Etidronate Side Effects
Some side effects of etidronate may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
For the Consumer
Applies to etidronate: oral tablet
Along with its needed effects, etidronate may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking etidronate:More common
- Bone pain or tenderness (increased, continuing, or returning—in patients with Paget's disease)
- Bone fractures, especially of the thigh bone
- Abdominal or stomach pain or burning
- bloody, black, or tarry stools
- chest pain
- cough or hoarseness
- general feeling of tiredness or weakness
- lower back or side pain
- noisy breathing
- painful or difficult urination
- pale skin
- skin rash or itching
- sore throat
- sores, ulcers, or white spots on the lips or inside the mouth
- swelling of the arms, legs, face, lips, tongue, or throat
- swollen glands
- tightness in the chest
- unusual bleeding or bruising
- Blistering, peeling, loosening of the skin
- bone, joint, or muscle pain that is severe and occasionally disabling
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- difficulty in moving
- difficulty in swallowing
- feeling sad or empty
- heavy jaw feeling
- lack of appetite
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- loosening of a tooth
- loss of interest or pleasure
- loss of memory
- pain or burning in the throat
- pain, swelling, or numbness in the mouth or jaw
- problems with memory
- rash with flat lesions or small raised lesions on the skin
- red irritated eyes
- red skin lesions, often with a purple center
- redness or discoloration of the skin
- seeing, hearing, or feeling things that are not there
- trouble concentrating
- trouble sleeping
- unusual tiredness or weakness
Get emergency help immediately if any of the following symptoms of overdose occur while taking etidronate:Symptoms of overdose
- Abdominal or stomach cramps
- difficulty in breathing
- irregular heartbeats
- mood or mental changes
- muscle cramps in the hands, arms, feet, legs, or face
- numbness and tingling around the mouth, fingertips, or feet
- shortness of breath
Some side effects of etidronate may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:More common - at higher doses
- Burning feeling in the chest or stomach
- hair loss, thinning of hair
- leg cramps
- stomach upset
- tenderness in the stomach area
For Healthcare Professionals
Applies to etidronate: intravenous solution, oral tablet
Etidronate has been generally well tolerated after both oral and intravenous administration. Side effects have been uncommon and appear to be dose related, usually occurring only with doses above 5 mg/kg per day. Because etidronate undergoes renal elimination, patients with reduced renal function may accumulate drug and are, therefore, at increased risk for side effects.
Etidronate use is associated with elevations in serum creatinine and BUN in up to 10% of patients. Patients with preexisting renal disease or on concomitant potentially renal toxic agents may be at increased risk. In addition, the use of higher than recommended doses or rapid infusion rates may contribute to the potential renal toxicity of etidronate. In animal studies, etidronate produced proximal renal tubular damage when used in high doses.
The risk of renal side effects may be reduced by delaying etidronate therapy until the patient is adequately volume expanded.
Renal side effects have included mild to moderate increases in serum creatinine (0.5 mg/dl or more) as well as BUN in up to 10% of patients.
Gastrointestinal side effects have included diarrhea, nausea, vomiting, abdominal discomfort, esophagitis, glossitis, and peptic ulcer. Loss of taste or metallic taste has been reported in up to 52% of patients receiving intravenous etidronate and in 4% of patients receiving oral etidronate.
Gastrointestinal side effects are more common with higher doses (10 to 20 mg/kg) and may be alleviated by dividing the daily dose. While these effects are generally mild and transient, perforated peptic ulcers, with or without subsequent peritonitis, have occurred. At least one fatality has been reported. Patients on high doses or unusually prolonged therapy may be at greater risk for severe gastrointestinal side effects of etidronate.
Cardiovascular side effects have included a case report of mitral and aortic valve thickening; causality is unknown.
Dermatologic side effects have included rash and pruritus. Alopecia has been reported in patients receiving etidronate.
Hypersensitivity side effects have included rash, follicular eruptions, urticaria, and angioedema. A case of Stevens-Johnson Syndrome has been reported.
Musculoskeletal side effects have included worsening of pagetic bone pain, arthralgias, fractures, and osteomalacia.
Worsening of pagetic bone pain as well as appearance of pain at sites which were previously asymptomatic is reported in 10 to 20% of patients. This generally resolves despite continued therapy in most patients.
In one study, 9/13 patients with Paget's disease had biopsy evidence of focal osteomalacia after treatment with etidronate. All 13 patients had evidence of a mineralization defect. Two patients suffered fissure fractures.
Worsening pagetic pain and a rapid decline in serum alkaline phosphatase levels were reported in a patient who experienced a fractured patella associated with the development of osteomalacia. The authors suggest that worsened pagetic pain in association with a rapid decline in alkaline phosphatase may be a predictor of osteomalacia risk.
Metabolic side effects have included hypocalcemia and hyperphosphatemia, although clinical manifestations are not noted.
Psychiatric side effects have included amnesia, confusion, depression and hallucinations.
Nervous system side effects have included paresthesia.
Respiratory side effects have included rare exacerbation of asthma.
Hematologic side effects have been rare, but have included agranulocytosis, pancytopenia, and a report of leukopenia with recurrence on rechallenge.
More etidronate resources
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