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Pamidronate Side Effects

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Common Pamidronate Side Effects


The most commonly reported Pamidronate side effects (click to view or check a box to report):

Osteonecrosis (327)
Tooth Extraction (140)
Bone Disorder (139)
Osteonecrosis Of Jaw (90)
Impaired Healing (65)
Pain In Jaw (61)
Bone Debridement (54)
Pain (53)
Infection (53)
Sequestrectomy (49)
Osteomyelitis (49)
Jaw Disorder (42)
Actinomycosis (37)
Malignant Neoplasm Progression (30)
Aseptic Necrosis Bone (27)
Fistula (27)
Femur Fracture (26)
Wound Debridement (25)
Primary Sequestrum (22)
Bone Pain (20)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Pamidronate Side Effects Reported to FDA



Pamidronate Side Effect Report#9870854
Osteonecrosis
This is a report of a 64-year-old female patient (weight: NA) from DE, suffering from the following health symptoms/conditions: plasma cell myeloma, who was treated with Pamidronate Disodium (dosage: 90 Mg, Every 4 Weeks, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Osteonecrosis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Pamidronate Disodium treatment in female patients, resulting in Osteonecrosis side effect.
Pamidronate Side Effect Report#9851306
Osteonecrosis Of Jaw, Osteonecrosis, Exostosis Of External Ear Canal
This report suggests a potential Pamidronate Disodium Osteonecrosis Of Jaw side effect(s) that can have serious consequences. A 64-year-old male patient (weight: NA) from SE was diagnosed with the following symptoms/conditions: plasma cell myeloma and used Pamidronate Disodium (dosage: 90 Mg, Monthly) starting NS. After starting Pamidronate Disodium the patient began experiencing various side effects, including: Osteonecrosis Of Jaw, Osteonecrosis, Exostosis Of External Ear CanalAdditional drugs used concurrently:
  • Zoledronic Acid (4 Mg, Monthly)
  • Dexamethasone (40 Mg/d 4 D Each Month)
  • Lenalidomide (15 Mg, Daily)
  • Interferon Alfa (Unk)
Although Pamidronate Disodium demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Osteonecrosis Of Jaw, may still occur.
Pamidronate Side Effect Report#9833033
Osteonecrosis Of Jaw, Exposed Bone In Jaw, Tooth Extraction
This Osteonecrosis Of Jaw problem was reported by a physician from GB. A 73-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: bone pain. On NS this consumer started treatment with Pamidronate Disodium (dosage: 90 Mg, Monthly). The following drugs were being taken at the same time:
  • Zometa (4 Mg, Monthly)
  • Clexane (Unk)
  • Dexamethasone (4 Mg, 1x/day)
  • Furosemide (40 Mg, 1x/day)
  • Metoclopramide (10 Mg, 3x/day)
  • Omeprazole (20 Mg, 1x/day)
  • Oxycodone (200 Mg, 2x/day)
  • Paracetamol (1 G, 3x/day)
When using Pamidronate Disodium, the patient experienced the following unwanted symptoms/side effects: Osteonecrosis Of Jaw, Exposed Bone In Jaw, Tooth ExtractionAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Osteonecrosis Of Jaw, may become evident only after a product is in use by the general population.
Pamidronate Side Effect Report#9708142
Hypercalcaemia
This Hypercalcaemia side effect was reported by a health professional from CA. A 62-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Pamidronate (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Pamidronate the consumer reported adverse symptoms, such as: HypercalcaemiaThese side effects may potentially be related to Pamidronate. The patient was hospitalized.
Pamidronate Side Effect Report#9586388
Osteonecrosis Of Jaw
This is a report of a 64-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: osteoporosis, who was treated with Pamidronate Disodium (dosage: Unk, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Osteonecrosis Of Jaw after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Pamidronate Disodium treatment in female patients, resulting in Osteonecrosis Of Jaw side effect.
Pamidronate Side Effect Report#9581975
Osteonecrosis Of Jaw
This report suggests a potential Pamidronate Disodium Osteonecrosis Of Jaw side effect(s) that can have serious consequences. A 79-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: osteoporosis and used Pamidronate Disodium (dosage: Unk) starting NS. After starting Pamidronate Disodium the patient began experiencing various side effects, including: Osteonecrosis Of JawAdditional drugs used concurrently: NA. Although Pamidronate Disodium demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Osteonecrosis Of Jaw, may still occur.
