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Reclast Side Effects

Common Reclast Side Effects


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

Arthralgia (596)
Pain (413)
Myalgia (402)
Headache (340)
Bone Pain (332)
Pyrexia (332)
Influenza Like Illness (315)
Nausea (271)
Chills (241)
Asthenia (234)
Fatigue (233)
Back Pain (227)
Pain In Extremity (213)
Dizziness (180)
Dyspnoea (176)
Chest Pain (163)
Vomiting (163)
Malaise (141)
Gait Disturbance (136)
Diarrhoea (128)

➢ 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.

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.

Reclast Side Effects Reported to FDA

The following Reclast 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.


The appearance of Reclast 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.
Dyspnoea, Fatigue, Muscle Spasms, Musculoskeletal Stiffness, Memory Impairment
This is a report of a 81-year-old female patient (weight: NA) from US, suffering from the following symptoms/conditions: osteoporosis, who was treated with Reclast (dosage: Once Yearly, start time: Dec 10, 2011), combined with:
  • Metformin
  • Bystolic
  • Nifediac
  • Folic Acid
  • Cyanocobalm
  • Cholestyramine
  • Preservision Ared
  • Metamucil
and developed a serious reaction and side effect(s). The consumer presented with:
  • Dyspnoea
  • Fatigue
  • Muscle Spasms
  • Musculoskeletal Stiffness
  • Memory Impairment
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Reclast treatment in female patients, resulting in dyspnoea side effect.

Influenza Like Illness, Impaired Work Ability, Iritis, Vision Blurred
This report suggests a potential Reclast Influenza Like Illness, Impaired Work Ability, Iritis, Vision Blurred side effect(s) that can have serious consequences. A 58-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: osteoporosis and used Reclast (dosage: Annually, Into A Vein) starting Feb 15, 2014. Soon after starting Reclast the patient began experiencing various side effects, including:
  • Influenza Like Illness
  • Impaired Work Ability
  • Iritis
  • Vision Blurred
Drugs used concurrently:
  • Diclofenac Sodium
  • Omeprazole Dr
  • Citracel Calcium Citrate
Although Reclast demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as influenza like illness, may still occur.

Heart Rate Increased, Blood Pressure Decreased, Palpitations, Fatigue, Pain, Diarrhoea, Headache, Viral Infection, Blood Glucose Increased
This Heart Rate Increased, Blood Pressure Decreased, Palpitations, Fatigue, Pain, Diarrhoea, Headache, Viral Infection, Blood Glucose Increased problem was reported by a consumer or non-health professional from US. A 65-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: senile osteoporosis,hypertension,menopause,gastrooesophageal reflux disease,hypothyroidism. On Dec 26, 2013 this consumer started treatment with Reclast (dosage: 5 Mg, Unk). The following drugs were being taken at the same time:
  • Clonidine Hcl (2 Tablet Qam And 1 Po Qhs)
  • Fluoxetine Hcl (10 Mg,daily)
  • Proton//omeprazole (40 Mg, Daily)
  • Synthyroid (Unk Ukn, Daily)
  • Wellbutrin (1 Df, Bid)
  • Caltrate (1 Df, Qd)
  • Aller Tec (1 Df, Qd)
  • Catapres /unk/ (0.2 Mg In Morning And 0.1 Mg At Bedtime)
When commencing Reclast, the patient experienced the following unwanted symptoms/side effects:
  • Heart Rate Increased
  • Blood Pressure Decreased
  • Palpitations
  • Fatigue
  • Pain
  • Diarrhoea
  • Headache
  • Viral Infection
  • Blood Glucose Increased
Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as heart rate increased, may become evident only after a product is in use by the general population.

