Amethia, Camrese, Daysee, Levonorgestrel Ethinyl Estradiol Extended, Setlakin, Simpesse, Jaimiess, Iclevia, Ashlyna, Rivelsa, Camrese Lo, Introvale, Fayosim, Lojaimiess

Introduction

Written by Sarah Lewis, PharmD
Medically reviewed by Rosanna Sutherby, PharmD
Updated on November 15, 2023

Simpesse (sim pe’ see) is a brand-name medication prescribed to help prevent pregnancy. Simpesse belongs to a group of drugs called oral contraceptives. The common name for this group of drugs is birth control pills.

Boxed warning: Risk of serious heart and blood vessel problems with cigarette smoking

Simpesse oral tablet has a boxed warning about the risk of serious heart and blood vessel problems with cigarette smoking. Boxed warnings are the most serious warnings from the Food and Drug Administration (FDA).

For details, see the “Interactions and warnings for Simpesse” section.

Side effects of Simpesse

Simpesse may cause mild or serious side effects. More common mild side effects of Simpesse and its serious side effects are listed below. This article doesn’t include all possible side effects of the drug. Side effects can vary based on your age, overall health, and any other medications you take.

To learn more about Simpesse’s side effects, ask your doctor or pharmacist. You can also refer to the prescribing information for Simpesse listed in the “Resources” section.

Mild side effects

More common mild side effects reported with Simpesse are listed below.

This article doesn’t include all possible mild side effects of the drug. To learn more about Simpesse’s side effects, refer to the prescribing information for Simpesse listed in the “Resources” section.

With many drugs, mild side effects may go away within a few days or a couple of weeks. If the side effects are bothersome, tell your doctor or pharmacist. They may be able to suggest ways to manage them.

Simpesse oral tablet’s mild side effects include:

• acne
• breast tenderness
• nausea
• weight gain
• mild allergic reaction*

* For details about this side effect, see the “Interactions and warnings for Simpesse” section.

Serious side effects

Serious side effects of Simpesse are listed below.

This article doesn’t include all possible serious side effects of the drug. To learn more about Simpesse’s side effects, refer to the prescribing information for Simpesse listed in the “Resources” section.

With many drugs, serious side effects are possible but not common. If you have serious side effects from this drug, call your doctor right away. If you’re having severe symptoms or a medical emergency, call 911 or a local emergency number.

In general, Simpesse’s serious side effects include:

• blood clots, which can affect several organs including the eyes, lungs, heart, and brain
• gallbladder disease
• high blood pressure
• increased blood fat levels, including cholesterol and triglycerides
• increased blood sugar levels
• liver problems, including liver tumors
• melasma (a hormone-related darkening of skin color, usually in patches on the face)
• menstrual bleeding changes, including breakthrough bleeding and heavy bleeding
• new or worsening depression
• new or worsening migraine headaches
• problems wearing contact lenses
• boxed warning(s): risk of serious heart and blood vessel problems with cigarette smoking*
• severe allergic reaction*

* For details about this side effect, see the “Interactions and warnings for Simpesse” section.

Common questions about Simpesse

Below you’ll find answers to a few commonly asked questions about Simpesse.

How does Simpesse compare with Ashlyna?

Simpesse and Ashlyna are considered equivalent drugs. Both birth control pills contain the same hormones, levonorgestrel and ethinyl estradiol, in the same amounts. The dosing for both of these birth control pills is also the same. It’s a 91-day extended cycle (about 13 weeks). Simpesse and Ashlyna have the same warnings and side effects as well.

To learn more about this, talk with your doctor or pharmacist.

Can Simpesse cause weight loss?

No, weight loss isn’t likely with Simpesse. It wasn’t reported in studies of the drug. On the other hand, weight gain was a common side effect reported in studies. It was also a common reason for stopping the drug.

If you’re having changes in your weight that are concerning, tell your doctor. They can explore the most likely cause and suggest ways to manage it.

How does Simpesse work? And how long does it take to start working?

The main way Simpesse works to help prevent pregnancy is by blocking ovulation. Ovulation is the release of an egg. Without an egg, there is nothing for sperm to fertilize.

It takes a week for Simpesse to work to prevent pregnancy. You’ll need to use a backup birth control method for the first 7 days of taking Simpesse. Your doctor can suggest an effective backup birth control option.

If you’d like to know more about this, talk with your doctor or pharmacist.

Uses of Simpesse

The Food and Drug Administration (FDA) approves prescription drugs such as Simpesse for certain conditions. Approved uses for Simpesse are described below.

Use for pregnancy prevention

Doctors may prescribe Simpesse oral tablet to help prevent pregnancy. It’s used for this purpose in female* adolescents who have gone through puberty and female* adults. It’s usually prescribed for long-term use.