Pamidronate Side Effect Report#9581822
Osteonecrosis Of Jaw
This Osteonecrosis Of Jaw problem was reported by a health professional from US. A 63-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: osteoporosis. On NS this consumer started treatment with Pamidronate Disodium (dosage: Unk). The following drugs were being taken at the same time: NA. When using Pamidronate Disodium, the patient experienced the following unwanted symptoms/side effects: Osteonecrosis Of JawAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Osteonecrosis Of Jaw, may become evident only after a product is in use by the general population.
Pamidronate Side Effect Report#9564821
Osteonecrosis Of Jaw, Exposed Bone In Jaw
This Osteonecrosis Of Jaw side effect was reported by a health professional from US. A 55-year-old male patient (weight:NA) experienced the following symptoms/conditions: plasma cell myeloma.The patient was prescribed Pamidronate (drug dosage: Unk Ukn, Unk), which was initiated on NS. Concurrently used drugs:
  • Zoledronate (Unk Ukn, Unk)
.After starting to take Pamidronate the consumer reported adverse symptoms, such as: Osteonecrosis Of Jaw, Exposed Bone In JawThese side effects may potentially be related to Pamidronate.
Pamidronate Side Effect Report#9536716
Osteonecrosis Of Jaw
This is a report of a 69-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: hypercalcaemia of malignancy, who was treated with Pamidronate (dosage: 60 Mg Other Frequency Iv, start time:
Jun 25, 2010), combined with: NA. and developed a serious reaction and side effect(s): Osteonecrosis Of Jaw after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Pamidronate treatment in male patients, resulting in Osteonecrosis Of Jaw side effect. The patient was hospitalized.
Pamidronate Side Effect Report#9529736
Osteonecrosis Of Jaw
This report suggests a potential Pamidronate Osteonecrosis Of Jaw side effect(s) that can have serious consequences. A 69-year-old male patient (weight: NA) from IL was diagnosed with the following symptoms/conditions: prostate cancer and used Pamidronate (dosage: Unk Ukn, Unk) starting NS. After starting Pamidronate the patient began experiencing various side effects, including: Osteonecrosis Of JawAdditional drugs used concurrently:
  • Zoledronate (Unk Ukn, Unk)
Although Pamidronate demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Osteonecrosis Of Jaw, may still occur.
Pamidronate Side Effect Report#9529726
Osteonecrosis Of Jaw
This Osteonecrosis Of Jaw problem was reported by a health professional from IL. A 56-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: breast cancer. On NS this consumer started treatment with Pamidronate (dosage: Unk Ukn, Unk). The following drugs were being taken at the same time:
  • Zoledronate (Unk Ukn, Unk)
When using Pamidronate, the patient experienced the following unwanted symptoms/side effects: Osteonecrosis Of JawAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Osteonecrosis Of Jaw, may become evident only after a product is in use by the general population.
Pamidronate Side Effect Report#9529725
Osteonecrosis Of Jaw
This Osteonecrosis Of Jaw side effect was reported by a health professional from IL. A 67-year-old female patient (weight:NA) experienced the following symptoms/conditions: breast cancer.The patient was prescribed Pamidronate (drug dosage: Unk Ukn, Unk), which was initiated on NS. Concurrently used drugs:
  • Zoledronate (Unk Ukn, Unk)
.After starting to take Pamidronate the consumer reported adverse symptoms, such as: Osteonecrosis Of JawThese side effects may potentially be related to Pamidronate.
Pamidronate Side Effect Report#9493238
Osteonecrosis Of Jaw, Exposed Bone In Jaw, Purulent Discharge, Fistula
This is a report of a 76-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: plasma cell myeloma, who was treated with Pamidronate (dosage: 90 Mg (4 Doses), start time: NS), combined with:
  • Zoledronic Acid (4 Mg /5 Ml (27 Doses))
and developed a serious reaction and side effect(s): Osteonecrosis Of Jaw, Exposed Bone In Jaw, Purulent Discharge, Fistula after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Pamidronate treatment in female patients, resulting in Osteonecrosis Of Jaw side effect.
Pamidronate Side Effect Report#9456439
Calciphylaxis, Haemoglobin Decreased, Enterococcus Test Positive, Escherichia Test Positive, Proteus Test Positive, Blood Calcium Decreased, Blood Parathyroid Hormone Decreased
