Cenestin

Last updated on RxList: 12/14/2020
Cenestin Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

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.

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.

SLIDESHOW

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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)

QUESTION

If menopause occurs in a woman younger than ___ years, it is considered to be premature. See Answer
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 ReactionCENESTINa 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 Pain20 (28)11 (23)31 (26)
Asthenia24 (33)20 (42)44 (37)
Headache49 (68)32 (67)81 (68)
Pain8 (11)9 (19)17 (14)
Digestive System
Dyspepsia7 (10)3 (6)10 (8)
Flatulence21 (29)14 (29)35 (29)
Nausea13 (18)9 (19)22 (18)
Vomiting5 (7)1 (2)6 (5)
Metabolic and Nutritional
Peripheral Edema7 (10)6 (13)13 (11)
Nervous System
Depression20 (28)18 (38)38 (32)
Dizziness8 (11)5 (10)13 (11)
Insomnia30 (42)23 (48)53 (44)
Leg Cramps7 (10)3 (6)10 (8)
Paresthesia24 (33)15 (31)39 (33)
Vertigo12 (17)12 (25)24 (20)
Urogenital System21 (29)7 (15)28(23)
Breast Pain4 (6)3 (6)7 (6)
Dysmenorrhea10 (14)3 (6)13 (11)
Metrorrhagia10 (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 TermCENESTIN 0.45 mgPlacebo
Any Adverse Reaction (%)40 (75.5%)39 (76.5%)
Body As A Whole20 (37.7%)24 (47.1%)
Asthenia6 (11.3%)7 (13.7%)
Headache6 (11.3%)8 (15.7%)
Infection1 (1.9%)6 (11.8%)
Pain6 (11.3%)1 (2.0%)
Pain abdominal5 (9.4%)3 (5.9%)
Cardiovascular5 (9.4%)10 (19.6%)
Palpitations3 (5.7%)3 (5.9%)
Vasodilations2 (3.8%)4 (7.8%)
Digestive8 (15.1%)7 (13.7%)
Nausea5 (9.4%)2 (3.9%)
Metabolic and Nutritional5 (9.4%)3 (5.9%)
Weight increase3 (5.7%)2 (3.9%)
Musculoskeletal5 (9.4%)6 (11.8%)
Arthralgia5 (9.4%)5 (9.8%)
Myalgia2 (3.8%)6 (11.8%)
Neurological15 (28.3%)19 (37.3%)
Anxiety3 (5.7%)1 (2.0%)
Insomnia3 (5.7%)5 (9.8%)
Nervousness2 (3.8%)7 (13.7%)
Paresthesia4 (7.5%)3 (5.9%)
Vertigo3 (5.7%)3 (5.9%)
Respiratory10 (18.9%)6 (11.8%)
Rhinitis3 (5.7%)2 (3.9%)
Urogenital19 (35.8%)7 (13.7%)
Endometrial thickening10 (18.9%)4 (7.8%)
Vaginitis4 (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 TermCENESTIN 0.30 mgPlacebo
Body as a Whole22 (60)13 (38)
Allergic Reaction3 (8)1 (3)
Flu Syndrome3 (8)1 (3)
Injury Accident2 (5)1 (3)
Back Pain2 (5)1 (3)
Cyst2 (5)0 (0)
Asthenia3 (8)2 (6)
Digestive10 (27)8 (24)
Nausea4 (11)2 (6)
Dyspepsia2 (5)1 (3)
Vomiting3 (8)0 (0)
Increased Appetite2 (5)0 (0)
Neurological7 (19)7 (21)
Dizziness3 (8)0 (0)
Urogenital22 (60)16 (47)
Leukorrhea12 (32)5 (15)
Vaginitis9 (24)5 (15)
Urinary Incontinence3 (8)1 (3)
Metrorrhagia2 (5)0 (0)
Urinary Frequency2 (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.

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