Atrial Fibrillation, Palpitations, Dizziness, Fatigue, Dyspnoea, Asthenia, Nausea, Heart Rate Increased, Cardiac Valve Disease
This is a report of a 78-year-old female patient (weight: NA) from US. The patient developed the following symptoms/conditions: osteoporosis postmenopausal and was treated with Reclast (dosage: 5 Mg/100ml Once Yearly) starting Nov 06, 2009. Concurrently used drugs: NA.Soon after that, the consumer experienced the following side effects:
  • Atrial Fibrillation
  • Palpitations
  • Dizziness
  • Fatigue
  • Dyspnoea
  • Asthenia
  • Nausea
  • Heart Rate Increased
  • Cardiac Valve Disease
The patient was hospitalized. This opens a possibility that Reclast treatment could cause the above reactions, including atrial fibrillation, and some female subjects may be more susceptible.


Chills, Pyrexia, Dizziness, Balance Disorder, Malaise, Gait Disturbance, Asthenia, Hyperhidrosis
A 87-year-old female patient (weight: NA) from US with the following symptoms/conditions: osteoporosis started Reclast treatment (dosage: Infusion) on Feb 09, 2014. Soon after starting Reclast treatment, the subject experienced various side effects, including:
  • Chills
  • Pyrexia
  • Dizziness
  • Balance Disorder
  • Malaise
  • Gait Disturbance
  • Asthenia
  • Hyperhidrosis
Concurrently used drugs:
  • Diovan
  • Prednisone
  • Baby Aspirin
  • Fish Oil
  • Meclizine
  • Vit E
  • Vitamin B Complex
  • Citracal
The patient was hospitalized and became disabled. This finding indicates that some female patients could be more vulnerable to Reclast.

Arthralgia, Back Pain, Condition Aggravated, Muscular Weakness
A 69-year-old male patient from US (weight: NA) experienced symptoms, such as: osteitis deformans and was treated with Reclast(dosage: NA). The treatment was initiated on NS. After that a consumer reported the following side effect(s):
  • Arthralgia
  • Back Pain
  • Condition Aggravated
  • Muscular Weakness
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Reclast efficacy: NA.

Parosmia, Ageusia, Hypophagia, Weight Decreased, Food Intolerance
In this report, Reclast was administered for the following condition: bone density abnormal.A 67-year-old female consumer from US (weight: NA) started Reclast treatment (dosage: NA) on Aug 10, 2009.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Parosmia
  • Ageusia
  • Hypophagia
  • Weight Decreased
  • Food Intolerance
A possible interaction with other drugs could have contributed to this reaction:
  • Creon
  • Zolpidem
  • Gabapentin
  • Meclizine
  • Vit D3
  • Escitalopram
  • Vesicare
  • Latanoprost
Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Reclast treatment could be related to the listed above side effect(s).

Uveitis
This is a report of the following Reclast (zoledronate) Solution For Injection side effect(s):
  • Uveitis
A 63-year-old male patient from US (weight: NA) presented with the following condition: NA and received a treatment with Reclast (zoledronate) Solution For Injection (dosage: NA) starting: NS.The following concurrently used drugs could have generated interactions: NA.This report suggests that a Reclast (zoledronate) Solution For Injection treatment could be associated with the listed above side effect(s).

Vomiting, Feeling Cold, Fatigue, Pain, Tremor, Malaise
This Reclast (zoledronate) Solution For Injection report was submitted by a 58-year-old female consumer from US (weight: NA). The patient was diagnosed with: NA and Reclast (zoledronate) Solution For Injection was administered (dosage: NA) starting: Mar 20, 2013. The consumer developed a set of symptoms:
  • Vomiting
  • Feeling Cold
  • Fatigue
  • Pain
  • Tremor
  • Malaise
Other drugs used simultaneously:
  • Azathioprine (azathioprine)
  • Allegra-d
Those unexpected symptoms could be linked to a Reclast (zoledronate) Solution For Injection treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

Injection Site Extravasation, Injection Site Pain, Injection Site Swelling
This is a report of a possible correlation between Reclast (zoledronate) Solution For Injection use and the following symptoms/side effect(s):
  • Injection Site Extravasation
  • Injection Site Pain
  • Injection Site Swelling
which could contribute to an assessment of Reclast (zoledronate) Solution For Injection risk profile.A 84-year-old female consumer from US (weight: NA) was suffering from osteoporosis and was treated with Reclast (zoledronate) Solution For Injection (dosage: 5 Mg In 100ml, Intravenous) starting May 29, 2013.Other concurrent medications: NA.

