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Reclast (Zoledronic Acid) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Reclast (Zoledronic Acid) 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 (1560)
Death (507)
Life Threatening Events (71)
Disability (126)

Reports by Reaction Type

Death (377)Pain (226)Arthralgia (210)Femur Fracture (154)Fall (153)Headache (137)Pain in Extremity (133)Nausea (121)Pyrexia (114)Myalgia (113)Bone Pain (109)Influenza Like Illness (108)

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

Possible Reclast side effects in

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient:

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Reclast



Possible Reclast side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: female

Reactions: Intervertebral Disc Protrusion, Intervertebral Disc Space Narrowing, Neck Pain, Bone Pain, Spinal Osteoarthritis, Exostosis, Spondyloarthropathy

Drug(s) suspected as cause:
Reclast



Possible Reclast side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: female

Reactions: Myocardial Infarction

Drug(s) suspected as cause:
Reclast



Possible Reclast side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: female

Reactions: Sepsis, Cardiac Failure Congestive

Adverse event resulted in: death

Drug(s) suspected as cause:
Reclast



Possible Reclast side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: female, weighing 91.6 kg (201.6 pounds)

Reactions: Fatigue, Arthralgia, Renal Pain

Drug(s) suspected as cause:
Reclast



Possible Reclast side effects in

Reported by a individual with unspecified qualification from United States on 2012-08-24

Patient:

Reactions: Seasonal Allergy, Spinal Compression Fracture, Femur Fracture, Fracture, Bone Disorder, Fall, Open Reduction of Fracture, RIB Fracture

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Actonel
    Dosage: 35 mg, unk
    Indication: Osteoporosis
    Start date: 2007-12-31
    End date: 2009-01-01

Fosamax
    Dosage: 70 mg, unk
    Administration route: Oral
    Indication: Osteoporosis
    Start date: 2000-01-01
    End date: 2007-06-01

Reclast
    Dosage: unk
    Indication: Osteoporosis
    Start date: 2009-01-01
    End date: 2011-01-01

Other drugs received by patient: Vitamins (Unspecified); Vitamin D; Calcium (Unspecified)



Possible Reclast side effects in 52 year old female

Reported by a physician from United States on 2012-08-24

Patient: 52 year old female, weighing 44.5 kg (97.8 pounds)

Reactions: Myalgia, Malaise, Arthralgia, Pain, Acute Phase Reaction, Joint Effusion, Pyrexia, Joint Stiffness

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Reclast



Possible Reclast side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: female

Reactions: HIP Fracture, Pelvic Fracture, Emotional Distress, Femur Fracture, Pain, Injury

Drug(s) suspected as cause:
Boniva

Fosamax

Reclast



Possible Reclast side effects in 63 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-24

Patient: 63 year old female, weighing 59.0 kg (129.7 pounds)

Reactions: Diplopia, Exophthalmos, Parophthalmia, Conjunctivitis, Ocular Hyperaemia, Eye Pain

Drug(s) suspected as cause:
Reclast



Possible Reclast side effects in female

Reported by a physician from United States on 2012-08-24

Patient: female

Reactions: Lung Neoplasm Malignant

Adverse event resulted in: death

Drug(s) suspected as cause:
Reclast



Possible Reclast side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient: female

Reactions: Diarrhoea Haemorrhagic

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Reclast



Possible Reclast side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-23

Patient: female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Reclast



Possible Reclast side effects in

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

Patient:

Reactions: Femur Fracture, Oropharyngeal Pain, Sinus Congestion, Radiculopathy, Anaemia Postoperative, Muscle Spasms, Back Pain, Fracture Delayed Union, Pain in Extremity, Gingival Disorder, Helicobacter Infection, Breast Calcifications, Stress Fracture, Haemorrhagic Diathesis, Gastric Polyps, Polyarthritis, Sleep Apnoea Syndrome, Osteoporosis, Upper-Airway Cough Syndrome, Mouth Ulceration, Fracture Nonunion, Hypokalaemia, Dyspnoea Exertional, Nerve Root Lesion, Intervertebral Disc Degeneration, RIB Fracture, Dyspnoea, Urinary Tract Infection, Hyponatraemia, Musculoskeletal Chest Pain, Anxiety, Osteoarthritis, Arthralgia, Impaired Healing, Dysuria, Arthritis

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Alendronate Sodium
    Dosage: 70 mg, unk

Fosamax
    Dosage: 70 mg, unk
    Administration route: Oral
    Indication: Osteopenia
    Start date: 2009-02-09
    End date: 2010-08-01

Fosamax
    Dosage: 70 mg, qw
    Administration route: Oral
    Start date: 2002-03-20

Fosamax
    Dosage: unk mg, unk
    Administration route: Oral
    Start date: 2002-04-01
    End date: 2007-12-01

Fosamax Plus D
    Dosage: unk mg, unk
    Administration route: Oral
    Indication: Osteopenia
    Start date: 2008-01-29
    End date: 2008-11-10

Reclast
    Indication: Osteopenia
    Start date: 2010-09-01
    End date: 2011-02-01

Other drugs received by patient: Calcium (Unspecified) (+) Vitamin D (Unspecified); Vitamin E; Esomeprazole Sodium; Calcium (Unspecified) (+) Vitamin D (Unspecified)



Possible Reclast side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient: female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Reclast



Possible Reclast side effects in

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

Patient:

Reactions: Foot Deformity, Pruritus, Tinnitus, Contusion, Femur Fracture, Hyperkeratosis, Tachycardia, Headache, Herpes Zoster, Cardiac Disorder, Arthropathy, Palpitations, Postmenopausal Haemorrhage, Joint Effusion, Tympanic Membrane Perforation, LOW Turnover Osteopathy, Back Pain, Cellulitis, Cerumen Impaction, Anaemia, Ear Disorder, Haemorrhagic Anaemia, Bursitis, Gastric Disorder, Flushing, Osteonecrosis, Dysphonia, Benign Neoplasm of Skin, Systemic Lupus Erythematosus, Essential Hypertension, Adverse Drug Reaction, Nail Infection, Fall, Liver Function Test Abnormal, Dermatomyositis, Gastrooesophageal Reflux Disease, Exostosis, Soft Tissue Injury, Urinary Tract Infection, Deafness Neurosensory, Arrhythmia, Carotid Artery Stenosis, Osteoarthritis, Arthralgia, Vertigo, Arthritis

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Alendronate Sodium
    Indication: Osteoporosis Prophylaxis

Alendronate Sodium
    Administration route: Oral
    Indication: Osteoporosis
    Start date: 2008-02-01
    End date: 2008-01-01

Fosamax
    Dosage: 70 mg, qw
    Administration route: Oral
    Indication: Osteopenia
    Start date: 2001-05-08
    End date: 2008-07-01

Fosamax
    Administration route: Oral
    Start date: 2008-02-01
    End date: 2008-01-01

Fosamax
    Indication: Osteoporosis Prophylaxis

Fosamax
    Dosage: 10 mg, qd
    Administration route: Oral
    Indication: Osteoporosis
    Start date: 1998-01-01
    End date: 2001-04-01

Prednisone TAB
    Dosage: unk
    Indication: Dermatomyositis
    Start date: 2002-12-01
    End date: 2008-02-01

Reclast
    Dosage: 5/100 ml
    Indication: Osteoporosis

Other drugs received by patient: Esomeprazole Sodium



Possible Reclast side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-22

Patient: female

Reactions: Angle Closure Glaucoma, Eye Pain

Drug(s) suspected as cause:
Reclast



Possible Reclast side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: female

Reactions: Fall

Drug(s) suspected as cause:
Reclast



Possible Reclast side effects in

Reported by a lawyer from United States on 2012-08-22

Patient:

Reactions: Vitamin D Deficiency, Dyslipidaemia, Periodontal Disease, Gastritis, Vitamin B12 Deficiency, Fracture, Irritable Bowel Syndrome, Patella Fracture, Depression, Exostosis, Myocardial Infarction, Gingival Bleeding, Cataract, Anaemia, Dental Caries, Cerebrovascular Accident, Anxiety, Osteoarthritis, Impaired Healing, Osteonecrosis of JAW, Oral Disorder, Vertigo, Gingival Infection, Oral Torus

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Fosamax
    Dosage: 70 mg, unk
    Administration route: Oral
    Indication: Osteopenia
    Start date: 2000-02-25
    End date: 2003-06-25

Fosamax
    Dosage: 70 mg, qw
    Administration route: Oral
    Start date: 2005-10-27
    End date: 2007-12-05

Reclast
    Start date: 2008-12-03
    End date: 2009-12-19

Other drugs received by patient: Norvasc; Synthroid; Simvastatin; Boniva



Possible Reclast side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: female

Reactions: Patella Fracture, Bone Density Decreased, RIB Fracture

Drug(s) suspected as cause:
Reclast



Possible Reclast side effects in female

Reported by a physician from United States on 2012-08-22

Patient: female

Reactions: Chronic Obstructive Pulmonary Disease, Lung Carcinoma Cell Type Unspecified Stage IV

Adverse event resulted in: death

Drug(s) suspected as cause:
Reclast



Possible Reclast side effects in female

Reported by a physician from United States on 2012-08-22

Patient: female, weighing 77.1 kg (169.6 pounds)

Reactions: Nausea, Pain in Extremity, Bone Pain, Pain, Convulsion, Joint Swelling, Arthralgia, Throat Irritation, Postural Orthostatic Tachycardia Syndrome, Influenza Like Illness

Drug(s) suspected as cause:
Reclast

Other drugs received by patient: Xanax; Percocet; Claritin; Nexium; Levothyroxine Sodium; Pindolol; Vitamin D; Colace; Midodrine Hydrochloride; Calcium



Possible Reclast side effects in female

Reported by a physician from United States on 2012-08-21

Patient: female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Reclast



Possible Reclast side effects in female

Reported by a physician from United States on 2012-08-21

Patient: female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Reclast



Possible Reclast side effects in 81 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-21

Patient: 81 year old male, weighing 65.8 kg (144.7 pounds)

Reactions: Myocardial Infarction, Cardiac Failure Congestive

Adverse event resulted in: death

Drug(s) suspected as cause:
Reclast



Possible Reclast side effects in female

Reported by a physician from United States on 2012-08-21

Patient: female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Reclast



Possible Reclast side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-21

Patient: female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Reclast



Possible Reclast side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-21

Patient: female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Reclast



Possible Reclast side effects in female

Reported by a physician from United States on 2012-08-21

Patient: female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Reclast



Possible Reclast side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-21

Patient: male, weighing 79.8 kg (175.6 pounds)

Reactions: Abasia, Parkinson's Disease, Musculoskeletal Stiffness, Asthenia, Tremor

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Reclast
    Dosage: 5 mg, 1 per year
    Indication: Osteoporosis
    Start date: 2009-01-01

Reclast
    Dosage: 5 mg, 1 per year
    Start date: 2010-07-16

Other drugs received by patient: Calcium; Tamsulosin HCL; Metoprolol Tartrate; Vitamin D; Aspirin; Vitamin B-12; Simvastatin; Omeprazole



Possible Reclast side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-21

Patient: female

Reactions: Lung Neoplasm Malignant, Asbestosis

Adverse event resulted in: death

Drug(s) suspected as cause:
Reclast

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