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Boniva Side Effects

Common Boniva Side Effects


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

Arthralgia (675)
Pain In Extremity (426)
Bone Pain (425)
Back Pain (419)
Myalgia (403)
Diarrhoea (389)
Nausea (345)
Chest Pain (340)
Pain (324)
Fall (323)
Headache (294)
Femur Fracture (280)
Influenza Like Illness (273)
Dizziness (241)
Abdominal Pain Upper (226)
Dyspnoea (225)
Dyspepsia (208)
Fatigue (206)
Pain In Jaw (190)
Asthenia (189)

➢ 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.

Boniva Side Effects Reported to FDA

The following Boniva 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 Boniva 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.

This is a report of a 70-year-old female patient (weight: NA) from US, suffering from the following symptoms/conditions: osteopenia,parkinson^s disease, who was treated with Boniva (dosage: NA, start time: Jun 11, 2012), combined with:
  • Pramipexole
  • Azilect
  • Sinemet-plus (1.5 X 25 Mg-100 Mg)
  • Reclast (5 Mg/100 Ml)
  • Restoril (united States)
  • Decadron
  • Temodar
  • Zofran
and developed a serious reaction and side effect(s). The consumer presented with:
    which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Boniva treatment in female patients, resulting in death side effect.

    Stress Fracture
    This report suggests a potential Boniva Stress Fracture 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 Boniva (dosage: NA) starting 2005. Soon after starting Boniva the patient began experiencing various side effects, including:
    • Stress Fracture
    Drugs used concurrently:
    • Doxepin
    • Zetia
    • Calcium
    • Magensium
    • D3
    • Flaxseed Oil
    Although Boniva demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as stress fracture, may still occur.

    Influenza, Nausea, Vomiting, Pain
    This Influenza, Nausea, Vomiting, Pain problem was reported by a physician from US. A 56-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: osteoporosis. On Jan 16, 2014 this consumer started treatment with Boniva (dosage: NA). The following drugs were being taken at the same time:
    • Nexium
    • Nexium
    • Premarine Vaginal Cream
    When commencing Boniva, the patient experienced the following unwanted symptoms/side effects:
    • Influenza
    • Nausea
    • Vomiting
    • Pain
    The 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 influenza, may become evident only after a product is in use by the general population.

    Oesophagitis, Upper Gastrointestinal Haemorrhage, Haemorrhagic Anaemia
    This is a report of a 84-year-old female patient (weight: NA) from US. The patient developed the following symptoms/conditions: osteoporosis and was treated with Boniva (dosage: Chronic) starting NS. Concurrently used drugs:
    • Oxybutynin
    • Cymbalta
    • Coreg
    • Remeron
    • Lipitor
    • Levothyroxine
    • Glipizide
    • Lisinopril
    Soon after that, the consumer experienced the following side effects:
    • Oesophagitis
    • Upper Gastrointestinal Haemorrhage
    • Haemorrhagic Anaemia
    The patient was hospitalized. This opens a possibility that Boniva treatment could cause the above reactions, including oesophagitis, and some female subjects may be more susceptible.


    Low Turnover Osteopathy, Femur Fracture, Emotional Distress
    A 74-year-old female patient (weight: NA) from US with the following symptoms/conditions: osteoporosis started Boniva treatment (dosage: NA) on 2002. Soon after starting Boniva treatment, the subject experienced various side effects, including:
    • Low Turnover Osteopathy
    • Femur Fracture
    • Emotional Distress
    Concurrently used drugs:
    • Fosamax
    This finding indicates that some female patients could be more vulnerable to Boniva.

    Muscle Tightness, Local Swelling, Erythema, Soft Tissue Mass, Injection Site Extravasation
    A 66-year-old female patient from US (weight: NA) experienced symptoms, such as: osteoporosis,gastrooesophageal reflux disease and was treated with Boniva(dosage: NA). The treatment was initiated on Dec 09, 2013. After that a consumer reported the following side effect(s):
    • Muscle Tightness
    • Local Swelling
    • Erythema
    • Soft Tissue Mass
    • Injection Site Extravasation
    Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Boniva efficacy:
    • Prilosec
    • Vitamin D3
    The patient was hospitalized.

    Influenza Like Illness, Myalgia, Nausea, Decreased Appetite, Feeling Of Body Temperature Change, Fatigue, Pain
    In this report, Boniva 150 Mg was administered for the following condition: osteoporosis.A 60-year-old female consumer from US (weight: NA) started Boniva 150 Mg treatment (dosage: 1 Pill One Per Month Taken By Mouth) on Jan 31, 2014.Sometime after starting the treatment, the patient complained of the following side effect(s):
    • Influenza Like Illness
    • Myalgia
    • Nausea
    • Decreased Appetite
    • Feeling Of Body Temperature Change
    • Fatigue
    • Pain
    A possible interaction with other drugs could have contributed to this reaction: NA.Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Boniva 150 Mg treatment could be related to the listed above side effect(s).