Dehydration, Nausea, Myalgia, Arthralgia, Pyrexia, Red Blood Cell Sedimentation Rate Increased, Vomiting, Asthenia, Joint Swelling
A 74-year-old female patient from US (weight: NA) presented with the following symptoms: osteoporosis and after a treatment with Reclast (zoledronate) Solution For Injection (dosage: NA) experienced the following side effect(s):
  • Dehydration
  • Nausea
  • Myalgia
  • Arthralgia
  • Pyrexia
  • Red Blood Cell Sedimentation Rate Increased
  • Vomiting
  • Asthenia
  • Joint Swelling
The treatment was started on May 13, 2013. Reclast (zoledronate) Solution For Injection was used in combination with the following drugs:
  • Synthroid (levothyroxine Sodium)
  • Vitamin D3 (colecalciferol)
  • Viactiv/can/ (calcium, Colecalciferol)
  • Vitamin D (ergocalciferol)
The patient was hospitalized and became disabled.This report could alert potential Reclast (zoledronate) Solution For Injection consumers.

Gout, Pain, Joint Swelling, Thrombosis, Pyrexia, Loss Of Consciousness, Local Swelling, Influenza Like Illness, Arthralgia
In this report, a 60-year-old female patient from US (weight: NA) was affected by a possible Reclast side effect.The patient was diagnosed with NA. After a treatment with Reclast (dosage: 5 Mg, Unk, start date: Dec 27, 2013), the patient experienced the following side effect(s):
  • Gout
  • Pain
  • Joint Swelling
  • Thrombosis
  • Pyrexia
  • Loss Of Consciousness
  • Local Swelling
  • Influenza Like Illness
  • Arthralgia
The following simultaneously used drugs could have led to this reaction: NA.The patient was hospitalized.The findings here stress that side effects should be taken into consideration when evaluating a Reclast treatment.

Femur Fracture, Pain
This is a report of a 52-year-old female patient from US (weight: NA), who used Reclast (dosage: Once Per Year Into A Vein) for a treatment of osteoporosis. After starting a treatment on NS, the patient experienced the following side effect(s):
  • Femur Fracture
  • Pain
The following drugs could possibly have interacted with the Reclast treatment NA.The patient was hospitalized and became disabled.Taken together, these observations suggest that a Reclast treatment could be related to side effect(s), such as Femur Fracture, Pain.

Pain, Arthralgia, Myalgia, Movement Disorder, Arthritis
This pain side effect was reported by a physician from US. A 52-year-old female patient (weight:NA) experienced the following symptoms/conditions: osteoporosis. The patient was prescribed Reclast (dosage: NA), which was started on Jan 13, 2014. Concurrently used drugs: NA. When starting to take Reclast the consumer reported the following symptoms:
  • Pain
  • Arthralgia
  • Myalgia
  • Movement Disorder
  • Arthritis
These side effects may potentially be related to Reclast.

Femur Fracture, Fall, Pain In Extremity, Muscular Weakness
This is a Reclast side effect report of a 69-year-old female patient (weight:NA) from US, suffering from the following symptoms/conditions: osteoporosis, who was treated with Reclast (dosage:Into A Vein, start time: Jul 10, 2008), combined with: NA., and developed a serious reaction and a femur fracture side effect. The patient presented with:
  • Femur Fracture
  • Fall
  • Pain In Extremity
  • Muscular Weakness
which developed after the beginning of treatment. The patient was hospitalized. This side effect report can indicate a possible existence of increased vulnerability to Reclast treatment in female patients suffering from osteoporosis, resulting in femur fracture.

