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Cenestin

Last reviewed on RxList: 7/3/2017
Cenestin Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 3/28/2016

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. 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

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.

Cenestin Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using conjugated estrogens and call your doctor at once if you have a serious side effect such as:

  • 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 severe headache, confusion, problems with vision, speech, or balance;
  • pain, swelling, warmth, or redness in one or both legs;
  • 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
  • mild 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)

Cenestin Professional Information

SIDE EFFECTS

The following serious adverse reactions are discussed elsewhere in the labeling:

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)

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© 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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