Cenestin (synthetic conjugated estrogens, A) is a blend of nine (9) synthetic estrogenic substances (female hormones) used to treat certain symptoms of menopause such as dryness, burning, and itching of the vaginal area.
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.
Additional Information
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.
Cenestin Consumer Information
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, sweating;
signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
signs of a blood clot--sudden vision loss, stabbing chest pain, coughing up blood, pain or warmth in one or both legs;
swelling, rapid weight gain;
jaundice (yellowing of the skin or eyes);
memory problems, confusion, unusual behavior;
unusual vaginal bleeding, pelvic pain;
a lump in your breast; or
high levels of calcium in your blood--vomiting, constipation, increased thirst or urination, muscle weakness, bone pain, lack of energy.
vaginal itching or discharge, changes in your menstrual periods, breakthrough bleeding.
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.
The following serious adverse reactions are discussed elsewhere in the labeling:
Cardiovascular Disorders [see BOXED WARNING, progestin therapy if a VTE occurs]
Malignant Neoplasms [see BOXED WARNING, progestin therapy if a VTE occurs]
Clinical Trials Experience
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.
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 reactions that occurred at a rate of ≥ 5 percent are summarized in Table 1.
Table 1: Number (%) of Patients with Adverse Reactions with ≥ 5 Percent Occurrence Rate by Body System and Treatment Group
Body System Adverse Reaction
CENESTINa 0.625 mg and 2 x 0.625 mg n=72
Placebo n=48
Total n=120
Any Adverse Reaction (%)
68 (94)
43 (90)
111 (93)
Body As A Whole
Abdominal Pain
20 (28)
11 (23)
31 (26)
Asthenia
24 (33)
20 (42)
44 (37)
Headache
49 (68)
32 (67)
81 (68)
Pain
8 (11)
9 (19)
17 (14)
Digestive System
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)
Nervous System
Depression
20 (28)
18 (38)
38 (32)
Dizziness
8 (11)
5 (10)
13 (11)
Insomnia
30 (42)
23 (48)
53 (44)
Leg Cramps
7 (10)
3 (6)
10 (8)
Paresthesia
24 (33)
15 (31)
39 (33)
Vertigo
12 (17)
12 (25)
24 (20)
Urogenital System
21 (29)
7 (15)
28(23)
Breast Pain
4 (6)
3 (6)
7 (6)
Dysmenorrhea
10 (14)
3 (6)
13 (11)
Metrorrhagia
10 (14)
3 (6)
13 (11)
a 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 and 51 women treated with placebo, adverse reactions that occurred at a rate of >5 percent are summarized in Table 2.
Table 2: Number (%) of Patients with a ≥ 5 Percent Occurrence Rate by Body System and Treatment Group
Body System and Term
CENESTIN 0.45 mg
Placebo
Any Adverse Reaction (%)
40 (75.5%)
39 (76.5%)
Body As A Whole
20 (37.7%)
24 (47.1%)
Asthenia
6 (11.3%)
7 (13.7%)
Headache
6 (11.3%)
8 (15.7%)
Infection
1 (1.9%)
6 (11.8%)
Pain
6 (11.3%)
1 (2.0%)
Pain abdominal
5 (9.4%)
3 (5.9%)
Cardiovascular
5 (9.4%)
10 (19.6%)
Palpitations
3 (5.7%)
3 (5.9%)
Vasodilations
2 (3.8%)
4 (7.8%)
Digestive
8 (15.1%)
7 (13.7%)
Nausea
5 (9.4%)
2 (3.9%)
Metabolic and Nutritional
5 (9.4%)
3 (5.9%)
Weight increase
3 (5.7%)
2 (3.9%)
Musculoskeletal
5 (9.4%)
6 (11.8%)
Arthralgia
5 (9.4%)
5 (9.8%)
Myalgia
2 (3.8%)
6 (11.8%)
Neurological
15 (28.3%)
19 (37.3%)
Anxiety
3 (5.7%)
1 (2.0%)
Insomnia
3 (5.7%)
5 (9.8%)
Nervousness
2 (3.8%)
7 (13.7%)
Paresthesia
4 (7.5%)
3 (5.9%)
Vertigo
3 (5.7%)
3 (5.9%)
Respiratory
10 (18.9%)
6 (11.8%)
Rhinitis
3 (5.7%)
2 (3.9%)
Urogenital
19 (35.8%)
7 (13.7%)
Endometrial thickening
10 (18.9%)
4 (7.8%)
Vaginitis
4 (7.5%)
1 (2.0%)
If a subject experiences the same event more than once, the first occurrence is tabulated.
In a 16-week clinical trial that included 36 women treated with 0.3 mg CENESTIN and 34 women treated with placebo, adverse reactions that occurred at a rate of ≥5 percent are summarized in Table 3.
Table 3: Number (%) of Patients with Adverse Reactions with ≥ 5 Percent Occurrence Rate by Body System and Treatment Group
Body System and Term
CENESTIN 0.30 mg
Placebo
Body as a Whole
22 (60)
13 (38)
Allergic Reaction
3 (8)
1 (3)
Flu Syndrome
3 (8)
1 (3)
Injury Accident
2 (5)
1 (3)
Back Pain
2 (5)
1 (3)
Cyst
2 (5)
0 (0)
Asthenia
3 (8)
2 (6)
Digestive
10 (27)
8 (24)
Nausea
4 (11)
2 (6)
Dyspepsia
2 (5)
1 (3)
Vomiting
3 (8)
0 (0)
Increased Appetite
2 (5)
0 (0)
Neurological
7 (19)
7 (21)
Dizziness
3 (8)
0 (0)
Urogenital
22 (60)
16 (47)
Leukorrhea
12 (32)
5 (15)
Vaginitis
9 (24)
5 (15)
Urinary Incontinence
3 (8)
1 (3)
Metrorrhagia
2 (5)
0 (0)
Urinary Frequency
2 (5)
0 (0)
Post Marketing Experience
The following adverse reactions have been identified during post-approval use of CENESTIN. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Gastrointestinal disorders: abdominal distension, nausea Investigations: weight increased Metabolism & Nutrition Disorders: fluid retention Neoplasms: breast cancer Nervous System Disorders: headache, insomnia, somnolence
Psychiatric Disorder: depression
Reproductive System and Breast Disorders: breast enlargement, breast pain, breast swelling, breast tenderness
&Copy; Cenestin Patient Information is supplied by Cerner Multum, Inc. and Cenestin Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
