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Reclast Side Effects and Adverse Effects reported to US Food and Drug Administration (FDA)

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Showing 1-25 of 2431 

Back Pain, Fatigue, Myalgia, Musculoskeletal Pain, Chest Pain (8511943-1)
on Aug 22, 2008 Female from UNITED STATES , 80 years of age, weighting 77.16 lb, was diagnosed with
  • osteoporosis
and was treated with Reclast. Directly after, patient experienced the unwanted or unexpected Reclast side effects: back pain, fatigue, myalgia, musculoskeletal pain, chest pain. Reclast dosage: 5 Mg, Once/single, Infusion.
Associated medications used:
  • Nexium
  • Nadolol
  • Xanax
  • Prinivil
Patient was hospitalized and became disabled.

Osteonecrosis (8510176-2)
Patient was taking Reclast. Patient felt the following Reclast side effects: osteonecrosis on Jul 20, 2009 from UNITED STATES Additional patient health information: Female , 56 years of age, weighting 106.9 lb, was diagnosed with
  • osteoporosis
and. Reclast dosage: 5 Mg, Infusion.

Impaired Work Ability, Arthralgia (8510101-4)
Adverse event was reported on Jul 02, 2009 by a Patient taking Reclast (Dosage: 5 Mg, Yearly, Intravenous) was diagnosed with
  • osteopenia
and. Location: UNITED STATES , 58 years of age, weighting 144.0 lb, After Reclast was administered, patient encountered several Reclast side effects: impaired work ability, arthralgia.

Hypocalcaemia (8510055-0)
on Jul 02, 2009 Female from UNITED STATES , 64 years of age, was treated with Reclast. Directly after, patient experienced the unwanted or unexpected Reclast side effects: hypocalcaemia. Reclast dosage: 5 Mg, Yearly, Intravenous.


Myalgia, Arthralgia, Gait Disturbance, Bone Pain (8510048-3)
on Oct 13, 2008 Female from UNITED STATES , 49 years of age, was treated with Reclast. Patient felt the following Reclast side effects: myalgia, arthralgia, gait disturbance, bone pain. Reclast dosage: Infusion.

Renal Failure Acute (8510009-4)
Patient was taking Reclast. After Reclast was administered, patient encountered several Reclast side effects: renal failure acute on Jun 24, 2009 from UNITED STATES Additional patient health information: Female , 87 years of age, weighting 171.1 lb, . Reclast dosage: N/A. Patient was hospitalized.

Headache, White Blood Cell Count Increased, Influenza Like Illness, Vomiting, Rash (8509834-5)
Adverse event was reported on Jun 10, 2009 by a Female taking Reclast (Dosage: 5 Mg, Once Yearly, Iv Infusion) was diagnosed with
  • osteoporosis
and. Location: UNITED STATES , 62 years of age, Directly after, patient experienced the unwanted or unexpected Reclast side effects: headache, white blood cell count increased, influenza like illness, vomiting, rash. Patient was hospitalized.

Swelling Face, Bone Disorder, Tooth Extraction, Lymphadenopathy, Osteonecrosis, Oral Surgery, Lymph Node Pain, Facial Pain (8509809-6)
on Jun 04, 2009 Male from UNITED STATES , 79 years of age, weighting 134.9 lb, was diagnosed with
  • osteoporosis
and was treated with Reclast. Patient felt the following Reclast side effects: swelling face, bone disorder, tooth extraction, lymphadenopathy, osteonecrosis, oral surgery, lymph node pain, facial pain. Reclast dosage: 5 Mg, Once/single, Influsion.
Multiple prescriptions taken:
  • Prilosec
  • Aldactone
  • Mysoline
  • Bystolic
  • Coumadin
  • Fosinopril Sodium


Bone Pain (8509807-2)
on Jun 24, 2009 Female from UNITED STATES , 51 years of age, weighting 134.0 lb, was diagnosed with
  • osteoporosis
and was treated with Reclast. After Reclast was administered, patient encountered several Reclast side effects: bone pain. Reclast dosage: 5 Mg Per Year, Intravenous.
Multiple concurrent drugs taken:
  • Allegra


Pain In Jaw, Myalgia, Bone Pain, Bedridden (8509792-3)
Patient was taking Reclast. Directly after, patient experienced the unwanted or unexpected Reclast side effects: pain in jaw, myalgia, bone pain, bedridden on Jun 01, 2009 from UNITED STATES Additional patient health information: Female , 74 years of age, was diagnosed with
  • osteoporosis
and. Reclast dosage: Infusion. Patient was hospitalized.

