Medical Editor: John P. Cunha, DO, FACOEP
Jaimiess (levonorgestrel/ethinyl estradiol and ethinyl estradiol) is combination of female hormones (a combined oral contraceptive, or COC) indicated for use by women to prevent pregnancy. Jaimiess is available in generic form. Common side effects of Jaimiess include:
Take one tablet of Jaimiess daily by mouth at the same time every day for 91 days. Jaimiess may interact with barbiturates, bosentan, carbamazepine, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, St. John's wort, topiramate, HIV protease inhibitors, non-nucleoside reverse transcriptase inhibitors, antibiotics, HCV drug combinations containing ombitasvir/paritaprevir/ritonavir (with or without dasabuvir), and lamotrigine. Tell your doctor all medications and supplements you use. Combined oral contraceptives such as Jaimiess are not intended for use during pregnancy. Breastfeeding is not recommended while using Jaimiess; it can decrease milk production.
Our Jaimiess (levonorgestrel/ethinyl estradiol and ethinyl estradiol) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling:
- Serious cardiovascular events and smoking[see BOXED WARNING AND WARNINGS AND PRECAUTIONS]
- Vascular events [see WARNINGS AND PRECAUTIONS]
- Liver disease [see WARNINGS AND PRECAUTIONS]
Adverse reactions commonly reported by COC users are:
- Irregular uterine bleeding
- Breast tenderness
Clinical Trial 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 the rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The clinical trial that evaluated the safety and efficacy of levonorgestrel/ethinyl estradiol and ethinyl estradiol was a 12-month, randomized, multicenter, open-label study, which enrolled women aged 18- 40, of whom 1,006 took at least one dose of levonorgestrel/ethinyl estradiol and ethinyl estradiol.
Adverse Reactions Leading To Study Discontinuation
16.3% of the women discontinued from the clinical trial due to an adverse reaction; the most common adverse reactions (≥ 1% of women) leading to discontinuation were irregular and/or heavy uterine bleeding (5.9%), weight gain (2.4%), mood changes (1.5%), and acne (1.0%).
Common Treatment-Emergent Adverse Reactions (≥ 5% of women)
Irregular and/or heavy uterine bleeding (17%), weight gain (5%), acne (5%).
Serious Adverse Reactions
Migraine, cholecystitis, cholelithiasis, pancreatitis, abdominal pain, and major depressive disorder.
The following adverse reactions have been identified during post-approval use of levonorgestrel/ethinyl estradiol and ethinyl estradiol. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency of establish a causal relationship to drug exposure.
Gastrointestinal disorders: abdominal distension, vomiting
General disorders and administration site conditions: chest pain, fatigue, malaise, edema peripheral, pain
Immune system disorders: hypersensitivity reaction
Investigations: blood pressure increased
Musculoskeletal and connective tissue disorders: muscle spasms, pain in extremity
Nervous system disorders: dizziness, loss of consciousness
Psychiatric disorders: insomnia
Reproductive and breast disorders: dysmenorrhea
Respiratory, thoracic and mediastinal disorders: pulmonary embolism, pulmonary thrombosis
Skin and subcutaneous tissue disorders: alopecia
Vascular disorders: thrombosis
Read the entire FDA prescribing information for Jaimiess (Levonorgestrel and Ethinyl Estradiol Tablets)