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Angeliq (Estradiol / Drospirenone) - 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.

The following are adverse events reported with ANGELIQ occurring in >5% of subjects:

Table 4: Adverse Events Regardless of Drug Relationship Reported at a Frequency of >5% in a 1-year Double-blind Clinical Trial

ADVERSE EVENT

E2 1 MG

(N=226)

n (%)

ANGELIQ

(N=227)

n (%)

BODY AS A WHOLE

Abdominal pain29 (12.8)25 (11)
Pain in extremity15 (6.6)19 (8.4)
Back pain11 (4.9)16 (7)
Flu syndrome15 (6.6)16 (7)
Accidental injury15 (6.6)13 (5.7)
Abdomen enlarged17 (7.5)16 (7)
Surgery6 (2.7)12 (5.3)
METABOLIC & NUTRITIONAL DISORDERS
Peripheral edema12 (5.3)4 (1.8)

NERVOUS SYSTEM

Headache26 (11.5)22 (9.7)

RESPIRATORY SYSTEM

Upper respiratory infection40 (17.7)43 (18.9)
Sinusitis8 (3.5)12(5.3)

SKIN AND APPENDAGES

Breast pain34 (15.0)43 (18.9)

UROGENITAL

Vaginal hemorrhage43 (19.0)21 (9.3)
Endometrial disorder22 (9.7)4 (1.8)
Leukorrhea14 (6.2)3 (1.3)

 

 

The following additional adverse reactions have been reported with

estrogen and or estrogen/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.

2. Breasts

Tenderness, enlargement, pain, nipple discharge, galactorrhea, fibrocystic breast changes, breast cancer.

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 gall bladder disease, pancreatitis, enlargement of hepatic hemangiomas.

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, anaphylactoid/anaphylactic reactions including urticaria and angioedema, hypocalcemia, exacerbation of asthma, increased triglycerides.



REPORTS OF SUSPECTED ANGELIQ SIDE EFFECTS / ADVERSE REACTIONS

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

Possible Angeliq side effects / adverse reactions in 48 year old female

Reported by a physician from Colombia on 2011-11-01

Patient: 48 year old female

Reactions: Dyspnoea, Haemoptysis, Chest Pain

Adverse event resulted in: hospitalization

Suspect drug(s):
Angeliq



Possible Angeliq side effects / adverse reactions in 56 year old female

Reported by a consumer/non-health professional from United States on 2011-12-13

Patient: 56 year old female

Reactions: NO Adverse Event, Breast Enlargement, Alopecia, Hypoaesthesia

Suspect drug(s):
Angeliq



See index of all Angeliq side effect reports >>

Drug label data at the top of this Page last updated: 2008-11-21

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