This report suggests a potential Pamidronate Calciphylaxis side effect(s) that can have serious consequences. A 83-year-old female patient (weight: NA) from MT was diagnosed with the following symptoms/conditions: hypercalcaemia and used Pamidronate (dosage: NA) starting NS. After starting Pamidronate the patient began experiencing various side effects, including: Calciphylaxis, Haemoglobin Decreased, Enterococcus Test Positive, Escherichia Test Positive, Proteus Test Positive, Blood Calcium Decreased, Blood Parathyroid Hormone DecreasedAdditional drugs used concurrently: NA. Although Pamidronate demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Calciphylaxis, may still occur.
Pamidronate Side Effect Report#9443620
Joint Effusion, Bone Marrow Oedema, Fracture, Feeling Abnormal, Arthralgia, Normal Newborn
This Joint Effusion problem was reported by a health professional from GB. A 37-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Pamidronate (dosage: 30 Mg, Daily). The following drugs were being taken at the same time:
  • Paracetamol (4 G)
  • Codeine Phosphate (240 Mg, Daily)
  • Pethidine (100 Mg)
  • Co-codamol (30/500 Mg, Eight Tablet Daily)
  • Analgesics (Unk Ukn, Unk)
  • Calcium (1000 Mg, Daily)
  • Vitamin D (800 Iu, Daily)
When using Pamidronate, the patient experienced the following unwanted symptoms/side effects: Joint Effusion, Bone Marrow Oedema, Fracture, Feeling Abnormal, Arthralgia, Normal NewbornAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Joint Effusion, may become evident only after a product is in use by the general population.
Pamidronate Side Effect Report#9379957
Swelling, Purulent Discharge, Poor Personal Hygiene, Exposed Bone In Jaw, Trismus, Malnutrition, Femur Fracture, Gas Gangrene, Osteomyelitis
This Swelling side effect was reported by a health professional from JP. A 64-year-old female patient (weight:NA) experienced the following symptoms/conditions: breast cancer.The patient was prescribed Pamidronate Disodium (drug dosage: Unk Ukn, Unk), which was initiated on 200807. Concurrently used drugs:
  • Zoledronic Acid (Unk Ukn, Unk)
.After starting to take Pamidronate Disodium the consumer reported adverse symptoms, such as: Swelling, Purulent Discharge, Poor Personal Hygiene, Exposed Bone In Jaw, Trismus, Malnutrition, Femur Fracture, Gas Gangrene, OsteomyelitisThese side effects may potentially be related to Pamidronate Disodium. The patient was hospitalized.
Pamidronate Side Effect Report#9356115
Osteonecrosis Of Jaw
This is a report of a 56-year-old male patient (weight: NA) from FR, suffering from the following health symptoms/conditions: rheumatoid arthritis, who was treated with Pamidronate Disodium (dosage: 18 Mg Cumulative Dose For 12 Months, start time: NS), combined with:
  • Zoledronate (48 Mg, Cumulative Dose For 36 Months)
and developed a serious reaction and side effect(s): Osteonecrosis Of Jaw after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Pamidronate Disodium treatment in male patients, resulting in Osteonecrosis Of Jaw side effect.
Pamidronate Side Effect Report#9342365
Femur Fracture, Off Label Use, Groin Pain, Pain In Extremity
This report suggests a potential Pamidronate Femur Fracture side effect(s) that can have serious consequences. A 64-year-old female patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: osteogenesis imperfecta and used Pamidronate (dosage: NA) starting NS. After starting Pamidronate the patient began experiencing various side effects, including: Femur Fracture, Off Label Use, Groin Pain, Pain In ExtremityAdditional drugs used concurrently:
  • Zoledronic Acid (zoledronic Acid)
Although Pamidronate demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Femur Fracture, may still occur.
Pamidronate Side Effect Report#9342132
Basal Cell Carcinoma, Dysplastic Naevus
This Basal Cell Carcinoma problem was reported by a health professional from US. A 44-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Apr 20, 2012 this consumer started treatment with Pamidronate (dosage: NA). The following drugs were being taken at the same time:
  • Acyclovir (800 Milligram)
  • Tylenol Pm
  • Revlimid
  • Revlimid
  • Revlimid
  • Velcade
  • Dexamethasone
  • Omeprazole (40 Milligram)
When using Pamidronate, the patient experienced the following unwanted symptoms/side effects: Basal Cell Carcinoma, Dysplastic NaevusAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Basal Cell Carcinoma, may become evident only after a product is in use by the general population.
Pamidronate Side Effect Report#8985886
