"April 10, 2012 -- Birth control pills that contain the hormone drospirenone must now carry a warning that they may increase the risk for potentially fatal blood clots, according to the FDA.
Drospirenone is a synthetic version of the f"...
Yasmin Side Effects Center
Medical Editor: Melissa Conrad Stöppler, MD
Yasmin (ethinyl estradiol/drospirenone) is a 28-day oral contraceptive pill used to prevent pregnancy. Yasmin is a combination of two hormones that works by inhibiting the release of an egg during the menstrual cycle. Common side effects of Yasmin include nausea, vomiting, headache, bloating, and weight changes.
Some medications that may interact with Yasmin including aromatase inhibitors (such as anastrozole [Arimidex], exemestane [Aromasin]), fosamprenavir (Lexiva), raloxifene (Evosta), sodium tetradecyl sulfate (Sotradecol), and tamoxifen (Soltamox, Nolvadex). Women who smoke cigarettes/use tobacco and are over 35 years old should not use Yasmin because of the risks of blood clots, stroke, and heart attack. If you become pregnant or think you may be pregnant, tell your doctor immediately. Yasmin passes into breast milk and may harm a nursing infant.
Our Yasmin 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.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Yasmin in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using this medication and call your doctor at once if you have any of these serious side effects:
- sudden numbness or weakness, confusion, pain behind the eyes, problems with vision, speech, or balance;
- chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
- a change in the pattern or severity of migraine headaches;
- stomach pain, loss of appetite, jaundice (yellowing of the skin or eyes);
- a breast lump; or
- symptoms of depression (sleep problems, weakness, mood changes).
Less serious side effects may include:
- breast pain, tenderness, or swelling;
- freckles or darkening of facial skin, increased hair growth, or loss of scalp hair;
- changes in weight or appetite, swelling of your hands or feet;
- problems with contact lenses;
- vaginal itching or discharge; or
- changes in your menstrual periods.
Read the entire detailed patient monograph for Yasmin (Drospirenone and Ethinyl Estradiol) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Yasmin Overview - Patient Information: Side Effects
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if any of these serious side effects occur: unusual changes in vaginal bleeding (such as continuous spotting, sudden heavy bleeding, missed periods).
This medication may rarely cause serious (sometimes fatal) problems from blood clots (such as deep vein thrombosis, pulmonary embolism, stroke, heart attack). Talk to your doctor about the risks and benefits of this birth control pill. Get medical help right away if you experience: sudden shortness of breath, chest/jaw/left arm pain, unusual sweating, confusion, coughing up blood, sudden dizziness/fainting, pain/swelling/warmth in the groin/calf, tingling/weakness/numbness in the arms/legs, unusual headaches (including headaches with vision changes/lack of coordination, worsening of migraines, sudden/very severe headaches), slurred speech, weakness on one side of the body, sudden vision changes (such as partial/complete blindness).
Get medical help right away if any of these rare but serious side effects occur: lumps in the breast, severe stomach/abdominal pain, dark urine, yellowing eyes/skin, mental/mood changes (such as new/worsening depression, suicidal thoughts).
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Yasmin (Drospirenone and Ethinyl Estradiol)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Yasmin FDA Prescribing Information: Side Effects
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]
- Vascular events [see WARNINGS AND PRECAUTIONS]
- Liver disease [see WARNINGS AND PRECAUTIONS]
Adverse reactions commonly reported by COC users are:
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared to rates in other clinical trials and may not reflect the rates observed in practice.
The data provided reflect the experience with the use of Yasmin (3 mg DRSP/0.03 mg EE) in the adequate and well-controlled studies for contraception (N=2,837). The US pivotal clinical study (N=326) was a multicenter, open-label trial in healthy women aged 18-35 who were treated for up to 13 cycles. The second pivotal study (N=442)was a multicenter, randomized, open-label comparative European study of Yasmin vs. 0.150 mg desogestrel/0.03 mg EE conducted in healthy women aged 17-40 who were treated for up to 26 cycles.
The most common adverse reactions (≥ 2% of users) were: premenstrual syndrome (13.2%), headache/migraine (10.7%), breast pain/tenderness/discomfort (8.3%), nausea/vomiting (4.5%) abdominal pain/discomfort/tenderness (2.3%) and mood changes (depression, depressed mood, irritability, mood swings, mood altered and affect lability (2.3%).
Adverse Reactions (≥ 1%) Leading to Study Discontinuation
Of 2,837 women, 6.7% discontinued from the clinical trials due to an adverse reaction; the most frequent adverse reaction leading to discontinuation was headache/migraine (1.5%).
Serious Adverse Reactions
The following adverse reactions have been identified during post-approval use of Yasmin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Adverse reactions, including fatalities, are grouped into System Organ Classes and ordered by frequency.
Vascular disorders: Venous and arterial thromboembolic events (including pulmonary emboli, deep vein thrombosis, intracardiac thrombosis, intracranial venous sinus thrombosis, sagittal sinus thrombosis, retinal vein occlusion, myocardial infarction and stroke), hypertension
Hepatobiliary disorders: Gallbladder disease
Immune system disorders: Hypersensitivity
Metabolism and nutrition disorders: Hyperkalemia
Skin and subcutaneous tissue disorders: Chloasma
Read the entire FDA prescribing information for Yasmin (Drospirenone and Ethinyl Estradiol) »
Additional Yasmin Information
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