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Boniva Injection

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Boniva Injection

Boniva Injection

Boniva Injection Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Boniva (ibandronate sodium) Injection is a bisphosphonate used to treat and prevent osteoporosis in women after menopause. It is available in generic form. Common side effects of Boniva include headache, upset stomach, flu-like symptoms, and redness or swelling at the injection site.

The recommended dosage of Boniva is 3 mg, every 3 months. NSAIDs such as aspirin, Celebrex, Voltaren, Motrin, Advil, Aleve, and naprosyn may interact with Boniva. Tell your doctor all medications you take. Do not lie down or recline for at least 60 minutes after taking Boniva. Before having any dental work done, tell your dentist if you are taking Boniva. If you are pregnant only take Boniva if the potential benefit outweighs the potential risk to the fetus. Exercise caution if you are taking Boniva while breastfeeding.

Our Boniva (ibandronate sodium) Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Boniva Injection in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using ibandronate and call your doctor at once if you have any of these serious side effects:

  • chest pain;
  • difficulty or pain when swallowing;
  • pain or burning under the ribs or in the back;
  • new or worsening heartburn;
  • severe joint, bone, or muscle pain;
  • new or unusual pain in your thigh or hip; or
  • jaw pain, numbness, or swelling.

Less serious side effects may include:

  • back pain, headache;
  • redness or swelling of your eyes;
  • diarrhea;
  • flu symptoms;
  • redness or swelling where the medicine was injected;
  • nausea or upset stomach; or
  • pain in your arms or legs.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Boniva Injection (Ibandronate Sodium Injection) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Boniva Injection Overview - Patient Information: Side Effects

SIDE EFFECTS: Headache, flu-like symptoms (such as fever, chills, tiredness, joint/muscle ache), or injection site reactions (such as redness, swelling) may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: increased or severe bone/joint/muscle pain, new or unusual hip/thigh/groin pain, jaw pain, vision changes, change in the amount of urine.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Boniva Injection (Ibandronate Sodium Injection)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Boniva Injection FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Adverse reactions that appear in other sections of the labeling include:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Quarterly Intravenous Injection

In a 1-year, double-blind, multicenter study comparing BONIVA Injection administered intravenously as 3 mg every 3 months to BONIVA 2.5 mg daily oral tablet in women with postmenopausal osteoporosis, the overall safety and tolerability profiles of the two dosing regimens were similar. The incidence of serious adverse reactions was 8.0% in the BONIVA 2.5 mg daily group and 7.5% in the BONIVA Injection 3 mg once every 3 months group. The percentage of patients who withdrew from treatment due to adverse reactions was approximately 6.7% in the BONIVA 2.5 mg daily group and 8.5% in the BONIVA Injection 3 mg every 3 months group. Table 1 lists the adverse reactions reported in greater than 2% of patients.

Table 1 : Adverse Reactions With an Incidence of at Least 2% in Patients Treated with BONIVA Injection (3 mg once every 3 months) or BONIVA Daily Oral Tablet (2.5 mg)

Body System/Adverse Reaction BONIVA 2.5 mg Daily (Oral) %
(n=465)
BONIVA 3 mg every 3 months (Intravenous) %
(n=469)
Infections and Infestations
  Influenza 8 5
  Nasopharyngitis 6 3
  Cystitis 3 2
  Gastroenteritis 3 2
  Urinary Tract Infection 3 3
  Bronchitis 3 2
  Upper Respiratory Tract Infection 3 1
Gastrointestinal Disorders
  Abdominal Pain* 6 5
  Dyspepsia 4 4
  Nausea 4 2
  Constipation 4 3
  Diarrhea 2 3
  Gastritis 2 2
Musculoskeletal and Connective Tissue Disorders
  Arthralgia 9 10
  Back Pain 8 7
  Localized Osteoarthritis 2 2
  Pain in Extremity 2 3
  Myalgia 1 3
Nervous System Disorders
  Dizziness 3 2
  Headache 3 4
Psychiatric Disorders
  Insomnia 3 1
  Depression 2 1
General Disorders and Administration Site Conditions
  Influenza-like Illness† 1 5
  Fatigue 1 3
Skin and Subcutaneous Tissue Disorders
  Rash‡ 3 2
* Combination of abdominal pain and abdominal pain upper
† Combination of influenza-like illness and acute phase reaction
‡ Combination of rash, rash pruritic, rash macular, dermatitis, dermatitis allergic, exanthema, erythema, rash papular, rash generalized, dermatitis medicamentosa, rash erythematous

Acute Phase Reaction-like Events

Symptoms consistent with acute phase reaction (APR) have been reported with intravenous bisphosphonate use. The overall incidence of patients with APR-like events was higher in the intravenous treatment group (4% in the BONIVA 2.5 mg daily oral tablet group vs. 10% in the BONIVA Injection 3 mg once every 3 months group). These incidence rates are based upon reporting of any of 33 potential APR-like symptoms within 3 days of an intravenous dose and lasting 7 days or less. In most cases, no specific treatment was required and the symptoms subsided within 24 to 48 hours.