Plasma Cell Myeloma, Monoclonal Immunoglobulin Present, Malignant Neoplasm Progression, Osteonecrosis Of Jaw, Facial Pain, Paraesthesia, Dysgeusia, Nausea
This Plasma Cell Myeloma side effect was reported by a health professional from US. A 64-year-old female patient (weight:NA) experienced the following symptoms/conditions: multiple myeloma.The patient was prescribed Pamidronate Disodium (drug dosage: Unk Ukn, Qmo), which was initiated on NS. Concurrently used drugs:
  • Imatinib (Unk Ukn, Unk)
  • Dexamethasone Sandoz (Unk Ukn, Unk)
  • Lenalidomide (Unk Ukn, Unk)
.After starting to take Pamidronate Disodium the consumer reported adverse symptoms, such as: Plasma Cell Myeloma, Monoclonal Immunoglobulin Present, Malignant Neoplasm Progression, Osteonecrosis Of Jaw, Facial Pain, Paraesthesia, Dysgeusia, NauseaThese side effects may potentially be related to Pamidronate Disodium.
Pamidronate Side Effect Report#8974275
Lung Adenocarcinoma, Second Primary Malignancy
This is a report of a 81-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: multiple myeloma, who was treated with Pamidronate Disodium (dosage: NA, start time:
May 12, 2010), combined with: NA. and developed a serious reaction and side effect(s): Lung Adenocarcinoma, Second Primary Malignancy after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Pamidronate Disodium treatment in male patients, resulting in Lung Adenocarcinoma side effect.
Pamidronate Side Effect Report#8974223
Osteonecrosis Of Jaw, Malnutrition, Respiratory Failure, Candida Pneumonia, Infection, Pseudomonas Test Positive
This report suggests a potential Pamidronate Osteonecrosis Of Jaw side effect(s) that can have serious consequences. A 75-year-old female patient (weight: NA) from NL was diagnosed with the following symptoms/conditions: osteoporosis and used Pamidronate (dosage: 1 In 3 M) starting NS. After starting Pamidronate the patient began experiencing various side effects, including: Osteonecrosis Of Jaw, Malnutrition, Respiratory Failure, Candida Pneumonia, Infection, Pseudomonas Test PositiveAdditional drugs used concurrently:
  • Zoledronic Acid (1 In 12 M)
  • Calcium + Vitamin D(calcium D3 /01483701/)
  • Prednisone (prednisone)
  • Azathioprine (azathioprine)
The patient was hospitalized and became disabled. Although Pamidronate demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Osteonecrosis Of Jaw, may still occur.
Pamidronate Side Effect Report#8900033
Neoplasm Progression, Malignant Neoplasm Progression, Influenza Like Illness, Myalgia
This Neoplasm Progression problem was reported by a consumer or non-health professional from Country Not Specified. A 49-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: breast cancer metastatic. On
Mar 07, 2011 this consumer started treatment with Pamidronate (dosage: 90 Mg, Q Monthly-3 Monthly). The following drugs were being taken at the same time:
  • Letrozole (2.5 Mg, Qd)
  • Tamoxifen
  • Zoladex (Unk Ukn, Unk)
  • Clodronic Acid (Unk Ukn, Unk)
When using Pamidronate, the patient experienced the following unwanted symptoms/side effects: Neoplasm Progression, Malignant Neoplasm Progression, Influenza Like Illness, MyalgiaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Neoplasm Progression, may become evident only after a product is in use by the general population.
Pamidronate Side Effect Report#8866389
Eating Disorder, Osteonecrosis Of Jaw, Osteomyelitis
This Eating Disorder side effect was reported by a health professional from NL. A 75-year-old female patient (weight:NA) experienced the following symptoms/conditions: osteoporosis.The patient was prescribed Pamidronate Disodium (drug dosage: 60 Mg, Every 3 Months), which was initiated on NS. Concurrently used drugs:
  • Zoledronic Acid (5 Mg, Unk)
  • Calcium With Vitamin D
.After starting to take Pamidronate Disodium the consumer reported adverse symptoms, such as: Eating Disorder, Osteonecrosis Of Jaw, OsteomyelitisThese side effects may potentially be related to Pamidronate Disodium. The patient was hospitalized.
Pamidronate Side Effect Report#8854003
Osteonecrosis Of Jaw
This is a report of a 85-year-old female patient (weight: NA) from CH, suffering from the following health symptoms/conditions: osteoporosis, who was treated with Pamidronate (dosage: Unk Ukn, Unk, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Osteonecrosis Of Jaw after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Pamidronate treatment in female patients, resulting in Osteonecrosis Of Jaw side effect.


