Remicade Side Effects
Generic Name: infliximab
Note: This page contains side effects data for the generic drug infliximab. It is possible that some of the dosage forms included below may not apply to the brand name Remicade.
Common side effects of Remicade include: chest pain, nausea, abdominal pain, and back pain. Other side effects include: candidiasis, pruritus, diarrhea, vomiting, and sinusitis. See below for a comprehensive list of adverse effects.
For the Consumer
Applies to infliximab: intravenous powder for solution
As well as its needed effects, infliximab (the active ingredient contained in Remicade) may cause unwanted side effects that require medical attention.
If any of the following side effects occur while taking infliximab, check with your doctor or nurse immediately:More common:
- Abdominal or stomach pain
- chest pain
- flushing of the face
- muscle pain
- nasal congestion
- runny nose
- sore throat
- tightness in the chest
- troubled breathing
- unusual tiredness or weakness
- Back pain
- bloody or cloudy urine
- cracks in the skin at the corners of the mouth
- difficult or painful urination
- frequent urge to urinate
- pain or tenderness around the eyes and cheekbones
- skin rash
- soreness or irritation of the mouth or tongue
- soreness or redness around the fingernails or toenails
- vaginal burning or itching and discharge
- white patches in the mouth or on the tongue
- Abscess (swollen, red, tender area of infection containing pus)
- back or side pain
- black, tarry stools
- blood in the urine or stools
- bone or joint pain
- feeling of fullness
- general feeling of illness
- hernia (bulge of tissue through the wall of the abdomen)
- irregular or pounding heartbeat
- pain in the rectum
- pain spreading from the abdomen or stomach to the left shoulder
- pinpoint red spots on the skin
- stomach pain (severe)
- swollen or painful glands
- tendon injury
- unusual bleeding or bruising
- weight loss (unusual)
- yellow skin and eyes
- Area rash
- bloody nose
- burning, tingling, numbness or pain in the hands, arms, feet, or legs
- change in mental status
- clay-colored stools
- continuing vomiting
- dark or bloody urine
- difficulty with speaking
- difficulty with swallowing
- fast heartbeat
- general feeling of tiredness or weakness
- heavier menstrual periods
- inability to move the arms and legs
- itching, puffiness, or swelling of the eyelids or around the eyes, face, lips, or tongue
- light-colored stools
- loss of appetite
- loss of bladder control
- lower back or side pain
- muscle spasm or jerking of all extremities
- noisy breathing
- painless swelling in the neck, armpits, or groin
- pale skin
- red, scaling, or crusted skin
- redness, soreness, or itching skin
- sensation of pins and needles
- severe abdominal or stomach pain
- severe muscle weakness, sudden and progressing
- slow or irregular breathing
- sores, welting, or blisters
- stabbing pain
- sudden loss of consciousness
- sudden numbness and weakness in the arms and legs
- unpleasant breath odor
- upper right abdominal or stomach pain
- vomiting of blood
For Healthcare Professionals
Applies to infliximab: intravenous powder for injection
One of the most-common reasons for discontinuation of treatment was infusion-related reactions (e.g., dyspnea, flushing, headache, and rash)[Ref]
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]
Most cases of tuberculosis occurred within the first two months after the start of infliximab therapy and may reflect recrudescence of latent disease.
Cutaneous and miliary tuberculosis, as a result of tuberculosis reactivation, has been reported in a 56-year-old white male with a history of Crohn's disease treated with infliximab.
Infections have been observed in all organ systems and have been reported in patients receiving infliximab alone or in combination with immunosuppressive agents.
Patients with antibodies to infliximab were more likely to have higher rates of clearance, reduced efficacy, and to experience an infusion reaction.
Crohn's patients with (+) ANA prior to infliximab were approximately 2 times as likely to develop anti-dsDNA antibodies.
Various case reports of non-Crohn's and Crohn's patient, developed clinical symptoms of a lupus-like syndrome. Symptoms resolved and antibodies disappeared when infliximab was discontinued.
Disseminated Salmonella typhimurium infection has been reported in a Fijian Indian man while undergoing his twenty-eighth week of infliximab therapy for the treatment of psoriasis and psoriatic arthritis. Patient's symptoms resolved after treatment with intravenous ciprofloxacin.
