Thymoglobulin Side Effects

Please note - some side effects for Thymoglobulin 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 Thymoglobulin - for the Consumer

Thymoglobulin

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 Thymoglobulin:

Chills; diarrhea; dizziness; fever; general body discomfort; headache; nausea; swelling of the hands and feet; urinary tract infection; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); diarrhea; dizziness; easy bleeding or bruising; fast or irregular heartbeat; fever; infection; joint or muscle pain; persistent sore throat; stomach pain; unusual fatigue.

Side Effects by Body System

General

General side effects have frequently included fever and chills during infusion. Premedication with corticosteroids, acetaminophen, and/or antihistamines and slowing the infusion rate are recommended to prevent/alleviate this reaction. Night sweats, weakness or faintness, peripheral edema, and malaise have also been reported.

Hematologic

Hematologic side effects have included thrombocytopenia and leukopenia. Eosinophilia, deep vein thrombosis, neutropenia, granulocytopenia, anemia, hemolysis, hemolytic anemia, aplasia, pancytopenia, and nosebleed have also been reported.

Immunologic

Immunologic side effects have included Herpes simplex infection or reactivation, cytomegalovirus infection, sepsis, moniliasis, pneumonia, localized infection, systemic infection, viral hepatitis, lymphadenopathy, and tender lymph nodes. Prolonged use or high dosage of antithymocyte lymphocyte immune globulin and other immunosuppressants may increase the risk of severe infections. In a clinical trial (n=168), anti-rabbit antibodies developed in 68% of patients treated with rabbit ATG, and anti-horse antibodies developed in 78% of patients treated with equine ATG.

Hypersensitivity

Hypersensitivity side effects have rarely included anaphylaxis. Postmarketing experience indicates that anaphylaxis may occur at any time during therapy. The drugs should be stopped immediately and resuscitative measures implemented. Patients should not be rechallenged with the drug.

Gastrointestinal

Gastrointestinal side effects have included nausea, vomiting, diarrhea, stomatitis, GI bleeding or perforation, epigastric or stomach pain, sore mouth or throat, and oral and gastrointestinal moniliasis. Gastrointestinal bleeding or perforation and abdominal pain have also been reported.

Cardiovascular

Cardiovascular side effects have included hypotension, hypertension, iliac vein obstruction, tachycardia, bradycardia, myocarditis, cardiac irregularity, congestive heart failure, edema, peripheral edema, pulmonary edema, thrombophlebitis, chemical phlebitis, vasculitis, and clotted AV fistula.

Dermatologic

Dermatologic side effects have included rash, pruritus, urticaria, wheal, flare, toxic epidermal necrolysis, burning soles/palms, and foot sole pain. Pain at the infusion site has also been reported.

Endocrine

Endocrine side effects have included sweating,

Genitourinary

Genitourinary side effects have included urinary tract infection and vaginitis.

Hepatic

Hepatic side effects have included hepatosplenomegaly and abnormal liver function tests (SGOT, SGPT, alkaline phosphatase). Viral hepatitis has also been reported.

Metabolic

Metabolic side effects have included hyperglycemia and hyperkalemia.

Local

Local side effects have included pain, redness, and swelling at the infusion site.

Musculoskeletal

Musculoskeletal side effects have included arthralgia, myalgia, leg pains, and joint stiffness. Asthenia has also been reported.

Nervous system

Nervous system side effects have included encephalitis, postviral encephalopathy, abnormal involuntary movement, tremor, rigidity, paresthesias, confusion, disorientation, dizziness, seizures, asthenia, agitation, lethargy, listlessness, and lightheadedness.

Ocular

Ocular side effects have included periorbital edema.

Oncologic

Oncologic side effects have included malignancies. Prolonged use or overdosage may increase the incidence of lymphoma or post-transplant proliferative disease (PTLD).

Renal

Renal side effects have included renal artery thrombosis, abnormal renal function tests (serum creatinine), acute renal failure, enlarged or ruptured kidney, and proteinuria.

Respiratory

Respiratory side effects have included bilateral pleural effusion, respiratory distress, laryngospasm/edema, dyspnea, apnea, pulmonary edema, cough, hiccoughs, and pneumonia.

Other

Other side effects have included fever, chills, chest, back, or flank pain, abdominal pain, weakness, faintness, headache, malaise, night sweats, and wound dehiscence.

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