deferoxamine mesylate for injection, USP Adverse Reactions

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6 ADVERSE REACTIONS

The following clinically significant adverse reactions are described elsewhere in the labeling:

•
Hypersensitivity Reactions [see Warnings and Precautions (5.1)]
•
Auditory and Ocular Toxicity [see Warnings and Precautions (5.2)]
•
Renal Toxicity [see Warnings and Precautions (5.3)]
•
Respiratory Toxicity [see Warnings and Precautions (5.4)]
•
Growth Suppression [see Warnings and Precautions (5.5)]
•
Serious Infections [see Warnings and Precautions (5.6)]
•
Cardiac Dysfunction with Concomitant Use of Vitamin C [see Warnings and Precautions (5.7)]
•
Risks of Deferoxamine mesylate Treatment in Patients with Aluminum Overload [see Warnings and Precautions (5.8)]
•
Effects on Ability to Drive and Use Machines [see Warnings and Precautions (5.9)]

6.1 Clinical Trials Experience

The following adverse reactions associated with the use of Deferoxamine mesylate were identified in clinical studies or postmarketing reports. Because some of these reactions were 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.

At the Injection Site: Localized irritation, pain, burning, swelling, induration, infiltration, pruritus, erythema, wheal formation, eschar, crust, vesicles, local edema. Injection site reactions may be associated with systemic allergic reactions (see Body as a Whole, below)

Hypersensitivity Reactions and Systemic Allergic Reactions: Generalized rash, urticaria, anaphylactic reaction with or without shock, angioedema

Body as a Whole: Local injection site reactions may be accompanied by systemic reactions like arthralgia, fever, headache, myalgia, nausea, vomiting, abdominal pain, or asthma

Infections: Yersinia, mucormycosis

Cardiovascular: Tachycardia, hypotension, shock

Digestive: Abdominal discomfort, diarrhea, nausea, vomiting

Hematologic: Blood dyscrasia (thrombocytopenia, leukopenia)

Hepatic: Increased transaminases, hepatic dysfunction

Musculoskeletal: Muscle spasms. Growth retardation and bone changes (e.g., metaphyseal dysplasia)

Nervous System: Neurological disturbances, including dizziness, peripheral sensory, motor, or mixed neuropathy, paresthesias, seizures; exacerbation or precipitation of aluminum-related dialysis encephalopathy

Special Senses: High-frequency sensorineural hearing loss, tinnitus, visual disturbances including acuity, blurred vision, loss of vision, dyschromatopsia, night blindness, visual field defects, scotoma, retinopathy (pigmentary degeneration), optic neuritis, and cataracts

Respiratory: Acute respiratory distress syndrome (with dyspnea, cyanosis, and/or interstitial infiltrates)

Skin: Generalized rash

Urogenital: Dysuria, acute renal failure, increased serum creatinine and renal tubular disorders

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Adverse Reactions

6 ADVERSE REACTIONS

The following clinically significant adverse reactions are described elsewhere in the labeling:

•
Hypersensitivity Reactions [see Warnings and Precautions (5.1)]
•
Auditory and Ocular Toxicity [see Warnings and Precautions (5.2)]
•
Renal Toxicity [see Warnings and Precautions (5.3)]
•
Respiratory Toxicity [see Warnings and Precautions (5.4)]
•
Growth Suppression [see Warnings and Precautions (5.5)]
•
Serious Infections [see Warnings and Precautions (5.6)]
•
Cardiac Dysfunction with Concomitant Use of Vitamin C [see Warnings and Precautions (5.7)]
•
Risks of Deferoxamine mesylate Treatment in Patients with Aluminum Overload [see Warnings and Precautions (5.8)]
•
Effects on Ability to Drive and Use Machines [see Warnings and Precautions (5.9)]

6.1 Clinical Trials Experience

The following adverse reactions associated with the use of Deferoxamine mesylate were identified in clinical studies or postmarketing reports. Because some of these reactions were 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.

At the Injection Site: Localized irritation, pain, burning, swelling, induration, infiltration, pruritus, erythema, wheal formation, eschar, crust, vesicles, local edema. Injection site reactions may be associated with systemic allergic reactions (see Body as a Whole, below)

Hypersensitivity Reactions and Systemic Allergic Reactions: Generalized rash, urticaria, anaphylactic reaction with or without shock, angioedema

Body as a Whole: Local injection site reactions may be accompanied by systemic reactions like arthralgia, fever, headache, myalgia, nausea, vomiting, abdominal pain, or asthma

Infections: Yersinia, mucormycosis

Cardiovascular: Tachycardia, hypotension, shock

Digestive: Abdominal discomfort, diarrhea, nausea, vomiting

Hematologic: Blood dyscrasia (thrombocytopenia, leukopenia)

Hepatic: Increased transaminases, hepatic dysfunction

Musculoskeletal: Muscle spasms. Growth retardation and bone changes (e.g., metaphyseal dysplasia)

Nervous System: Neurological disturbances, including dizziness, peripheral sensory, motor, or mixed neuropathy, paresthesias, seizures; exacerbation or precipitation of aluminum-related dialysis encephalopathy

Special Senses: High-frequency sensorineural hearing loss, tinnitus, visual disturbances including acuity, blurred vision, loss of vision, dyschromatopsia, night blindness, visual field defects, scotoma, retinopathy (pigmentary degeneration), optic neuritis, and cataracts

Respiratory: Acute respiratory distress syndrome (with dyspnea, cyanosis, and/or interstitial infiltrates)

Skin: Generalized rash

Urogenital: Dysuria, acute renal failure, increased serum creatinine and renal tubular disorders
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