    Hip Fracture, Fall
    This is a report of the following Boniva side effect(s):
    • Hip Fracture
    • Fall
    A 84-year-old female patient from CR (weight: NA) presented with the following condition: osteoporosis and received a treatment with Boniva (dosage: NA) starting: Aug 01, 2009.The following concurrently used drugs could have generated interactions: NA.The patient was hospitalized.This report suggests that a Boniva treatment could be associated with the listed above side effect(s).

    Constipation, Myocardial Infarction, Cerebrovascular Accident, Bone Pain, Arthralgia, Myalgia, Back Pain, Muscle Spasms
    This Boniva report was submitted by a 87-year-old female consumer from US (weight: NA). The patient was diagnosed with: arthralgia and Boniva was administered (dosage: Pill; Started 5-6 Years Ago) starting: NS. The consumer developed a set of symptoms:
    • Constipation
    • Myocardial Infarction
    • Cerebrovascular Accident
    • Bone Pain
    • Arthralgia
    • Myalgia
    • Back Pain
    • Muscle Spasms
    Other drugs used simultaneously:
    • Aspirin
    • Tylenol
    • Meclizine
    The patient was hospitalized.Those unexpected symptoms could be linked to a Boniva treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

    Gastroenteritis, Urinary Tract Infection, Diarrhoea, Psychotic Disorder, Prothrombin Time Prolonged, Electrolyte Imbalance
    This is a report of a possible correlation between Boniva use and the following symptoms/side effect(s):
    • Gastroenteritis
    • Urinary Tract Infection
    • Diarrhoea
    • Psychotic Disorder
    • Prothrombin Time Prolonged
    • Electrolyte Imbalance
    which could contribute to an assessment of Boniva risk profile.A female consumer from US (weight: NA) was suffering from senile osteoporosis and was treated with Boniva (dosage: NA) starting NS.Other concurrent medications:
    • Synthroid (100 Mcg)
    • Lisinopril
    • Lisinopril
    • Toprol Xl
    • Coumadin (As Adjusted By Cardiologist)
    • Temazepam (Q H S)
    • Xanax
    • Digoxin
    The patient was hospitalized.

    Cellulitis, Oesophageal Ulcer, Hypoaesthesia, Malaise, Weight Decreased, Local Swelling, Myalgia, Amnesia, Fatigue
    A 89-year-old male patient from US (weight: NA) presented with the following symptoms: senile osteoporosis,type 2 diabetes mellitus and after a treatment with Boniva (dosage: 3mg/ml) experienced the following side effect(s):
    • Cellulitis
    • Oesophageal Ulcer
    • Hypoaesthesia
    • Malaise
    • Weight Decreased
    • Local Swelling
    • Myalgia
    • Amnesia
    • Fatigue
    The treatment was started on 201110. Boniva was used in combination with the following drugs:
    • Januvia (50mg Daily)
    The patient was hospitalized.This report could alert potential Boniva consumers.

    Hepatomegaly, Post-traumatic Stress Disorder, Abdominal Pain, Haemorrhoids, Ovarian Cancer, Depression, Constipation
    In this report, a 58-year-old female patient from US (weight: NA) was affected by a possible Boniva side effect.The patient was diagnosed with osteoporosis. After a treatment with Boniva (dosage: NA, start date: NS), the patient experienced the following side effect(s):
    • Hepatomegaly
    • Post-traumatic Stress Disorder
    • Abdominal Pain
    • Haemorrhoids
    • Ovarian Cancer
    • Depression
    • Constipation
    The following simultaneously used drugs could have led to this reaction: NA.The findings here stress that side effects should be taken into consideration when evaluating a Boniva treatment.


    This is a report of a 73-year-old male patient from US (weight: NA), who used Boniva (dosage: NA) for a treatment of thoracic vertebral fracture. After starting a treatment on NS, the patient experienced the following side effect(s):
      The following drugs could possibly have interacted with the Boniva treatment NA.Taken together, these observations suggest that a Boniva treatment could be related to side effect(s), such as .


      This death side effect was reported by a physician from US. A 93-year-old male patient (weight:NA) experienced the following symptoms/conditions: senile osteoporosis. The patient was prescribed Boniva (dosage: NA), which was started on NS. Concurrently used drugs: NA. When starting to take Boniva the consumer reported the following symptoms:
        These side effects may potentially be related to Boniva.

