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Didronel

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Didronel

Didronel Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Didronel (etidronate disodium) is used to treat Paget's disease, and to treat conditions of irregular bone growth due to hip fracture or spinal cord injury. It is a bisphosphonate. This medication may be available in generic form. Common side effects include stomach upset or diarrhea.

To treat Paget's Disease, the initial treatment regimens of Didronel are 5 to 10 mg/kg/day, not to exceed 6 months, or 11 to 20 mg/kg/day, not to exceed 3 months. Didronel may interact with blood thinners. Other drugs may interact with Didronel. Tell your doctor all prescription and over-the-counter medications and supplements you use. Caution is advised if you are pregnant or planning to become pregnant in the future. Didronel may stay in your body for many years. Effects on a fetus are unknown. Consult your doctor before starting treatment with this medication. It is unknown if this medication passes into breast milk, and the effect on a nursing infant is unknown. Consult your doctor before breastfeeding.

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

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Didronel in Detail - Patient Information: Side Effects

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

Stop using etidronate and call your doctor at once if you have any of these serious side effects:

  • painful or difficult swallowing;
  • severe heartburn, burning pain in your upper stomach, or coughing up blood;
  • severe joint, bone, or muscle pain;
  • jaw pain, numbness, or swelling;
  • severe diarrhea;
  • bone fracture; or
  • a red, blistering, peeling skin rash.

Less serious side effects may include:

  • mild diarrhea;
  • headache, confusion;
  • muscle cramps, joint pain; or
  • numbness or tingly feeling.

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 Didronel (Etidronate Disodium) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Didronel Overview - Patient Information: Side Effects

SIDE EFFECTS: Stomach upset or diarrhea may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: new or worsening bone/joint/muscle pain, new or unusual hip/thigh/groin pain, jaw pain, mental/mood changes, signs of infection (such as fever, persistent sore throat).

This medication may infrequently cause irritation and ulcers in your stomach or esophagus. Seek immediate medical attention if any of these serious side effects occur: new/severe/worsening heartburn, chest pain, difficult/painful swallowing, stomach/abdominal pain, black/tarry stools, vomit that looks like coffee grounds.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Didronel (Etidronate Disodium)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Didronel FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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, 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 including perforation has been reported rarely.

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.

Read the entire FDA prescribing information for Didronel (Etidronate Disodium) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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