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Reclast Side Effects

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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.

Reclast Side Effects Reported to FDA



Reclast Side Effect Report#9995262
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 health 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): Dyspnoea, Fatigue, Muscle Spasms, Musculoskeletal Stiffness, Memory Impairment 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.
Reclast Side Effect Report#9970388
Influenza Like Illness, Impaired Work Ability, Iritis, Vision Blurred
This report suggests a potential Reclast Influenza Like Illness 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. After starting Reclast the patient began experiencing various side effects, including: Influenza Like Illness, Impaired Work Ability, Iritis, Vision BlurredAdditional 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.
Reclast Side Effect Report#9964643
Heart Rate Increased, Blood Pressure Decreased, Palpitations, Fatigue, Pain, Diarrhoea, Headache, Viral Infection, Blood Glucose Increased
This Heart Rate 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 using 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 IncreasedAlthough 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.
Reclast Side Effect Report#9942390
Atrial Fibrillation, Palpitations, Dizziness, Fatigue, Dyspnoea, Asthenia, Nausea, Heart Rate Increased, Cardiac Valve Disease
This Atrial Fibrillation side effect was reported by a health professional from US. A 78-year-old female patient (weight:NA) experienced the following symptoms/conditions: osteoporosis postmenopausal.The patient was prescribed Reclast (drug dosage: 5 Mg/100ml Once Yearly), which was initiated on
Nov 06, 2009. Concurrently used drugs: NA..After starting to take Reclast the consumer reported adverse symptoms, such as: Atrial Fibrillation, Palpitations, Dizziness, Fatigue, Dyspnoea, Asthenia, Nausea, Heart Rate Increased, Cardiac Valve DiseaseThese side effects may potentially be related to Reclast. The patient was hospitalized.
Reclast Side Effect Report#9915834
Chills, Pyrexia, Dizziness, Balance Disorder, Malaise, Gait Disturbance, Asthenia, Hyperhidrosis
This is a report of a 87-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: osteoporosis, who was treated with Reclast (dosage: Infusion, start time:
Feb 09, 2014), combined with:
  • Diovan
  • Prednisone
  • Baby Aspirin
  • Fish Oil
  • Meclizine
  • Vit E
  • Vitamin B Complex
  • Citracal
and developed a serious reaction and side effect(s): Chills, Pyrexia, Dizziness, Balance Disorder, Malaise, Gait Disturbance, Asthenia, Hyperhidrosis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Reclast treatment in female patients, resulting in Chills side effect. The patient was hospitalized and became disabled.
Reclast Side Effect Report#9909722
Arthralgia, Back Pain, Arthralgia, Condition Aggravated, Muscular Weakness
This report suggests a potential Reclast Arthralgia side effect(s) that can have serious consequences. A 69-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: osteitis deformans and used Reclast (dosage: NA) starting NS. After starting Reclast the patient began experiencing various side effects, including: Arthralgia, Back Pain, Arthralgia, Condition Aggravated, Muscular WeaknessAdditional drugs used concurrently: NA. Although Reclast demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Arthralgia, may still occur.
Reclast Side Effect Report#9880378
Parosmia, Ageusia, Hypophagia, Weight Decreased, Food Intolerance
This Parosmia problem was reported by a consumer or non-health professional from US. A 67-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: bone density abnormal. On
Aug 10, 2009 this consumer started treatment with Reclast (dosage: NA). The following drugs were being taken at the same time:
  • Creon
  • Zolpidem
  • Gabapentin
  • Meclizine
  • Vit D3
  • Escitalopram
  • Vesicare
  • Latanoprost
When using Reclast, the patient experienced the following unwanted symptoms/side effects: Parosmia, Ageusia, Hypophagia, Weight Decreased, Food IntoleranceAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Parosmia, may become evident only after a product is in use by the general population.
Reclast Side Effect Report#9849713
Uveitis
This Uveitis side effect was reported by a health professional from US. A 63-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Reclast (zoledronate) Solution For Injection (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Reclast (zoledronate) Solution For Injection the consumer reported adverse symptoms, such as: UveitisThese side effects may potentially be related to Reclast (zoledronate) Solution For Injection.
Reclast Side Effect Report#9849686
Vomiting, Feeling Cold, Fatigue, Pain, Tremor, Malaise
This is a report of a 58-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Reclast (zoledronate) Solution For Injection (dosage: NA, start time:
Mar 20, 2013), combined with:
  • Azathioprine (azathioprine)
  • Allegra-d
and developed a serious reaction and side effect(s): Vomiting, Feeling Cold, Fatigue, Pain, Tremor, Malaise after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Reclast (zoledronate) Solution For Injection treatment in female patients, resulting in Vomiting side effect.
Reclast Side Effect Report#9849651
Injection Site Extravasation, Injection Site Pain, Injection Site Swelling