Tremor, Chest Discomfort, Myalgia, Arthralgia, Eye Pain, Headache, Pyrexia, Chills, Dizziness
This report suggests a potential Reclast tremor side effect(s) that can have serious consequences. A 56-year-old female patient from US (weight:NA) was diagnosed with the following health condition(s): osteopenia and used Reclast (dosage: NA) starting Jan 14, 2012. Soon after starting Reclast the patient began experiencing various side effects, including:
  • Tremor
  • Chest Discomfort
  • Myalgia
  • Arthralgia
  • Eye Pain
  • Headache
  • Pyrexia
  • Chills
  • Dizziness
Drugs used concurrently:NA. Although Reclast demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as tremor, may still occur.

Headache, Facial Pain, Neck Pain, Back Pain, Pain In Extremity, Chest Pain, Pain In Jaw, Pyrexia, Chills
This headache problem was reported by a consumer or non-health professional from US. A 39-year-old female patient (weight: NA) was diagnosed with the following medical condition(s): osteoporosis,vitamin d deficiency.On Jan 08, 2014 a consumer started treatment with Reclast (dosage: Into A Vein Once An Year.). The following drugs/medications were being taken at the same time: NA. When commencing Reclast, the patient experienced the following unwanted symptoms /side effects:
  • Headache
  • Facial Pain
  • Neck Pain
  • Back Pain
  • Pain In Extremity
  • Chest Pain
  • Pain In Jaw
  • Pyrexia
  • Chills
Although all drugs are carefully tested before they are licensed for use, they carry potential side effect risks. Some side effects, such as headache, may become evident only after a product is in use by the general population.

Sleep Disorder, Road Traffic Accident, Cervical Vertebral Fracture
This is a Reclast side effect report of a 81-year-old female patient (weight: NA) from US. The patient developed the following symptoms/conditions: NA and was treated with Reclast (dosage: Unk Ukn, Unk) starting NS. Concurrently used drugs: NA. Soon after that, the consumer experienced the following of symptoms:
  • Sleep Disorder
  • Road Traffic Accident
  • Cervical Vertebral Fracture
The patient was hospitalized. This opens a possibility that Reclast could cause sleep disorder and that some female patients may be more susceptible.

Mobility Decreased, Oral Pain, Gastrointestinal Disorder, Groin Pain, Pain In Extremity
A 74-year-old female patient (weight: NA) from US with the following symptoms: osteoporosis started Reclast treatment (dosage: Unk Ukn, Unk) on Oct 31, 2013. Soon after starting Reclast treatment, the consumer experienced several side effects, including:
  • Mobility Decreased
  • Oral Pain
  • Gastrointestinal Disorder
  • Groin Pain
  • Pain In Extremity
. Concurrently used drugs:
  • Amlodipine Besylate (Unk Ukn, Unk)
  • Levothyroxine (Unk Ukn, Unk)
  • Omeprazole (Unk Ukn, Unk)
  • Fosamax (Unk Ukn, Unk)
This finding indicates that some patients can be more vulnerable to developing Reclast side effects, such as mobility decreased.

Dysuria, Insomnia
This dysuria side effect was reported by a consumer or non-health professional from US. A female patient (weight:NA) experienced the following symptoms/conditions: osteoporosis.The patient was prescribed Reclast (dosage: NA), which was started on Oct 28, 2013. Concurrently used drugs: NA..When starting to take Reclast the consumer reported symptoms, such as:
  • Dysuria
  • Insomnia
These side effects may potentially be related to Reclast.

Renal Failure Chronic
This is a report of a 64-year-old female patient (weight: NA) from US, suffering from the following symptoms/conditions: NA, who was treated with Reclast (dosage: NA, start time: 201001), combined with: NA. and developed a serious reaction and side effect(s). The consumer presented with:
  • Renal Failure Chronic
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Reclast treatment in female patients, resulting in renal failure chronic side effect.