Disseminated cryptococcal infection has been reported in a 72-year-old male after his second infusion of infliximab for rheumatoid arthritis.
A 56-year-old male developed protothecosis after a stem cell transplantation coincident with infliximab therapy. He was administered infliximab for graft-versus-host disease. Two weeks later, he became lethargic and developed bilateral olecranon bursitis and bullous skin lesions. Blood cultures grew Klebsiella pneumoniae and Prototheca wickerhamii. The patient subsequently developed multiorgan failure and died after 5 weeks of hospitalization. The use of infliximab likely played a role in this case.[Ref]
Very common (10% or more): Upper respiratory tract infection (up to 32%), sinusitis (up to 14%), pharyngitis (up to 12%), cough (up to 12%), bronchitis (up to 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]
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]
In order to avoid the development of delayed severe systemic reactions, some researchers recommend multiple early infusions of infliximab (the active ingredient contained in Remicade) if retreatment is anticipated.
Delayed hypersensitivity reactions during psoriasis studies generally occurred within 2 weeks following repeat infusion.
During one clinical trial, Crohn's disease patients were retreated following 2 to 4 years without infliximab. Patients experiencing side effects following readministration did not have infusion-related side effects associated with their initial infliximab treatment.[Ref]
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]
Very common (10% or more): Headache (up to 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]
One patient reported hypoesthesia in the left leg eight hours after her first infliximab infusion.
Another patient reported dysesthesia in the distribution of the left peroneal nerve, after her 6th intravenous infliximab infusion.
Although demyelination observed in postmarketing experience did not show causal relationship between adverse events and infliximab, the neurologic side effects resolved, partially or completely, on discontinuation of therapy.
A 51-year-old female with Crohn's disease experienced meningitis coincident with infliximab therapy. The patient developed a headache, fever, arthralgia, myalgia, and meningismus after receiving an infliximab infusion. Cerebrospinal fluid analysis was remarkable for a neutrophilic pleocytosis and elevated protein. Other potential causes of meningitis were ruled out. The patient's symptoms completely resolved within 24 hours of presentation.
A 28-year-old female with a 7-year history of Crohn disease experienced acute neuropathy with multiple conduction blocks coincident with infliximab therapy. Infliximab (5 mg/kg, 4 infusions in 2 years) therapy was added to azathioprine (150 mg per day) 5 years into her disease. Three weeks after the overall fourth dose of infliximab treatment, she developed left radial nerve palsy and slight weakness of left foot flexion and extension. Neurologic examination and motor nerve conduction studies were positive for acute neuropathy with multiple conduction blocks.
A 66-year-old male with rheumatoid arthritis experienced West Nile virus (WNV) coincident with infliximab therapy. The patient presented with a 2-day history of fever, headache, confusion, agitation, nausea, malaise, myalgias, gait instability, and rapidly worsening lower extremity weakness. He had received infliximab 3 weeks prior to symptom onset. His only other medications were amlodipine (5 mg per day) and methotrexate (15 mg per week). WNF was confirmed by with cerebral spinal fluid positive for WNV IgM antibodies by ELISA capture technique. The patient eventually died due to WNF infection.
A 41-year-old female with erosive rheumatoid arthritis experienced neurosarcoidosis coincident with infliximab therapy. She had been successfully treated with infliximab 3 mg/kg every 6 to 8 weeks together with methotrexate, without side effects. Approximately five years later, after receiving an infliximab infusion, she experienced feeling tired, a low grade fever, and headache. Two weeks later, she presented without any neurological symptoms besides headache. She was hospitalized one week later. The headache remained unchanged and 4 weeks after admission, she developed diplopia. At neuron-ophthalmological examination, nerve palsy of the left eye and a severe papilledema in both eyes were observed. Further, bilateral granulomatous iridocyclitis and retinal periphlebitis, typical for sarcoidosis, were noted. The sarcoidosis diagnosis was supported by the increased activity in the mediastinal lymph nodes bilaterally and in the parotid glands observed with In-DTPA-octreotide scintigraphy. She received a ventriculoperitoneal shunt 5 weeks after being admitted. Following surgery, the patient became free of headache and the pathological ophthalmologic changes slowly subsided.
