Aredia Side Effects

Generic Name: pamidronate

Note: This page contains information about the side effects of pamidronate. Some of the dosage forms included on this document may not apply to the brand name Aredia.

Not all side effects for Aredia may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to pamidronate: intravenous powder for solution, intravenous solution

In addition to its needed effects, some unwanted effects may be caused by pamidronate (the active ingredient contained in Aredia). In the event that any of these side effects do occur, they may require medical attention.

If any of the following side effects occur while taking pamidronate, check with your doctor or nurse immediately:

More common
  • Abdominal or stomach cramps
  • black, tarry stools
  • bloody in the urine or stools
  • blurred vision
  • chest pain
  • chills
  • confusion
  • convulsions (seizures)
  • decrease in the amount of urine
  • dizziness
  • drowsiness
  • fainting
  • fast or irregular heartbeat
  • fever
  • headache
  • increased thirst
  • loss of appetite
  • muscle pain, cramps, spasms, or twitching
  • nausea or vomiting
  • nervousness
  • noisy, rattling breathing
  • numbness or tingling in the hands, feet, or lips
  • pinpoint red spots on the skin
  • pounding in the ears
  • shortness of breath
  • slow or fast heartbeat
  • swelling of the fingers, hands, feet, or lower legs
  • trembling
  • troubled breathing at rest
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • vomiting of blood or material that looks like coffee grounds
  • weight gain
Less common
  • Cough
  • dilated neck veins
  • extreme fatigue
  • irregular breathing
  • lower back or side pain
  • painful or difficult urination
  • pale skin
  • swelling
  • ulcers, sores, or white spots in the mouth
Rare
  • Decreased vision
  • difficulty with swallowing
  • eye pain or tenderness
  • eye redness
  • hives
  • itching
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • sensitivity of the eye to light
  • skin rash
  • sweating
  • tearing of the eye
  • tightness in the chest
Incidence not known
  • Bone, joint, or muscle pain, severe and occasionally incapacitating
  • faintness, or lightheadedness when getting up suddenly from a lying or sitting position

Some of the side effects that can occur with pamidronate may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Acid or sour stomach
  • belching
  • bladder pain
  • bloody or cloudy urine
  • body aches or pain
  • bone pain
  • constipation
  • cracks in the skin at the corners of mouth
  • diarrhea
  • difficult, burning, or painful urination
  • difficult or labored breathing
  • difficulty moving
  • ear congestion
  • fear
  • frequent urge to urinate
  • heartburn
  • indigestion
  • joint pain
  • lack or loss of strength
  • lower back or side pain
  • muscle aching, cramping, pains, or stiffness
  • nasal congestion
  • nervousness
  • pain and swelling at the injection site
  • sensitivity to heat
  • shivering
  • sneezing
  • soreness or redness around the fingernails and toenails
  • stomach discomfort, upset, or pain
  • sweating
  • swollen joints
  • trouble sleeping
  • weight loss
Less common
  • Ammonia-like breath odor
  • feeling, seeing, or hearing things that are not there
  • feeling that others are watching you or controlling your behavior
  • feeling that others can hear your thoughts
  • feeling unusually cold
  • swelling or inflammation of the mouth
  • unusual behavior

For Healthcare Professionals

Applies to pamidronate: intravenous powder for injection, intravenous solution

General

In patients with osteolytic bone involvement associated with breast cancer and multiple myeloma, the most commonly reported (>15%) adverse effects occurred with similar frequency in pamidronate (the active ingredient contained in Aredia) and placebo treatment groups.

Five pamidronate associated serious and unexpected adverse events occurred in multiple myeloma patients during clinical trials. Symptoms included worsening renal function or multiple myeloma associated amyloidosis (3), adult respiratory distress syndrome (1), and an allergic reaction after the sixth infusion (1).

Four breast cancer patients discontinued pamidronate because of serious adverse events including interstitial pneumonitis, malaise, dyspnea, symptomatic hypocalcemia, and severe bone pain.[Ref]

Pamidronate has been generally well tolerated and many adverse effects that occurred during treatment may have been related to the underlying disease state. Adverse effects have been most often associated with larger (90 mg) doses of pamidronate. The most common adverse effect has been fever, occurring in up to 41% of patients. The fever was generally mild and transient. Onset was typically within the first 48 hours after infusion and resolution was within another 48 hours.[Ref]

Local

Local side effects associated with intravenous infusion have been reported in up to 18% of patients and included phlebitis as well as redness, swelling, and pain at the injection site.[Ref]

Metabolic

Metabolic side effects have included hypophosphatemia (18%), hypokalemia (18%), hypocalcemia (12%), and hypomagnesemia (12%). While usually asymptomatic, rare cases of symptomatic hypocalcemia have been reported.[Ref]

