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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
on Mar 07, 2014 Female from US , 81 years of age, weighting 135.0 lb, was diagnosed with and was treated with Reclast. Directly after, patient experienced the unwanted or unexpected Reclast side effects: dyspnoea, fatigue, muscle spasms, musculoskeletal stiffness, memory impairment. Reclast dosage: Once Yearly.
Associated medications used:
  • Metformin
  • Bystolic
  • Nifediac
  • Folic Acid
  • Cyanocobalm
  • Cholestyramine
  • Preservision Ared
  • Metamucil


Influenza Like Illness, Impaired Work Ability, Iritis, Vision Blurred
Patient was taking Reclast. Patient felt the following Reclast side effects: influenza like illness, impaired work ability, iritis, vision blurred on Mar 05, 2014 from US Additional patient health information: Female , 58 years of age, weighting 185.0 lb, was diagnosed with and. Reclast dosage: Annually, Into A Vein.
Multiple prescriptions taken:
  • Diclofenac Sodium
  • Omeprazole Dr
  • Citracel Calcium Citrate


Heart Rate Increased, Blood Pressure Decreased, Palpitations, Fatigue, Pain, Diarrhoea, Headache, Viral Infection, Blood Glucose Increased
Adverse event was reported on Mar 21, 2014 by a Female taking Reclast (Dosage: 5 Mg, Unk) was diagnosed with and. Location: US , 65 years of age, After Reclast was administered, patient encountered several Reclast side effects: heart rate increased, blood pressure decreased, palpitations, fatigue, pain, diarrhoea, headache, viral infection, blood glucose increased.
Multiple concurrent drugs taken:
  • 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)


Atrial Fibrillation, Palpitations, Dizziness, Fatigue, Dyspnoea, Asthenia, Nausea, Heart Rate Increased, Cardiac Valve Disease
on Mar 21, 2014 Female from US , 78 years of age, was diagnosed with and was treated with Reclast. Directly after, patient experienced the unwanted or unexpected Reclast side effects: atrial fibrillation, palpitations, dizziness, fatigue, dyspnoea, asthenia, nausea, heart rate increased, cardiac valve disease. Reclast dosage: 5 Mg/100ml Once Yearly. Patient was hospitalized.


Chills, Pyrexia, Dizziness, Balance Disorder, Malaise, Gait Disturbance, Asthenia, Hyperhidrosis
on Feb 19, 2014 Female from US , 87 years of age, weighting 120.0 lb, was diagnosed with and was treated with Reclast. Patient felt the following Reclast side effects: chills, pyrexia, dizziness, balance disorder, malaise, gait disturbance, asthenia, hyperhidrosis. Reclast dosage: Infusion.
Multiple prescriptions taken:
  • Diovan
  • Prednisone
  • Baby Aspirin
  • Fish Oil
  • Meclizine
  • Vit E
  • Vitamin B Complex
  • Citracal
Patient was hospitalized and became disabled.

Arthralgia, Back Pain, Condition Aggravated, Muscular Weakness
Patient was taking Reclast. After Reclast was administered, patient encountered several Reclast side effects: arthralgia, back pain, condition aggravated, muscular weakness on Feb 18, 2014 from US Additional patient health information: Male , 69 years of age, weighting 179.0 lb, was diagnosed with and. Reclast dosage: N/A.

Parosmia, Ageusia, Hypophagia, Weight Decreased, Food Intolerance
Adverse event was reported on Feb 06, 2014 by a Female taking Reclast (Dosage: N/A) was diagnosed with and. Location: US , 67 years of age, weighting 137.0 lb, Directly after, patient experienced the unwanted or unexpected Reclast side effects: parosmia, ageusia, hypophagia, weight decreased, food intolerance.
Associated medications used:
  • Creon
  • Zolpidem
  • Gabapentin
  • Meclizine
  • Vit D3
  • Escitalopram
  • Vesicare
  • Latanoprost


Uveitis
on Dec 26, 2013 Male from US , 63 years of age, was treated with Reclast (zoledronate) Solution For Injection. Patient felt the following Reclast side effects: uveitis. Reclast (zoledronate) Solution For Injection dosage: N/A.