* Sex and gender exist on spectrums. In this article, we use the term “female” to refer to a person’s sex assigned at birth.

Interactions and warnings for Simpesse

Below you’ll find information about Simpesse’s possible interactions and warnings.

Interactions of Simpesse

Certain things may affect how a drug works. These include getting vaccines, consuming alcohol or certain foods, or taking the drug with other medications. This effect is called a drug interaction.

Before you take Simpesse, ask your doctor to check for possible interactions. Be sure to tell them about any of the following you take or use:

• prescription or over-the-counter drugs
• vitamins, herbs, or supplements

To learn about drug-condition interactions, see the “Warnings for Simpesse” section below.

Warnings for Simpesse

Some people should not take Simpesse, and others should take it cautiously.

Boxed warning: Risk of serious heart and blood vessel problems with cigarette smoking

Simpesse has a boxed warning about the risk of serious heart and blood vessel problems with cigarette smoking. Boxed warnings are the most serious warnings from the Food and Drug Administration (FDA).

Smoking cigarettes while you’re on birth control pills increases the risk of serious heart and blood vessel problems. These problems include heart attack, blood clots, and stroke, all of which can be fatal. The risk of having these problems is highest if you’re older than 35 years or smoke more than 15 cigarettes per day.

Due to this risk, you should not take Simpesse if you’re older than 35 years and smoke. If you take Simpesse, you should not smoke no matter how old you are.

Symptoms of serious heart or blood vessel problems may include:

• breathing problems
• chest pain
• drooping on one side of the face
• leg pain, coolness, or color changes
• trouble speaking or understanding what people are saying
• weakness or numbness on one side of the body

If you experience any of these symptoms, seek emergency medical care or call 911. If you smoke, tell your doctor. They’ll likely recommend ways to stop smoking. They may also suggest using birth control methods that don’t contain hormones.

To learn more, talk with your doctor or pharmacist.

Other warnings

Simpesse could cause harm to people with certain health conditions. This effect is called a drug-condition interaction. Other factors can also affect whether Simpesse is a safe option for you.

Ask your doctor about specific warnings for Simpesse, and be sure to tell your doctor about your:

• current health, including any allergies to medications
• past health conditions or surgeries

Allergic reaction

Simpesse can cause an allergic reaction in some people. Severe allergic reactions are rare but possible.

If you’ve had an allergic reaction to Simpesse or any of its ingredients, your doctor will likely not prescribe Simpesse. They can tell you about medications that are safer options for you.

A mild allergic reaction may cause the following symptoms:

• skin rash
• itchiness
• flushing (temporary warmth, redness, or deepening of skin color)

A severe allergic reaction may cause the following symptoms:

• swelling under your skin, usually in your hands, feet, eyelids, or lips
• swelling of your mouth, throat, or tongue, which can cause breathing problems

If you have an allergic reaction to Simpesse, call your doctor right away. If you have severe symptoms, call 911 or a local emergency number.

Overdose of Simpesse

You should not take more Simpesse than your doctor prescribes. For some drugs, doing so may lead to harmful effects or overdose.

If you think you’ve taken too much Simpesse, call your doctor or pharmacist right away. Or you could call 800-222-1222 to speak with someone at America’s Poison Centers. You can also use its online resource. If you have concerning symptoms, call 911 or a local emergency number immediately. You can also go to the closest emergency room.

Pregnancy or breastfeeding and Simpesse

Information about Simpesse and pregnancy and breastfeeding is described below.

Simpesse and pregnancy

Simpesse should not be taken during pregnancy. Doctors prescribe this medication to help prevent pregnancy. Although rare, pregnancy can occur while taking it. Tell your doctor right away if you think you could be pregnant while taking Simpesse. They’ll likely recommend stopping Simpesse.

Simpesse and breastfeeding

Simpesse should not be taken while breastfeeding. If you’re currently breastfeeding or planning to do so, talk with your doctor before taking this medication. Your doctor may recommend other forms of birth control while you are breastfeeding.

What to ask your doctor

Let your doctor know if you have questions about Simpesse or would like more details about it.

Here’s a list of some possible questions you may want to ask your doctor:

• How long is it safe to take Simpesse?
• What should I do if I want to stop taking Simpesse?
• What is the most important information I need to know about Simpesse?

Resources

• Food and Drug Administration. (2023). Orange Book: Approved drug products with therapeutic equivalence evaluations. https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm
• Simpesse (levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets) for oral use. (2023). https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/abea62b3-6a55-40a4-9e68-1ee9801e0f2c/spl-doc

Disclaimer: Optum Perks has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.