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Didronel (Etidronate) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Didronel (Etidronate) 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 (20)
Death (1)
Life Threatening Events (2)
Disability (1)

Reports by Reaction Type

Femur Fracture (11)Fall (8)Fracture Displacement (8)Gait Disturbance (8)Pain in Extremity (7)Muscular Weakness (7)Stress Fracture (7)Myopathy (6)Arthralgia (6)Pain (5)Abdominal Discomfort (5)Oedema Peripheral (5)

Possible Didronel side effects in

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

Patient:

Reactions: Thrombosis, Vitamin D Deficiency, Asthma, Femur Fracture, Wrist Fracture, Eye Operation, Nephrolithiasis, Oesophageal Dilatation, Blood Cholesterol Increased, Sinusitis, RIB Fracture, Nausea, Squamous Cell Carcinoma, Urinary Tract Infection, Cystitis, Hormone Level Abnormal, Seasonal Allergy, Arthralgia, Stress Fracture, Hypertension

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Fosamax Plus D
    Indication: Osteoporosis

Fosamax
    Dosage: 10 mg, unk
    Administration route: Oral
    Indication: Osteopenia
    Start date: 1998-09-01
    End date: 2001-10-25

Fosamax
    Dosage: 70 mg, unk
    Administration route: Oral
    Indication: Osteoporosis
    Start date: 2001-10-25
    End date: 2008-07-25

Fosamax Plus D
    Dosage: 70 mg, unk
    Administration route: Oral
    Indication: Osteopenia
    Start date: 2007-06-02
    End date: 2008-07-25

Alendronate Sodium
    Dosage: 70 mg, unk
    Administration route: Oral
    Indication: Osteoporosis
    Start date: 2008-07-25
    End date: 2010-02-07

Didronel
    Dosage: unk
    Indication: Osteopenia
    Start date: 1998-05-21
    End date: 1998-06-20

Other drugs received by patient: Asacol; Vitamins (Unspecified); Compazine; Chlordiazepoxide; Calcium Carbonate; Corticosteroids (Unspecified); Vitamin B-12



Possible Didronel side effects in female

Reported by a physician from Finland on 2012-07-13

Patient: female

Reactions: Femur Fracture, Fracture Delayed Union, Hand Fracture

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Didronel
    Administration route: Oral
    Indication: Osteoporosis

Fosamax
    Administration route: Oral
    Indication: Osteoporosis

Boniva
    Administration route: Oral
    Indication: Osteoporosis
    Start date: 2007-01-01
    End date: 2010-01-01

Calcium
    Administration route: Oral
    Indication: Osteoporosis

Zoledronoc Acid
    Indication: Osteoporosis

Other drugs received by patient: Medrol; Vitamin D; Calcium; Humira



Possible Didronel side effects in 38 year old female

Reported by a physician from Japan on 2012-07-11

Patient: 38 year old female

Reactions: Asthma, White Blood Cell Count Decreased, Pneumonia, Urine Output Decreased, Pseudomonas Infection, Anaemia, Iron Deficiency, Condition Aggravated, Pyrexia, Sepsis, Oedema, Acute Respiratory Distress Syndrome, Hypoalbuminaemia, Hypoxia, Neutrophil Count Decreased

Adverse event resulted in: death

Drug(s) suspected as cause:
Onon (Pranklukast)
    Dosage: 180 mg, oral
    Administration route: Oral
    Indication: Asthma
    Start date: 2010-03-01

Didronel
    Dosage: 200 mg, per day, oral
    Administration route: Oral
    Indication: Osteoporosis
    Start date: 2010-05-10
    End date: 2012-01-24

Promac / 01312301 / (Polaprezinc)
    Dosage: 150 mg, oral
    Administration route: Oral
    Indication: Zinc Deficiency
    Start date: 2010-04-01
    End date: 2012-04-12

Valproate Sodium
    Dosage: 498 mg,qd, oral
    Administration route: Oral
    Indication: Epilepsy
    Start date: 1974-02-01

Other drugs received by patient: Sennoside (Sennoside A+b); Intal; Glycerol 2.6%; Depas (Etizolam); ALL Other Therapeutica Products; Polmicort (Budesonide); Arderphyllin (Theophylline); Mucodyne (Carbocisteine)



