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Evista (Raloxifene) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Evista (Raloxifene) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (273)
Death (7)
Life Threatening Events (6)
Disability (22)

Reports by Reaction Type

Fall (43)HIP Fracture (26)Pain (22)Dizziness (22)Breast Cancer (21)Nausea (21)Drug Ineffective (20)Arthralgia (20)Vomiting (19)Femur Fracture (16)Bone Pain (16)Muscle Spasms (16)

Below are a few examples of reports where side effects / adverse reactions may be related to Evista (Raloxifene). For a complete list or a specific selection of reports, please use the links above.

Possible Evista side effects in female

Reported by a physician from United States on 2012-08-23

Patient: female, weighing 71.2 kg (156.7 pounds)

Reactions: Retinal Vein Thrombosis

Drug(s) suspected as cause:
Evista



Possible Evista side effects in 67 year old female

Reported by a consumer/non-health professional from United States on 2012-08-07

Patient: 67 year old female, weighing 54.4 kg (119.7 pounds)

Reactions: Thrombophlebitis Superficial, Venous Thrombosis

Drug(s) suspected as cause:
Evista



Possible Evista side effects in 76 year old female

Reported by a consumer/non-health professional from United States on 2012-08-01

Patient: 76 year old female

Reactions: Irritability, Breast Cancer

Drug(s) suspected as cause:
Evista

Other drugs received by patient: Lovastatin



Possible Evista side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-01

Patient: female

Reactions: Arthropathy, Joint Swelling, Arthralgia, Bursitis, Mobility Decreased, Inflammation

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Evista



Possible Evista side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-31

Patient: female

Reactions: Body Temperature Increased, Upper Limb Fracture, Blood Magnesium Decreased, Headache, Fall, Hospitalisation, Malaise, Musculoskeletal Disorder, Bone Disorder, Blood Pressure Increased, Vomiting, Urinary Tract Infection, Muscular Weakness, Amnesia, Ill-Defined Disorder, Arthralgia, Dehydration

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Cymbalta
    Dosage: 60 mg, qd
    Indication: Depression

Evista
    Dosage: 60 mg, qd
    Indication: Osteoporosis
    Start date: 2011-04-01

Forteo
    Dosage: 20 ug, qd

Forteo
    Dosage: 20 ug, qd
    Indication: Osteoporosis
    Start date: 2011-06-30

Other drugs received by patient: Fluticasone Propionate; Albuterol; Nexium; Polyethylene Glycol; Novolog; Stool Softener; Diovan; Ferrous Sulfate TAB; Furosemide; Multi-Vitamin; Loratadine; Simvastatin; Isosorbide Dinitrate; Singulair; Oxycodone HCL; Aspirin; Amlodipine Besylate; Bupropion HCL; Oxygen; Famotidine; Provigil; Lantus



Possible Evista side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-30

Patient: female

Reactions: Breast Cancer

Drug(s) suspected as cause:
Evista



Possible Evista side effects in

Reported by a consumer/non-health professional from United States on 2012-07-25

Patient:

Reactions: Eye Haemorrhage, Vertebroplasty, Pain, Hearing Impaired, Visual Acuity Reduced

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Evista

Forteo
    Dosage: 20 ug, qd
    Indication: Osteoporosis
    Start date: 2012-05-04

Other drugs received by patient: Asmanex Twisthaler; Levothyroxine Sodium; Fentanyl; Hydrocodone; Lanoxin; Lopressor; Lasix; Omeprazole; Qualaquin; Vitamins / 90003601 /; Coumadin; Ambien



Possible Evista side effects in 77 year old female

Reported by a pharmacist from Japan on 2012-07-24

Patient: 77 year old female

Reactions: Rash Generalised, Pyrexia, Intentional Drug Misuse

Drug(s) suspected as cause:
Celebrex
    Dosage: 100 mg daily
    Administration route: Oral
    Indication: Osteoarthritis
    Start date: 2012-06-12
    End date: 2012-06-26

Evista
    Dosage: 60 mg daily
    Administration route: Oral
    Indication: Osteoporosis
    End date: 2012-06-26