Vomiting, Feeling Cold, Fatigue, Pain, Tremor, Malaise
on Dec 26, 2013 Female from US , 58 years of age, was treated with Reclast (zoledronate) Solution For Injection. After Reclast was administered, patient encountered several Reclast side effects: vomiting, feeling cold, fatigue, pain, tremor, malaise. Reclast (zoledronate) Solution For Injection dosage: N/A.
Multiple concurrent drugs taken:
  • Azathioprine (azathioprine)
  • Allegra-d


Injection Site Extravasation, Injection Site Pain, Injection Site Swelling
Patient was taking Reclast (zoledronate) Solution For Injection. Directly after, patient experienced the unwanted or unexpected Reclast side effects: injection site extravasation, injection site pain, injection site swelling on Dec 26, 2013 from US Additional patient health information: Female , 84 years of age, weighting 125.7 lb, was diagnosed with and. Reclast (zoledronate) Solution For Injection dosage: 5 Mg In 100ml, Intravenous.

Dehydration, Nausea, Myalgia, Arthralgia, Pyrexia, Red Blood Cell Sedimentation Rate Increased, Vomiting, Asthenia, Joint Swelling
Adverse event was reported on Dec 26, 2013 by a Female taking Reclast (zoledronate) Solution For Injection (Dosage: N/A) was diagnosed with and. Location: US , 74 years of age, weighting 141.1 lb, Patient felt the following Reclast side effects: dehydration, nausea, myalgia, arthralgia, pyrexia, red blood cell sedimentation rate increased, vomiting, asthenia, joint swelling.
Multiple prescriptions taken:
  • Synthroid (levothyroxine Sodium)
  • Vitamin D3 (colecalciferol)
  • Viactiv/can/ (calcium, Colecalciferol)
  • Vitamin D (ergocalciferol)
Patient was hospitalized and became disabled.

Gout, Pain, Joint Swelling, Thrombosis, Pyrexia, Loss Of Consciousness, Local Swelling, Influenza Like Illness, Arthralgia
on Jan 27, 2014 Female from US , 60 years of age, was treated with Reclast. After Reclast was administered, patient encountered several Reclast side effects: gout, pain, joint swelling, thrombosis, pyrexia, loss of consciousness, local swelling, influenza like illness, arthralgia. Reclast dosage: 5 Mg, Unk. Patient was hospitalized.

Femur Fracture, Pain
on Jan 23, 2014 Female from US , 52 years of age, weighting 189.0 lb, was diagnosed with and was treated with Reclast. Directly after, patient experienced the unwanted or unexpected Reclast side effects: femur fracture, pain. Reclast dosage: Once Per Year Into A Vein. Patient was hospitalized and became disabled.

Pain, Arthralgia, Myalgia, Movement Disorder, Arthritis
Patient was taking Reclast. Patient felt the following Reclast side effects: pain, arthralgia, myalgia, movement disorder, arthritis on Jan 21, 2014 from US Additional patient health information: Female , 52 years of age, was diagnosed with and. Reclast dosage: N/A.

Femur Fracture, Fall, Pain In Extremity, Muscular Weakness
Adverse event was reported on Jan 14, 2014 by a Female taking Reclast (Dosage: Into A Vein) was diagnosed with and. Location: US , 69 years of age, weighting 122.0 lb, After Reclast was administered, patient encountered several Reclast side effects: femur fracture, fall, pain in extremity, muscular weakness. Patient was hospitalized.

Tremor, Chest Discomfort, Myalgia, Arthralgia, Eye Pain, Headache, Pyrexia, Chills, Dizziness
on Jan 14, 2014 Female from US , 56 years of age, weighting 122.0 lb, was diagnosed with and was treated with Reclast. Directly after, patient experienced the unwanted or unexpected Reclast side effects: tremor, chest discomfort, myalgia, arthralgia, eye pain, headache, pyrexia, chills, dizziness. Reclast dosage: N/A.

Headache, Facial Pain, Neck Pain, Back Pain, Pain In Extremity, Chest Pain, Pain In Jaw, Pyrexia, Chills
on Jan 10, 2014 Female from US , 39 years of age, weighting 110.0 lb, was diagnosed with and was treated with Reclast. Patient felt the following Reclast side effects: headache, facial pain, neck pain, back pain, pain in extremity, chest pain, pain in jaw, pyrexia, chills. Reclast dosage: Into A Vein Once An Year..

Sleep Disorder, Road Traffic Accident, Cervical Vertebral Fracture
Patient was taking Reclast. After Reclast was administered, patient encountered several Reclast side effects: sleep disorder, road traffic accident, cervical vertebral fracture on Jan 10, 2014 from US Additional patient health information: Female , 81 years of age, . Reclast dosage: Unk Ukn, Unk. Patient was hospitalized.

