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: solution
Along with its needed effects, golimumab (the active ingredient contained in Simponi) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking golimumab:More common
- Body aches or pain
- difficulty with breathing
- ear congestion
- loss of voice
- muscle aches
- sore throat
- stuffy or runny nose
- unusual tiredness or weakness
- Blurred vision
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- cough with mucus
- general feeling of discomfort or illness
- joint pain
- loss of appetite
- muscle aches and pains
- pain or tenderness around the eyes and cheekbones
- painful cold sores or blisters on the lips
- pounding in the ears
- shortness of breath or troubled breathing
- slow or fast heartbeat
- tender, swollen glands in the neck
- tightness of the chest or wheezing
- trouble with sleeping
- trouble with swallowing
- voice changes
- Bone pain
- frequent or painful urination
- pain and inflammation at the joints
- redness, soreness, or itching skin
- severe abdominal or stomach pain
- sores, welting, or blisters
- yellow eyes or skin
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- red, scaling, or crusted skin
- skin rash
- swelling of the face, throat, or tongue
Some side effects of golimumab may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:Less common
- Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
- burning or stinging of the skin
- difficulty having a bowel movement (stool)
For Healthcare Professionals
Applies to golimumab: intravenous solution, 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) Postmarketing oncologic side effects have included melanoma.
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. Postmarketing respiratory side effects have included interstitial lung disease.
Local side effects have included injection site erythema.
Postmarketing dermatologic side effects have included skin exfoliation and rash.
Postmarketing hypersensitivity side effects have included serious systemic hypersensitivity reactions (including anaphylactic reaction).
More about Simponi (golimumab)
- Other brands: Simponi Aria
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