        Arthralgia, Feeling Hot, Back Disorder
        This is a Boniva side effect report of a 61-year-old female patient (weight:NA) from US, suffering from the following symptoms/conditions: osteoporosis, who was treated with Boniva (dosage:NA, start time: Aug 05, 2013), combined with: NA., and developed a serious reaction and a arthralgia side effect. The patient presented with:
        • Arthralgia
        • Feeling Hot
        • Back Disorder
        which developed after the beginning of treatment. This side effect report can indicate a possible existence of increased vulnerability to Boniva treatment in female patients suffering from osteoporosis, resulting in arthralgia.

        Chest Pain, Chest Discomfort, Musculoskeletal Pain, Myalgia
        This report suggests a potential Boniva chest pain side effect(s) that can have serious consequences. A 58-year-old female patient from US (weight:NA) was diagnosed with the following health condition(s): osteopenia and used Boniva (dosage: 150 Mg/ 1 Dose Once Monthly Oral) starting Nov 21, 2013. Soon after starting Boniva the patient began experiencing various side effects, including:
        • Chest Pain
        • Chest Discomfort
        • Musculoskeletal Pain
        • Myalgia
        Drugs used concurrently:NA. The patient was hospitalized. Although Boniva demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as chest pain, may still occur.

        Pain In Extremity, Insomnia
        This pain in extremity problem was reported by a consumer or non-health professional from US. A 57-year-old male patient (weight: NA) was diagnosed with the following medical condition(s): osteoporosis.On Jun 11, 2009 a consumer started treatment with Boniva (dosage: NA). The following drugs/medications were being taken at the same time: NA. When commencing Boniva, the patient experienced the following unwanted symptoms /side effects:
        • Pain In Extremity
        • Insomnia
        Although all drugs are carefully tested before they are licensed for use, they carry potential side effect risks. Some side effects, such as pain in extremity, may become evident only after a product is in use by the general population.

        Femur Fracture
        This is a Boniva side effect report of a 55-year-old female patient (weight: NA) from US. The patient developed the following symptoms/conditions: osteoporosis and was treated with Boniva (dosage: NA) starting Jan 16, 2008. Concurrently used drugs:
        • Fosamax
        • Hctz
        • Valium
        • Oxycodone
        • Flonase
        Soon after that, the consumer experienced the following of symptoms:
        • Femur Fracture
        The patient was hospitalized. This opens a possibility that Boniva could cause femur fracture and that some female patients may be more susceptible.

        Lower Limb Fracture, Pain In Extremity, Gait Disturbance
        A female patient (weight: NA) from US with the following symptoms: osteoporosis started Boniva treatment (dosage: Every Three Months Injection) on 2008. Soon after starting Boniva treatment, the consumer experienced several side effects, including:
        • Lower Limb Fracture
        • Pain In Extremity
        • Gait Disturbance
        . Concurrently used drugs:
        • Fosamax
        • Actonel
        • Bonivia
        This finding indicates that some patients can be more vulnerable to developing Boniva side effects, such as lower limb fracture.

        Stress Fracture, Femur Fracture
        This stress fracture side effect was reported by a consumer or non-health professional from US. A 71-year-old female patient (weight:NA) experienced the following symptoms/conditions: osteoporosis,prophylaxis.The patient was prescribed Boniva 150mg Genentech (dosage: 1 150mg Pill Monthly Taken By Mouth), which was started on Sep 01, 2006. Concurrently used drugs: NA..When starting to take Boniva 150mg Genentech the consumer reported symptoms, such as:
        • Stress Fracture
        • Femur Fracture
        These side effects may potentially be related to Boniva 150mg Genentech. The patient was hospitalized and became disabled.

        Movement Disorder, Chest Discomfort, Back Pain, Arthralgia, Pain In Extremity, Abdominal Pain Upper, Micturition Urgency
        This is a report of a 52-year-old female patient (weight: NA) from US, suffering from the following symptoms/conditions: NA, who was treated with Boniva (dosage: 1 Pill Taken By Mouth, start time: Sep 28, 2013), combined with: NA. and developed a serious reaction and side effect(s). The consumer presented with:
        • Movement Disorder
        • Chest Discomfort
        • Back Pain
        • Arthralgia
        • Pain In Extremity
        • Abdominal Pain Upper
        • Micturition Urgency
        which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Boniva treatment in female patients, resulting in movement disorder side effect.

        Ankle Fracture, Femur Fracture
        This report suggests a potential Boniva Ankle Fracture, Femur Fracture side effect(s) that can have serious consequences. A 67-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: osteopenia and used Boniva (dosage: NA) starting Jun 20, 2009. Soon after starting Boniva the patient began experiencing various side effects, including:
        • Ankle Fracture
        • Femur Fracture
        Drugs used concurrently: NA. Although Boniva demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as ankle fracture, may still occur.

