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
  • chills
  • cough
  • difficulty with breathing
  • ear congestion
  • fever
  • headache
  • loss of voice
  • muscle aches
  • sneezing
  • sore throat
  • stuffy or runny nose
  • unusual tiredness or weakness
Less common
  • Blurred vision
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • congestion
  • cough with mucus
  • diarrhea
  • dizziness
  • general feeling of discomfort or illness
  • hoarseness
  • joint pain
  • loss of appetite
  • muscle aches and pains
  • nausea
  • nervousness
  • pain or tenderness around the eyes and cheekbones
  • painful cold sores or blisters on the lips
  • pounding in the ears
  • shivering
  • shortness of breath or troubled breathing
  • slow or fast heartbeat
  • sweating
  • tender, swollen glands in the neck
  • tightness of the chest or wheezing
  • trouble with sleeping
  • trouble with swallowing
  • voice changes
  • vomiting
Rare
  • 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
Incidence not known
  • Hives
  • 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

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

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

Cardiovascular side effects have included cases of worsening congestive heart failure (CHF) and new onset CHF. Hypertension has also been reported.

Nervous system

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

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

Hematologic side effects have included reports of pancytopenia, leukopenia, neutropenia, aplastic anemia, and thrombocytopenia in patients receiving TNF blockers.

Immunologic

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

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

Local side effects have included injection site erythema.

Dermatologic

Postmarketing dermatologic side effects have included skin exfoliation and rash.

Hypersensitivity

Postmarketing hypersensitivity side effects have included serious systemic hypersensitivity reactions (including anaphylactic reaction).

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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