Presentation of hypocalcemia may be delayed. In one case report, the patient presented with fingertip paresthesias and a serum calcium of 6.8 mEq/L (7.8 mEq/mL, corrected) 13 days after a single infusion of pamidronate.[Ref]

Hematologic

Leukopenia was generally mild and transient. In one study, granulocytopenia occurred in 4.2% of patients but completely resolved after discontinuation of pamidronate (the active ingredient contained in Aredia) therapy. Patients with anemia, leukopenia, or thrombocytopenia prior to initiation of pamidronate should be carefully monitored during the first 2 weeks of therapy.[Ref]

Hematologic side effects have included anemia, mild leukopenia, and granulocytopenia. Chronic idiopathic thrombocytopenic purpura has also been cited in a case report.[Ref]

Renal

Renal side effects have included postmarketing reports of focal segmental glomerulosclerosis including the collapsing variant and nephrotic syndrome. Monitoring of renal function during and following pamidronate (the active ingredient contained in Aredia) therapy is recommended.[Ref]

Ocular

Ocular side effects have included abnormal vision as well as uveitis, iritis, episcleritis, scleritis, and nonspecific transitory conjunctivitis. Post marketing reports have included orbital inflammation.[Ref]

Uveitis generally occurs within 24 to 48 hours after administration of pamidronate. The uveitis may be bilateral, and reversible, partial 3rd and 4th nerve palsies have been reported with the uveitis. Recurrences have occurred with rechallenge of the drug. Therapy with pamidronate should be discontinued if uveitis occurs. Although severe cases have been reported, most symptoms have resolved on discontinuation of pamidronate with minimal or no intervention.

A nonspecific conjunctivitis has been reported with pamidronate use. The conjunctivitis may consist of any or all of the following symptoms: conjunctival hyperemia, irritation, epiphora, discharge, and blurred vision. These symptoms may appear within the first 6 to 48 hours after administration of the drug and generally resolve within a few days after drug discontinuation.[Ref]

Musculoskeletal

Musculoskeletal side effects have included worsening of bone pain, arthralgias, and myalgias. In addition, cases of osteomalacia and mineralization defects have been reported. Post marketing reports have included cases of osteonecrosis, primarily of the jaws.[Ref]

Nervous system

Nervous system side effects have included headache in 15% of patients with Paget's disease receiving pamidronate (the active ingredient contained in Aredia) Insomnia, somnolence, and psychoses have also been reported. Seizures have been reported although causality has not been established. Postmarketing reports have included confusion and visual hallucinations, sometimes in the presence of electrolyte imbalance.[Ref]

Gastrointestinal

In one study, 4.7% of patients taking oral pamidronate (the active ingredient contained in Aredia) required interruption of therapy due to gastrointestinal side effects.[Ref]

Gastrointestinal side effects have been more frequently reported with oral pamidronate (not available in the United States) than with the IV formulation and have included abdominal pain, anorexia, constipation, diarrhea, stomatitis, gastrointestinal hemorrhage, nausea, and vomiting.[Ref]

Other

Other side effects have included rigors (3% to 8%) and general malaise (9% to 12%).[Ref]

Cardiovascular

Cardiovascular side effects such as fluid overload and hypertension have occurred in at least 15% of patients treated with pamidronate (the active ingredient contained in Aredia) during clinical trials. Rare cases of atrial fibrillation, atrial flutter, tachycardia, syncope, and cardiac failure have been reported.[Ref]

Genitourinary

Genitourinary side effects have included urinary tract infections (15%) and moniliasis (6%).[Ref]

Respiratory

Respiratory side effects including dyspnea, rales, rhinitis, and upper respiratory infections have been uncommon and occurred more frequently with larger doses of pamidronate (the active ingredient contained in Aredia) [Ref]

Endocrine

Endocrine side effects have been uncommon. Hypothyroidism has been reported in patients receiving 90 mg of pamidronate (the active ingredient contained in Aredia) .[Ref]

Other

Other side effects have included postmarketing reports of reactivation of Herpes simplex and Herpes zoster and influenza-like symptoms.

Dermatologic

Dermatologic side effects have included postmarketing reports of rash and pruritus.

References

1. Gallacher SJ, Ralston SH, Patel U, Boyle IT "Side-effects of pamidronate." Lancet 2 (1989): 42-3

2. "Product Information. Aredia (pamidronate)." Ciba Pharmaceuticals, Summit, NJ.