A 62-year-old female reported she was hospitalized for five days due to a reaction characterized by shaking uncontrollably due to taking infliximab. The patient did not know the date of admission stating it was a long time ago when she was in her twenties. The patient reported being diagnosed with Crohn's disease at age 21.[Ref]
Very common (10% or more): Nausea (up to 21%), abdominal pain (up to 12%), diarrhea (up to 12%), dyspepsia (up to 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]
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]
A higher incidence of mortality and hospitalization for worsening heart failure have been reported among patients with moderate to severe (NYHA class III-IV) heart failure treated with the higher dose of infliximab (10 mg/kg). At 1 year, eight patients in the infliximab 10 mg/kg group had died compared with four deaths each in the infliximab 5 mg/kg and the placebo group.
Heart failure (n=18) reported in postmarketing experience developed on average 6 months after initiation of infliximab therapy.
Bradycardia with second degree atrioventricular (AV) block has been reported to occur, as soon as 30 minutes into the infliximab infusion, in a 52-year-old woman with fistulizing Crohn's disease who had no previous history of cardiac disease. The bradycardia, and second degree AV block, persisted for 36 hours after infliximab was discontinued. After a cardiology consult, and placement of a pacemaker, patient resumed her infliximab therapy without adverse events reported.
A 70-year-old man with fistulizing Crohn's disease, and a prior history of coronary artery disease and taking atenolol, developed dyspnea, chest heaviness, and dizziness while receiving his third infusion of infliximab. He had reported chills and pruritus during previous infusions of infliximab. He presented with a drop in heart rate with ECG showing type 2 Sinoatrial block. Patient received a permanent pacemaker. Infliximab therapy was stopped and patient had surgery for fistulizing Crohn's disease.[Ref]
Very common (10% or more): Rash (up to 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, necrotising fasciitis, bullous skin lesions, aggressive cutaneous T-cell lymphomas
Postmarketing reports: Worsening of symptoms of dermatomyositis[Ref]
Necrotizing fasciitis resulting in death has been reported in a 54-year-old man with rheumatoid arthritis receiving infliximab every 8 weeks along with intramuscular methotrexate weekly dosage. Blood cultures and skin swabs grew hemolytic group A streptococcus.
Bullous skin lesions have been reported in a 72-year-old white man one day after his fourth dose of infliximab for the treatment of severe rheumatoid arthritis. Although proximity of symptoms point to infliximab, causality was not definitive.
Two cases of aggressive cutaneous T-cell lymphomas that progressed rapidly have been reported during therapy with infliximab. Sezary syndrome developed in one patient after 18 months of treatment and systemic anaplastic large cell lymphoma with cutaneous involvement developed in the other patient four weeks following the third dose of infliximab.
A 40-year-old female with Crohn disease experienced acne coincident with infliximab therapy. The patient had been administered infliximab 5 mg/kg with rapid and effective symptomatic control. Several weeks after initiating infliximab therapy, the patient developed a papulopustular eruption on the face and back with some comedones. The eruption persisted, albeit with fluctuating severity, and dermatological opinion was obtained. Histology was consistent with the clinical diagnosis of acne and other Crohn disease-associated dermatoses were excluded. Infliximab was not discontinued because of the excellent control of the bowel disease. Instead, the patient was treated with minocycline 100 mg daily.
A 70-year-old male with rheumatoid arthritis (RA) experienced a primary cutaneous Nocardia otitidiscaviarum infection after a skin injury coincident with infliximab therapy. He was treated for RA with infliximab (3 mg/kg) for 3 years, as well as methotrexate (20 mg/week), and corticosteroids. Two weeks before the 18th infusion of infliximab, he was injured, and had a deep wound in his right palm. The hand lesion was not inflamed, but an erythematous pustular lesion appeared on the anterior side of his right forearm. Two weeks later the lesion spontaneously drained and formed a cutaneous nonpainful ulcer covered by white pus, with erythematous periphery. Nocardia otitidiscaviarum was subsequently isolated from the ulcer and biological samples showed inflammation. Infliximab therapy was discontinued. He was treated with combination clindamycin and ofloxacin antibiotic therapy for 3 months. Twenty days later, the skin ulcer had completely healed.