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The appearance of Pamidronate on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.

What are common Pamidronate Side Effects for Women?

Women Side EffectsReports
Osteonecrosis 199
Tooth Extraction 87
Bone Disorder 81
Osteonecrosis Of Jaw 68
Impaired Healing 42
Infection 41
Sequestrectomy 36
Pain 35
Pain In Jaw 35
Osteomyelitis 34

What are common Pamidronate Side Effects for Men?

Men Side EffectsReports
Osteonecrosis 120
Bone Disorder 54
Tooth Extraction 49
Pain In Jaw 26
Bone Debridement 25
Impaired Healing 23
Osteonecrosis Of Jaw 21
Pain 18
Actinomycosis 15
Jaw Disorder 14

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    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

    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.

    Pamidronate reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
    FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

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    Pamidronate Safety Alerts, Active Ingredients, Usage Information

    NDC0069-0107
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NamePamidronate Disodium
    NamePamidronate Disodium
    Dosage FormINJECTION, SOLUTION
    RouteINTRAVENOUS
    On market since20110510
    LabelerPfizer Laboratories Div Pfizer Inc
    Active Ingredient(s)PAMIDRONATE DISODIUM
    Strength(s)3
    Unit(s)mg/mL
    Pharma ClassBisphosphonate [EPC],Diphosphonates [Chemical/Ingredient]

    More About Pamidronate

    Side Effects reported to FDA: 780

    Pamidronate safety alerts: 2007 2005

    Reported deaths: 52

    Reported hospitalizations: 123

    Bisphosphonates marketed as Alendronate (Fosamax, Fosamax Plus D), Etidronate (Didronel), Ibandronate (Boniva), Pamidronate (Aredia), Risedronate (Actonel, Actonel W/Calcium), Tiludronate (Skelid), and Zoledronic acid (Reclast, Zometa)

    Audience: Geriatricians, gynecologists, orthopedic surgeons, other healthcare professionals, consumers

    [Posted 10/01/2007] FDA issued an early communication about the ongoing review of new safety data regarding the association of atrial fibrillation with the use of bisphosphonates. Bisphosphonates are a class of drugs used primarily to increase bone mass and reduce the risk for fracture in patients with osteoporosis, slow bone turnover in patients with Pagetā??s disease of the bone, treat bone metastases, and lower elevated levels of blood calcium in patients with cancer.

    FDA reviewed spontaneous postmarketing reports of atrial fibrillation reported in association with oral and intravenous bisphosphonates and did not identify a population of bisphosphonate users at increased risk of atrial fibrillation. In addition, as part of the data review for the recent approval of once-yearly Reclast for the treatment of postmenopausal osteoporosis, FDA evaluated the possible association between atrial fibrillation and the use of Reclast. Most cases of atrial fibrillation occurred more than a month after drug infusion. Also, in a subset of patients monitored by electrocardiogram up to the 11th day following infusion, there was no significant difference in the prevalence of atrial fibrillation between patients who received Reclast and patients who received placebo.

    Upon initial review, it is unclear how these data on serious atrial fibrillation should be interpreted. Therefore, FDA does not believe that healthcare providers or patients should change either their prescribing practices or their use of bisphosphonates at this time.

    [October 2007 - Early Communication - FDA]

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