Norvasc
    Dosage: 2.5 mg daily
    Administration route: Oral
    Indication: Hypertension
    End date: 2012-06-26

Other drugs received by patient: Candesartan Cilexetil



Possible Evista side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-23

Patient: female

Reactions: HIP Arthroplasty, Spinal Fracture, Sternal Fracture, HIP Surgery, Fall, HIP Fracture, Arthropathy, Road Traffic Accident, Arthralgia, Activities of Daily Living Impaired

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Evista
    Dosage: 60 mg, qd
    Indication: Osteoporosis
    Start date: 2002-01-01

Forteo
    Dosage: 20 ug, qd
    Indication: Osteoporosis
    Start date: 2011-10-01

Forteo
    Dosage: 20 ug, qd

Other drugs received by patient: Dairy Care; Fish OIL; Levoxyl; Nasacort AQ; Astepro; Crestor; Nexium; Glucosamine; Aspirin; Miralax; Plavix; Citrical / 00751501 /; Citrucel; Multi-Vitamin; Triamterene; Allegra; Vitamin D



Possible Evista side effects in

Reported by a lawyer from United States on 2012-07-20

Patient:

Reactions: Vitamin D Deficiency, Tooth Abscess, Tooth Extraction, Osteomyelitis, Tooth Infection, Lipids Increased, Fall, Muscle Strain, Scoliosis, Denture Wearer, Pneumonia, Gouty Arthritis, Cerumen Impaction, Haemorrhoids, Oral Infection, Anal Fissure, Osteoarthritis, Diverticulum, Osteonecrosis of JAW, Impaired Healing, Fungal Skin Infection, Pollakiuria, Actinomycosis, Bronchitis, Tooth Disorder

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Actonel
    Dosage: 35 mg, qw
    Administration route: Oral
    Indication: Osteoporosis
    Start date: 2004-01-22
    End date: 2009-03-01

Actonel
    Dosage: 35 mg, qw
    Administration route: Oral
    Indication: Osteopenia
    Start date: 2005-02-28
    End date: 2009-03-04

Evista
    Dosage: 60 mg, unk
    Administration route: Oral
    Indication: Osteoporosis
    Start date: 2009-09-16

Fosamax
    Dosage: unk mg, qw
    Administration route: Oral
    Indication: Osteoporosis
    Start date: 2004-01-22
    End date: 2005-02-28

Fosamax
    Dosage: 70 mg, qw
    Administration route: Oral
    Start date: 2008-06-24
    End date: 2008-12-30

Fosamax
    Indication: Osteopenia



Possible Evista side effects in female

Reported by a physician from Japan on 2012-07-19

Patient: female, weighing 47.0 kg (103.4 pounds)

Reactions: Renal Impairment, Hypercalcaemia

Drug(s) suspected as cause:
Evista



Possible Evista side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-19

Patient: female, weighing 55.0 kg (120.9 pounds)

Reactions: Confusional State, Osteoporosis, Bone Pain, Pain, Fall, Lumbar Spinal Stenosis, Road Traffic Accident, Fatigue, Oedema Peripheral, Decreased Appetite, Nausea, Lumbar Vertebral Fracture, Joint Injury, Ankle Fracture, Accident, Post-Traumatic Stress Disorder, Arthralgia, Mobility Decreased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Evista
    Dosage: 60 mg, qd
    Administration route: Oral
    Indication: Osteoporosis Prophylaxis

Evista
    Dosage: 60 mg, qd
    Administration route: Oral

Forteo
    Dosage: 20 ug, qd
    Indication: Osteoporosis Postmenopausal

Forteo
    Dosage: 20 ug, qd

Forteo
    Dosage: 20 ug, qd

Forteo
    Dosage: 20 ug, qd

Forteo
    Dosage: 20 ug, qd

Forteo
    Dosage: 20 ug, qd

Other drugs received by patient: Tylenol W / Codeine; Multi-Vitamins; Propylene Glycol; Seroquel; Prilosec; Vitamin D; Clonazepam; Docusate Sodium; Fluoxetine Hydrochloride; Nasal Saline; Citracal-D; Midrin