A 63-year-old female with a history of rheumatoid arthritis (RA) experienced atypical varicella exanthema coincident with infliximab therapy. The patient presented with a 10-day history of pruritic generalized papulovesicles which quickly progressed to flaccid vesicles, pustules, or erosions accompanied by fever and sore throat. Her RA had been treated with methotrexate (10 mg per week) and bucillamine (200 mg per day) for 6 years. Despite this medication, her RA was poorly controlled, so infliximab (3 mg/kg) was additionally administered twice, separated by 2-weekly intervals. Two days after the second course of infliximab therapy, a cutaneous eruption developed abruptly. Polymerase chain reaction showed varicella zoster virus. Based on these findings, the patient was diagnosed with varicella and was promptly started on a course of intravenous acyclovir and prophylactic antibiotics for 7 days. Three weeks later, her recovery was complete with minimal scars.
A 60-year-old male with a 5-year history of diffuse polyarthritis experienced leprosy and type 1 leprosy reaction coincident with infliximab therapy. The patient had been given 3 courses of infliximab; the last had been given 3 months prior to admission. One month after he received the first dose of infliximab, the patient developed a rash on 1 extremity that progressed to all extremities. Results of a skin biopsy suggested leprosy or Hansen disease. He was treated with multidrug therapy (MDT) of dapsone (100 mg daily), clofazimine (50 mg daily), and rifampin (300 mg monthly). One month after starting this treatment, the patient developed "reversal," or type 1, reactions. After 4 years, the cutaneous lesions had resolved, and MDT was withdrawn. Results of a skin biopsy performed 5 years after diagnosis showed advanced regression of the lesion with no residual bacilli.
A 37-year-old female with Crohn disease developed palmoplantar pustulosis (PPP) coincident with infliximab therapy. The patient was given a regimen of infliximab of 5 mg/kg resulting in complete remission of her bowel symptoms. One month later, she experienced classic PPP together with a mild psoriasiform eruption on the lower legs. In particular, the patient's feet were painful, which adversely affected her mobility. As treatment, she was prescribed betamethasone dipropionate twice daily, polythene occlusion at night, and soap-free wash and moisturizer. Over the following 3 to 4 weeks, the patient improved clinically and symptomatically and did not need additional psoriasis therapy.
Alopecia areata has been reported in a 51-year-old white woman with rheumatoid arthritis and Sjogren syndrome after 11 months of infliximab therapy. The hair loss eventually involved 100% of the scalp as well as her eyebrows and eyelashes.[Ref]
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]
Clinical trials of infliximab have reported a 3-fold higher incidence than expected in the general population of developing lymphomas among rheumatoid arthritis patients. Among patients diagnosed with Crohn's disease and rheumatoid arthritis, there is 6-fold higher incidence than expected in the general population. Patients with highly active disease and/or chronic exposure to immunosuppressants may be at a higher risk (up to several fold) than the population at large for the development of lymphoma.
During a controlled clinical trial studying the use of infliximab in 157 patients with moderate to severe COPD who were either current smokers or ex-smokers, 9 patients developed a malignancy, including 1 lymphoma.
Acute lymphoblastic leukemia has been diagnosed in a patient eight days after receiving a third infusion of infliximab 5 mg/kg for the treatment of Crohn's disease. A causal relationship was not clearly established.
Postmarketing adverse events reports have included lymphoproliferative disorders (n=8) that developed, on average, 8 weeks after initiation of therapy with infliximab. The majority of cases (81%) were non-Hodgkin's lymphomas.
A meta-analysis has reported that there is dose-dependent increased risk of malignancies in patients with rheumatoid arthritis treated with anti-TNF antibody therapy.
A 75-year-old male with ankylosing spondylitis experienced Sezary syndrome coincident with infliximab therapy. He had been initially treated with nonsteroidal antiinflammatory drugs, then with prednisone 10 mg daily for 6 months, and thereafter treatment was switched to infliximab 3 mg/kg at 2 monthly intervals. After 17 months of this therapy, he was diagnosed with Sezary syndrome. Cutaneous lesions partially remitted following infliximab discontinuation and methotrexate treatment.[Ref]
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]
Severe hepatic reactions have occurred between weeks two to more than a year after initiation of infliximab.
In general, patients who developed elevated ALT and AST were asymptomatic, and the abnormalities decreased or resolved with either continuation or discontinuation of infliximab, or modification of concomitant medications.
Cholestatic liver disease has been reported in a 44-year-old woman 19 days after a single dose of infliximab.
