Aygestin Side Effects

Please note - some side effects for Aygestin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Aygestin - for the Consumer

Aygestin

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 Aygestin:

Acne; changes in menstrual flow, including breakthrough bleeding, spotting, or missed periods; dizziness; drowsiness; fever; headache; hot flashes; nausea; nervousness; pain; rash; stomach pain; trouble sleeping; weakness; weight gain or loss.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; depression; lumps in the breast or under the armpits; migraine headache; partial or complete loss of vision or changes in vision; shortness of breath; slurred speech; sudden loss of coordination; sudden or severe headache; sudden severe headache, dizziness, vomiting, or fainting; swelling of fingers or ankles; tenderness, pain, or swelling of the calf; weakness, numbness, or pain in the arms or legs; yellowing of the skin or eyes.

Aygestin Side Effects - for the Professional

Aygestin

See WARNINGS and PRECAUTIONS.

The following adverse reactions have been observed in women taking progestins:

• Breakthrough bleeding
• Spotting
• Change in menstrual flow
• Amenorrhea
• Edema
• Changes in weight (decreases, increases)
• Changes in the cervical squamo-columnar junction and cervical secretions
• Cholestatic jaundice
• Rash (allergic) with and without pruritus
• Melasma or chloasma
• Clinical depression
• Acne
• Breast enlargement/tenderness
• Headache/migraine
• Urticaria
• Abnormalities of liver tests (i.e., AST, ALT, Bilirubin)
• Decreased HDL cholesterol and increased LDL/HDL ratio
• Mood swings
• Nausea
• Insomnia
• Anaphylactic/anaphylactoid reactions
• Thrombotic and thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism, retinal vascular thrombosis, cerebral thrombosis and embolism)
• Optic neuritis (which may lead to partial or complete loss of vision)

Side Effects by Body System

Genitourinary

Genitourinary side effects have included breakthrough bleeding, spotting, change in menstrual flow, amenorrhea, changes in cervical erosion and secretion, and breast tenderness. Changes in the cervical squamocolumnar junction and cervical secretions have also been reported.

Endocrine

Endocrine side effects have included increases in PBI, BEI levels, and a decrease in T3 uptake.

Hematologic

Hematologic side effects have included an increase in prothrombin time and clotting factors VII, VIII, IX, and X.

Hepatic

Hepatic side effects have included hepatic adenomas and cholestatic jaundice.

Dermatologic

Dermatologic side effects have included acne, melasma, chloasma, and pruritus.

General

General side effects have included weight gain/loss and hirsutism.

Psychiatric

The psychiatric side effects have included mental depression.

Cardiovascular

Cardiovascular side effects have included edema

Gastrointestinal

Gastrointestinal side effects have included nausea.

Nervous system

Nervous system side effects have included insomnia, headache and dizziness.

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