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Cenestin

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Cenestin

Cenestin

Cenestin Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Cenestin (synthetic conjugated estrogens, A) is used to treat certain symptoms of menopause such as dryness, burning, and itching of the vaginal area. Common side effects include nausea and vomiting, bloating, breast tenderness, headache, or weight changes.

Cenestin is available in tablet form ranging in strengths of 0.3 mg to 1.25 mg. Dosage adjustment may be made based on patient response. Cenestin may interact with blood thinners, thyroid medications, insulin or oral diabetes medications, rifampin, ketoconazole or itraconazole, seizure medicines, barbiturates, or antidepressants. Tell your doctor all medications you are taking. Cenestin must not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor immediately. This medication passes into breast milk. Consult your doctor before using Cenestin if you are breastfeeding.

Our (synthetic conjugated estrogens, A) 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.

Cenestin 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 taking this medication and call your doctor at once if you have any of these serious side effects:

  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • sudden numbness or weakness, especially on one side of the body;
  • sudden headache, confusion, problems with vision, speech, or balance;
  • pain or swelling in your lower leg;
  • abnormal vaginal bleeding;
  • migraine headache;
  • pain, swelling, or tenderness in your stomach;
  • confusion, problems with memory or concentration;
  • jaundice (yellowing of the skin or eyes);
  • swelling in your hands, ankles, or feet; or
  • a breast lump.

Less serious 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. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Cenestin (Synthetic conjugated estrogens) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Cenestin Overview - Patient Information: Side Effects

SIDE EFFECTS: See also Warning section.

Stomach upset, nausea/vomiting, bloating, breast tenderness, headache, or weight changes may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Tell your doctor promptly if you see the tablet in your stool.

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 you have any serious side effects, including: mental/mood changes (such as depression, memory loss), breast lumps, unusual vaginal bleeding (such as spotting, breakthrough bleeding, prolonged/recurrent bleeding), increased or new vaginal irritation/itching/odor/discharge, severe stomach/abdominal pain, persistent nausea/vomiting, yellowing eyes/skin, dark urine, swelling hands/ankles/feet, increased thirst/urination.

This medication may rarely cause serious problems from blood clots (such as heart attacks, strokes, deep vein thrombosis, pulmonary embolism). Get medical help right away if you have any serious side effects, including: chest/jaw/left arm pain, unusual sweating, sudden/severe headache, weakness on one side of the body, confusion, slurred speech, sudden vision changes (such as partial/complete blindness), pain/redness/swelling of legs, tingling/weakness/numbness in the arms/legs, trouble breathing, coughing up blood, sudden dizziness/fainting.

A very serious allergic reaction to this product 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 Cenestin (Synthetic conjugated estrogens)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Cenestin FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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 (synthetic conjugated estrogens) and 48 women treated with placebo, adverse events that occurred at a rate of > 5% are summarized in Table 5.

Table 5
Number (%) of Patients with Adverse Events With > 5% Occurrence Rate By Body System and Treatment Group

Body System
Adverse Event
Cenestin* 0.625 mg and 2 x 0.625 mg
n (%)
Placebo
n (%)
Total
n (%)
Number of Patients Who Received Medication 72 (100) 48 (100) 120 (100)
Number of Patients With Adverse Events 68 (94) 43 (90) 111 (93)
Number of Patients Without Any Adverse Events 4 (6) 5 (10) 9 (8)
Body As A Whole
    Abdominal Pain 20 (28) 11 (23) 31 (26)
    Asthenia 24 (33) 20 (42) 44 (37)
    Back Pain 10 (14) 6 (13) 16 (13)
    Fever 1 (1) 3 (6) 4 (3)
    Headache 49 (68) 32 (67) 81 (68)
    Infection 10 (14) 5 (10) 15 (13)
    Pain 8 (11) 9 (19) 17 (14)
Cardiovascular System
    Palpitation 15 (21) 13 (27) 28 (23)
Digestive System
    Constipation 4 (6) 2 (4) 6 (5)
    Diarrhea 4 (6) 0 (0) 4 (3)
    Dyspepsia 7 (10) 3 (6) 10 (8)
    Flatulence 21 (29) 14 (29) 35 (29)
    Nausea 13 (18) 9 (19) 22 (18)
    Vomiting 5 (7) 1 (2) 6 (5)
Metabolic and Nutritional
    Peripheral Edema 7 (10) 6 (13) 13 (11)
Musculoskeletal System
    Arthralgia 18 (25) 13 (27) 31 (26)
    Myalgia 20 (28) 15 (31) 35 (29)
Nervous System
    Depression 20 (28) 18 (38) 38 (32)
    Dizziness 8 (11) 5 (10) 13 (11)
    Hypertonia 4 (6) 0 (0) 4 (3)
    Insomnia 30 (42) 23 (48) 53 (44)
    Leg Cramps 7 (10) 3 (6) 10 (8)
    Nervousness 20 (28) 20 (42) 40 (33)
    Paresthesia 24 (33) 15 (31) 39 (33)
    Vertigo 12 (17) 12 (25) 24 (20)
Respiratory System
    Cough Increased 4 (6) 1 (2) 5 (4)
    Pharyngitis 6 (8) 4 (8) 10 (8)
    Rhinitis 6 (8) 7(15) 13 (11)
Skin and Appendages      
    Rash 3 (4) 3 (6) 6 (5)
Urogenital System
    Breast Pain 21 (29) 7 (15) 28 (23)
    Dysmenorrhea 4 (6) 3 (6) 7 (6)
    Metrorrhagia 10 (14) 3 (6) 13 (11)
* Combined results for 0.625 mg and 2 x 0.625 mg Cenestin Tablets

