Cenestin Side Effects

Generic Name: conjugated estrogens

Please note - some side effects for Cenestin 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 Cenestin - for the Consumer

Cenestin

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 Cenestin:

Back pain; bloating; breast pain; depression; diarrhea; dizziness; flu syndrome; gas; hair loss; headache; increased cough; increased/decreased interest in sex; indigestion; infection; irregular vaginal bleeding or spotting; itching; joint pain; lightheadedness; leg cramps; muscle aches; nausea; nervousness; pain; runny nose; sinus inflammation; sleeplessness; sore throat; stomach pain; upper respiratory tract infection; vaginal inflammation; weakness; weight changes.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal bleeding from the vagina; breast lumps; changes in vision or speech; chest pain; dizziness; fainting; mental/mood changes; pain or tenderness in the upper abdomen; pain in the calves; severe headache; sudden shortness of breath; swelling of the hands or feet; unusual vaginal discharge/itching/odor; vomiting; weakness or numbness of an arm or leg; 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.

Cenestin Side Effects - for the Professional

Cenestin

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.

In a 12-week clinical trial that included 72 women treated with 0.625 mg and 2 x 0.625 mg Cenestin and 48 women treated with placebo, adverse events that occurred at a rate of ≥ 5% are summarized in Table 5.

In a second 12-week clinical trial that included 52 women treated with 0.45 mg Cenestin and 51 women treated with placebo, adverse events that occurred at a rate of >5% are summarized in Table 6.

P-value by Fisher's Exact (2-tail) Test

If a subject experiences the same event more than once, the first occurrence is tabulated.

The following additional adverse reactions have been reported with estrogen and/or 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 gallbladder 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; arthalgias; leg cramps; changes in libido; urticaria, angioedema; anaphylactoid/anaphylactic reactions; hypocalcemia; exacerbation of asthma; increased triglycerides.

Side Effects by Body System - for Healthcare Professionals

Oncologic

Oncologic side effects have included increased risks of endometrial carcinoma, ovarian cancer, and breast cancer.

Cardiovascular

The manufacturer recommends close observation if conjugated estrogens must be used in patients who may be particularly sensitive to fluid retention because of underlying asthma, epilepsy, migraine, heart disease, and renal dysfunction.

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

Genitourinary

Genitourinary side effects have included breakthrough bleeding, spotting, changes in vaginal bleeding pattern, abnormal withdrawal bleeding or flow, dysmenorrhea, increase the size of preexisting uterine leiomyomata, vaginitis, including vaginal candidiasis, change in cervical erosion and in degree of cervical secretion, cystitis-like syndrome, application site reactions of vulvovaginal discomfort including burning and irritation, genital pruritus, ovarian cancer, endometrial hyperplasia, and precocious puberty.

Metabolic

Metabolic side effects have included increased serum triglyceride levels and reduced carbohydrate tolerance. Aggravation of porphyria has been reported.

General

General side effects have included reports of fluid retention and increase or decrease in weight.

Gastrointestinal

Cases of oral pigmentation and ischemic colitis have been reported rarely.

Gastrointestinal side effects have included nausea, vomiting, abdominal cramps, bloating, cholestatic jaundice, pancreatitis, ischemic colitis, and increased incidence of gallbladder disease.

Hematologic

Hematologic side effects have included hypercoagulability. Several cases of the hemolytic uremic syndrome have also been associated with conjugated estrogen therapy.

Hepatic

Hepatic side effects have also included many reports of hepatic tumors in women taking long-term oral contraceptives. However, some tumors have been reported in women taking isolated estrogen therapy.

Hepatic side effects have included enlargement of hepatic hemangiomas and rare cases of focal nodular hyperplasia, liver cell adenomas, hepatic hemangiomas and well-differentiated hepatocellular carcinomas.

Nervous system

Nervous system side effects have included headache, migraine, dizziness, stroke, chorea, nervousness, exacerbation of epilepsy, dementia, and mental depression. Possible growth potentiation of benign meningioma has been reported.

Other

Other side effects have included breast tenderness, pain, enlargement, secretion, and fibrocystic breast changes.

Psychiatric

Psychiatric side effects have included case reports of rapid mood cycling in patients with severe depression.

Respiratory

Respiratory side effects have included pulmonary embolism, exacerbation of asthma, and rare cases of exacerbations of pulmonary lymphangioleiomyomatosis. In addition, combinations of high-dose conjugated estrogens and progestin have been reported to increase ventilation and increase the hypoxic ventilatory response.

Dermatologic

Dermatologic side effects have included chloasma or melasma, which did not always resolve following discontinuation of estrogen therapy, scalp hair loss, hirsutism, rash, erythema multiforme, erythema nodosum, and hemorrhagic eruptions.

Hypersensitivity

Hypersensitivity side effects have included anaphylactoid/anaphylaxis reactions including urticaria and angioedema.

Endocrine

Endocrine side effects have included reports of increased levels of thyroxin-binding globulin, leading to an increase in total thyroid serum levels and a decrease in resin uptake of T3. Free thyroid hormone levels remained unchanged. Other endocrine effects have included decreased fasting plasma glucose.

Ocular

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

Local

Local side effects have included phlebitis at the injection site and injection site pain and edema.

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