Dienogest and estradiol side effects

What does the patient leaflet say about side effects?

From the patient leaflet: What are the Common Side Effects of Birth Control Pills?

The most common side effects of birth control pills are: • Spotting or bleeding between menstrual periods • Nausea • Breast tenderness • Headache These side effects are usually mild and usually disappear with time. Less common side effects are: • Acne • Less sexual desire • Bloating or fluid retention • Blotchy darkening of the skin, especially on the face • High blood sugar, especially in women who already have diabetes • High fat levels in the blood • Depression, especially if you have had depression in the past. Call your healthcare provider immediately if you have any thoughts of harming yourself. • Problems tolerating contact lenses • Weight changes This is not a complete list of possible side effects. Talk to your healthcare provider if you develop any side effects that concern you. You may report side effects to the FDA at 1-800-FDA-1088. […]

What does the label list?

From the label: adverse reactions

The most common adverse reactions (≥ 2%) in clinical trials for Natazia are headache (including migraines) 13%, breast pain 7%, menstrual disorders 7%, nausea/vomiting 6%, acne 4%, mood changes (3%) and increased weight 3%.

From the label: adverse reactions, continued

The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling: • Serious cardiovascular events and stroke [see Boxed Warning and Warnings and Precautions ( 5.1 )] • Vascular events [see Warnings and Precautions ( 5.1 )] • Liver disease [see Warnings and Precautions ( 5.3 )] Adverse reactions commonly reported by COC users are: • Irregular uterine bleeding • Nausea • Breast tenderness • Headache The most common adverse reactions (≥ 2%) in clinical trials for Natazia are headache (including migraines) 13%, breast pain 7%, menstrual disorders 7%, nausea/vomiting 6%, acne 4%, mood changes (3%) and increased weight 3%. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Bayer HealthCare Pharmaceuticals Inc. at 1-888-842-2937 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Contraception and Heavy Menstrual Bleeding Studies A total of 2,131 women, 18 to 54 years of age, who took at least one dose of Natazia were enrolled in four clinical phase 3 trials.

What do FAERS reports show?

316 reports list dienogest and estradiol among the medicines taken, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 19 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 16 reactions below, 5 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

The 25 most reported reactions

• Metrorrhagia35
• Drug Dose Omission (a use or a product term, not a reaction)34
• Headache (named in the label)17
• Vaginal Haemorrhage15
• Off Label Use (a use or a product term, not a reaction)14
• Menstruation Delayed12
• Pregnancy On Oral Contraceptive12
• Nausea (named in the label)11
• Product Use Issue (a use or a product term, not a reaction)11
• Amenorrhoea (named in the label)10
• Inappropriate Schedule Of Drug Administration (a use or a product term, not a reaction)9
• Product Use In Unapproved Indication (a use or a product term, not a reaction)9
• Vomiting (named in the label)9
• Abnormal Withdrawal Bleeding8
• Menorrhagia8
• No Adverse Event (a use or a product term, not a reaction)8
• Dizziness (named in the label)7
• Drug Ineffective (a use or a product term, not a reaction)7
• Extra Dose Administered7
• Product Dose Omission Issue (a use or a product term, not a reaction)7
• Inappropriate Schedule Of Product Administration (a use or a product term, not a reaction)6
• Anaemia5
• Depression5
• Dyspnoea5
• Fatigue5

What next?

Dienogest and estradiol: the full record

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Side effects hub

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