Feeling Abnormal, Gait Disturbance, Renal Disorder, Gastric Disorder, Tremor, Influenza Like Illness, Body Temperature Increased, Diarrhoea, Chills
This report suggests a potential Reclast Feeling Abnormal, Gait Disturbance, Renal Disorder, Gastric Disorder, Tremor, Influenza Like Illness, Body Temperature Increased, Diarrhoea, Chills side effect(s) that can have serious consequences. A 72-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Reclast (dosage: Unk Ukn, Unk) starting Dec 16, 2013. Soon after starting Reclast the patient began experiencing various side effects, including:
  • Feeling Abnormal
  • Gait Disturbance
  • Renal Disorder
  • Gastric Disorder
  • Tremor
  • Influenza Like Illness
  • Body Temperature Increased
  • Diarrhoea
  • Chills
Drugs used concurrently:
  • Plavix (Unk Ukn, Unk)
  • Atorvastatin (Unk Ukn, Unk)
  • Amlodipine (Unk Ukn, Unk)
  • Baby Aspirin (Unk Ukn, Unk)
  • Vitamin D3 (1000 Iu, Qd)
  • Calcium Citrate (2 Df, Qd)
  • Losartan (Unk Ukn, Unk)
  • Clopidogrel (Unk Ukn, Unk)
Although Reclast demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as feeling abnormal, may still occur.

Abdominal Distension, Flatulence, Abdominal Pain Upper, Aphagia, Diarrhoea, Nausea, Vomiting, Endoscopic Retrograde Cholangiopancreatography
This Abdominal Distension, Flatulence, Abdominal Pain Upper, Aphagia, Diarrhoea, Nausea, Vomiting, Endoscopic Retrograde Cholangiopancreatography problem was reported by a consumer or non-health professional from US. A 46-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: osteopenia. On Oct 16, 2013 this consumer started treatment with Reclast (dosage: 5mg(100ml) Iv Once A Year Intravenous Infusion). The following drugs were being taken at the same time:
  • Nasonex
  • Alvesco Hfa
  • Zantac
  • Calcium
  • Mvi
  • Vit D3
  • Flaxseed Oil
  • Probiotics
When commencing Reclast, the patient experienced the following unwanted symptoms/side effects:
  • Abdominal Distension
  • Flatulence
  • Abdominal Pain Upper
  • Aphagia
  • Diarrhoea
  • Nausea
  • Vomiting
  • Endoscopic Retrograde Cholangiopancreatography
The patient was hospitalized and became disabled.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as abdominal distension, may become evident only after a product is in use by the general population.

Body Temperature Increased, Arthralgia, Abasia, Pain, Pain In Extremity, Impaired Work Ability
This is a report of a 54-year-old male patient (weight: NA) from US. The patient developed the following symptoms/conditions: senile osteoporosis and was treated with Reclast (dosage: NA) starting Dec 01, 2013. Concurrently used drugs:
  • Advair
  • Atrovent
  • Pravastatin
  • Zemaira
Soon after that, the consumer experienced the following side effects:
  • Body Temperature Increased
  • Arthralgia
  • Abasia
  • Pain
  • Pain In Extremity
  • Impaired Work Ability
This opens a possibility that Reclast treatment could cause the above reactions, including body temperature increased, and some male subjects may be more susceptible.

Exophthalmos, Antibody Test Positive, Iritis, Eye Inflammation, Eye Pain, Iridocyclitis, Eye Swelling, Eyelid Oedema
A 60-year-old female patient (weight: NA) from US with the following symptoms/conditions: osteoporosis started Reclast treatment (dosage: 5 Mg, Once) on Sep 20, 2013. Soon after starting Reclast treatment, the subject experienced various side effects, including:
  • Exophthalmos
  • Antibody Test Positive
  • Iritis
  • Eye Inflammation
  • Eye Pain
  • Iridocyclitis
  • Eye Swelling
  • Eyelid Oedema
Concurrently used drugs:
  • Azilect (1 Mg, Qd)
  • Mirapex (1 Mg, Tid)
  • Sinarest /00384601/ (1 Df, Qid)
  • Amantadine (1 Df, Bid)
  • Sonata (1 Df, Pm)
This finding indicates that some female patients could be more vulnerable to Reclast.

