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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

OBETICHOLIC ACID: 6,716 Adverse Event Reports & Safety Profile

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6,716
Total FAERS Reports
529 (7.9%)
Deaths Reported
1,402
Hospitalizations
6,716
As Primary/Secondary Suspect
23
Life-Threatening
12
Disabilities
May 27, 2016
FDA Approved
Discontinued
Status
Yes
Generic Available

FDA Application: 207999 ·

Patent Expires: Sep 6, 2033 · First Report: 2003 · Latest Report: 20250921

What Are the Most Common OBETICHOLIC ACID Side Effects?

#1 Most Reported
Pruritus
2,338 reports (34.8%)
#2 Most Reported
Fatigue
854 reports (12.7%)
#3 Most Reported
Nausea
367 reports (5.5%)

All OBETICHOLIC ACID Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Pruritus 2,338 34.8% 20 190
Fatigue 854 12.7% 9 93
Death 367 5.5% 367 44
Nausea 367 5.5% 6 59
Arthralgia 295 4.4% 2 20
Drug ineffective 292 4.4% 13 31
Hospitalisation 278 4.1% 9 273
Constipation 268 4.0% 4 35
Rash 268 4.0% 3 23
Therapy interrupted 255 3.8% 6 117
Dizziness 254 3.8% 4 35
Blood alkaline phosphatase increased 251 3.7% 8 36
Diarrhoea 217 3.2% 3 48
Abdominal pain upper 208 3.1% 5 34
Therapy cessation 184 2.7% 2 53
Headache 183 2.7% 2 25
Malaise 183 2.7% 11 49
Drug dose omission 161 2.4% 0 28
Insomnia 161 2.4% 3 21
Blood alkaline phosphatase abnormal 152 2.3% 4 33

Who Reports OBETICHOLIC ACID Side Effects? Age & Gender Data

Gender: 90.8% female, 9.2% male. Average age: 61.9 years. Most reports from: US. View detailed demographics →

Is OBETICHOLIC ACID Getting Safer? Reports by Year

YearReportsDeathsHosp.
2003 1 0 0
2010 1 0 0
2012 1 0 0
2013 3 0 0
2014 1 0 0
2015 1 0 0
2016 314 4 21
2017 1,056 50 130
2018 786 51 140
2019 503 37 169
2020 439 51 152
2021 336 51 137
2022 210 41 89
2023 196 27 79
2024 220 33 85
2025 90 25 23

View full timeline →

What Is OBETICHOLIC ACID Used For?

IndicationReports
Primary biliary cholangitis 4,838
Biliary cirrhosis primary 1,012
Product used for unknown indication 192
Biliary cirrhosis 187
Product use in unapproved indication 87
Non-alcoholic steatohepatitis 57
Cholangitis 48
Hepatic cirrhosis 33
Autoimmune hepatitis 12
Liver disorder 11

OBETICHOLIC ACID vs Alternatives: Which Is Safer?

OBETICHOLIC ACID vs OBINUTUZUMAB OBETICHOLIC ACID vs OCELLA OBETICHOLIC ACID vs OCRELIZUMAB OBETICHOLIC ACID vs OCRIPLASMIN OBETICHOLIC ACID vs OCTINOXATE\OCTISALATE\ZINC OBETICHOLIC ACID vs OCTINOXATE\OCTOCRYLENE OBETICHOLIC ACID vs OCTREOTIDE OBETICHOLIC ACID vs OCTREOTIDE\OCTREOTIDE OBETICHOLIC ACID vs ODEVIXIBAT OBETICHOLIC ACID vs OFATUMUMAB

Official FDA Label for OBETICHOLIC ACID

Official prescribing information from the FDA-approved drug label.