Possible Didronel side effects in 61 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-05-24

Patient: 61 year old female, weighing 57.6 kg (126.7 pounds)

Reactions: Oesophageal Squamous Cell Carcinoma, Oesophageal Stenosis

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Didronel



Possible Didronel side effects in 60 year old female

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-05-17

Patient: 60 year old female, weighing 48.7 kg (107.1 pounds)

Reactions: Primary Sequestrum, Tooth Loss, Dysmorphism, Exposed Bone in JAW, Tooth Extraction, Oral Cavity Fistula, Gingival Disorder, Osteonecrosis of JAW, Impaired Healing, Breath Odour, Tenderness, Sinusitis, Pain in JAW

Drug(s) suspected as cause:
Alendronate Sodium
    Dosage: 5 mg, oral
    Administration route: Oral
    Indication: Osteitis Deformans
    Start date: 2003-03-01
    End date: 2004-09-01

Didronel
    Dosage: oral
    Administration route: Oral
    Indication: Back Pain
    Start date: 2000-11-01
    End date: 2003-03-01

Didronel
    Dosage: oral
    Administration route: Oral
    Indication: Osteitis Deformans
    Start date: 2000-11-01
    End date: 2003-03-01

Didronel
    Dosage: oral
    Administration route: Oral
    Indication: Neck Pain
    Start date: 2000-11-01
    End date: 2003-03-01

Risedronate Sodium
    Dosage: oral
    Administration route: Oral
    Indication: Osteitis Deformans
    Start date: 2004-09-01
    End date: 2005-09-01

Other drugs received by patient: Onealfa (Alfacalcidol)



Possible Didronel side effects in

Reported by a physician from Denmark on 2012-04-26

Patient:

Reactions: Primary Sequestrum, JAW Disorder, Osteomyelitis, Arteriosclerosis Coronary Artery, Acute Myocardial Infarction, Osteitis, Periostitis

Drug(s) suspected as cause:
Didronel



Possible Didronel side effects in 64 year old female

Reported by a individual with unspecified qualification from Austria on 2012-03-20

Patient: 64 year old female

Reactions: Myelofibrosis, Femur Fracture, Bone Pain, Anaphylactic Reaction, Lumbar Vertebral Fracture, Blood Parathyroid Hormone Increased, Dysstasia, Blood 25-Hydroxycholecalciferol Decreased, NO Therapeutic Response, Stress Fracture, Bone Density Decreased, Gait Disturbance, Osteocalcin Decreased, Pathological Fracture

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Didronel
    Dosage: oral
    Administration route: Oral
    Indication: Osteoporosis
    Start date: 1990-01-01
    End date: 1995-01-01

Alendronate Sodium
    Dosage: 70 m weekly, oral
    Administration route: Oral
    Indication: Osteoporosis
    Start date: 1995-01-01
    End date: 2000-01-01

Alendronate Sodium
    Dosage: 70 m weekly, oral
    Administration route: Oral
    Indication: Osteoporosis
    Start date: 2000-01-01
    End date: 2005-01-01



Possible Didronel side effects in

Reported by a health professional (non-physician/pharmacist) from Denmark on 2012-02-29

Patient:

Reactions: Arteriosclerosis Coronary Artery, Acute Myocardial Infarction

Drug(s) suspected as cause:
Didronel



Possible Didronel side effects in male

Reported by a health professional (non-physician/pharmacist) from Denmark on 2012-02-21

Patient: male, weighing 74.0 kg (162.8 pounds)

Reactions: Impaired Healing, Osteonecrosis of JAW, Hypophagia, Pain in JAW

Drug(s) suspected as cause:
Zometa
    Dosage: 4 mg, per 100mi nacl
    Indication: Osteoporosis
    Start date: 2003-10-16

Zometa
    Dosage: 4 mg, per 100mi nacl
    Start date: 2004-01-14

Didronel
    Dosage: unk ukn, unk
    Administration route: Oral
    Start date: 2001-04-10
    End date: 2002-06-10

Zometa
    Dosage: 4 mg, per 100mi nacl
    Start date: 2004-07-15

Didronel
    Administration route: Oral
    Indication: Osteoporosis
    Start date: 2001-03-01
    End date: 2002-06-01

