TIBOLONE: 68 Adverse Event Reports & Safety Profile
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68
Total FAERS Reports
12 (17.6%)
Deaths Reported
33
Hospitalizations
68
As Primary/Secondary Suspect
21
Life-Threatening
20
Disabilities
First Report: 2000 · Latest Report: 20240724
What Are the Most Common TIBOLONE Side Effects?
#1 Most Reported
Off label use
16 reports (23.5%)
#2 Most Reported
Malaise
13 reports (19.1%)
#3 Most Reported
Arthralgia
13 reports (19.1%)
All TIBOLONE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Off label use | 16 | 23.5% | 12 | 13 |
| Adverse drug reaction | 13 | 19.1% | 9 | 9 |
| Anxiety | 13 | 19.1% | 12 | 12 |
| Arthralgia | 13 | 19.1% | 10 | 10 |
| Malaise | 13 | 19.1% | 8 | 8 |
| Abdominal pain | 12 | 17.7% | 10 | 11 |
| Alopecia | 12 | 17.7% | 12 | 12 |
| Amnesia | 12 | 17.7% | 10 | 11 |
| Gait disturbance | 12 | 17.7% | 7 | 7 |
| Medication error | 12 | 17.7% | 12 | 12 |
| Intentional product use issue | 11 | 16.2% | 10 | 10 |
| Rheumatoid arthritis | 11 | 16.2% | 7 | 7 |
| Abdominal discomfort | 10 | 14.7% | 10 | 10 |
| Abdominal pain upper | 10 | 14.7% | 10 | 10 |
| Adjustment disorder with depressed mood | 10 | 14.7% | 10 | 10 |
| Anti-cyclic citrullinated peptide antibody positive | 10 | 14.7% | 10 | 10 |
| Lower respiratory tract infection | 10 | 14.7% | 10 | 10 |
| Memory impairment | 10 | 14.7% | 8 | 9 |
| Muscle injury | 10 | 14.7% | 10 | 10 |
| Product quality issue | 10 | 14.7% | 10 | 10 |
Who Reports TIBOLONE Side Effects? Age & Gender Data
Gender: 100.0% female, 0.0% male. Average age: 51.1 years. Most reports from: GB. View detailed demographics →
Is TIBOLONE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2000 | 4 | 0 | 0 |
| 2003 | 1 | 0 | 1 |
| 2005 | 1 | 0 | 0 |
| 2006 | 1 | 0 | 1 |
| 2011 | 1 | 0 | 0 |
| 2013 | 2 | 0 | 1 |
| 2015 | 2 | 0 | 0 |
| 2016 | 1 | 0 | 0 |
| 2017 | 6 | 0 | 6 |
| 2018 | 1 | 0 | 0 |
| 2019 | 2 | 0 | 0 |
| 2021 | 4 | 0 | 1 |
| 2022 | 7 | 0 | 7 |
| 2023 | 2 | 0 | 0 |
| 2024 | 4 | 0 | 1 |
What Is TIBOLONE Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 29 |
| Menopausal symptoms | 9 |
| Hormone replacement therapy | 6 |
Official FDA Label for TIBOLONE
Official prescribing information from the FDA-approved drug label.