A 45-year-old female with a history of Crohn disease experienced cytomegalovirus hepatitis coincident with infliximab therapy. She had been administered mercaptopurine 50 mg per day for the past 8 years until intravenous infliximab 5 mg/kg at 4 to 8 week intervals was added for better control of the disease. Approximately one year later, the patient was admitted to the hospital with a 4-week history of daily fever and chills unresponsive to several courses of empirical antimicrobial therapy. Histological examination of a liver biopsy specimen showed intranuclear inclusion bodies, confirmed by cytomegalovirus by paraffin immunoperoxidase staining with antibody against this virus. After intravenous ganciclovir 5 mg/kg twice daily therapy, the patient's symptoms and laboratory values improved within a few days.[Ref]
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]
Some cases of leukopenia, neutropenia, thrombocytopenia, and pancytopenia had a fatal outcome.[Ref]
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]
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]
Uncommon (0.1% to 1%): Dehydration
Frequency not reported: Extra-high levels of VLDL-triglycerides[Ref]
Very common (10% or more): Injection site reaction (up to 27%)(mainly erythema, pruritus, rash, and pain of mild to moderate severity)[Ref]
Common (1% to 10%): Urinary tract infection, moniliasis
Frequency not reported: Menstrual irregularity, herpes simplex, endometritis, dysuria, urethral obstruction[Ref]
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]
A 55-year-old woman diagnosed with rheumatoid arthritis developed decreased vision in the left eye accompanied by pain with eye movement 3 days after her 9th infusion (at 1 year of treatment) with infliximab. Patient's vision slowly improved and her visual field deficit resolved after treatment with 1 g methylprednisolone injection per day for 3 days followed by a tapering dose of oral prednisone over 10 days.
A week after the seventh infusion of infliximab 5 mg/kg, a 45-year-old woman with type 2 diabetes mellitus and Crohn's disease developed pain and blurred vision in the left eye. Visual acuity was 20/70. Patient recovered after treatment with intravenous methylprednisolone, followed by a tapering dose of oral prednisone. On examination 3 months later she had 20/20 visual acuity, normal color vision, mild residual left-sided headache, and a normal-appearing optic nerve in the left eye.
A 42-year-old male developed severe unilateral orbital cellulitis while receiving infliximab therapy for ankylosing spondylitis during a clinical trial. Cultures showed Staphylococcus aureus. Infliximab therapy was stopped and the patient made a full recovery after receiving appropriate antibiotic therapy. Infliximab treatment was resumed after three weeks.
A 47-year-old male with rheumatoid arthritis experienced third nerve palsy coincident with infliximab therapy. He received monthly infusions of 300 mg of infliximab for the disease. He initially presented with painless ptosis of his right upper eyelid along with double vision in left and up gaze. Brain magnetic resonance imaging (MRI) showed gadolinium enhancement of the cisternal segment of the right oculomotor nerve. After stopping infliximab therapy, the diplopia and ptosis gradually resolved during 3 months. Repeat MRI imaging showed resolution of the oculomotor nerve enhancement.[Ref]
Common (1% to 10%): Depression, insomnia
Uncommon (0.1% to 1%): Amnesia, agitation, confusion, somnolence, nervousness
Rare (less than 0.1%): Apathy
Frequency not reported: Suicide attempt[Ref]
1. Kinder A, Stephens S, Mortimer N, Sheldon P "Severe herpes zoster after infliximab infusion." Postgrad Med J 80 (2004): 26
2. Fu A, Bertouch JV, McNeil HP "Disseminated Salmonella typhimurium infection secondary to infliximab treatment." Arthritis Rheum 50 (2004): 3049
