DIENOGEST: 157 Adverse Event Reports & Safety Profile
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157
Total FAERS Reports
2 (1.3%)
Deaths Reported
50
Hospitalizations
157
As Primary/Secondary Suspect
13
Life-Threatening
8
Disabilities
First Report: 20010201 · Latest Report: 20250426
What Are the Most Common DIENOGEST Side Effects?
#1 Most Reported
Coeliac disease
21 reports (13.4%)
#2 Most Reported
Off label use
16 reports (10.2%)
#3 Most Reported
Abdominal pain
15 reports (9.6%)
All DIENOGEST Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Coeliac disease | 21 | 13.4% | 0 | 0 |
| Off label use | 16 | 10.2% | 0 | 2 |
| Abdominal pain | 15 | 9.6% | 0 | 8 |
| Genital haemorrhage | 14 | 8.9% | 0 | 5 |
| Neutropenia | 11 | 7.0% | 0 | 1 |
| Amenorrhoea | 10 | 6.4% | 0 | 2 |
| Depression | 10 | 6.4% | 0 | 5 |
| Drug ineffective | 10 | 6.4% | 0 | 1 |
| Anaemia | 9 | 5.7% | 0 | 5 |
| Cognitive disorder | 9 | 5.7% | 0 | 0 |
| Endometriosis | 9 | 5.7% | 0 | 5 |
| Product use in unapproved indication | 9 | 5.7% | 0 | 1 |
| Pulmonary embolism | 9 | 5.7% | 0 | 7 |
| Cerebellar stroke | 8 | 5.1% | 0 | 8 |
| Metrorrhagia | 7 | 4.5% | 0 | 3 |
| Constipation | 6 | 3.8% | 0 | 4 |
| Vaginal haemorrhage | 6 | 3.8% | 0 | 0 |
| Abdominal pain lower | 5 | 3.2% | 0 | 0 |
| Dysarthria | 5 | 3.2% | 0 | 0 |
| Dyspnoea | 5 | 3.2% | 0 | 1 |
Who Reports DIENOGEST Side Effects? Age & Gender Data
Gender: 100.0% female, 0.0% male. Average age: 34.3 years. Most reports from: CA. View detailed demographics →
Is DIENOGEST Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2001 | 1 | 0 | 0 |
| 2002 | 1 | 0 | 1 |
| 2003 | 1 | 0 | 0 |
| 2009 | 1 | 0 | 0 |
| 2013 | 1 | 0 | 0 |
| 2014 | 5 | 0 | 1 |
| 2015 | 2 | 0 | 0 |
| 2016 | 9 | 0 | 2 |
| 2017 | 4 | 0 | 2 |
| 2018 | 3 | 0 | 0 |
| 2019 | 5 | 0 | 3 |
| 2020 | 14 | 1 | 11 |
| 2021 | 10 | 0 | 9 |
| 2022 | 4 | 0 | 3 |
| 2023 | 15 | 0 | 5 |
| 2024 | 2 | 0 | 1 |
| 2025 | 9 | 0 | 0 |
What Is DIENOGEST Used For?
| Indication | Reports |
|---|---|
| Endometriosis | 60 |
| Product used for unknown indication | 41 |
| Adenomyosis | 11 |
| Contraception | 7 |
DIENOGEST vs Alternatives: Which Is Safer?
DIENOGEST vs DIENOGEST\ESTRADIOL
DIENOGEST vs DIENOGEST\ETHINYL ESTRADIOL
DIENOGEST vs DIETARY SUPPLEMENT
DIENOGEST vs DIETARY SUPPLEMENT\HERBALS
DIENOGEST vs DIETARY SUPPLEMENT\MINERALS\VITAMINS
DIENOGEST vs DIETARY SUPPLEMENT\UBIDECARENONE
DIENOGEST vs DIFELIKEFALIN
DIENOGEST vs DIFLUNISAL
DIENOGEST vs DIFLUPREDNATE
DIENOGEST vs DIGITOXIN
Official FDA Label for DIENOGEST
Official prescribing information from the FDA-approved drug label.