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Cenestin

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Cenestin




Side Effects
Interactions

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 Cenestin (synthetic conjugated estrogens) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

No drug-drug interaction studies have been conducted with Cenestin.

Metabolic Interactions

In vitro and in vivo studies have shown that estrogens are metabolized partially by cytochrome P450 3A4 (CYP3A4). Therefore, inducers and inhibitors of CYP3A4 may affect estrogen drug metabolism. Inducers of CYP3A4 such as St. John's wort (Hypericum perforatum) preparations, phenobarbital, carbamazepine, and rifampin may reduce plasma concentrations of estrogens, possibly resulting in a decrease in therapeutic effects and/or changes in the uterine bleeding profile. Inhibitors of CYP3A4 such as erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir and grapefruit juice may increase plasma concentrations of estrogens and may result in side effects.

Read the Cenestin Drug Interactions Center for a complete guide to possible interactions

Last reviewed on RxList: 4/6/2015
This monograph has been modified to include the generic and brand name in many instances.

Side Effects
Interactions
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Cenestin - User Reviews

Cenestin User Reviews

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