Mobility Decreased, Oral Pain, Gastrointestinal Disorder, Groin Pain, Pain In Extremity
Adverse event was reported on Jan 06, 2014 by a Female taking Reclast (Dosage: Unk Ukn, Unk) was diagnosed with and. Location: US , 74 years of age, Directly after, patient experienced the unwanted or unexpected Reclast side effects: mobility decreased, oral pain, gastrointestinal disorder, groin pain, pain in extremity.
Associated medications used:
  • Amlodipine Besylate (Unk Ukn, Unk)
  • Levothyroxine (Unk Ukn, Unk)
  • Omeprazole (Unk Ukn, Unk)
  • Fosamax (Unk Ukn, Unk)


Dysuria, Insomnia
on Jan 03, 2014 Female from US , weighting 149.0 lb, was diagnosed with and was treated with Reclast. Patient felt the following Reclast side effects: dysuria, insomnia. Reclast dosage: N/A.

Renal Failure Chronic
on Jan 03, 2014 Female from US , 64 years of age, weighting 148.0 lb, was treated with Reclast. After Reclast was administered, patient encountered several Reclast side effects: renal failure chronic. Reclast dosage: N/A.

Feeling Abnormal, Gait Disturbance, Renal Disorder, Gastric Disorder, Tremor, Influenza Like Illness, Body Temperature Increased, Diarrhoea, Chills
Patient was taking Reclast. Directly after, patient experienced the unwanted or unexpected Reclast side effects: feeling abnormal, gait disturbance, renal disorder, gastric disorder, tremor, influenza like illness, body temperature increased, diarrhoea, chills on Dec 26, 2013 from US Additional patient health information: Male , 72 years of age, . Reclast dosage: Unk Ukn, Unk.
Associated medications used:
  • 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)


Abdominal Distension, Flatulence, Abdominal Pain Upper, Aphagia, Diarrhoea, Nausea, Vomiting, Endoscopic Retrograde Cholangiopancreatography
Adverse event was reported on Dec 19, 2013 by a Female taking Reclast (Dosage: 5mg(100ml) Iv Once A Year Intravenous Infusion) was diagnosed with and. Location: US , 46 years of age, Patient felt the following Reclast side effects: abdominal distension, flatulence, abdominal pain upper, aphagia, diarrhoea, nausea, vomiting, endoscopic retrograde cholangiopancreatography.
Multiple prescriptions taken:
  • Nasonex
  • Alvesco Hfa
  • Zantac
  • Calcium
  • Mvi
  • Vit D3
  • Flaxseed Oil
  • Probiotics
Patient was hospitalized and became disabled.

Body Temperature Increased, Arthralgia, Abasia, Pain, Pain In Extremity, Impaired Work Ability
on Dec 18, 2013 Male from US , 54 years of age, weighting 195.0 lb, was diagnosed with and was treated with Reclast. After Reclast was administered, patient encountered several Reclast side effects: body temperature increased, arthralgia, abasia, pain, pain in extremity, impaired work ability. Reclast dosage: N/A.
Multiple concurrent drugs taken:
  • Advair
  • Atrovent
  • Pravastatin
  • Zemaira


Exophthalmos, Antibody Test Positive, Iritis, Eye Inflammation, Eye Pain, Iridocyclitis, Eye Swelling, Eyelid Oedema
on Dec 17, 2013 Female from US , 60 years of age, weighting 130.0 lb, was diagnosed with and was treated with Reclast. Directly after, patient experienced the unwanted or unexpected Reclast side effects: exophthalmos, antibody test positive, iritis, eye inflammation, eye pain, iridocyclitis, eye swelling, eyelid oedema. Reclast dosage: 5 Mg, Once.
Associated medications used:
  • Azilect (1 Mg, Qd)
  • Mirapex (1 Mg, Tid)
  • Sinarest /00384601/ (1 Df, Qid)
  • Amantadine (1 Df, Bid)
  • Sonata (1 Df, Pm)


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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


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    Discuss Reclast Side Effects

    Did You Have a Reclast Side Effect?

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    Safety Alerts, Active Ingredients, Usage Information

    Alternative RECLAST Names:ZOLEDRONI

    Active Ingredient: ZOLEDRONI

    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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