July 30, 2015
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Enjuvia

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Enjuvia




Side Effects
Interactions

SIDE EFFECTS

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

Cardiovascular Disorders [see BOXED WARNINGS, WARNINGS AND PRECAUTIONS]

Malignant Neoplasms [see BOXED WARNINGS, WARNINGS AND PRECAUTIONS]

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, 209 postmenopausal women with vasomotor symptoms were treated with ENJUVIA. Adverse reactions that occurred in the study at a rate greater than or equal to 3% and greater than placebo are summarized in Table 1.

Table 1: Number (%) of Women Reporting Adverse Reactions with ≥ 3 Percent Occurrence Rate and Greater than Placebo by Body System and Treatment Group

Body System/ Adverse Reaction 0.3 mg
n=68
0.625 mg
n=72
1.25 mg
n=69
Placebo
n=72
Number of Patients in Safety Sample (%) 68 (100) 72 (100) 69 (100) 72 (100)
Number of Patients with Adverse Reactions (%) 49 (72) 55 (76) 56 (81) 51 (71)
Number of Patients without Adverse Reactions (%) 19 (28) 17 (24) 13 (19) 21 (29)
Body as a Whole
Abdominal Pain 3 (4) 11 (15) 3 (4) 7 (10)
Accidental Injury 6 (9) 2 (3) 3 (4) 5 (7)
Asthenia 2 (3) 3 (4) 2 (3) 0
Chest Pain 2 (3) 3 (4) 0 0
Chills 0 3 (4) 1 (1) 1 (1)
Flu Syndrome 4 (6) 3 (4) 5 (7) 3 (4)
Headache 10 (15) 18(25) 11(16) 15 (21)
Pain 10 (15) 14 (19) 7 (10) 6 (8)
Digestive System
Constipation 3 (4) 2 (3) 1 (1) 2 (3)
Diarrhea 4 (6) 2 (3) 3 (4) 4 (6)
Flatulence 3 (4) 5 (7) 3 (4) 2 (3)
Nausea 5 (7) 7 (10) 8 (12) 6 (8)
Metabolic and Nutritional Disorders
Peripheral Edema 1 (2) 3 (4) 3 (4) 2 (3)
Nervous System
Depression 2 (3) 3 (4) 1 (1) 1 (1)
Dizziness 5 (7) 3 (4) 1 (1) 3 (4)
Emotional Lability 2 (3) 3 (4) 1 (1) 1 (1)
Paresthesia 0 4 (6) 1 (1) 0
Respiratory System
Bronchitis 0 3 (4) 5 (7) 3 (4)
Cough Increased 1 (2) 2 (3) 3 (4) 2 (3)
Pharyngitis 3 (4) 2 (3) 0 0
Rhinitis 3 (4) 4 (6) 5 (7) 4 (6)
Sinusitis 2 (3) 3 (4) 5 (7) 2 (3)
Skin and Appendages
Acne 0 3 (4) 1 (1) 0
Fungal Dermatitis 1 (2) 0 3 (4) 1 (1)
Pruritus 2 (3) 2 (3) 4 (6) 3 (4)
Urogenital System
Breast Pain 0 9 (13) 10 (15) 3 (4)
Dysmenorrhea 1 (2) 6 (8) 1 (1) 2 (3)
Vaginitis 1 (2) 5 (7) 2 (3) 3 (4)

In a second 12-week clinical trial, 310 women with symptoms of vulvar and vaginal atrophy were treated (154 women with ENJUVIA 0.3 mg tablets and 156 women with placebo). Adverse reactions that occurred in the study at a rate greater than or equal to 3% and greater than placebo are summarized in Table 2.

Table 2: Number (%) of Women Reporting Adverse Reactions with ≥ 3 Percent Occurrence Rate and Greater than Placebo by Body System and Treatment Group

Body System/ Adverse Reaction 0.3 mg
n=154
Placebo
n=156
Number of Patients in Safety Sample (%) 154 (100) 156 (100)
Number of Patients with Adverse Reactions (%) 83 (54) 74 (47)
Number of Patients without Adverse Reactions (%) 71 (46) 82 (53)
Infections and Infestations
Upper Respiratory Tract Infection 6 (4) 4 (3)
Sinusitis 5 (3) 2 (1)
Reproductive System and Breast Disorders
Breast Tenderness 6 (4) 1 (1)
Musculoskeletal and Connective Tissue Disorders
Back Pain 6 (4) 2 (1)

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of ENJUVIA. 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 discomfort, abdominal distension, nausea

Immune System Disorders: anaphylactic reaction, hypersensitivity

Musculoskeletal and connective tissue disorders: muscle spasms

Nervous System Disorders: headache, dizziness

Psychiatric disorders: insomnia

Reproductive system and Breast Disorders: breast pain, breast tenderness

Skin and Subcutaneous Tissue Disorders: alopecia, rash, urticaria

Vascular Disorders: deep vein thrombosis, thrombosis

Read the Enjuvia (synthetic conjugated estrogens, b) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

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

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 Enjuvia Drug Interactions Center for a complete guide to possible interactions

Last reviewed on RxList: 7/14/2015
This monograph has been modified to include the generic and brand name in many instances.

Side Effects
Interactions

Enjuvia - User Reviews

Enjuvia User Reviews

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Here is a collection of user reviews for the medication Enjuvia sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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