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Top 10 Reclast Side Effects for Women

Women Side EffectsReports
Arthralgia 557
Pain 388
Myalgia 385
Headache 321
Bone Pain 307
Pyrexia 301
Influenza Like Illness 292
Nausea 261
Fatigue 216
Asthenia 214

Top 10 Reclast Side Effects for Men

Men Side EffectsReports
Arthralgia 30
Chills 29
Pyrexia 27
Bone Pain 24
Pain 22
Influenza Like Illness 21
Asthenia 19
Death 19
Headache 18
Dyspnoea 17

Keep Track of Side Effects

Note Your Observations

It is really important to keep of your symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

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

    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.


    Discuss Reclast Side Effects

    Did You Have a Reclast Side Effect?

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    Yes, Moderate
    Yes, Minor
    No

    How Effective is Reclast for You?

    Exceeded Expectations
    Effective
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    Reclast Safety Alerts, Active Ingredients, Usage Information

    NDC0078-0435
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameReclast
    Namezoledronic acid
    Dosage FormINJECTION, SOLUTION
    RouteINTRAVENOUS
    On market since20070401
    LabelerNovartis Pharmaceuticals Corporation
    Active Ingredient(s)ZOLEDRONIC ACID
    Strength(s)5
    Unit(s)mg/100mL
    Pharma ClassBisphosphonate [EPC],Diphosphonates [Chemical/Ingredient]

    Reclast Dosage, Warnings, Usage.

    Side Effects reported to FDA: 2861

    Reclast safety alerts: 2011 2008 2007

    Reported deaths: 377

    Reported hospitalizations: 1045

    Reclast (zoledronic acid): Drug Safety Communication - New Contraindication and Updated Warning on Kidney Impairment

    [Posted 09/01/2011]

    AUDIENCE: Endocrinology, Pharmacy, Patient

    ISSUE: FDA notified healthcare professionals and patients of an update to the drug label for Reclast (zoledronic acid) regarding the risk of kidney failure. Cases of acute renal failure requiring dialysis or having a fatal outcome following Reclast use have been reported to FDA. The revised label states that Reclast is contraindicated in patients with creatinine clearance less than 35 mL/min or in patients with evidence of acute renal impairment. The label also recommends that healthcare professionals screen patients prior to administering Reclast in order to identify at-risk patients.

    The Reclast Medication Guide for patients is being updated to contain information about the risk of severe kidney problems. In addition, the manufacturer of Reclast will issue a Dear Healthcare Provider letter to inform healthcare professionals about this risk.

    BACKGROUND: Risk factors for developing renal failure include underlying moderate to severe renal impairment, use of kidney-damaging (nephrotoxic) or diuretic medications at the same time as Reclast, or severe dehydration occurring before or after Reclast is given. The risk of developing renal failure in patients with underlying renal impairment also increases with age.

    These labeling changes are being made to the Reclast label only, although zoledronic acid, also sold as Zometa, is approved for treatment of cancer-related indications. Renal toxicity is already addressed in the Warnings and Precautions section of the Zometa as well as in the Reclast label. Dose reductions for Zometa are provided for patients with renal impairment.

    RECOMMENDATIONS: Reclast is contraindicated in patients with creatinine clearance less than 35 mL/min, or in patients with evidence of acute renal impairment. Healthcare professionals should screen patients prior to administering Reclast in order to identify at-risk patients. Healthcare professionals should also monitor renal function in patients who are receiving Reclast.

    Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

    • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
    • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178


    [09/01/2011 – Drug Safety Communication - FDA]

    [08/31/2011 - Prescribing Information - Novartis]

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