Remicade Side Effects

Generic name: infliximab

Medically reviewed by Philip Thornton, DipPharm. Last updated on Feb 5, 2024.

Note: This document contains side effect information about infliximab. Some dosage forms listed on this page may not apply to the brand name Remicade.

Applies to infliximab: intravenous powder for solution. Other dosage forms:

powder for solution

Warning

Intravenous route (Powder for Solution)

Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis) and infections due to other opportunistic pathogens. Discontinue infliximab if a patient develops a serious infection. Perform test for latent TB; if positive, start treatment for TB prior to starting infliximab. Monitor all patients for active TB during treatment, even if initial latent TB test is negative. Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor (TNF) blockers, including infliximab. Postmarketing cases of fatal hepatosplenic T-cell lymphoma (HSTCL) have been reported in patients treated with TNF blockers including infliximab. Almost all had received azathioprine or 6-mercaptopurine concomitantly with a TNF-blocker at or prior to diagnosis. The majority of infliximab cases were reported in patients with Crohn’s disease or ulcerative colitis, most of whom were adolescent or young adult males.

Intravenous route (Powder for Solution)

Warning: Serious Infections and MalignancySerious InfectionsPatients treated with infliximab products are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Infliximab-dyyb should be discontinued if a patient develops a serious infection or sepsis.Reported infections include: 1) Active tuberculosis, including reactivation of latent tuberculosis. Patients with tuberculosis have frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent tuberculosis before infliximab-dyyb use and during therapy. Treatment for latent infection should be initiated prior to Infliximab-dyyb use. Active tuberculosis, including reactivation of latent tuberculosis. Patients with tuberculosis have frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent tuberculosis before infliximab-dyyb use and during therapy. Treatment for latent infection should be initiated prior to Infliximab-dyyb use. 2) Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Empiric anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness. 3) Bacterial, viral and other infections due to opportunistic pathogens, including Legionella and Listeria.The risks and benefits of treatment with infliximab-dyyb should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with infliximab-dyyb, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.MalignancyLymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including infliximab products.Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers including infliximab products. These cases have had a very aggressive disease course and have been fatal. Almost all patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. The majority of reported cases have occurred in patients with Crohn’s disease or ulcerative colitis and most were in adolescent and young adult males.

Intravenous route (Powder for Solution)

Increased risk of serious infections leading to hospitalization or death, including TB, bacterial sepsis, invasive fungal infections (such as histoplasmosis) and infections due to other opportunistic pathogens. Discontinue infliximab-abda if a patient develops a serious infection. Perform test for latent TB; if positive, start treatment for TB prior to starting infliximab-abda. Monitor all patients for active TB during treatment, even if initial latent TB test is negative. Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor (TNF) blockers, including infliximab. Postmarketing cases of fatal hepatosplenic T-cell lymphoma (HSTCL) have been reported in patients treated with TNF blockers including infliximab products. Almost all had received azathioprine or 6-mercaptopurine concomitantly with a TNF-blocker at or prior to diagnosis. The majority of reported cases have occurred in patients with Crohn’s disease or ulcerative colitis, most of whom were adolescent or young adult males.

Intravenous route (Powder for Solution)

Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis) and infections due to other opportunistic pathogens. Discontinue infliximab-qbtx if a patient develops a serious infection. Perform test for latent TB; if positive, start treatment for TB prior to starting infliximab-qbtx. Monitor all patients for active TB during treatment, even if initial latent TB test is negative. Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor (TNF) blockers, including infliximab products. Postmarketing cases of fatal hepatosplenic T-cell lymphoma (HSTCL) have been reported in patients treated with TNF blockers including infliximab products. Almost all had received azathioprine or 6-mercaptopurine concomitantly with a TNF-blocker at or prior to diagnosis. The majority of cases were reported in patients with Crohn disease or ulcerative colitis, most of whom were adolescent or young adult males.

Intravenous route (Powder for Solution)

Increased risk of serious infections leading to hospitalization or death, including TB, bacterial sepsis, invasive fungal infections (such as histoplasmosis) and infections due to other opportunistic pathogens. Discontinue infliximab-axxq if a patient develops a serious infection. Perform test for latent TB; if positive, start treatment for TB prior to starting infliximab-axxq. Monitor all patients for active TB during treatment, even if initial latent TB test is negative. Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor (TNF) blockers, including infliximab. Postmarketing cases of fatal hepatosplenic T-cell lymphoma (HSTCL) have been reported in patients treated with TNF blockers including infliximab products. Almost all had received azathioprine or 6-mercaptopurine concomitantly with a TNF-blocker at or prior to diagnosis. The majority of reported cases have occurred in patients with Crohn’s disease or ulcerative colitis, most of whom were adolescent or young adult males.

