OpenClaim

Dienogest Side Effects

The most commonly reported side effects of dienogest include off label use, headache, and nausea, based on 698 FDA adverse event reports from 2008 to 2025. 4.9% of reports found the drug to be ineffective.

Dienogest side effects

Percentages show how often each reaction appears relative to total reports for dienogest.

1
Off Label Use11.9%83
2
Headache8.0%56
3
Nausea6.3%44
4
Pain5.0%35
5
Drug Dose Omission4.9%34
6
Drug Ineffective4.9%34
7
Fatigue4.0%28
8
Weight Increased4.0%28
9
Condition Aggravated4.0%28
10
Metrorrhagia3.6%25
11
Malaise3.6%25
12
Dyspnoea3.4%24
13
Abdominal Pain3.4%24
14
Vomiting3.3%23
15
Coeliac Disease3.0%21

These are voluntary reports and do not establish that dienogest caused these reactions.

Report severity

60.5%Serious422 reports
21.8%Hospitalizations152 reports
0.9%Fatal6 reports

Seriousness is determined by the reporter, not by OpenClaim.

Dienogest drug interactions

Other drugs that appear in adverse event reports alongside dienogest. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Estradiol37.5%262
2
Infliximab4.2%29
3
Omeprazole4.2%29
4
Vedolizumab3.7%26
5
Venlafaxine3.6%25
6
Levonorgestrel3.3%23
7
Insulin3.3%23
8
Albuterol3.3%23
9
Azithromycin3.2%22
10
Sodium-oxybate3.0%21
11
Fluticasone3.0%21
12
Salmeterol-xinafoate3.0%21
13
Levothyroxine-sodium3.0%21
14
Adalimumab2.4%17
15
Tacrolimus2.3%16

Taken alongside

1
Estradiol9.7%68
2
Ergocalciferol5.7%40
3
Prednisone5.0%35
4
Pantoprazole-sodium4.7%33
5
Acetaminophen4.4%31
6
Levothyroxine-sodium3.7%26
7
Gabapentin3.7%26
8
Clonazepam3.6%25
9
Fluticasone3.3%23
10
Sertraline-hydrochloride3.0%21
11
Cyanocobalamin2.9%20
12
Ethinyl-estradiol2.7%19
13
Bupropion2.7%19
14
Pregabalin2.7%19
15
Montelukast-sodium2.6%18

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports dienogest side effects

92.7% of dienogest adverse event reports involve female patients and 0.6% involve male patients. The largest age group is adult at 96%. These figures reflect who reports side effects, not underlying risk.

Sex

Female92.7%
Male0.6%
Unknown6.7%

Age group

< 20.2%
2–110.4%
12–173.6%
18–6495.5%
65+0.2%

What is dienogest used for

Conditions and purposes for which patients were taking dienogest when the adverse event was reported.

AdenomyosisAnaemiaAdenomyosisAutoimmune DermatitisBleeding Menstrual HeavyCervix DisorderChemical ContraceptionContraceptionContraceptionDysfunctional Uterine BleedingDysmenorrhoeaDysmenorrhoeaEndometriosisEpistaxisEndometriosis

Showing 15 of 59 indications

Dienogest brand names and reporting trend

Dienogest is sold under the brand name Natazia.

Brand names

Natazia408

Quarterly reports (20082025)

2008201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking dienogest with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.