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Divigel (Estradiol Topical) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

See BOXED WARNINGS, WARNINGS  and  PRECAUTIONS.

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. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.

Divigel® was studied at doses of 0.25, 0.5 and 1.0 g/day in a 12-week, double-blind, placebo-controlled study that included a total of 495 postmenopausal women (86.5% Caucasian). The adverse events that occurred at a rate greater than 5% in any of the treatment groups are summarized in Table 5.

Table 5: Number (%) of Subjects with Common Adverse Events* in a 12-Week Placebo- Controlled Study of Divigel®

*     Adverse events reported by ≥5% of patients in any treatment group.

Divigel ® Placebo
0.25 g/day 0.5 g/day 1.0 g/day
SYSTEM ORGAN CLASS N=122 N=123 N=125 N=125
     Preferred Term n (%) n (%) n (%) n (%)
INFECTIONS & INFESTATIONS
     Nasopharyngitis 7 (5.7) 5 (4.1) 6 (4.8) 5 (4.0)
     Upper Respiratory Tract Infection 7 (5.7) 3 (2.4) 2 (1.6) 2 (1.6)
     Vaginal mycosis 1 (0.8) 3 (2.4) 8 (6.4) 4(3.2)
REPRODUCTIVE SYSTEM & BREAST DISORDERS
     Breast Tenderness 3 (2.5) 7 (5.7) 11 (8.8) 2 (1.6)
     Metrorrhagia 5 (4.1) 7 (5.7) 12 (9.6) 2 (1.6)

In a 12-week placebo-controlled study of Divigel®, application site reactions were seen in <1% of subjects.

The following additional adverse reactions have been reported with estrogen and/or progestin therapy.

  1. Genitourinary system: Changes in vaginal bleeding pattern and abnormal withdrawal bleeding or flow; breakthrough bleeding; spotting; dysmenorrhea; increase in size of uterine leiomyomata; vaginitis, including vaginal candidiasis; change in amount of cervical secretion; changes in cervical ectropion; ovarian cancer; endometrial hyperplasia; endometrial cancer; vaginal discharge.
  2. Breasts: Tenderness; enlargement, pain, nipple discharge, galactorrhea, fibrocystic breast changes; breast cancer; nipple pain.
  3. Cardiovascular: Deep and superficial venous thrombosis, pulmonary embolism; thrombophlebitis; myocardial infarction; stroke; increase in blood pressure.
  4. Gastrointestinal: Nausea; vomiting; abdominal cramps; bloating; cholestatic jaundice; increased incidence of gallbladder disease; pancreatitis; enlargement of hepatic hemangiomas; abdominal pain.
  5. Skin: Chloasma or melasma, which may persist when drug is discontinued; erythema multiforme; erythema nodosum; hemorrhagic eruption; loss of scalp hair; hirsutism; pruritus; rash.
  6. Eyes: Retinal vascular thrombosis, intolerance to contact lenses.
  7. Central Nervous System: Headache; migraine; dizziness; mental depression; chorea; nervousness; mood disturbances; irritability; exacerbation of epilepsy; dementia.
  8. Miscellaneous: Increase or decrease in weight; reduced carbohydrate tolerance; aggravation of porphyria; edema; arthralgias; leg cramps; changes in libido; urticaria; angioedema; anaphylactoid/anaphylactic reactions; hypocalcemia; exacerbation of asthma; increased triglycerides; muscle cramps.


REPORTS OF SUSPECTED DIVIGEL SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Divigel. The information is not vetted and should not be considered as verified clinical evidence.

Possible Divigel side effects / adverse reactions in 60 year old female

Reported by a consumer/non-health professional from United States on 2011-12-16

Patient: 60 year old female

Reactions: Weight Increased, Abdominal Distension

Suspect drug(s):
Divigel
    Administration route: Topical
    Indication: Night Sweats
    Start date: 2011-07-01

Prometrium
    Indication: Night Sweats
    Start date: 2011-07-01

Other drugs received by patient: TWO Unspecified Natural Products



Possible Divigel side effects / adverse reactions in 38 year old female

Reported by a physician from Ukraine on 2012-04-12

Patient: 38 year old female

Reactions: Systemic Lupus Erythematosus

Adverse event resulted in: hospitalization

Suspect drug(s):
Divigel
    Start date: 2009-01-01

Progesterone
    Start date: 2009-01-01

Lisinopril
    Administration route: Oral
    Indication: Hypertension

Methyldopa
    Indication: Hypertension

Metoprolol Tartrate

Progesterone
    Start date: 2009-01-01

Progesterone
    Start date: 2009-01-01

Other drugs received by patient: Curantyl; Aspigrel



See index of all Divigel side effect reports >>

Drug label data at the top of this Page last updated: 2009-08-31

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