Serious side effects of Remicade

Along with its needed effects, infliximab (the active ingredient contained in Remicade) 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 or nurse immediately if any of the following side effects occur while taking infliximab:

More common

Black, tarry stools
bladder pain
bloody or cloudy urine
blurred vision
body aches or pain
chest pain
chills
cough
cough producing mucus
difficult, burning, or painful urination
difficulty breathing
dizziness
dryness or soreness of the throat
ear congestion
fever
frequent urge to urinate
headache
hoarseness
hives, itching, or rash
loss of voice
lower back or side pain
muscle pain
nervousness
pain or swelling in the arms or legs
pain or tenderness around the eyes and cheekbones
painful or difficult urination
pale skin
pounding in the ears
runny or stuffy nose
slow or fast heartbeat
sneezing
sore throat
sores, ulcers, or white spots on the lips or in the mouth
stomach pain
tender, swollen glands in the neck
tightness in the chest
trouble breathing
trouble swallowing
unusual bleeding or bruising
unusual tiredness or weakness
voice changes

Rare

Bleeding gums
blood in the stool
blue lips and fingernails
changes in skin color or tenderness of the foot or leg
chest discomfort
confusion
coughing that sometimes produces a pink frothy sputum
dark urine
decreased urination
dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
dry mouth
fast or noisy breathing
feeling of discomfort
general feeling of illness
general tiredness and weakness
high fever
hives
increased sweating
irregular or pounding heartbeat
light-colored stools
muscle aches
nausea
pinpoint red spots on the skin
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
rapid, shallow breathing
swelling of the joints
sunken eyes
thirst
upper right abdominal or stomach pain
vomiting
unusual weight loss
wrinkled skin
yellow skin and eyes

Incidence not known

Back pain, sudden and severe
blistering, peeling, loosening of the skin
bloody nose
burning, tingling, numbness or pain in the hands, arms, feet, or legs
change in mental status
clay-colored stools
dark or bloody urine
diarrhea
difficulty with speaking
dilated neck veins
double vision
heavier menstrual periods
inability to move the arms, legs, or facial muscles
inability to speak
loss of appetite
muscle weakness, sudden and progressing
red, irritated eyes
red skin lesions, often with a purple center
seizures
sensation of pins and needles
slow or irregular breathing
slow speech
stabbing pain
temporary vision loss
vomiting of blood

Other side effects of Remicade

Some side effects of infliximab 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:

More common

Belching
difficulty in moving
feeling of warmth
heartburn
indigestion
muscle stiffness
redness of the face, neck, arms, and occasionally, upper chest

Less common

Constipation, severe

For Healthcare Professionals

Applies to infliximab: intravenous powder for injection, subcutaneous kit.

General

One of the most-common reasons for discontinuation of treatment was infusion-related reactions (e.g., dyspnea, flushing, headache, rash)^[Ref]

Immunologic

Very common (10% or more): Viral infection (e.g., influenza, herpes virus infection)

Common (1% to 10%): Bacterial infections (e.g., sepsis, cellulitis, abscess), moniliasis

Uncommon (0.1% to 1%): Tuberculosis, fungal infections (e.g., candidiasis), vaginitis

Rare (less than 0.1%): Meningitis, opportunistic infections (such as invasive fungal infections [pneumocystosis, histoplasmosis, aspergillosis, coccidioidomycosis, cryptococcosis, blastomycosis], bacterial infections [atypical mycobacterial, listeriosis, salmonellosis], and viral infections [cytomegalovirus]), parasitic infections, hepatitis B reactivation^[Ref]

Respiratory

Very common (10% or more): Upper respiratory tract infection (32%), sinusitis (14%), pharyngitis (12%), cough (12%), bronchitis (10%)

Common (1% to 10%): Lower respiratory tract infection (e.g., pneumonia), dyspnea, epistaxis

Uncommon (0.1% to 1%): Pulmonary edema, bronchospasm, pleurisy, pleural effusion

Rare (less than 0.1%): Interstitial lung disease (including rapidly progressive disease, lung fibrosis, pneumonitis), adult respiratory distress syndrome

Frequency not reported: Respiratory insufficiency, pulmonary embolism, shortness of breath^[Ref]

Other

Common (1% to 10%): Hot flush, flushing, fatigue, fever, chills

Uncommon (0.1% to 1%): Impaired healing, autoantibody positive

Rare (less than 0.1%): Granulomatous lesion, complement factor abnormal^[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Anaphylactic reaction, lupus-like syndrome, serum sickness or serum sickness-like reaction

Rare (less than 0.1%): Anaphylactic shock, vasculitis, sarcoid-like reaction

Frequency not reported: Facial, hand, or lip edema, sore throat^[Ref]

Nervous system

Very common (10% or more): Headache (18%)

Common (1% to 10%): Vertigo, dizziness, hypoesthesia, paresthesia

Uncommon (0.1% to 1%): Seizure, neuropathy

Rare (less than 0.1%): Transverse myelitis, central nervous system demyelinating disorders (multiple sclerosis-like disease and optic neuritis), peripheral demyelinating disorders (such as Guillain-Barre syndrome, chronic inflammatory demyelinating polyneuropathy and multifocal motor neuropathy), rheumatoid vasculitis, systemic vasculitis