Injection Site Reactions

Local reactions at the injection site, such as redness or swelling, were observed at a higher incidence in patients treated with BONIVA Injection 3 mg every 3 months (1.7%; 8/469) than in patients treated with placebo injections (0.2%; 1/465). In most cases, the reaction was of mild to moderate severity.

Daily Oral Tablet

The safety of BONIVA 2.5 mg once daily in the treatment and prevention of postmenopausal osteoporosis was assessed in 3577 patients aged 41 - 82 years. The duration of the trials was 2 to 3 years, with 1134 patients exposed to placebo and 1140 exposed to BONIVA 2.5 mg. Patients with pre-existing gastrointestinal disease and concomitant use of non-steroidal anti-inflammatory drugs, proton pump inhibitors and H2 antagonists were included in these clinical trials. All patients received 500 mg calcium plus 400 international units vitamin D supplementation daily.

The incidence of all-cause mortality was 1% in the placebo group and 1.2% in the BONIVA 2.5 mg daily group. The incidence of serious adverse reactions was 20% in the placebo group and 23% in the BONIVA 2.5 mg daily oral tablet group. The percentage of patients who withdrew from treatment due to adverse reactions was approximately 17% in both the placebo group and the BONIVA 2.5 mg daily oral tablet group. Table 2 lists adverse reactions from the Treatment and Prevention Studies reported in greater than or equal to 2% of patients and in more patients treated with BONIVA 2.5 mg daily oral tablet than patients treated with placebo.

Table 2 : Adverse Reactions Occurring at an Incidence greater than or equal to 2% and in More Patients Treated with BONIVA 2.5 mg Daily Oral Tablet than in Patients Treated with Placebo in the Osteoporosis Treatment and Prevention Studies

Body System Placebo %
(n=1134)
BONIVA 2.5 mg daily %
(n=1140)
Body as a Whole
  Back Pain 12 14
  Pain in Extremity 6 8
  Asthenia 2 4
  Allergic Reaction 2 3
Digestive System
  Dyspepsia 10 12
  Diarrhea 5 7
  Tooth Disorder 2 4
  Vomiting 2 3
  Gastritis 2 2
Musculoskeletal System
  Myalgia 5 6
  Joint Disorder 3 4
  Arthritis 3 3
Nervous System
  Headache 6 7
  Dizziness 3 4
  Vertigo 3 3
Respiratory System
  Upper Respiratory 33 34
Infection
  Bronchitis 7 10
  Pneumonia 4 6
  Pharyngitis 2 3
Urogenital System
  Urinary Tract Infection 4 6

Gastrointestinal Adverse Reactions

The incidence of selected gastrointestinal adverse reactions in the placebo and BONIVA 2.5 mg daily groups were: dyspepsia (10% vs. 12%), diarrhea (5% vs. 7%), and abdominal pain (5% vs. 6%).

Musculoskeletal Adverse Reactions

The incidence of selected musculoskeletal adverse reactions in the placebo and BONIVA 2.5 mg daily groups were: back pain (12% vs. 14%), arthralgia (14% vs. 14%) and myalgia (5% vs. 6%).

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of BONIVA Injection. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Hypersensitivity: Allergic reactions including anaphylaxis with fatalities, angioedema, asthma exacerbation, bronchospasm, and rash [see CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS].

Hypocalcemia: Hypocalcemia [see WARNINGS AND PRECAUTIONS].

Renal Toxicity: Acute renal failure [see WARNINGS AND PRECAUTIONS].

Osteonecrosis of the Jaw: Osteonecrosis of the jaw [see WARNINGS AND PRECAUTIONS].

Musculoskeletal Pain: Bone, joint, or muscle pain (musculoskeletal pain), described as severe or incapacitating [see WARNINGS AND PRECAUTIONS].

Atypical Femoral Shaft Fracture: Atypical, low-energy, or low-trauma fractures of the femoral shaft [see WARNINGS AND PRECAUTIONS].

Eye Inflammation: Iritis and uveitis. In some cases with other bisphosphonates, these events did not resolve until the bisphosphonate was discontinued.

Read the entire FDA prescribing information for Boniva Injection (Ibandronate Sodium Injection) »

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Boniva Injection - User Reviews

Boniva Injection User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Boniva Injection sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

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.


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