Other drugs received by patient: Fosamax; Calciferol; Forteo; Sodium Fluoride; Fosamax; Natriumfluorid



Possible Didronel side effects in 76 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-02-17

Patient: 76 year old female

Reactions: Femur Fracture, Pain, Fall, Abdominal Discomfort, Oedema Peripheral, Fracture Displacement, Adhesion, Haematoma, LOW Turnover Osteopathy, Hyperparathyroidism Primary, Fracture Delayed Union, Muscular Weakness, Bursitis, Myopathy, Stress Fracture, Gait Disturbance, Scar

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Fosamax
    Dosage: 10 mgdaily, oral
    Administration route: Oral
    Indication: Osteoporosis Postmenopausal
    Start date: 1995-12-29
    End date: 2002-07-01

Actonel
    Dosage: 35 mg once weekly, oral
    Administration route: Oral
    Indication: Osteoporosis Postmenopausal
    Start date: 2002-10-30
    End date: 2003-01-01

Boniva
    Dosage: 150 mg once monthly, oral
    Administration route: Oral
    Indication: Osteopenia
    Start date: 2005-12-29
    End date: 2009-04-01

Boniva
    Dosage: 150 mg once monthly, oral
    Administration route: Oral
    Indication: Osteoporosis Postmenopausal
    Start date: 2005-12-29
    End date: 2009-04-01

Didronel
    Dosage: 200 mg twice daily times 2 weeks q 10 weeks, oral
    Administration route: Oral
    Indication: Osteoporosis Postmenopausal
    Start date: 1993-12-21
    End date: 1995-12-27

Other drugs received by patient: Acyclovir / 00587301 / (Aciclovir); Lidoderm; Arthrotec / 00372302 (Diclofenac Sodium); Cephalexin / 00145501 / (Cefalexin); Cozaar; Hydrocodone W / Apap (Hydrocodone, Paracetamol)



Possible Didronel side effects in 76 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-02-17

Patient: 76 year old female

Reactions: Soft Tissue Disorder, Femur Fracture, Fall, Abdominal Discomfort, Hyperparathyroidism, Oedema Peripheral, Fracture Displacement, LOW Turnover Osteopathy, Haematoma, Pain in Extremity, Fracture Delayed Union, Muscular Weakness, Bursitis, Myopathy, Stress Fracture, Gait Disturbance, Parathyroid Tumour Benign, Deep Vein Thrombosis, Scar

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Didronel
    Dosage: 200 mg twice daily times two weeks cyclic every 10 weeks, oral
    Administration route: Oral
    Indication: Osteoporosis Postmenopausal
    Start date: 1993-12-21
    End date: 1995-12-29

Actonel
    Dosage: 35 mg once weekly, oral
    Administration route: Oral
    Start date: 2002-10-30
    End date: 2003-01-01

Fosamax
    Dosage: 10 mg daily, oral
    Administration route: Oral
    Start date: 1995-12-29
    End date: 2002-07-01

Boniva
    Dosage: 150 mg once monthly, oral
    Administration route: Oral
    Start date: 2005-12-29
    End date: 2009-04-01

Other drugs received by patient: Tagamet; Cytotec; Voltaren; Ranitidine Hydrochloride



Possible Didronel side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-01-04

Patient:

Reactions: Pancreatic Carcinoma, Hepatic Neoplasm Malignant, Oesophageal Carcinoma, Gastric Cancer

Drug(s) suspected as cause:
Didronel



Possible Didronel side effects in 76 year old female

Reported by a physician from United States on 2011-12-29

Patient: 76 year old female

Reactions: Femur Fracture, Pain, Fall, Abdominal Discomfort, Oedema Peripheral, Fracture Displacement, Haematoma, LOW Turnover Osteopathy, Anaemia Postoperative, Intervertebral Disc Operation, Hiatus Hernia, Hyperparathyroidism Primary, Pain in Extremity, Muscular Weakness, Radiotherapy, Breast Cancer Female, Bursitis, Myopathy, Osteoarthritis, Hysterectomy, Arthralgia, Stress Fracture, Parathyroid Tumour Benign, Gait Disturbance

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Fosamax
    Dosage: 10 mg daily, oral
    Administration route: Oral
    Indication: Osteoporosis Postmenopausal
    Start date: 1995-12-29
    End date: 2002-01-01