3. Purohit OP, Radstone CR, Anthony C, Kanis JA, Coleman RE "A randomised double-blind comparison of intravenous pamidronate and clodronate in the hypercalcaemia of malignancy." Br J Cancer 72 (1995): 1289-93

4. Lourwood DL "The pharmacology and therapeutic utility of bisphosphonates." Pharmacotherapy 18 (1998): 779-89

5. Theriault RL, Lipton A, Hortobagyi GN, Leff R, Gluck S, Stewart JF, Costello S, Kennedy I, Simeone J, Seaman JJ, Knight RD, "Pamidronate reduces skeletal morbidity in women with advanced breast cancer and lytic bone lesions: A randomized, placebo-controlled trial." J Clin Oncol 17 (1999): 846-54

6. Jodrell DI, Iveson TJ, Smith IE "Symptomatic hypocalcaemia after treatment with high-dose aminohydroxypropylidene diphosphonate." Lancet 1 (1987): 622

7. Palmieri C, Dhillon T, Coombes C, Vigushin D "Hypocalcaemia after intravenous bisphosphonate: adjuvant bisphosphonate is not currently accepted practice." BMJ 328 (2004): 1439; author reply 1439-40

8. Rosen CJ, Brown S "Severe hypocalcemia after intravenous bisphosphonate therapy in occult vitamin D deficiency." N Engl J Med 348 (2003): 1503-4

9. Lipton A, Theriault RL, Hortobagyi GN, Simeone J, Knight RD, Mellars K, Reitsma DJ, Heffernan M, Seaman JJ "Pamidronate prevents skeletal complications and is effective palliative treatment in women with breast carcinoma and osteolytic bone metastases - Long term follow-up of two randomized, placebo-controlled trials." Cancer 88 (2000): 1082-90

10. Mautalen CA, Casco CA, Gonzalez D, Ghiringhelli GR, Massironi C, Fromm GA, Plantalech L "Side effects of disodium aminohydroxypropylidenediphosphonate (APD) during treatment of bone diseases." Br Med J (Clin Res Ed) 288 (1984): 828-9

11. Machado CE, Flombaum CD "Safety of pamidronate in patients with renal failure and hypercalcemia." Clin Nephrol 45 (1996): 175-9

12. Macarol V, Fraunfelder FT "Pamidronate disodium and possible ocular adverse drug reactions." Am J Ophthalmol 118 (1994): 220-4

13. Odonnell NP, Rao GP, Aguisfernandez A "Paget's disease: ocular complications of disodium pamidronate treatment." Br J Clin Pract 49 (1995): 272-3

14. De S, Meyer P, Crisp AJ "Pamidronate and uveitis." Br J Rheumatol 34 (1995): 479

15. Stewart GO, Stuckey BGA, Ward LC, Prince RL, Gutteridge DH, Constable IJ "Iritis following intravenous pamidronate." Aust N Z J Med 26 (1996): 414-5

16. Ghose K, Waterworth R, Trolove P, Highton J "Uveitis associated with pamidronate." Aust N Z J Med 24 (1994): 320

17. Malnick SD, Ariel-Ronen S, Evron E, Sthoeger ZM "Acute pseudogout as a complication of pamidronate." Ann Pharmacother 31 (1997): 499-500

18. Adamson BB, Gallacher SJ, Byars J, Ralston SH, Boyle IT, Boyce BF "Mineralisation defects with pamidronate therapy for paget's disease." Lancet 342 (1993): 1459-60

19. Kellihan MJ, Mangino PD "Pamidronate." Ann Pharmacother 26 (1992): 1262-9

20. Liens D, Delmas PD, Meunier PJ "Long-term effects of intravenous pamidronate in fibrous dysplasia of bone." Lancet 343 (1994): 953-4

21. Reid IR, Cundy T, Ibbertson HK, King AR "Osteomalacia after pamidronate for pagets disease." Lancet 343 (1994): 855

22. Bamias A, Kastritis E, Bamia C, et al. "Osteonecrosis of the jaw in cancer after treatment with bisphosphonates: incidence and risk factors." J Clin Oncol 23 (2005): 8580-7

23. Foley-Nolan D, Daly MJ, Williams D, Wasti A, Martin M "Pamidronate associated hallucinations." Ann Rheum Dis 51 (1992): 927-8

24. Herrera JA, Sarabia MO, Gonzalez MM "Effects of treatment with bisphosphonates on gastrointestinal and esophageal mucosa in patients with osteoporosis: Pamidronate versus alendronate." Curr Ther Res Clin Exp 60 (1999): 307-13

25. Spivacow FR, Zanchetta JR, Kerzberg EM, Frigeri A, Fiasche R, Roldan EJA "Tolerability of oral pamidronate in elderly patients with osteoporosis and other metabolic bone diseases." Curr Ther Res Clin Exp 57 (1996): 123-30

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