Possible Evista side effects in 79 year old female

Reported by a pharmacist from Japan on 2012-07-19

Patient: 79 year old female

Reactions: Liver Disorder

Drug(s) suspected as cause:
Crestor
    Dosage: unk
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Enbrel
    Dosage: unk
    Indication: Rheumatoid Arthritis

Evista
    Dosage: unk
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Lansoprazole
    Dosage: unk
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

ONE-Alpha
    Dosage: unk
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication



Possible Evista side effects in 59 year old female

Reported by a consumer/non-health professional from Japan on 2012-07-19

Patient: 59 year old female

Reactions: Dermatitis Contact, Injection Site Erythema, Spinal Compression Fracture, Nausea, Bone Pain, Hyponatraemia, Eczema

Drug(s) suspected as cause:
Evista
    Dosage: unk
    Start date: 2011-06-01
    End date: 2012-07-01

Evista
    Dosage: unk
    Administration route: Oral
    Indication: Osteoporosis
    Start date: 2009-01-01

Forteo
    Dosage: unk, qd
    Indication: Osteoporosis
    Start date: 2012-07-03



Possible Evista side effects in female

Reported by a physician from United States on 2012-07-18

Patient: female

Reactions: Breast Cancer, Drug Ineffective

Drug(s) suspected as cause:
Evista



Possible Evista side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-18

Patient: female, weighing 55.0 kg (120.9 pounds)

Reactions: Confusional State, Osteoporosis, Bone Pain, Pain, Fall, Lumbar Spinal Stenosis, Fatigue, Road Traffic Accident, Oedema Peripheral, Decreased Appetite, Nausea, Lumbar Vertebral Fracture, Ankle Fracture, Joint Injury, Accident, Post-Traumatic Stress Disorder, Arthralgia, Mobility Decreased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Evista
    Dosage: 60 mg, qd
    Administration route: Oral
    Indication: Osteoporosis Prophylaxis

Evista
    Dosage: 60 mg, qd
    Administration route: Oral

Forteo
    Dosage: 20 ug, qd

Forteo
    Dosage: 20 ug, qd

Forteo
    Dosage: 20 ug, qd
    Indication: Osteoporosis Postmenopausal

Forteo
    Dosage: 20 ug, qd

Forteo
    Dosage: 20 ug, qd

Forteo
    Dosage: 20 ug, qd

Other drugs received by patient: Tylenol W / Codeine; Midrin; Vitamin D; Nasal Saline; Propylene Glycol; Prilosec; Multi-Vitamins; Fluoxetine Hydrochloride; Citracal-D; Clonazepam; Docusate Sodium; Seroquel



Possible Evista side effects in female

Reported by a physician from Japan on 2012-07-18

Patient: female

Reactions: Liver Disorder

Drug(s) suspected as cause:
Evista

Other drugs received by patient: Taiproton; Enbrel; Crestor; Onealfa



Possible Evista side effects in female

Reported by a physician from United States on 2012-07-18

Patient: female

Reactions: Breast Cancer

Drug(s) suspected as cause:
Evista



Possible Evista side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-17

Patient: female

Reactions: Injection Site Pain, Hyperhidrosis, Biliary Tract Disorder

Drug(s) suspected as cause:
Evista
    Dosage: 60 mg, unk

Forteo
    Dosage: 20 ug, qd

Forteo
    Dosage: 20 ug, qd

Forteo
    Dosage: 20 ug, qd
    Indication: Osteoporosis
    Start date: 2011-07-27

Other drugs received by patient: Zetia; Omeprazole; Tramadol HCL; Citrical / 00751501 /; D3; Atenolol; Multi-Vitamin



Possible Evista side effects in 68 year old female

Reported by a physician from Japan on 2012-07-12

Patient: 68 year old female

Reactions: Gastric Ulcer

Drug(s) suspected as cause:
Evista



Possible Evista side effects in 70 year old female

Reported by a physician from Japan on 2012-07-12

Patient: 70 year old female

Reactions: Alopecia

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Evista
    Administration route: Oral

