Side Effects > Boniva

Boniva Side Effects

Please note - some side effects for Boniva may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Boniva - for the Consumer

Boniva

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Boniva:

Constipation; diarrhea; dizziness; headache; heartburn; mild flu-like symptoms; nausea; pain in the arms, legs, or back; stomach upset; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur when using Boniva:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody or black, tarry stools; chest pain; eye pain; painful or difficult swallowing; severe bone, joint, or muscle pain; severe or persistent dizziness or headache; severe or persistent heartburn or stomach pain; swelling or pain in your jaw; vision changes; vomiting blood or a substance that looks like coffee grounds.

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Boniva Side Effects - for the Professional

Boniva

Daily Oral Tablet

Treatment with Boniva 2.5 mg daily oral tablet was studied in over 3900 patients in postmenopausal osteoporosis trials of up to 3 years duration. The overall adverse event profile of Boniva 2.5 mg once daily tablet in these studies was similar to that of placebo.

Most adverse events were mild or moderate and did not lead to discontinuation. The incidence of serious adverse events 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 events was approximately 17% in both the Boniva 2.5 mg daily oral tablet group and the placebo group. Overall, and according to body system, there was no difference between Boniva daily oral tablet and placebo, with adverse events of the digestive system being the most common reason for withdrawal.

Table 3 lists adverse events from the Treatment and Prevention Studies reported in ≥2% of patients and in more patients treated with Boniva 2.5 mg daily oral tablet than patients treated with placebo. Adverse events are shown without attribution of causality.

Table 3  Adverse Events Occurring at a Frequency ≥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	12.2	13.5
Pain in Extremity	6.4	7.8
Infection	3.4	4.3
Asthenia	2.3	3.5
Allergic Reaction	1.9	2.5
Digestive System
Dyspepsia	9.8	11.9
Diarrhea	5.0	6.8
Tooth Disorder	2.3	3.5
Vomiting	2.1	2.7
Gastritis	1.9	2.2
Metabolic and Nutritional Disorders
Hypercholesterolemia	4.2	4.8
Musculoskeletal System
Myalgia	5.1	5.7
Joint Disorder	3.3	3.6
Arthritis	2.7	3.2
Nervous System
Headache	5.8	6.5
Dizziness	2.6	3.7
Vertigo	2.5	3.0
Nerve Root Lesion	1.9	2.2
Respiratory System
Upper Respiratory Infection	33.2	33.7
Bronchitis	6.8	10.0
Pneumonia	4.3	5.9
Pharyngitis	1.5	2.5
Urogenital System
Urinary Tract Infection	4.2	5.5

Quarterly IV Injection – DIVA Study

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 events 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 events 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 4 lists the adverse events reported in >2% of patients without attribution of causality.

Table 4  Adverse Events 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 Event	Boniva 2.5 mg Daily (Oral) % (n=465)	Boniva 3 mg q 3 mo (IV) % (n=469)
* Is a 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, exanthem, erythema, rash papular, rash generalized, dermatitis medicamentosa, rash erythematous
Infections and Infestations
Influenza	8.0	4.7
Nasopharyngitis	6.0	3.4
Cystitis	3.4	1.9
Gastroenteritis	3.4	1.5
Urinary Tract Infection	3.2	2.6
Bronchitis	2.8	2.1
Upper Respiratory Tract Infection	2.8	1.1
Gastrointestinal Disorders
Abdominal Pain*	5.6	5.1
Dyspepsia	4.3	3.6
Nausea	4.3	2.1
Constipation	4.1	3.4
Diarrhea	2.4	2.8
Gastritis	2.2	1.9
Musculoskeletal and Connective Tissue Disorders
Arthralgia	8.6	9.6
Back Pain	7.5	7.0
Localized Osteoarthritis	2.4	1.5
Pain in Extremity	2.2	2.8
Myalgia	0.9	2.8
Nervous System Disorders
Dizziness	2.8	1.9
Headache	2.6	3.6
Vascular Disorders
Hypertension	7.1	5.3
Psychiatric Disorders
Insomnia	2.6	1.1
Depression	2.2	1.3
General Disorders and Administration Site Conditions
Influenza-like Illness†	1.1	4.9
Fatigue	1.1	2.8
Skin and Subcutaneous Tissue Disorders
Rash‡	2.8	2.3
Metabolism and Nutrition Disorders
Hypercholesterolemia	4.3	1.5

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 on reporting of any of 33 potential APR-like symptoms within 3 days of an IV dose and for a duration of 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 infrequently, but at a higher incidence in patients treated with Boniva Injection 3 mg every 3 months (<2%; 8/469) than in patients treated with placebo injections (<1%; 1/465). In most cases, the reaction was of mild to moderate severity.

Ocular Adverse Events

Bisphosphonates may be associated with ocular inflammation such as uveitis and scleritis. In some cases, these events did not resolve until the bisphosphonate was discontinued.

Laboratory Test Findings

There were no clinically significant changes from baseline values or shifts in any laboratory variable with oral ibandronate. As expected with bisphosphonate treatment, a decrease in total alkaline phosphatase levels was seen with 2.5 mg daily oral ibandronate compared to placebo. There was no difference compared with placebo for laboratory abnormalities indicative of hepatic or renal dysfunction, hypocalcemia, or hypophosphatemia. There also was no evidence that Boniva Injection 3 mg every 3 months induced clinically significant laboratory abnormalities indicative of hepatic or renal dysfunction compared to Boniva 2.5 mg daily oral tablet.

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Side Effects by Body System

Gastrointestinal

Gastrointestinal side effects have included nausea, dyspepsia, diarrhea, tooth disorder, vomiting, gastritis, constipation and abdominal pain.

Metabolic

Metabolic side effects have included hypercholesterolemia.

Musculoskeletal

Musculoskeletal side effects have included myalgia, joint disorder, back pain, pain in extremities, localized osteoarthritis, muscle cramps and arthritis. Hypocalcemia following dosing has been reported postmarketing.

Cardiovascular

Cardiovascular side effects have included hypertension.

Nervous system

Nervous system side effects have included headache, dizziness, insomnia, vertigo, and nerve root lesion.

Respiratory

Respiratory side effects have included upper respiratory tract infection, bronchitis, pneumonia, and pharyngitis.

Genitourinary

Genitourinary side effects have included urinary tract infection.

General

General side effects have included back pain, infection, asthenia, and influenza-like illness.

Dermatologic

Dermatologic side effects have included rash.

Hypersensitivity

Hypersensitivity side effects have included allergic reactions.

Ocular

Ocular side effects have included ocular inflammation such as uveitis and scleritis.

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