This report suggests a potential Reclast (zoledronate) Solution For Injection Injection Site Extravasation side effect(s) that can have serious consequences. A 84-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: osteoporosis and used Reclast (zoledronate) Solution For Injection (dosage: 5 Mg In 100ml, Intravenous) starting
May 29, 2013. After starting Reclast (zoledronate) Solution For Injection the patient began experiencing various side effects, including: Injection Site Extravasation, Injection Site Pain, Injection Site SwellingAdditional drugs used concurrently: NA. Although Reclast (zoledronate) Solution For Injection demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Injection Site Extravasation, may still occur.
Reclast Side Effect Report#9849640
Dehydration, Nausea, Myalgia, Arthralgia, Pyrexia, Red Blood Cell Sedimentation Rate Increased, Vomiting, Asthenia, Joint Swelling
This Dehydration problem was reported by a physician from US. A 74-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: osteoporosis. On
May 13, 2013 this consumer started treatment with Reclast (zoledronate) Solution For Injection (dosage: NA). The following drugs were being taken at the same time:
  • Synthroid (levothyroxine Sodium)
  • Vitamin D3 (colecalciferol)
  • Viactiv/can/ (calcium, Colecalciferol)
  • Vitamin D (ergocalciferol)
When using Reclast (zoledronate) Solution For Injection, the patient experienced the following unwanted symptoms/side effects: Dehydration, Nausea, Myalgia, Arthralgia, Pyrexia, Red Blood Cell Sedimentation Rate Increased, Vomiting, Asthenia, Joint SwellingThe 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 Dehydration, may become evident only after a product is in use by the general population.
Reclast Side Effect Report#9847424
Gout, Pain, Joint Swelling, Thrombosis, Pyrexia, Loss Of Consciousness, Local Swelling, Influenza Like Illness, Arthralgia
This Gout side effect was reported by a physician from US. A 60-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Reclast (drug dosage: 5 Mg, Unk), which was initiated on
Dec 27, 2013. Concurrently used drugs: NA..After starting to take Reclast the consumer reported adverse symptoms, such as: Gout, Pain, Joint Swelling, Thrombosis, Pyrexia, Loss Of Consciousness, Local Swelling, Influenza Like Illness, ArthralgiaThese side effects may potentially be related to Reclast. The patient was hospitalized.
Reclast Side Effect Report#9846508
Femur Fracture, Pain
This is a report of a 52-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: osteoporosis, who was treated with Reclast (dosage: Once Per Year Into A Vein, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Femur Fracture, Pain after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Reclast treatment in female patients, resulting in Femur Fracture side effect. The patient was hospitalized and became disabled.
Reclast Side Effect Report#9840456
Pain, Arthralgia, Myalgia, Movement Disorder, Arthritis
This report suggests a potential Reclast Pain side effect(s) that can have serious consequences. A 52-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: osteoporosis and used Reclast (dosage: NA) starting
Jan 13, 2014. After starting Reclast the patient began experiencing various side effects, including: Pain, Arthralgia, Myalgia, Movement Disorder, ArthritisAdditional drugs used concurrently: NA. Although Reclast demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Pain, may still occur.
Reclast Side Effect Report#9820795
Femur Fracture, Fall, Pain In Extremity, Muscular Weakness
This Femur Fracture problem was reported by a consumer or non-health professional from US. A 69-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: osteoporosis. On
Jul 10, 2008 this consumer started treatment with Reclast (dosage: Into A Vein). The following drugs were being taken at the same time: NA. When using Reclast, the patient experienced the following unwanted symptoms/side effects: Femur Fracture, Fall, Pain In Extremity, Muscular WeaknessThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Femur Fracture, may become evident only after a product is in use by the general population.
Reclast Side Effect Report#9818706
Tremor, Chest Discomfort, Myalgia, Arthralgia, Eye Pain, Headache, Pyrexia, Chills, Dizziness
This Tremor side effect was reported by a health professional from US. A 56-year-old female patient (weight:NA) experienced the following symptoms/conditions: osteopenia.The patient was prescribed Reclast (drug dosage: NA), which was initiated on
Jan 14, 2012. Concurrently used drugs: NA..After starting to take Reclast the consumer reported adverse symptoms, such as: Tremor, Chest Discomfort, Myalgia, Arthralgia, Eye Pain, Headache, Pyrexia, Chills, DizzinessThese side effects may potentially be related to Reclast.
Reclast Side Effect Report#9813108
Headache, Facial Pain, Neck Pain, Back Pain, Pain In Extremity, Chest Pain, Pain In Jaw, Pyrexia, Chills
This is a report of a 39-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: osteoporosis,vitamin d deficiency, who was treated with Reclast (dosage: Into A Vein Once An Year., start time:
Jan 08, 2014), combined with: NA. and developed a serious reaction and side effect(s): Headache, Facial Pain, Neck Pain, Back Pain, Pain In Extremity, Chest Pain, Pain In Jaw, Pyrexia, Chills after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Reclast treatment in female patients, resulting in Headache side effect.