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

Table 6
Number (%) of Patients with a > 5% Occurrence Rate by Body System and Treatment Group

Body System and Term Cenestin 0.45 mg Control p-value
Any Adverse Event (%) 40 (75.5%) 39 (76.5%) 1.0000
Body as a whole 20 (37.7%) 24 (47.1%) 0.4275
    Asthenia 6 (11.3%) 7 (13.7%) 0.7731
    Headache 6 (11.3%) 8 (15.7%) 0.5748
    Infection 1 (1.9%) 6 (11.8%) 0.0576
    Pain 6 (11.3%) 1 (2.0%) 0.1128
    Pain abdominal 5 (9.4%) 3 (5.9%) 0.7159
Cardiovascular 5 (9.4%) 10 (19.6%) 0.1695
    Palpitations 3 (5.7%) 3 (5.9%) 1.0000
    Vasodilations 2 (3.8%) 4 (7.8%) 0.4324
Digestive 8 (15.1%) 7 (13.7%) 1.0000
    Nausea 5 (9.4%) 2 (3.9%) 0.4374
Metabolic and nutritional 5 (9.4%) 3 (5.9%) 0.7159
    Weight increase 3 (5.7%) 2 (3.9%) 1.0000
Musculoskeletal 5 (9.4%) 6 (11.8%) 0.7582
    Arthralgia 5 (9.4%) 5 (9.8%) 1.0000
    Myalgia 2 (3.8%) 6 (11.8%) 0.1566
Neurological 15 (28.3%) 19 (37.3%) 0.4044
    Anxiety 3 (5.7%) 1 (2.0%) 0.6179
    Depression 2 (3.8%) 7 (13.7%) 0.0895
    Insomnia 3 (5.7%) 5 (9.8%) 0.4839
    Nervousness 2 (3.8%) 7 (13.7%) 0.0895
    Paresthesia 4 (7.5%) 3 (5.9%) 1.0000
    Vertigo 3 (5.7%) 3 (5.9%) 1.0000
Respiratory 10 (18.9%) 6 (11.8%) 0.4173
    Upper Respiratory Tract Infection 7 (13.2%) 1 (2.0%) 0.0603
    Rhinitis 3 (5.7%) 2 (3.9%) 1.0000
    Pharyngitis 1 (1.9%) 3 (5.9%) 0.3581
Urogenital 19 (35.8%) 7 (13.7%) 0.0124
    Endometrial thickening 10 (18.9%) 4 (7.8%) 0.1503
    Vaginitis 4 (7.5%) 1 (2.0%) 0.3632
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:

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.

Breasts

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

Cardiovascular

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

Gastrointestinal

Nausea, vomiting; abdominal cramps, bloating; cholestatic jaundice; increased incidence of gallbladder disease; pancreatitis, enlargement of hepatic hemangiomas

Skin

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

Eyes

Retinal vascular thrombosis; intolerance to contact lenses.

Central nervous system

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

Miscellaneous

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

Read the entire FDA prescribing information for Cenestin (Synthetic conjugated estrogens) »

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Cenestin - User Reviews

Cenestin User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Cenestin sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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