3. Daniel CL, Moreland LW "Infliximab: additional safety data from an open label study." J Rheumatol 29 (2002): 647-9
4. Targan SR, Hanauer SB, van Deventer SJ, et al. "A short-term study of chimeric monoclonal antibody cA2 to tumor necrosis factor a for Crohn's disease." N Engl J Med 337 (1997): 1029-35
5. True DG, Penmetcha M, Peckham SJ "Disseminated cryptococcal infection in rheumatoid arthritis treated with methotrexate and infliximab." J Rheumatol 29 (2002): 1561-3
6. Wasserman MJ, Weber DA, Guthrie JA, Bykerk VP, Lee P, Keystone EC "Infusion-related reactions to infliximab in patients with rheumatoid arthritis in a clinical practice setting: relationship to dose, antihistamine pretreatment, and infusion number." J Rheumatol 31 (2004): 1912-7
7. Goulet CJ, Iqbal SS "A 20 year-old man with ileo-colonic histoplasmosis exacerbated by infliximab." Am J Gastroenterol 98(9S) (2003): S170
8. Kugathasan S, Levy MB, Saeian K, et al. "Infliximab retreatment in adults and children with Crohn's disease: risk factors for the development of delayed severe systemic reaction." Am J Gastroenterol 97 (2002): 1408-14
9. Bruyn GA "Extraarticular rheumatoid arthritis and drug-induced syndromes: understanding the role of tumor necrosis factor inhibitors." J Rheumatol 31 (2004): 1461; author reply 1462
10. Cheifetz A, Smedley M, Martin S, et al. "The incidence and management of infusion reactions to infliximab: a large center experience." Am J Gastroenterol 98 (2003): 1315-24
11. Nakelchik M, Mangino JE "Reactivation of histoplasmosis after treatment with infliximab." Am J Med 112 (2002): 78-9
12. Gottlieb GS, Lesser CF, Holmes KK, Wald A "Disseminated Sporotrichosis Associated with Treatment with Immunosuppressants and Tumor Necrosis Factor-alpha Antagonists." Clin Infect Dis 37 (2003): 838-40
13. Wallis RS, Broder MS, Wong JY, Hanson ME, Beenhouwer DO "Granulomatous infectious diseases associated with tumor necrosis factor antagonists." Clin Infect Dis 38 (2004): 1261-5
14. Ricart E, Panaccione R, Loftus EV, Tremaine WJ, Sandborn WJ "Successful management of Crohn's disease of the ileoanal pouch with infliximab." Gastroenterology 117 (1999): 429-32
15. Vonkeman H, Ten Napel C, Rasker H, van de Laar M "Disseminated primary varicella infection during infliximab treatment." J Rheumatol 31 (2004): 2517-8
16. Maini R, StClair EW, Breedveld F, Furst D, Kalden J, Weisman M, Smolen J, Emery P, Harriman G, Feldmann M, Lipsky P "Infliximab (Chimeric anti-tumour necrosis factor alpha monoclonal antibody) versus placebo in rheumatoid arthritis patients receiving concomitant methotrexate: a randomised phase III trial." Lancet 354 (1999): 1932-9
17. Hage CA, Wood KL, Winer-Muram HT, Wilson SJ, Sarosi G, Knox KS "Pulmonary Cryptococcosis After Initiation of Anti-Tumor Necrosis Factor-alpha Therapy." Chest 124 (2003): 2395-7
18. Netea MG, Radstake T, Joosten LA, Van Der Meer JW, Barrera P, Kullberg BJ "Salmonella septicemia in rheumatoid arthritis patients receiving anti-tumor necrosis factor therapy: Association with decreased interferon-gamma production and toll-like receptor 4 expression." Arthritis Rheum 48 (2003): 1853-7
19. Baert F, Noman M, Vermeire S, et al. "Influence of immunogenicity on the long-term efficacy of infliximab in Crohn's disease." N Engl J Med 348 (2003): 601-8
20. Ali Y, Shah S "Infliximab-induced systemic lupus erythematosus." Ann Intern Med 137 (2002): 625-6
21. De Rycke L, Kruithof E, Van Damme N, et al. "Antinuclear antibodies following infliximab treatment in patients with rheumatoid arthritis or spondylarthropathy." Arthritis Rheum 48 (2003): 1015-23
22. Present DH, Rutgeerts P, Targan S, et al. "Infliximab for the treatment of fistulas in patients with Crohn's disease." N Engl J Med 340 (1999): 1398-405
