Common duct exploration quadruples the rates in all categories. The rates rise with each decade of life and increase tenfold or more in all categories with severe or extreme systemic disease.