Lybrel

Lybrel 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 Lybrel and call your doctor at once if you have any of these serious side effects:

• sudden numbness or weakness, especially on one side of the body;
• sudden headache, 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;
• nausea, stomach pain, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes);
• swelling in your hands, ankles, or feet; or
• symptoms of depression (sleep problems, weakness, mood changes).

Less serious Lybrel side effects may include:

• mild nausea, vomiting, bloating, stomach cramps;
• breast pain, tenderness, or swelling;
• freckles or darkening of facial skin;
• increased hair growth, loss of scalp hair;
• changes in weight or appetite;
• problems with contact lenses;
• vaginal itching or discharge;
• changes in your menstrual periods, decreased sex drive; or
• headache, nervousness, dizziness, tired feeling.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Side Effects of Lybrel - for the Consumer

Lybrel

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Lybrel:

Breast tenderness; changes in appetite; dizziness; headache; mild hair loss; nausea; nervousness; vaginal spotting or breakthrough bleeding; vomiting; weight gain.

Seek medical attention right away if any of these SEVERE side effects occur when using Lybrel:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); breast discharge; breast lumps; calf or leg pain, swelling, or tenderness; change in amount of urine produced; chest pain or heaviness; confusion; coughing of blood; dark urine; fainting; mental or mood changes (eg, depression); migraines; numbness of an arm or leg; one-sided weakness; pale stools; persistent, severe, or recurring headache or dizziness; persistent vaginal spotting; severe pain or tenderness in the stomach; shortness of breath; slurred speech; sudden severe headache or vomiting; swelling of the fingers, hands, legs, or ankles; unusual or severe vaginal bleeding; unusual tiredness or weakness; vaginal irritation, discharge, or odor; vision changes (eg, sudden vision loss, double vision); yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Lybrel Side Effects - for the Professional

Lybrel

An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives:

Thromboembolic and thrombotic disorders and other vascular problems (including thrombophlebitis and venous thrombosis with or without pulmonary embolism, mesenteric thrombosis, arterial thromboembolism, myocardial infarction, cerebral hemorrhage, cerebral thrombosis, transient ischemic attack), carcinoma of the reproductive organs and breasts, hepatic neoplasia/liver disease (including hepatic adenomas or benign liver tumors), ocular lesions (including retinal vascular thrombosis), gallbladder disease, carbohydrate and lipid effects, elevated blood pressure, and headache including migraine.

The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug related (alphabetically listed):

Acne

Amenorrhea

Anaphylactic/anaphylactoid reactions, including urticaria, angioedema, and severe reactions with respiratory and circulatory symptoms

Breast changes: tenderness, pain, enlargement, secretion

Budd-Chiari syndrome

Cervical erosion and secretion, change in

Cholestatic jaundice

Chorea, exacerbation of

Colitis

Contact lenses, intolerance to

Corneal curvature (steepening), change in

Dizziness

Edema/fluid retention

Erythema multiforme

Erythema nodosum

Focal nodular hyperplasia

Gastrointestinal symptoms (such as abdominal pain, cramps, and bloating)

Hirsutism

Infertility after discontinuation of treatment, temporary

Lactation, diminution in, when given immediately postpartum

Libido, change in

Melasma/chloasma which may persist

Menstrual flow, change in

Mood changes, including depression

Nausea

Nervousness

Pancreatitis

Porphyria, exacerbation of

Rash (allergic)

Scalp hair, loss of

Serum folate levels, decrease in

Spotting

Systemic lupus erythematosus, exacerbation of

Unscheduled bleeding

Vaginitis, including candidiasis

Varicose veins, aggravation of

Vomiting

Weight or appetite (increase or decrease), change in

 

The following adverse reactions have been reported in users of oral contraceptives:

Cataracts

Cystitis-like syndrome

Dysmenorrhea

Hemolytic uremic syndrome

Hemorrhagic eruption

Optic neuritis, which may lead to partial or complete loss of vision

Premenstrual syndrome

Renal function, impaired

What other drugs will affect Lybrel?

Some drugs can make Lybrel less effective, which may result in pregnancy. Before using Lybrel, tell your doctor if you are using any of the following drugs:

• acetaminophen (Tylenol) or ascorbic acid (vitamin C);
• prednisolone (Orapred);
• theophylline (Respbid, Theo-Dur);
• cyclosporine (Neoral, Sandimmune, Gengraf);
• St. John's wort;
• an antibiotic;
• seizure medications;
• a barbiturate sedative such as secobarbital (Seconal), or phenobarbital (Luminal, Solfoton); or
• HIV or AIDS medications.

This list is not complete and there may be other drugs not listed that can affect Lybrel. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.