Cenestin
- Generic Name: synthetic conjugated estrogens
- Brand Name: Cenestin
Cenestin (Synthetic conjugated estrogens) side effects drug center
Cenestin Side Effects Center
What Is Cenestin?
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.
What Are Side Effects of Cenestin?
Common side effects of Cenestin include:
- nausea
- vomiting
- bloating
- stomach cramps
- breast tenderness/pain/swelling
- headache
- changes in weight or appetite
- freckles or darkening of facial skin
- increased hair growth
- loss of scalp hair
- problems with contact lenses
- vaginal itching or discharge
- changes in your menstrual periods
- decreased sex drive
- nervousness
- dizziness, or
- tired feeling
Dosage for Cenestin
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.
What Drugs, Substances, or Supplements Interact with Cenestin?
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 During Pregnancy and Breastfeeding
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.
Common side effects may include:
- swelling;
- hair loss;
- numbness, tingling, burning pain;
- back pain, leg cramps, pain;
- bloating, gas, indigestion, nausea, vomiting, stomach pain;
- dizziness, headache;
- breast pain; or
- 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.
Read the entire detailed patient monograph for Cenestin (Synthetic conjugated estrogens)
Cenestin Professional Information
SIDE EFFECTS
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
Skin & Subcutaneous Tissue Disorders: alopecia, pruritus, pruritus generalized, rash pruritic, rash
Read the entire FDA prescribing information for Cenestin (Synthetic conjugated estrogens)
© 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.