23. Rutgeerts P, DHaens G, Targan S, Vasiliauskas E, Hanauer SB, Present DH, Mayer L, VanHogezand RA, Braakman T, DeWoody KL, Scha "Efficacy and safety of retreatment with anti-tumor necrosis factor antibody (Infliximab) to maintain remission in Crohn's disease." Gastroenterology 117 (1999): 761-9
24. Everitt DE "Important Drug Warning. Available from: URL: http://www.fda.gov/medwatch/SAFETY/2004/remicade_DHCP_dec04.pdf." ([2004 Dec]):
25. Vermeire S, Noman M, Van Assche G, et al. "Autoimmunity associated with anti-tumor necrosis factor alpha treatment in Crohn's disease: A prospective cohort study." Gastroenterology 125 (2003): 32-9
26. High WA, Muldrow ME, Fitzpatrick JE "Cutaneous lupus erythematosus induced by infliximab." J Am Acad Dermatol 52 (2005): E5
27. "Infliximab retreatment: caution advised." Am J Health Syst Pharm 56 (1999): 11
28. Christopher-Stine L, Wigley F "Tumor necrosis factor-alpha antagonists induce lupus-like syndrome in patients with scleroderma overlap/mixed connective tissue disease." J Rheumatol 30 (2003): 2725-7
29. Morelli J, Wilson FA "Does administration of infliximab increase susceptibility to listeriosis?." Am J Gastroenterol 95 (2000): 841-2
30. Louis M, Rauch J, Armstrong M, Fitzcharles MA "Induction of autoantibodies during prolonged treatment with infliximab." J Rheumatol 30 (2003): 2557-62
31. "Alemtuzumab induction and prednisone-free immunosuppression in solitary pancreas transplantation." Transplantation 82(1 Suppl 2) (2006): 221
32. Pharmaceutical Society of Australia "APPGuide online. Australian prescription products guide online. Available from: URL: http://www.appco.com.au/appguide/default.asp." ():
33. Lim WS, Powell RJ, Johnston ID "Tuberculosis and treatment with infliximab." N Engl J Med 346 (2002): 623-6
34. Weisman MH "What are the risks of biologic therapy in rheumatoid arthritis? An update on safety." J Rheumatol 29 Suppl 65 (2002): 33-8
35. "Product Information. Remicade (infliximab)." Centocor Inc, Malvern, PA.
36. Gomez-Reino JJ, Carmona L, Valverde VR, Mola EM, Montero MD "Treatment of rheumatoid arthritis with tumor necrosis factor inhibitors may predispose to significant increase in tuberculosis risk: A multicenter active-surveillance report." Arthritis Rheum 48 (2003): 2122-7
37. Lee JH, Slifman NR, Gershon SK, et al. "Life-threatening histoplasmosis complicating immunotherapy with tumor necrosis factor alpha antagonists infliximab and etanercept." Arthritis Rheum 46 (2002): 2565-70
38. Patel S, Kulkarni A, Agrawal R, Shahwali A "Cutaneous tuberculosis associated with infliximab treatment." Am J Gastroenterol 98(9S) (2003): S185-S186
39. Keane J, Gershon S, Wise RP, et al. "Tuberculosis associated with infliximab, a tumor necrosis factor alpha-neutralizing agent." N Engl J Med 345 (2001): 1098-104
40. Kramer N, Chuzhin Y, Kaufman LD, Ritter JM, Rosenstein ED "Methotrexate pneumonitis after initiation of infliximab therapy for rheumatoid arthritis." Arthritis Rheum 47 (2002): 670-1
41. Khoury JA, Dubberke ER, Devine SM "Fatal case of protothecosis in a hematopoietic stem cell transplant recipient after infliximab treatment for graft-versus-host disease." Blood 104 (2004): 3414-5
42. Bowie VL, Snella KA, Gopalachar AS, Bharadwaj P "Listeria meningitis associated with infliximab." Ann Pharmacother 38 (2004): 58-61
43. Slifman NR, Gershon SK, Lee JH, Edwards ET, Braun MM "Listeria monocytogenes infection as a complication of treatment with tumor necrosis factor alpha-neutralizing agents." Arthritis Rheum 48 (2003): 319-24
44. Farrell RJ, Shah SA, Lodhavia PJ, Alsahli M, Falchuk KR, Michetti P, Peppercorn MA "Clinical experience with infliximab therapy in 100 patients with Crohn's disease." Am J Gastroenterol 95 (2000): 3490-7
