Didronel (Etidronate Disodium) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

The incidence of gastrointestinal complaints (diarrhea, nausea) is the same for Didronel at 5 mg/kg/day as for placebo, about 1 patient in 15. At 10 to 20 mg/kg/day the incidence may increase to 2 or 3 in 10. These complaints are often alleviated by dividing the total daily dose.

Paget's Disease: In Paget's patients, increased or recurrent bone pain at pagetic sites, and/or the onset of pain at previously asymptomatic sites has been reported. At 5 mg/kg/day about 1 patient in 10 (versus 1 in 15 in the placebo group) report these phenomena. At higher doses the incidence rises to about 2 in 10. When therapy continues, pain resolves in some patients but persists in others.

Heterotopic Ossification: No specific adverse reactions.

Worldwide Postmarketing Experience: The worldwide postmarketing experience for etidronate disodium reflects its use in the following approved indications: Paget's disease, heterotopic ossification, and hypercalcemia of malignancy. It also reflects the use of etidronate disodium for osteoporosis where approved in countries outside the US. Other adverse events that have been reported and were thought to be possibly related to etidronate disodium include the following: alopecia; arthropathies, including arthralgia and arthritis; bone fracture; esophagitis; glossitis; hypersensitivity reactions, including angioedema, follicular eruption, macular rash, maculopapular rash, pruritus, a single case of Stevens-Johnson syndrome, and urticaria; osteomalacia; neuropsychiatric events, including amnesia, confusion, depression, and hallucination; and paresthesias.

In patients receiving etidronate disodium, there have been rare reports of agranulocytosis, pancytopenia, and a report of leukopenia with recurrence on rechallenge. In addition, there have been rare reports of exacerbation of asthma. Exacerbation of existing peptic ulcer disease has been reported in a few patients. In one patient, perforation also occurred.

In osteoporosis clinical trials, headache, gastritis, leg cramps, and arthralgia occurred at a significantly greater incidence in patients who received etidronate as compared with those who received placebo.

REPORTS OF SUSPECTED DIDRONEL SIDE EFFECTS / ADVERSE REACTIONS

Possible Didronel side effects / adverse reactions 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

Suspect drug(s):
Didronel

Possible Didronel side effects / adverse reactions 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

Suspect drug(s):
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 / adverse reactions 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

Suspect drug(s):
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