Actonel
    Dosage: 35 mg once weekly, oral
    Administration route: Oral
    Indication: Osteopenia
    Start date: 2002-10-30
    End date: 2002-11-01

Didronel
    Dosage: oral
    Administration route: Oral
    Indication: Osteoporosis
    End date: 1995-12-27

Boniva
    Dosage: 150 mg once montly, oral
    Administration route: Oral
    Indication: Osteoporosis
    Start date: 2005-12-29
    End date: 2009-04-01

Other drugs received by patient: Cozaar; Arthrotec / 00372302 / (Diclofenac Sodium); Cephalexin



Possible Didronel side effects in 76 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-12-29

Patient: 76 year old female

Reactions: Femur Fracture, Pain, Fall, Abdominal Discomfort, Oedema Peripheral, Fracture Displacement, LOW Turnover Osteopathy, Anaemia Postoperative, Haematoma, Pain in Extremity, Hyperparathyroidism Primary, Muscular Weakness, Myopathy, Stress Fracture, Gait Disturbance, Parathyroid Tumour Benign

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Fosamax
    Dosage: 10 mg daily, oral
    Administration route: Oral
    Start date: 1995-12-29
    End date: 2002-01-01

Actonel
    Dosage: 35 mg once weekly, oral
    Administration route: Oral
    Start date: 2002-10-30
    End date: 2002-11-01

Didronel
    Dosage: oral
    Administration route: Oral
    Indication: Osteoporosis Postmenopausal
    End date: 1995-12-29

Boniva
    Dosage: 150 ma once monthly, oral
    Administration route: Oral
    Start date: 2005-12-29
    End date: 2009-04-01



Possible Didronel side effects in 67 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-12-07

Patient: 67 year old female

Reactions: Joint Instability, Femur Fracture, Sciatica, Bone Pain, Pain, Fall, Fracture Nonunion, Synovial Cyst, Myalgia, Fracture Displacement, Joint Effusion, Back Pain, Pain in Extremity, Device Damage, Muscular Weakness, Ankle Fracture, Myopathy, Device Failure, Impaired Healing, Arthralgia, Gait Disturbance, Muscle Disorder, Asthenia, Device Breakage

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Boniva
    Dosage: 150 mg, 1 /month, oral
    Administration route: Oral
    Indication: Osteoporosis
    Start date: 2006-01-01
    End date: 2008-11-04

Actonel
    Dosage: oral
    Administration route: Oral

Boniva
    Dosage: 150 mg, 1 /month, oral
    Administration route: Oral
    Indication: Osteoporosis

Fosamax
    Dosage: 70 mg, 1 /week, oral
    Administration route: Oral
    Indication: Osteoporosis
    Start date: 2004-01-01
    End date: 2006-01-01

Boniva
    Dosage: 150 mg, 1 /month, oral
    Administration route: Oral
    Indication: Osteoporosis
    Start date: 2009-05-26
    End date: 2010-03-01

Didronel
    Dosage: oral
    Administration route: Oral
    Indication: Osteoporosis

Alendronate Sodium
    Dosage: 70 mg, 1 /week
    Indication: Osteoporosis
    Start date: 2008-11-04
    End date: 2009-05-26

Fosamax
    Dosage: 5 mg
    Indication: Osteoporosis
    Start date: 1998-01-01
    End date: 2004-01-01

Other drugs received by patient: Avalide; Lisinopril; Toprol-XL; Aspirin; Simvastatin; Celebrex; Prozac



Possible Didronel side effects in 67 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-11-25

Patient: 67 year old female

Reactions: Joint Instability, Femur Fracture, Sciatica, Fracture Nonunion, Fall, Synovial Cyst, Myalgia, Fracture Displacement, Pain in Extremity, Muscular Weakness, Ankle Fracture, Myopathy, Arthralgia, Gait Disturbance, Muscle Disorder, Asthenia, Device Breakage

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Actonel
    Dosage: oral
    Administration route: Oral

Fosamax
    Dosage: 5 mg,
    Indication: Osteoporosis
    Start date: 1998-01-01
    End date: 2004-01-01

Boniva
    Dosage: 150 mg, 1/month, oral
    Administration route: Oral
    Indication: Osteoporosis
    Start date: 2006-01-01
    End date: 2008-11-04