Frequency not reported: Dysesthesia, meningitis, brain infarction, neuritis, peripheral neuropathy, Miller Fisher syndrome^[Ref]

Gastrointestinal

Very common (10% or more): Nausea (21%), abdominal pain (12%), diarrhea (12%), dyspepsia (10%)

Common (1% to 10%): Gastrointestinal hemorrhage, gastroesophageal reflux, constipation, vomiting

Uncommon (0.1% to 1%): Intestinal perforation, intestinal stenosis, diverticulitis, pancreatitis, cheilitis

Frequency not reported: Abdominal hernia, abscess, intestinal obstruction, proctalgia, ileus, abdominal hernia, abscess, intestinal obstruction, peritonitis, proctalgia^[Ref]

Cardiovascular

Common (1% to 10%): Tachycardia, palpitation, chest pain

Uncommon (0.1% to 1%): Cardiac failure (new onset or worsening), arrhythmia, syncope, bradycardia, peripheral ischemia

Rare (0.01% to 0.1%): Cyanosis, pericardial effusion, circulatory failure, vasospasm

Very rare (less than 0.01%): Heart block

Frequency not reported: Myocardial ischemia/myocardial infarction occurring during or within 2 hours of infusion^[Ref]

Dermatologic

Very common (10% or more): Rash (10%)

Common (1% to 10%): Ecchymosis, new onset or worsening psoriasis including pustular psoriasis (primarily palms and soles), urticaria, pruritus, hyperhidrosis, dry skin, fungal dermatitis, alopecia

Uncommon (0.1% to 1%): Bullous eruption, onychomycosis, rosacea, skin papilloma, hyperkeratosis, abnormal skin pigmentation, cellulitis, eczema/seborrhea, furunculosis, verruca

Rare (0.01% to 0.1%): Petechia, granulomatous lesion

Very rare (less than 0.01%): Toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, necrotizing fasciitis, bullous skin lesions, aggressive cutaneous T-cell lymphomas

Postmarketing reports: Worsening of symptoms of dermatomyositis, lichenoid reactions^[Ref]

Oncologic

Rare (less than 0.1%): Lymphoma, non-Hodgkin's lymphoma, Hodgkin's disease, leukemia, melanoma

Very rare (0.01% to 0.01%): Breast cancer, colorectal cancer

Frequency not reported: Hepatosplenic T-cell lymphoma (primarily in adolescents and young adults with Crohn's disease and ulcerative colitis), Merkel cell carcinoma

Frequency not reported: Nonmelanoma skin cancer, neoplasms (basal cell and breast)^[Ref]

Hepatic

Common (1% to 10%): Hepatic function abnormal, transaminases increased

Uncommon (0.1% to 1%): Hepatitis, hepatocellular damage, cholecystitis, cholelithiasis

Rare (less than 0.1%): Autoimmune hepatitis, jaundice

Frequency not reported: Liver failure, autoimmune hepatitis, biliary pain, cytomegalovirus^[Ref]

Hematologic

Common (1% to 10%): Neutropenia, leucopenia, lymphadenopathy

Uncommon (0.1% to 1%): Thrombocytopenia, lymphopenia, lymphocytosis, thrombophlebitis, hematoma, pyelonephritis

Rare (less than 0.1%): Agranulocytosis, thrombotic thrombocytopenic purpura, pancytopenia, hemolytic anemia, idiopathic thrombocytopenic purpura,

Frequency not reported: Aplastic anemia, splenic infarction, splenomegaly^[Ref]

Musculoskeletal

Common (1% to 10%): Arthralgia, myalgia, back pain

Uncommon (0.1% to 1%): Tendon injury

Frequency not reported: Intervertebral disk herniation, infective arthritis, swelling of fingers, paresthesia in the forearm region^[Ref]

Renal

Common (1% to 10%): Kidney infarction (less than 2%)

Uncommon (0.1% to 1%): Renal calculus, renal failure

Very rare (less than 0.01%): IgA nephropathy, pyelonephritis^[Ref]

Metabolic

Uncommon (0.1% to 1%): Dehydration

Frequency not reported: Extra-high levels of VLDL-triglycerides^[Ref]

Local

Very common (10% or more): Injection site reaction (e.g., erythema, pruritus, rash, mild to moderate pain) (27%)^[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection, moniliasis

Frequency not reported: Menstrual irregularity, herpes simplex, endometritis, dysuria, urethral obstruction^[Ref]

Ocular

Common (1% to 10%): Conjunctivitis

Uncommon (0.1% to 1%): Keratitis, periorbital edema, hordeolum

Rare (0.01% to 0.1%): Endophthalmitis

Very rare (less than 0.01%): Retrobulbar optic neuritis of the left eye, orbital cellulitis, third nerve palsy, transient visual loss associated with infliximab (the active ingredient contained in Remicade) administration (during or within 2 hours of infusion)

Frequency not reported: Transient visual loss occurring during or within 2 hours of infusion^[Ref]