Back Pain, Dysstasia, Pain In Extremity, Arthralgia (8509790-X)
Adverse event was reported on Jun 11, 2009 by a Female taking Reclast (Dosage: 5 Mg, Infusion) was diagnosed with
  • osteoporosis
and. Location: UNITED STATES , 82 years of age, weighting 137.3 lb, Patient felt the following Reclast side effects: back pain, dysstasia, pain in extremity, arthralgia.

Bone Pain, Bedridden (8509742-X)
on May 20, 2009 Female from UNITED STATES , 81 years of age, was treated with Reclast. After Reclast was administered, patient encountered several Reclast side effects: bone pain, bedridden. Reclast dosage: Infusion.

Arthralgia, Bone Pain, Bedridden (8509740-6)
on May 22, 2009 Female from UNITED STATES , 88 years of age, was diagnosed with
  • senile osteoporosis
and was treated with Reclast. Directly after, patient experienced the unwanted or unexpected Reclast side effects: arthralgia, bone pain, bedridden. Reclast dosage: 5 Mg/ 100 Ml, Infusion.
Associated medications used:
  • Diovan Hct
  • Lexapro
  • Atenolol
  • Soma


Sensitivity Of Teeth, Pain, Insomnia, Pain In Jaw, Vertigo, Headache, Pyrexia, Abdominal Pain Upper, Arthralgia (8509710-8)
Patient was taking Reclast. Patient felt the following Reclast side effects: sensitivity of teeth, pain, insomnia, pain in jaw, vertigo, headache, pyrexia, abdominal pain upper, arthralgia on Jul 08, 2009 from UNITED STATES Additional patient health information: Female , 59 years of age, weighting 123.2 lb, was diagnosed with
  • osteopenia
and. Reclast dosage: 5 Mg/100 Ml Yearly, Infusion.
Multiple prescriptions taken:
  • Phenobarbital Tab
  • Celebrex
  • Activella
  • Valtrex


Blood Creatinine Increased, Hypocalcaemia (8509694-2)
Adverse event was reported on May 13, 2009 by a Female taking Reclast (Dosage: Infusion) was diagnosed with
  • osteoporosis
  • spinal fracture
and. Location: UNITED STATES , weighting 181.9 lb, After Reclast was administered, patient encountered several Reclast side effects: blood creatinine increased, hypocalcaemia.

Bedridden, Hypocalcaemia, Muscular Weakness (8508451-0)
on Jan 09, 2009 Female from UNITED STATES , 79 years of age, weighting 181.0 lb, was diagnosed with
  • osteoporosis
and was treated with Reclast. Directly after, patient experienced the unwanted or unexpected Reclast side effects: bedridden, hypocalcaemia, muscular weakness. Reclast dosage: 5 Mg Yearly, Intravenous.
Associated medications used:
  • Serax
  • Methotrexate ^lederle^ (methotrexate Sodium)


Joint Swelling, Osteonecrosis, Erythema, Bone Disorder, Pain In Jaw (8508450-9)
on Apr 06, 2009 Female from UNITED STATES , 77 years of age, was diagnosed with
  • osteopenia
and was treated with Reclast. Patient felt the following Reclast side effects: joint swelling, osteonecrosis, erythema, bone disorder, pain in jaw. Reclast dosage: 5 Mg, Infusion.

Dysstasia, Fall, Back Pain, Abasia, Pain In Extremity (8508426-1)
Patient was taking Reclast. After Reclast was administered, patient encountered several Reclast side effects: dysstasia, fall, back pain, abasia, pain in extremity on Feb 16, 2009 from UNITED STATES Additional patient health information: Female , 76 years of age, was diagnosed with
  • osteoporosis
and. Reclast dosage: 5 Mg/100 Ml, Intravenous.