Boniva
    Dosage: 150 mg, 1/month, oral
    Administration route: Oral
    Indication: Osteoporosis
    Start date: 2009-05-26
    End date: 2010-03-01

Alendronate Sodium
    Dosage: 70 mg, 1/week,
    Indication: Osteoporosis
    Start date: 2008-11-04
    End date: 2009-05-26

Fosamax
    Dosage: 70 mg, 1/week, oral
    Administration route: Oral
    Indication: Osteoporosis
    Start date: 2004-01-01
    End date: 2006-01-01

Didronel
    Dosage: oral
    Administration route: Oral
    Indication: Osteoporosis



Possible Didronel side effects in 76 year old female

Reported by a physician from United States on 2011-11-25

Patient: 76 year old female

Reactions: Femur Fracture, Pain in Extremity, Hyperparathyroidism Primary, Pain, Fall, Abdominal Discomfort, Arthralgia, Oedema Peripheral, Fracture Displacement, Stress Fracture, Haematoma, LOW Turnover Osteopathy, Anaemia Postoperative

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Didronel
    Dosage: oral
    Administration route: Oral
    Indication: Osteoporosis Postmenopausal
    End date: 1995-12-29

Actonel
    Dosage: 35 mg once weekly, oral
    Administration route: Oral
    Start date: 2002-10-30
    End date: 2002-11-01

Fosamax
    Dosage: 10 mg daily, oral
    Administration route: Oral
    Start date: 1995-12-29
    End date: 2002-01-01

Boniva
    Dosage: 150 mg once monthly, oral
    Administration route: Oral
    Start date: 2005-12-29
    End date: 2009-04-01



Possible Didronel side effects in 67 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-11-25

Patient: 67 year old female

Reactions: Femur Fracture, Pain in Extremity, Muscular Weakness, Fracture Nonunion, Fall, Ankle Fracture, Arthralgia, Fracture Displacement, Gait Disturbance, Device Breakage

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Fosamax
    Dosage: 70 mg, 1 /week, oral
    Administration route: Oral
    Indication: Osteoporosis
    Start date: 2004-01-01
    End date: 2006-01-01

Alendronate Sodium
    Dosage: 70 mg, 1 /week
    Indication: Osteoporosis
    Start date: 2008-11-04
    End date: 2009-05-26

Boniva
    Dosage: 150 mg, 1 /month, oral ; 150 mg, 1 /month, oral ; 150 mg, 1 /month, oral
    Administration route: Oral
    Indication: Osteoporosis
    Start date: 2006-01-01
    End date: 2008-11-04

Boniva
    Dosage: 150 mg, 1 /month, oral ; 150 mg, 1 /month, oral ; 150 mg, 1 /month, oral
    Administration route: Oral
    Indication: Osteoporosis
    Start date: 2009-05-26
    End date: 2010-03-01

Didronel
    Dosage: oral
    Administration route: Oral
    Indication: Osteoporosis

Fosamax
    Dosage: 5 mg
    Indication: Osteoporosis
    Start date: 1998-01-01
    End date: 2004-01-01

Actonel
    Dosage: oral
    Administration route: Oral



Possible Didronel side effects in male

Reported by a consumer/non-health professional from Denmark on 2011-11-07

Patient: male, weighing 74.0 kg (162.8 pounds)

Reactions: Impaired Healing, Osteonecrosis of JAW, Hypophagia, Pain in JAW

Drug(s) suspected as cause:
Zometa
    Dosage: 4 mg, per 100mi nacl
    Indication: Osteoporosis
    Start date: 2003-10-16

Didronel
    Administration route: Oral
    Start date: 2001-03-01
    End date: 2002-06-01

Zometa
    Dosage: 4 mg, per 100mi nacl
    Start date: 2004-07-15

Zometa
    Dosage: 4 mg, per 100mi nacl
    Start date: 2004-01-14

Other drugs received by patient: Calciferol; Sodium Fluoride; Fosamax; Forteo



Possible Didronel side effects in 61 year old female

Reported by a physician from United Kingdom on 2011-10-07

Patient: 61 year old female, weighing 5706.0 kg (12553.2 pounds)

Reactions: Dysphagia, Oesophageal Squamous Cell Carcinoma

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Didronel

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