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

General

The most common side effects were upper respiratory tract infection, sepsis, increased ALT, increased AST, tuberculosis, and anemia. The most serious side effects were serious infections and malignancies.

Respiratory

Very common (10% or more): Upper respiratory tract infections (nasopharyngitis, pharyngitis, laryngitis, and rhinitis) (up to 16%)
Common (1% to 10%): Bronchitis, sinusitis
Uncommon (0.1% to 1%): Lower respiratory tract infection (e.g., pneumonia), asthma and related symptoms (such as wheezing and bronchial hyperactivity), interstitial lung disease
Rare (less than 0.1%): Tuberculosis

Oncologic

Uncommon (0.1% to 1%): Neoplasms (e.g., skin cancer, squamous cell carcinoma, melanocytic nevus)
Rare (less than 0.1%): Lymphoma, leukemia, melanoma

Other

Common (1% to 10%): Pyrexia, asthenia
Rare (less than 0.1%): Impaired healing

Cardiovascular

Common (1% to 10%): Hypertension
Uncommon (0.1% to 1%): Congestive heart failure (new onset or worsening), arrhythmia, ischemic coronary artery disorders, thrombosis (e.g., deep venous and aortic), Raynaud's phenomenon, flushing, chest discomfort
Rare (less than 0.1%): Vasculitis (systemic)

Nervous system

Common (1% to 10%): Dizziness, headache
Uncommon (0.1% to 1%): Demyelinating disorders (central and peripheral), balance disorders, dysgeusia, paresthesia

Hepatic

Common (1% to 10%): Increased ALT and AST
Uncommon (0.1% to 1%): Cholelithiasis, hepatic disorders
Rare (less than 0.1%): Hepatitis B reactivation

Hematologic

Common (1% to 10%): Anemia
Uncommon (0.1% to 1%): Leucopenia, thrombocytopenia, pancytopenia
Frequency not reported: Aplastic anemia

Immunologic

Common (1% to 10%): Bacterial infections (such as cellulitis), viral infections (such as influenza and herpes), superficial fungal infections, autoantibody positive
Uncommon (0.1% to 1%): Septic shock, sepsis, opportunistic infections (e.g., invasive fungal infections [histoplasmosis, coccidioidomycosis, pneumocytosis], bacterial, atypical mycobacterial infection and protozoal), abscess
Rare (less than 0.1%): Sarcoidosis

Local

Common (1% to 10%): Injection site reactions (e.g., injection site erythema, urticaria, induration, pain, bruising, irritation, paresthesia)

Dermatologic

Common (1% to 10%): Pruritus, rash
Uncommon (0.1% to 1%): Psoriasis (new onset or worsening of pre-existing psoriasis, palmar/plantar and pustular), urticaria, vasculitis (cutaneous), alopecia, dermatitis
Rare (less than 0.1%): Skin exfoliation

Hypersensitivity

Common (1% to 10%): Allergic reactions (bronchospasm, urticaria)
Rare (less than 0.1%): Serious systemic hypersensitivity reactions (including anaphylactic reaction)

Endocrine

Uncommon (0.1% to 1%): Hypothyroidism, hyperthyroidism, goiter

Gastrointestinal

Common (1% to 10%): Constipation, dyspepsia, gastrointestinal and abdominal pain, nausea
Uncommon (0.1% to 1%): Gastrointestinal inflammatory disorders (e.g., gastritis and colitis), gastro-esophageal reflux disease, stomatitis

Genitourinary

Uncommon (0.1% to 1%): Breast disorders, menstrual disorders, bladder disorders

Metabolic

Uncommon (0.1% to 1%): Increased blood glucose, increased lipids

Musculoskeletal

Uncommon (0.1% to 1%): Bacterial arthritis, bone fractures
Rare (less than 0.1%): Infective bursitis, lupus-like syndrome

Ocular

Uncommon (0.1% to 1%): Blurred vision, decreased visual acuity, conjunctivitis, eye allergy (e.g., pruritus, irritation)

Psychiatric

Uncommon (0.1% to 1%): Depression, insomnia

Renal

Uncommon (0.1% to 1%): Renal disorders
Rare (less than 0.1%): Pyelonephritis

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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