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Evista

Evista (Raloxifene) side effects drug center

 

PROFESSIONAL

CONSUMER

SIDE EFFECTS

 

Evista Side Effects Center

What Is Evista?

Evista (raloxifene hydrochloride) is an estrogen agonist/antagonist used to treat or prevent osteoporosis in postmenopausal women. Evista is also used to reduce the risk of invasive breast cancer in postmenopausal women who have osteoporosis or who are otherwise at risk of invasive breast cancer.

What Are Side Effects of Evista?

Common side effects of Evista include:

Seek medical attention if you have unlikely but serious side effects of Evista including:

Dosage for Evista

The recommended dosage is one 60 mg Evista tablet daily, taken any time of day without regard to meals.

What Drugs, Substances, or Supplements Interact with Evista?

Evista may interact with cholestyramine, blood thinners, diazepam, diazoxide, birth control pills or hormone replacement therapy. Tell your doctor all medications you use.

Evista During Pregnancy and Breastfeeding

Evista must not be used during pregnancy because it may cause harm to a fetus. It is not known whether this drug passes into breast milk. Breastfeeding while using this medication is not recommended.

Additional Information

Our Evista (raloxifene hydrochloride) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Evista Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using raloxifene and call your doctor at once if you have:

  • swelling, tenderness, or other changes in your breasts;
  • signs of a stroke--sudden numbness or weakness (especially on one side of the body), slurred speech, vision problems;
  • signs of a blood clot in the lung--chest pain, trouble breathing, coughing up blood; or
  • signs of a blood clot deep in the body--swelling, warmth, or redness in an arm or leg.

Common side effects may include:

  • hot flashes;
  • leg cramps;
  • swelling in your hands, feet, or ankles;
  • joint pain;
  • flu symptoms; or
  • increased sweating.

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 Evista (Raloxifene)

 

Evista Professional Information

SIDE EFFECTS

Clinical Trials Experience

Because clinical studies 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 data described below reflect exposure to EVISTA in 8429 patients who were enrolled in placebocontrolled trials, including 6666 exposed for 1 year and 5685 for at least 3 years.

Osteoporosis Treatment Clinical Trial (MORE)

The safety of raloxifene in the treatment of osteoporosis was assessed in a large (7705 patients) multinational, placebo-controlled trial. Duration of treatment was 36 months, and 5129 postmenopausal women were exposed to raloxifene hydrochloride (2557 received 60 mg/day, and 2572 received 120 mg/day). The incidence of all-cause mortality was similar among groups: 23 (0.9%) placebo, 13 (0.5%) EVISTA-treated (raloxifene HCl 60 mg), and 28 (1.1%) raloxifene HCl 120 mg women died. Therapy was discontinued due to an adverse reaction in 10.9% of EVISTA-treated women and 8.8% of placebo-treated women.

Venous Thromboembolism: The most serious adverse reaction related to EVISTA was VTE (deep venous thrombosis, pulmonary embolism, and retinal vein thrombosis). During an average of study-drug exposure of 2.6 years, VTE occurred in about 1 out of 100 patients treated with EVISTA. Twenty-six EVISTA-treated women had a VTE compared to 11 placebo-treated women, the hazard ratio was 2.4 (95% confidence interval, 1.2, 4.5), and the highest VTE risk was during the initial months of treatment.

Common adverse reactions considered to be related to EVISTA therapy were hot flashes and leg cramps. Hot flashes occurred in about one in 10 patients on EVISTA and were most commonly reported during the first 6 months of treatment and were not different from placebo thereafter. Leg cramps occurred in about one in 14 patients on EVISTA.

Placebo-Controlled Osteoporosis Prevention Clinical Trials

The safety of raloxifene has been assessed primarily in 12 Phase 2 and Phase 3 studies with placebo, estrogen, and estrogen-progestin therapy control groups. The duration of treatment ranged from 2 to 30 months, and 2036 women were exposed to raloxifene HCl (371 patients received 10 to 50 mg/day, 828 received 60 mg/day, and 837 received from 120 to 600 mg/day).

