Angeliq Side Effects

Please note - some side effects for Angeliq may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Angeliq - for the Consumer

Angeliq

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 Angeliq:

Back pain; breast tenderness, pain, or enlargement; headache; mild hair loss; nausea; nervousness; stomach cramps, bloating, or pain; vaginal spotting or breakthrough bleeding; vomiting; weight changes.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); calf pain, swelling, or tenderness; chest pain; confusion; discharge from the nipples; fainting; irregular heartbeat; lumps in the breast; mental or mood changes (eg, depression, irritability, memory loss); numbness of an arm or leg; one-sided weakness; severe or persistent dizziness or stomach pain; severe or persistent breast pain; severe, persistent, or recurring abnormal vaginal bleeding; speech changes (eg, slurred speech); sudden severe headache, nausea, or vomiting; sudden shortness of breath; sudden weight gain; swelling of the hands or feet; unusual vaginal discharge, itching, or odor; vision changes (eg, double vision, sudden vision loss); 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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Angeliq Side Effects - for the Professional

Angeliq

See Boxed Warnings , Warnings, AND Precautions.

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 rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.

The following are adverse events reported with Angeliq occurring in >5% of subjects:

Table 4: Adverse Events Regardless of Drug Relationship Reported at a Frequency of >5% in a 1-year Double-blind Clinical Trial

ADVERSE EVENT	E2 1 MG (N=226) n (%)	Angeliq (N=227) n (%)
BODY AS A WHOLE
Abdominal pain	29 (12.8)	25 (11)
Pain in extremity	15 (6.6)	19 (8.4)
Back pain	11 (4.9)	16 (7)
Flu syndrome	15 (6.6)	16 (7)
Accidental injury	15 (6.6)	13 (5.7)
Abdomen enlarged	17 (7.5)	16 (7)
Surgery	6 (2.7)	12 (5.3)
METABOLIC & NUTRITIONAL DISORDERS
Peripheral edema	12 (5.3)	4 (1.8)
NERVOUS SYSTEM
Headache	26 (11.5)	22 (9.7)
RESPIRATORY SYSTEM
Upper respiratory infection	40 (17.7)	43 (18.9)
Sinusitis	8 (3.5)	12(5.3)
SKIN AND APPENDAGES
Breast pain	34 (15.0)	43 (18.9)
UROGENITAL
Vaginal hemorrhage	43 (19.0)	21 (9.3)
Endometrial disorder	22 (9.7)	4 (1.8)
Leukorrhea	14 (6.2)	3 (1.3)

 

 

The following additional adverse reactions have been reported with

estrogen and or estrogen/progestin therapy:

1. Genitourinary system

Changes in vaginal bleeding pattern and abnormal withdrawal bleeding or flow; breakthrough bleeding, spotting, dysmenorrhea, increase in size of uterine leiomyomata, vaginitis, including vaginal candidiasis, change in amount of cervical secretion, changes in cervical ectropion, ovarian cancer, endometrial hyperplasia, endometrial cancer.

2. Breasts

Tenderness, enlargement, pain, nipple discharge, galactorrhea, fibrocystic breast changes, breast cancer.

3. Cardiovascular

Deep and superficial venous thrombosis, pulmonary embolism, thrombophlebitis, myocardial infarction, stroke, increase in blood pressure.

4. Gastrointestinal

Nausea, vomiting, abdominal cramps, bloating, cholestatic jaundice, increased incidence of gall bladder disease, pancreatitis, enlargement of hepatic hemangiomas.

5. Skin

Chloasma or melasma, which may persist when drug is discontinued, erythema multiforme, erythema nodosum, hemorrhagic eruption, loss of scalp hair, hirsutism, pruritus, rash.

6. Eyes

Retinal vascular thrombosis, intolerance to contact lenses.

7. Central nervous system

Headache, migraine, dizziness, mental depression, chorea, nervousness, mood disturbances, irritability, exacerbation of epilepsy, dementia.

8. Miscellaneous

Increase or decrease in weight, reduced carbohydrate tolerance, aggravation of porphyria, edema, arthralgias, leg cramps, changes in libido, anaphylactoid/anaphylactic reactions including urticaria and angioedema, hypocalcemia, exacerbation of asthma, increased triglycerides.

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Side Effects by Body System - for Healthcare Professionals

Cardiovascular

Cardiovascular side effects have included deep and superficial venous thrombosis, pulmonary embolism, thrombophlebitis, myocardial infarction, stroke and increased blood pressure.

Gastrointestinal

Gastrointestinal side effects have included nausea, vomiting, abdominal cramps, bloating, cholestatic jaundice, increased incidence of gall bladder disease, pancreatitis, abdominal pain, enlarged abdomen, and enlargement of hepatic hemangiomas.

Dermatologic

Dermatologic side effects have included chloasma or melasma, erythema multiforme, erythema nodosum, hemorrhagic resumption, loss of scalp hair, hirsutism, pruritus, and rash.

Nervous system

Nervous system side effects have included headache, migraine, dizziness, mental depression, chorea, nervousness, mood disturbances, irritability, exacerbation of epilepsy and dementia.

Ocular

Ocular side effects have included retinal vascular thrombosis and intolerance to contact lenses.

Genitourinary

Genitourinary side effects have included breast tenderness, pain and enlargement, nipple discharge, galactorrhea, fibrocystic breast disease, breast cancer, vaginal hemorrhage, endometrial disorder, leukorrhea, breast pain, increase in size of leiomyomata, vaginitis, changes in vaginal bleeding pattern, abnormal withdrawal bleeding or flow, breakthrough bleeding, spotting, dysmenorrhea, vaginal candidiasis, change in amount of cervical secretion, changes in cervical ectropion, ovarian cancer, endometrial hyperplasia, and endometrial cancer.

Hypersensitivity

Hypersensitivity side effects have included anaphylactic reactions including urticaria and angioedema.

Endocrine

Endocrine side effects have included reduced carbohydrate tolerance, hypocalcemia, and increased triglycerides.

Respiratory

Respiratory side effects have included upper respiratory infection, sinusitis, and exacerbation of asthma.

General

General side effects have included increase or decrease in weight, edema, flu syndrome, accidental injury, surgery, pain in extremity, and changes in libido.

Metabolic

Metabolic side effects have included aggravation of porphyria.

Musculoskeletal

Musculoskeletal side effects have included arthralgias, back pain and leg cramps

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