Evista
    Dosage: 60 mg, each morning
    Administration route: Oral
    Start date: 2012-02-01

Other drugs received by patient: Mucosta; Ketoprofen; Diovan; Minodronic Acid; Norvasc; Alinamin F; Vitamin B12; Valsartan / Hydrochloorthiazide; Rizaben; Loxonin



Possible Evista side effects in female

Reported by a physician from Japan on 2012-07-12

Patient: female

Reactions: Breast Cancer

Drug(s) suspected as cause:
Evista



Possible Evista side effects in female

Reported by a consumer/non-health professional from Japan on 2012-07-11

Patient: female

Reactions: Road Traffic Accident

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Evista



Possible Evista side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-11

Patient: female

Reactions: Osteoporosis, Pubis Fracture

Drug(s) suspected as cause:
Evista



Possible Evista side effects in

Reported by a consumer/non-health professional from United States on 2012-07-10

Patient:

Reactions: Femur Fracture, Breast Cancer in Situ, Chronic Obstructive Pulmonary Disease, Fall, Breast Cyst, Breast Hyperplasia, Fibula Fracture, Injury, Hypercalciuria, LOW Turnover Osteopathy, Mitral Valve Prolapse, Lung Neoplasm, Breast Mass, Granuloma, Ankle Fracture, Rhinitis Allergic, Bone Neoplasm Malignant, Lung Disorder, Procedural Vomiting, Procedural Nausea, Sleep Apnoea Syndrome, Face Injury

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Evista
    Indication: Bone Disorder
    Start date: 2008-01-01

Fosamax
    Dosage: 70 mg, qw
    Administration route: Oral
    Start date: 2002-01-31
    End date: 2010-01-01

Fosamax
    Administration route: Oral
    Indication: Osteopenia
    Start date: 2000-10-01
    End date: 2009-09-01

Fosamax
    Dosage: 10 mg, unk
    Administration route: Oral
    Indication: Osteoporosis
    Start date: 2000-10-01
    End date: 2001-12-17

Other drugs received by patient: Calcium (Unspecified); Vitamin D (Unspecified); MK-9278



Possible Evista side effects in female

Reported by a physician from United States on 2012-07-09

Patient: female

Reactions: Pelvic Fracture, Injection Site Haematoma, Pain in Extremity, Intentional Drug Misuse, Fall, Sleep Disorder, Balance Disorder, Feeling Abnormal

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Evista
    Dosage: 60 mg, qd
    Indication: Osteoporosis
    Start date: 2007-01-01
    End date: 2011-07-01

Forteo
    Dosage: 20 ug, qd

Forteo
    Dosage: 20 ug, qd
    Indication: Osteoporosis

Forteo
    Dosage: 20 ug, qd

Other drugs received by patient: Vitamin D; Prilosec; Aspirin; Levothyroxine Sodium; Tums / 00193601 /



Possible Evista side effects in 55 year old female

Reported by a consumer/non-health professional from United States on 2012-07-09

Patient: 55 year old female

Reactions: Body Height Decreased, Pain, Lower Limb Fracture

Drug(s) suspected as cause:
Evista



Possible Evista side effects in 72 year old female

Reported by a consumer/non-health professional from United States on 2012-07-05

Patient: 72 year old female

Reactions: Precancerous Cells Present

Drug(s) suspected as cause:
Evista



Possible Evista side effects in 53 year old female

Reported by a consumer/non-health professional from United States on 2012-07-05

Patient: 53 year old female

Reactions: HIP Fracture, Pelvic Fracture, Spinal Fracture, Pain

Drug(s) suspected as cause:
Evista



Possible Evista side effects in 60 year old female

Reported by a physician from Japan on 2012-07-05

Patient: 60 year old female

Reactions: Jaundice, Bile Duct Stone

Drug(s) suspected as cause:
Evista

Other drugs received by patient: Gasmotin; Nexium

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