Premarin (Conjugated Estrogens) - 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.

During the first year of a 2-year clinical trial with 2,333 postmenopausal women between 40 and 65 years of age (88% Caucasian), 1,012 women were treated with conjugated estrogens and 332 were treated with placebo. Table 6 summarizes adverse events that occurred at a rate of ≥ 5%.

TABLE 6. NUMBER (%) OF PATIENTS REPORTING ≥ 5% TREATMENT EMERGENT ADVERSE EVENTS

	--Conjugated Estrogens Treatment Group--
Body System	0.625 mg	0.45 mg	0.3 mg	Placebo
Adverse event	(n = 348)	(n = 338)	(n = 326)	(n = 332)
Any adverse event	323 (93%)	305 (90%)	292 (90%)	281 (85%)
Body as a Whole
Abdominal pain     Accidental injury     Asthenia     Back pain     Flu syndrome     Headache     Infection     Pain	56 (16%) 21 (6%) 25 (7%) 49 (14%) 37 (11%) 90 (26%) 61 (18%) 58 (17%)	50 (15%) 41 (12%) 23 (7%) 43 (13%) 38 (11%) 109 (32%) 75 (22%) 61 (18%)	54 (17%) 20 (6%) 25 (8%) 43 (13%) 33 (10%) 96 (29%) 74 (23%) 66 (20%)	37 (11%) 29 (9%) 16 (5%) 39 (12%) 35 (11%) 93 (28%) 74 (22%) 61 (18%)
Digestive System
Diarrhea     Dyspepsia     Flatulence     Nausea	21 (6%) 33 (9%) 24 (7%) 32 (9%)	25 (7%) 32 (9%) 23 (7%) 21 (6%)	19 (6%) 36 (11%) 18 (6%) 21 (6%)	21 (6%) 46 (14%) 9 (3%) 30 (9%)
Musculoskeletal System
Arthralgia     Leg cramps     Myalgia	47 (14%) 19 (5%) 18 (5%)	42 (12%) 23 (7%) 18 (5%)	22 (7%) 11 (3%) 29 (9%)	39 (12%) 7 (2%) 25 (8%)
Nervous System
Depression     Dizziness     Insomnia     Nervousness	25 (7%) 19 (5%) 21 (6%) 12 (3%)	27 (8%) 20 (6%) 25 (7%) 17 (5%)	17 (5%) 12 (4%) 24 (7%) 6 (2%)	22 (7%) 17 (5%) 33 (10%) 7 (2%)
Respiratory System
Cough increased     Pharyngitis     Rhinitis     Sinusitis     Upper respiratory infection	13 (4%) 35 (10%) 21 (6%) 22 (6%) 42 (12%)	22 (7%) 35 (10%) 30 (9%) 36 (11%) 34 (10%)	14 (4%) 40 (12%) 31 (10%) 24 (7%) 28 (9%)	14 (4%) 38 (11%) 42 (13%) 24 (7%) 35 (11%)
Skin and Appendages
Pruritus	14 (4%)	17 (5%)	16 (5%)	7 (2%)
Urogenital System
Breast pain     Leukorrhea     Vaginal hemorrhage     Vaginal moniliasis     Vaginitis	38 (11%) 18 (5%) 47 (14%) 20 (6%) 24 (7%)	41 (12%) 22 (7%) 14 (4%) 18 (5%) 20 (6%)	24 (7%) 13 (4%) 7 (2%) 17 (5%) 16 (5%)	29 (9%) 9 (3%) 0 6 (2%) 4 (1%)

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

1. Genitourinary system

Abnormal uterine bleeding/spotting
Dysmenorrhea/pelvic pain
Increase in size of uterine leiomyomata
Vaginitis, including vaginal candidiasis
Change in amount of cervical secretion
Change in cervical ectropion
Ovarian cancer
Endometrial hyperplasia
Endometrial cancer

2. Breasts

Tenderness, enlargement, pain, 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 gallbladder disease
Pancreatitis
Enlargement of hepatic hemangiomas
Ischemic colitis

5. Skin

Chloasma or melasma that 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
Exacerbation of chorea
Nervousness
Mood disturbances
Irritability
Exacerbation of epilepsy
Dementia
Possible growth potentiation of benign meningioma

8. Miscellaneous

Increase or decrease in weight
Glucose intolerance
Aggravation of porphyria
Edema
Arthralgias
Leg cramps
Changes in libido
Urticaria, angioedema, anaphylactoid/anaphylactic reactions
Hypocalcemia (preexisting condition)
Exacerbation of asthma
Increased triglycerides

REPORTS OF SUSPECTED PREMARIN SIDE EFFECTS / ADVERSE REACTIONS

Possible Premarin side effects / adverse reactions in 58 year old female

Reported by a consumer/non-health professional from United States on 2011-09-29

Patient: 58 year old female weighing 77.1 kg (169.6 pounds)

Reactions: Dyspnoea, Pruritus, Diabetes Mellitus, Tendon Rupture, Urticaria, Rash, Erythema, Oedema Peripheral, Dizziness, Mental Disorder, Disturbance in Attention, Neuralgia

Suspect drug(s):
Advil Liqui-Gels
    Indication: Pain
    End date: 2011-07-30

Etodolac
    Dosage: 200 mg
    Indication: Inflammation
    End date: 2011-07-01

Lyrica
    Dosage: 300 mg;bid;po ; 50 mg;po ; 100 mg;po ; 150 mg;po ; 200 mg;po
    Administration route: Oral
    Indication: Neuralgia
    Start date: 2009-12-01

Lyrica
    Dosage: 300 mg;bid;po ; 50 mg;po ; 100 mg;po ; 150 mg;po ; 200 mg;po
    Administration route: Oral
    Indication: Neuralgia
    End date: 2010-07-01

Lyrica
    Dosage: 300 mg;bid;po ; 50 mg;po ; 100 mg;po ; 150 mg;po ; 200 mg;po
    Administration route: Oral
    Indication: Neuralgia
    Start date: 2011-07-31
    End date: 2011-07-31

Lyrica
    Dosage: 300 mg;bid;po ; 50 mg;po ; 100 mg;po ; 150 mg;po ; 200 mg;po
    Administration route: Oral
    Indication: Neuralgia
    Start date: 2011-08-02

Lyrica
    Dosage: 300 mg;bid;po ; 50 mg;po ; 100 mg;po ; 150 mg;po ; 200 mg;po
    Administration route: Oral
    Indication: Neuralgia
    Start date: 2011-08-01
    End date: 2011-08-01

Premarin
    Dosage: 0.625 mg ; 0.3 mg ; 0.625 mg
    Indication: Inadequate Lubrication

Ultram
    Indication: Pain
    End date: 2011-07-01

Possible Premarin side effects / adverse reactions in 42 year old female

Reported by a consumer/non-health professional from United States on 2011-10-03

Patient: 42 year old female

Reactions: Vulvovaginal Dryness, Vulvovaginal Burning Sensation

Suspect drug(s):
Premarin
    Dosage: unk
    Indication: Vulvovaginal Dryness
    Start date: 2011-09-20

Premarin
    Indication: Vulvovaginal Burning Sensation

Possible Premarin side effects / adverse reactions in 63 year old female

Reported by a consumer/non-health professional from United States on 2011-10-03

Patient: 63 year old female

Reactions: Hot Flush, Insomnia

Suspect drug(s):
Premarin