45. Strong BY, Erny BC, Herzenberg H, Razzeca KJ "Retrobulbar optic neuritis associated with infliximab in a patient with Crohn disease." Ann Intern Med 140 (2004): W34
46. Nanavati SA, Ergun GA, Schwartz JT "Avoiding infliximab in the treatment of Crohn's disease in patients with multiple sclerosis." Am J Gastroenterol 98 (2003): 2333-4
47. Mohan N, Edwards ET, Cupps TR, et al. "Demyelination occurring during anti-tumor necrosis factor alpha therapy for inflammatory arthritides." Arthritis Rheum 44 (2001): 2862-9
48. Foroozan R, Buono LM, Sergott RC, Savino PJ "Clinicopathologic reports, case reports, and small case series: retrobulbar optic neuritis associated with infliximab." Arch Ophthalmol 120 (2002): 985-7
49. Richette P, Dieude P, Damiano J, Liote F, Orcel P, Bardin T "Sensory neuropathy revealing necrotizing vasculitis during infliximab therapy for rheumatoid arthritis." J Rheumatol 31 (2004): 2079-81
50. Khanna D, McMahon M, Furst DE "Anti-tumor necrosis factor alpha therapy and heart failure: what have we learned and where do we go from here?" Arthritis Rheum 50 (2004): 1040-50
51. Anand CP, Al-Juburi A, Sandeep B "Heart block occurring during infliximab infusion: a report of two cases." Am J Gastroenterol 98(9S) (2003): S144
52. Kwon HJ, Cote TR, Cuffe MS, Kramer JM, Braun MM "Case reports of heart failure after therapy with a tumor necrosis factor antagonist." Ann Intern Med 138 (2003): 807-11
53. "Summaries for patients. Tumor necrosis factor antagonists and heart failure." Ann Intern Med 138 (2003): I48
54. Adams AE, Zwicker J, Curiel C, et al. "Aggressive cutaneous T-cell lymphomas after TNFalpha blockade." J Am Acad Dermatol 51 (2004): 660-2
55. Jarrett SJ, Cunnane G, Conaghan PG, et al. "Anti-tumor necrosis factor-alpha therapy-induced vasculitis: case series." J Rheumatol 30 (2003): 2287-91
56. Chan AT, Cleeve V, Daymond TJ "Necrotising fasciitis in a patient receiving infliximab for rheumatoid arthritis." Postgrad Med J 78 (2002): 47-8
57. Kent PD, Davis JM 3rd, Davis MD, Matteson EL "Bullous skin lesions following infliximab infusion in a patient with rheumatoid arthritis." Arthritis Rheum 46 (2002): 2257-8; discussion 2259
58. Verea MM, Del Pozo J, Yebra-Pimentel MT, Porta A, Fonseca E "Psoriasiform eruption induced by infliximab." Ann Pharmacother 38 (2004): 54-7
59. Vergara G, Silvestre JF, Betlloch I, Vela P, Albares MP, Pascual JC "Cutaneous drug eruption to infliximab: report of 4 cases with an interface dermatitis pattern." Arch Dermatol 138 (2002): 1258-9
60. Esser AC, Abril A, Fayne S, Doyle JA "Acute development of multiple keratoacanthomas and squamous cell carcinomas after treatment with infliximab." J Am Acad Dermatol 50(5 Suppl) (2004): 75-7
61. Bickston SJ, Lichtenstein GR, Arseneau KO, Cohen RB, Cominelli F "The relationship between infliximab treatment and lymphoma in Crohn's disease." Gastroenterology 117 (1999): 1433-7
62. Mahe E, Descamps V, Grossin M, Fraitag S, Crickx B "CD30+ T-cell lymphoma in a patient with psoriasis treated with ciclosporin and infliximab." Br J Dermatol 149 (2003): 170-3
63. Alcain G, Andrade RJ, Queipo de Llano MP, Moreno MJ, Garcia-Cortes M, Franquelo E "Acute leukemia after infliximab therapy." Am J Gastroenterol 98 (2003): 2577
64. Brown SL, Greene MH, Gershon SK, Edwards ET, Braun MM "Tumor necrosis factor antagonist therapy and lymphoma development: Twenty-six cases reported to the Food and Drug Administration." Arthritis Rheum 46 (2002): 3151-8
65. Menghini VV, Arora AS "Infliximab-associated reversible cholestatic liver disease." Mayo Clin Proc 76 (2000): 84-6
66. Selby L, Harris C, deVilliers W "Crohn's disease, infliximab treatment and IgA nephropathy." Am J Gastroenterol 98(9S) (2003): S199
67. Mejico LJ "Infliximab-associated retrobulbar optic neuritis." Arch Ophthalmol 122 (2004): 793-4
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