Reclast Side Effect Report#9809050
Sleep Disorder, Road Traffic Accident, Cervical Vertebral Fracture
This report suggests a potential Reclast Sleep Disorder side effect(s) that can have serious consequences. A 81-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Reclast (dosage: Unk Ukn, Unk) starting NS. After starting Reclast the patient began experiencing various side effects, including: Sleep Disorder, Road Traffic Accident, Cervical Vertebral FractureAdditional drugs used concurrently: NA.The patient was hospitalized. Although Reclast demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Sleep Disorder, may still occur.
Reclast Side Effect Report#9799512
Mobility Decreased, Oral Pain, Gastrointestinal Disorder, Groin Pain, Pain, Pain In Extremity
This Mobility Decreased problem was reported by a physician from US. A 74-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: osteoporosis. On
Oct 31, 2013 this consumer started treatment with Reclast (dosage: Unk Ukn, Unk). The following drugs were being taken at the same time:
  • Amlodipine Besylate (Unk Ukn, Unk)
  • Levothyroxine (Unk Ukn, Unk)
  • Omeprazole (Unk Ukn, Unk)
  • Fosamax (Unk Ukn, Unk)
When using Reclast, the patient experienced the following unwanted symptoms/side effects: Mobility Decreased, Oral Pain, Gastrointestinal Disorder, Groin Pain, Pain, Pain In ExtremityAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Mobility Decreased, may become evident only after a product is in use by the general population.
Reclast Side Effect Report#9798871
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 (drug dosage: NA), which was initiated on
Oct 28, 2013. Concurrently used drugs: NA..After starting to take Reclast the consumer reported adverse symptoms, such as: Dysuria, InsomniaThese side effects may potentially be related to Reclast.
Reclast Side Effect Report#9798854
Renal Failure Chronic
This is a report of a 64-year-old female patient (weight: NA) from US, suffering from the following health 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): Renal Failure Chronic 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.
Reclast Side Effect Report#9782597
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 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. 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, ChillsAdditional 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.
Reclast Side Effect Report#9774871
Abdominal Distension, Flatulence, Abdominal Pain Upper, Aphagia, Diarrhoea, Nausea, Diarrhoea, Vomiting, Endoscopic Retrograde Cholangiopancreatography
This Abdominal Distension 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 using Reclast, the patient experienced the following unwanted symptoms/side effects: Abdominal Distension, Flatulence, Abdominal Pain Upper, Aphagia, Diarrhoea, Nausea, Diarrhoea, Vomiting, Endoscopic Retrograde CholangiopancreatographyThe 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.
Reclast Side Effect Report#9772084
Body Temperature Increased, Arthralgia, Abasia, Pain, Pain In Extremity, Impaired Work Ability, Arthralgia
This Body Temperature Increased side effect was reported by a consumer or non-health professional from US. A 54-year-old male patient (weight:NA) experienced the following symptoms/conditions: senile osteoporosis.The patient was prescribed Reclast (drug dosage: NA), which was initiated on
Dec 01, 2013. Concurrently used drugs:
  • Advair
  • Atrovent
  • Pravastatin
  • Zemaira
.After starting to take Reclast the consumer reported adverse symptoms, such as: Body Temperature Increased, Arthralgia, Abasia, Pain, Pain In Extremity, Impaired Work Ability, ArthralgiaThese side effects may potentially be related to Reclast.
Reclast Side Effect Report#9767905
Exophthalmos, Antibody Test Positive, Iritis, Eye Inflammation, Eye Pain, Iridocyclitis, Eye Swelling, Eyelid Oedema
This is a report of a 60-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: osteoporosis, who was treated with Reclast (dosage: 5 Mg, Once, start time:
Sep 20, 2013), combined with:
  • Azilect (1 Mg, Qd)
  • Mirapex (1 Mg, Tid)
  • Sinarest /00384601/ (1 Df, Qid)
  • Amantadine (1 Df, Bid)
  • Sonata (1 Df, Pm)
and developed a serious reaction and side effect(s): Exophthalmos, Antibody Test Positive, Iritis, Eye Inflammation, Eye Pain, Iridocyclitis, Eye Swelling, Eyelid Oedema after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Reclast treatment in female patients, resulting in Exophthalmos side effect.


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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.

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What are common 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

What are common 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

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health 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

    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.

    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.

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    Discuss Reclast Side Effects

    Did You Have a Reclast Side Effect?

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    How Effective is Reclast for You?

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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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