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Enjuvia

Last reviewed on RxList: 6/16/2017
Enjuvia Side Effects Center

Last reviewed on RxList 6/16/2017

Enjuvia (synthetic conjugated estrogens, B) is a form of estrogen, a female sex hormone, used to treat symptoms of menopause such as hot flashes, and vaginal dryness, burning, and irritation. Other uses of Enjuvia include prevention of osteoporosis in postmenopausal women, and replacement of estrogen in women with ovarian failure or other conditions that cause a lack of natural estrogen in the body. Conjugated estrogens are sometimes used as part of cancer treatment in women and men. Common side effects of Enjuvia include stomach upset or cramps, nausea, vomiting, bloating, breast pain/tenderness/swelling, headache, nervousness, dizziness, tired feeling, weight or appetite changes, 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, or decreased sex drive.

Patients should be started at the lowest approved dose of 0.3 mg Enjuvia daily. Enjuvia may interact with blood thinner, thyroid medications, insulin or oral diabetes medicines, rifampin, ketoconazole or itraconazole, seizure medicines, barbiturates, or antidepressants. Tell your doctor all medications and supplements you use. Enjuvia must not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor immediately. Enjuvia passes into breast milk. It may reduce the quality and amount of breast milk produced. Consult your doctor before breastfeeding.

Our Enjuvia (synthetic conjugated estrogens, B) 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.

Enjuvia 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 Enjuvia (Synthetic Conjugated Estrogens, B)

Enjuvia Professional Information

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 entire FDA prescribing information for Enjuvia (Synthetic Conjugated Estrogens, B)

Related Resources for Enjuvia

Read the Enjuvia User Reviews »

© Enjuvia Patient Information is supplied by Cerner Multum, Inc. and Enjuvia Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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