Renal Failure Acute, Blood Creatinine Increased, Blood Urea Increased (8508411-X)
Adverse event was reported on Feb 06, 2009 by a Female taking Reclast (Dosage: 5 Mg, Once/single, Intravenous) was diagnosed with
  • osteoporosis
and. Location: UNITED STATES , 75 years of age, Directly after, patient experienced the unwanted or unexpected Reclast side effects: renal failure acute, blood creatinine increased, blood urea increased.

Arthralgia, Rash, Pain In Jaw, Pyrexia (8508410-8)
on Mar 18, 2009 Female from UNITED STATES , 65 years of age, weighting 163.1 lb, was diagnosed with
  • osteoporosis
and was treated with Reclast. Patient felt the following Reclast side effects: arthralgia, rash, pain in jaw, pyrexia. Reclast dosage: 5 Mg, Infusion.

Fatigue, Asthenia, Vitamin D Decreased (8508404-2)
on Mar 09, 2009 Female from UNITED STATES , 87 years of age, was diagnosed with
  • osteoporosis
and was treated with Reclast. After Reclast was administered, patient encountered several Reclast side effects: fatigue, asthenia, vitamin d decreased. Reclast dosage: Unk.

Chills, Arthralgia, Myalgia, Nausea, Diarrhoea, Dyspnoea, Vomiting, Pyrexia, Oedema (8508403-0)
Patient was taking Reclast. Directly after, patient experienced the unwanted or unexpected Reclast side effects: chills, arthralgia, myalgia, nausea, diarrhoea, dyspnoea, vomiting, pyrexia, oedema on Mar 23, 2009 from UNITED STATES Additional patient health information: Female , 56 years of age, was diagnosed with
  • osteoporosis
and. Reclast dosage: 5 Mg, Infusion.

Soft Tissue Infection, Bone Graft, Primary Sequestrum, Abscess, Osteonecrosis (8508402-9)
Adverse event was reported on Jan 05, 2009 by a Female taking Reclast (Dosage: 5 Mg, Once/single, Intravenous) was diagnosed with
  • osteoporosis
and. Location: UNITED STATES , 67 years of age, Patient felt the following Reclast side effects: soft tissue infection, bone graft, primary sequestrum, abscess, osteonecrosis.

Mobility Decreased, Arthralgia, Bone Pain, Myalgia (8508364-4)
on Mar 10, 2009 Female from UNITED STATES , weighting 112.9 lb, was diagnosed with
  • osteoporosis
and was treated with Reclast. After Reclast was administered, patient encountered several Reclast side effects: mobility decreased, arthralgia, bone pain, myalgia. Reclast dosage: 5 Mg, Once/single, Infusion.

Dyspnoea (8508363-2)
on Nov 21, 2008 Female from UNITED STATES , 62 years of age, weighting 175.9 lb, was diagnosed with
  • osteoporosis postmenopausal
and was treated with Reclast. Directly after, patient experienced the unwanted or unexpected Reclast side effects: dyspnoea. Reclast dosage: 5 Mg, Once/single, Intravenous. Patient was hospitalized.

Showing 1-25 of 2431 

Reclast Health Episodes

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Record and Track Your Side Effects

It is very important to keep track of all side effects and discuss them with your doctor. If you think you may have a medical emergency, call your doctor or 911 immediately.

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Most drugs have a large list of nonsevere or mild adverse effects which do not rule out continued usage. These effects depend on individual sensitivity, and can include nausea, dizziness, diarrhea, malaise, vomiting, headache, dermatitis, dry mouth, etc. Check commonly reported side effects . These can be considered a form of pseudo-allergic reaction, as not all users experience these effects; many users experience none at all.

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 Information

Alternative RECLAST Names:ZOLEDRONI

Active Ingredient: ZOLEDRONI

Reclast Dosage, Warnings, Usage.

Side Effects reported to FDA: 2431. View Reclast Adverse Reports

Reclast safety alerts: 2011 2008 2007

Reported deaths: 124

Reported hospitalizations: 755

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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