        Pain In Extremity, Local Swelling, Foot Fracture, Atypical Fracture, Fracture Nonunion, Bone Disorder
        This Pain In Extremity, Local Swelling, Foot Fracture, Atypical Fracture, Fracture Nonunion, Bone Disorder problem was reported by a consumer or non-health professional from US. A female patient (weight: NA) was diagnosed with the following symptoms/conditions: osteopenia. On 1998 this consumer started treatment with Boniva (dosage: Iv Every 3 Months). The following drugs were being taken at the same time:
        • Fosamax
        • Diovan
        • Effexor
        • Temazepam
        • Forteo
        • Probiotics
        • Calcium
        • Vitamin D
        When commencing Boniva, the patient experienced the following unwanted symptoms/side effects:
        • Pain In Extremity
        • Local Swelling
        • Foot Fracture
        • Atypical Fracture
        • Fracture Nonunion
        • Bone Disorder
        Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as pain in extremity, may become evident only after a product is in use by the general population.

        Femur Fracture, Pathological Fracture
        This is a report of a 65-year-old female patient (weight: NA) from US. The patient developed the following symptoms/conditions: prophylaxis and was treated with Boniva (dosage: 1 Pill) starting NS. Concurrently used drugs: NA.Soon after that, the consumer experienced the following side effects:
        • Femur Fracture
        • Pathological Fracture
        This opens a possibility that Boniva treatment could cause the above reactions, including femur fracture, and some female subjects may be more susceptible.

        Fracture Delayed Union
        A 64-year-old female patient (weight: NA) from US with the following symptoms/conditions: osteoporosis started Boniva treatment (dosage: NA) on 200503. Soon after starting Boniva treatment, the subject experienced various side effects, including:
        • Fracture Delayed Union
        Concurrently used drugs:
        • Aclasta
        • Prolia
        • Fosamax
        • Vitamin D
        • Calcimagon
        • Clexane
        • Nexium
        • Supradyn
        The patient was hospitalized. This finding indicates that some female patients could be more vulnerable to Boniva.

        1 of 225 



        Top 10 Boniva Side Effects for Women

        Women Side EffectsReports
        Arthralgia 654
        Bone Pain 411
        Pain In Extremity 411
        Back Pain 401
        Myalgia 388
        Diarrhoea 373
        Nausea 328
        Chest Pain 327
        Pain 315
        Fall 308

        Top 10 Boniva Side Effects for Men

        Men Side EffectsReports
        Arthralgia 20
        Chills 20
        Back Pain 18
        Diarrhoea 15
        Dizziness 15
        Myalgia 15
        Nausea 15
        Fall 14
        Pain In Extremity 14
        Bone Pain 13

        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 Boniva Side Effects

        Did You Have a Boniva Side Effect?

        Yes, Severe
        Yes, Moderate
        Yes, Minor
        No

        How Effective is Boniva for You?

        Exceeded Expectations
        Effective
        Somewhat Effective
        Not Effective

        Boniva Safety Alerts, Active Ingredients, Usage Information

        NDC0004-0186
        TypeHUMAN PRESCRIPTION DRUG
        Proprietary NameBoniva
        Nameibandronate sodium
        Dosage FormTABLET, FILM COATED
        RouteORAL
        On market since20020715
        LabelerGenentech, Inc.
        Active Ingredient(s)IBANDRONATE SODIUM
        Strength(s)150
        Unit(s)mg/1
        Pharma ClassBisphosphonate [EPC],Diphosphonates [Chemical/Ingredient]

        Boniva Dosage, Warnings, Usage.

        Side Effects reported to FDA: 5605

        Boniva safety alerts: 2008 2007

        Reported deaths: 340

        Reported hospitalizations: 1761

        Bisphosphonates (marketed as Actonel, Actonel+Ca, Aredia, Boniva, Didronel, Fosamax, Fosamax+D, Reclast, Skelid, and Zometa)

        Audience: Pharmacists, other healthcare professionals

        [Posted 01/07/2008] FDA informed healthcare professionals and patients of the possibility of severe and sometimes incapacitating bone, joint, and/or muscle (musculoskeletal) pain in patients taking bisphosphonates. Although severe musculoskeletal pain is included in the prescribing information for all bisphosphonates, the association between bisphosphonates and severe musculoskeletal pain may be overlooked by healthcare professionals, delaying diagnosis, prolonging pain and/or impairment, and necessitating the use of analgesics. The severe musculoskeletal pain may occur within days, months, or years after starting a bisphosphonates. Some patients have reported complete relief of symptoms after discontinuing the bisphosphonate, whereas others have reported slow or incomplete resolution. The risk factors for and incidence of severe musculoskeletal pain associated with bisphosphonates are unknown.

        Healthcare professionals should consider whether bisphosphonate use might be responsible for severe musculoskeletal pain in patients who present with these symptoms and consider temporary or permanent discontinuation of the drug.

        [January 07, 2008 - Drug Information page - FDA]

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