Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Delayed Reactions [see Warnings and Precautions ( 5.2 )] Increased Risk of Toxicity in Patients with Underlying Conditions [see Warnings and Precautions ( 5.3 )] Iron Overload [see Warnings and Precautions ( 5.4 ) ] Fetal bradycardia [see Use in Specific Populations ( 8.1 )] The following adverse reactions associated with the use of INFeD 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.
Blood and lymphatic system disorders : Leukocytosis, lymphadenopathy.
Gastrointestinal disorders : Abdominal pain, nausea, vomiting, diarrhea.
General disorders and administration site conditions : chest pain, chest tightness, weakness, malaise, febrile episodes, chills, shivering, sterile abscess, atrophy/fibrosis (intramuscular injection site), brown skin and/or underlying tissue discoloration (staining), soreness or pain at or near intramuscular injection sites, swelling, inflammation.
Musculoskeletal and connective tissue disorders : Arthralgia, arthritis (may represent reactivation in patients with quiescent rheumatoid arthritis – [ s ee Warnings and Precautions ( 5.3 ) ] , myalgia, backache.
Ne rvous system disorders : Convulsions, seizures, syncope, headache, unresponsiveness, paresthesia, dizziness, numbness, unconsciousness, altered taste.
P sy chiatric disorders : Disorientation Respiratory , thoracic and mediastinal disorders : Respiratory arrest, dyspnea, bronchospasm, wheezing.
Renal and urinary disorders : Hematuria.
Skin and subcutaneous disorders : Urticaria, pruritus, purpura, rash, sweating.
5 WARNINGS AND PRECAUTIONS Delayed Reactions: May occur with large intravenous doses.
( 5.2 ) Increased Risk of Toxicity in Patients with Underlying Conditions: Monitor for toxicity in these patients.
( 5.3 ) Iron Overload: Excessive therapy can lead to iatrogenic hemosiderosis.
Do not administer to patients with iron overload.
Periodically monitor hematologic and iron parameters.
Like all medications, Infed can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: