Simponi Side Effects
Generic name: golimumab
Note: This document contains side effect information about golimumab. Some of the dosage forms listed on this page may not apply to the brand name Simponi.
Some side effects of Simponi may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
For the Consumer
Applies to golimumab: subcutaneous solution
Get emergency medical help if you have any of these signs of an allergic reaction while taking golimumab (the active ingredient contained in Simponi) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using golimumab and call your doctor right away if you have any of these symptoms of lymphoma:
fever, night sweats, weight loss, tiredness;
feeling full after eating only a small amount;
pain in your upper stomach that may spread to your shoulder;
easy bruising or bleeding, pale skin, feeling light-headed or short of breath, rapid heart rate; or
nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Stop using golimumab and call your doctor at once if you have any of these other serious side effects:
signs of infection (fever, chills, sore throat, flu symptoms, stomach pain, diarrhea, muscle aches);
shortness of breath with swelling of your ankles or feet;
chest pain, ongoing cough, coughing up mucus or blood;
vision changes, neck stiffness, seizure;
numbness or tingly feeling, weakness in your legs;
loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
joint pain or swelling with fever, swollen glands, muscle aches, nausea, vomiting, chest pain, unusual thoughts or behavior, and/or seizure (convulsions); or
patchy skin color, red spots, or a butterfly-shaped skin rash over your cheeks and nose (worsens in sunlight).
Less serious side effects of golimumab may include:
cold symptoms such as stuffy nose, sneezing, sore throat;
redness where you injected the medicine.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.
For Healthcare Professionals
Applies to golimumab: subcutaneous solution
Other side effects have included serious and sometimes fatal infections due to bacterial, mycobacterial, invasive fungal, viral, protozoal, or other opportunistic pathogens. Among opportunistic infections, tuberculosis, histoplasmosis, aspergillosis, candidiasis, coccidioidomycosis, listeriosis, and pneumocystosis were the most commonly reported with TNF blockers.
Other side effects have included the reactivation of hepatitis B virus (HBV) in patients who are chronic hepatitis B carriers (i.e., surface antigen positive).
Oncologic side effects have included an increase in the development of lymphoma in patients treated with TNF blockers including golimumab (the active ingredient contained in Simponi)
Cardiovascular side effects have included cases of worsening congestive heart failure (CHF) and new onset CHF. Hypertension has also been reported.
Nervous system side effects have included cases of new onset or exacerbation of central nervous system (CNS) demyelinating disorders, including multiple sclerosis (MS). Paraesthesia and dizziness has also been reported.
Hepatic side effects have included severe hepatic reactions including acute liver failure in patients receiving TNF blockers such as golimumab (the active ingredient contained in Simponi) Elevations of alanine aminotransferase and aspartate aminotransferase have been reported with the use of golimumab. A small number of deaths which have been attributed hepatosplenic T Cell Lymphoma have been reported in patients receiving other TNF blockers.
Hematologic side effects have included reports of pancytopenia, leukopenia, neutropenia, aplastic anemia, and thrombocytopenia in patients receiving TNF blockers.
Immunologic side effects have included the formation of autoantibodies and, rarely, with the development of a lupus-like syndrome. Cases of new onset psoriasis, including pustular psoriasis and palmoplantar psoriasis, have been reported with the use of TNF blockers, including golimumab (the active ingredient contained in Simponi) Postmarketing reports of sarcoidosis have been received.
Respiratory side effects have included upper respiratory tract infection, nasopharyngitis, bronchitis, sinusitis, influenza, pharyngitis, and rhinitis.
Local side effects have included injection site erythema.
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