Therapy was discontinued due to an adverse reaction in 11.4% of 581 EVISTA-treated women and 12.2% of 584 placebo-treated women. Discontinuation rates due to hot flashes did not differ significantly between EVISTA and placebo groups (1.7% and 2.2%, respectively).

Common adverse reactions considered to be drug-related were hot flashes and leg cramps. Hot flashes occurred in about one in four patients on EVISTA versus about one in six on placebo. The first occurrence of hot flashes was most commonly reported during the first 6 months of treatment.

Table 1 lists adverse reactions occurring in either the osteoporosis treatment or in five prevention placebo-controlled clinical trials at a frequency ≥ 2.0% in either group and in more EVISTA-treated women than in placebo-treated women. Adverse reactions are shown without attribution of causality. The majority of adverse reactions occurring during the studies were mild and generally did not require discontinuation of therapy.

Table 1: Adverse Reactions Occurring in Placebo-Controlled Osteoporosis Clinical Trials at a Frequency ≥ 2.0% and in More EVISTA-Treated (60 mg Once Daily) Women than Placebo- Treated Womena

  Treatment Prevention
EVISTA
(N=2557) %		 Placebo
(N=2576) %		 EVISTA
(N=581) %		 Placebo
(N=584) %
Body as a Whole
  Infection A A 15.1 14.6
  Flu Syndrome 13.5 11.4 14.6 13.5
  Headache 9.2 8.5 A A
  Leg Cramps 7.0 3.7 5.9 1.9
  Chest Pain A A 4.0 3.6
  Fever 3.9 3.8 3.1 2.6
Cardiovascular System
  Hot Flashes 9.7 6.4 24.6 18.3
  Migraine A A 2.4 2.1
  Syncope 2.3 2.1 B B
  Varicose Vein 2.2 1.5 A A
Digestive System
  Nausea 8.3 7.8 8.8 8.6
  Diarrhea 7.2 6.9 A A
  Dyspepsia A A 5.9 5.8
  Vomiting 4.8 4.3 3.4 3.3
  Flatulence A A 3.1 2.4
  Gastrointestinal Disorder A A 3.3 2.1
  Gastroenteritis B B 2.6 2.1
Metabolic and Nutritional
  Weight Gain A A 8.8 6.8
  Peripheral Edema 5.2 4.4 3.3 1.9
Musculoskeletal System
  Arthralgia 15.5 14.0 10.7 10.1
  Myalgia A A 7.7 6.2
  Arthritis A A 4.0 3.6
  Tendon Disorder 3.6 3.1 A A
Nervous System
  Depression A A 6.4 6.0
  Insomnia A A 5.5 4.3
  Vertigo 4.1 3.7 A A
  Neuralgia 2.4 1.9 B B
  Hypesthesia 2.1 2.0 B B
Respiratory System
  Sinusitis 7.9 7.5 10.3 6.5
  Rhinitis 10.2 10.1 A A
  Bronchitis 9.5 8.6 A A
  Pharyngitis 5.3 5.1 7.6 7.2
  Cough Increased 9.3 9.2 6.0 5.7
  Pneumonia A A 2.6 1.5
  Laryngitis B B 2.2 1.4
Skin and Appendages
  Rash A A 5.5 3.8
  Sweating 2.5 2.0 3.1 1.7
  Special Senses
  Conjunctivitis 2.2 1.7 A A
Urogenital System
  Vaginitis A A 4.3 3.6
  Urinary Tract Infection A A 4.0 3.9
  Cystitis 4.6 4.5 3.3 3.1
  Leukorrhea A A 3.3 1.7
  Uterine Disorderb, c 3.3 2.3 A A
  Endometrial Disorderb B B 3.1 1.9
  Vaginal Hemorrhage 2.5 2.4 A A
  Urinary Tract Disorder 2.5 2.1 A A
aA: Placebo incidence greater than or equal to EVISTA incidence; B: Less than 2% incidence and more frequent with EVISTA.
bIncludes only patients with an intact uterus: Prevention Trials: EVISTA, n=354 , Placebo, n=364 ; Treatment Trial: EVISTA, n=194 8, Placebo, n=1999.
cActual terms most frequently referred to endometrial fluid.

Comparison Of EVISTA And Hormone Therapy

EVISTA was compared with estrogen-progestin therapy in three clinical trials for prevention of osteoporosis. Table 2 shows adverse reactions occurring more frequently in one treatment group and at an incidence ≥ 2.0% in any group. Adverse reactions are shown without attribution of causality.

Table 2: Adverse Reactions Reported in the Clinical Trials for Osteoporosis Prevention with EVISTA (60 mg Once Daily) and Continuous Combined or Cyclic Estrogen Plus Progestin (Hormone Therapy) at an Incidence ≥ 2.0% in any Treatment Groupa

  EVISTA
(N=317) %		 Hormone Therapy-Continuous Combinedb
(N=96) %		 Hormone Therapy-Cyclicc
(N=219) %
Urogenital
  Breast Pain 4.4 37.5 29.7
  Vaginal Bleedingd 6.2 64.2 88.5
Digestive
  Flatulence 1.6 12.5 6.4
Cardiovascular
  Hot Flashes 28.7 3.1 5.9
Body as a Whole
  Infection 11.0 0 6.8
  Abdominal Pain 6.6 10.4 18.7
  Chest Pain 2.8 0 0.5
aThese data are from both blinded and open-label studies.
bContinuous Combined Hormone Therapy = 0.625 mg conjugated estrogens plus 2.5 mg medroxyprogesterone acetate.
cCyclic Hormone Therapy = 0.625 mg conjugated estrogens for 28 days with concomitant 5 mg medroxyprogesterone acetate or 0.15 mg norgestrel on Days 1 through 14 or 17 through 28.
dIncludes only patients with an intact uterus: EVISTA, n=290; Hormone Therapy-Continuous Combined, n=67; Hormone Therapy-Cyclic, n=217.

Breast Pain

Across all placebo-controlled trials, EVISTA was indistinguishable from placebo with regard to frequency and severity of breast pain and tenderness. EVISTA was associated with less breast pain and tenderness than reported by women receiving estrogens with or without added progestin.

Gynecologic Cancers

EVISTA-treated and placebo-treated groups had similar incidences of endometrial cancer and ovarian cancer.

Placebo-Controlled Trial Of Postmenopausal Women At Increased Risk For Major Coronary Events (RUTH)

The safety of EVISTA (60 mg once daily) was assessed in a placebo-controlled multinational trial of 10,101 postmenopausal women (age range 55-92) with documented coronary heart disease (CHD) or multiple CHD risk factors. Median study drug exposure was 5.1 years for both treatment groups [see Clinical Studies]. Therapy was discontinued due to an adverse reaction in 25% of 5044 EVISTA-treated women and 24% of 5057 placebo-treated women. The incidence per year of all-cause mortality was similar between the raloxifene (2.07%) and placebo (2.25%) groups.

Adverse reactions reported more frequently in EVISTA-treated women than in placebo-treated women included peripheral edema (14.1% raloxifene versus 11.7% placebo), muscle spasms/leg cramps (12.1% raloxifene versus 8.3% placebo), hot flashes (7.8% raloxifene versus 4.7% placebo), venous thromboembolic events (2.0% raloxifene versus 1.4% placebo), and cholelithiasis (3.3% raloxifene versus 2.6% placebo) [see Clinical Studies].

Tamoxifen-Controlled Trial Of Postmenopausal Women At Increased Risk For Invasive Breast Cancer (STAR)

The safety of EVISTA 60 mg/day versus tamoxifen 20 mg/day over 5 years was assessed in 19,747 postmenopausal women (age range 35-83 years) in a randomized, double-blind trial. As of 31 December 2005, the median follow-up was 4.3 years. The safety profile of raloxifene was similar to that in the placebo-controlled raloxifene trials [see Clinical Studies].

Postmarketing Experience

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.

Adverse reactions reported very rarely since market introduction include retinal vein occlusion, stroke, and death associated with venous thromboembolism (VTE).

Read the entire FDA prescribing information for Evista (Raloxifene)

&Copy; Evista Patient Information is supplied by Cerner Multum, Inc. and Evista Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.