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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.

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

Minor Side Effects

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

This drug 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 active ingredient contained in Aredia) 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]

Gastrointestinal

Very common (10% or more): Nausea, vomiting, abdominal pain, diarrhea, constipation, gastritis, dyspepsia[Ref]

Genitourinary

Very common (10% or more): Urinary tract infection (15%)
Common (1% to 10%): Moniliasis[Ref]

Metabolic

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 (the active ingredient contained in Aredia) [Ref]

Very common (10% or more): Hypocalcemia, hypophosphatemia, anorexia, fluid overload
Common (1% to 10%): Hypokalemia, hypomagnesemia
Very rare (less than 0.01%): Hyperkalemia, hypernatremia[Ref]

Musculoskeletal

Very common (10% or more): Arthrosis
Common (1% to 10%): Transient bone pain, arthralgia, myalgia, generalized pain
Uncommon (0.1% to 1%): Muscle cramps, osteonecrosis
Postmarketing reports: Atypical subtrochanteric and diaphyseal femoral fractures[Ref]

Other

Very common (10% or more): Fever and influenza-like symptoms sometimes accompanied by malaise, rigor, fatigue, flushes, asthenia
Very rare (less than 0.01%): Reactivation of Herpes simplex, reactivation of Herpes zoster[Ref]

Respiratory

Very rare (less than 0.01%): Acute respiratory distress syndrome, interstitial lung disease
Postmarketing reports: Adult respiratory distress syndrome (ARDS), interstitial lung disease (ILD)[Ref]

Cardiovascular

Common (1% to 10%): Atrial fibrillation, hypertension
Uncommon (0.1% to 1%): Hypotension
Very rare (less than 0.01%): Left ventricular failure (dyspnea, pulmonary edema), congestive heart failure (edema) due to fluid overload[Ref]

Dermatologic

Common (1% to 10%): Rash
Uncommon (0.1% to 1%): Pruritus[Ref]

Hematologic

Common (1% to 10%): Anemia, thrombocytopenia, lymphocytopenia, leukopenia[Ref]

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

Local

Common (1% to 10%): Reactions at the infusion site (pain, redness, swelling, induration, phlebitis, thrombophlebitis)[Ref]

Nervous system

Common (1% to 10%): Symptomatic hypocalcemia (tetany, paresthesia), headache
Uncommon (0.1% to 1%): Seizures, lethargy, dizziness
Very rare (less than 0.01%): Confusion[Ref]

Ocular

Uveitis generally occurs within 24 to 48 hours after administration of pamidronate (the active ingredient contained in Aredia) 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]

Common (1% to 10%): Conjunctivitis
Uncommon (0.1% to 1%): Uveitis (iritis, iridocyclitis)
Very rare (less than 0.01%): Scleritis, episcleritis, xanthopsia
Frequency not reported: Optic neuritis
Postmarketing reports: Orbital inflammation[Ref]

Psychiatric

Common (1% to 10%): Insomnia
Uncommon (0.1% to 1%): Agitation
Very rare (less than 0.01%): Visual hallucinations[Ref]

Renal

Common (1% to 10%): Increase in serum creatinine
Uncommon (0.1% to 1%): Increase in serum urea, acute renal failure
Rare (0.01% to 0.1%): Focal segmental glomerulosclerosis including the collapsing variant, nephrotic syndrome
Very rare (less than 0.01%): Deterioration of pre-existing renal disease, hematuria, renal tubular disorder, tubulointerstitial nephritis, glomerulonephropathy[Ref]

Endocrine

Uncommon (0.1% to 1%): Hypothyroidism in patients receiving doses of 90 mg[Ref]

Hepatic

Uncommon (0.1% to 1%): Abnormal liver function test[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Allergic reactions including anaphylactoid reactions, bronchospasm/dyspnea, Quincke's (angioneurotic) edema
Very rare (less than 0.01%): Anaphylactic shock[Ref]

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. Cerner Multum, Inc. "Australian Product Information." O 0

3. "Product Information. Pamidronate Disodium (pamidronate)." Teva Pharmaceuticals USA, North Wales, PA.

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

5. "Product Information. Aredia (pamidronate)." Novartis Pharmaceuticals, East Hanover, NJ.

6. 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

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

8. 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

9. 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

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. 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

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

13. 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

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

15. 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

16. 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

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

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

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

20. 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

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

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

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

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

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

26. 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

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

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

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.

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