Applies to monomethyl fumarate: oral capsule delayed release.
Serious side effects of Monomethyl fumarate
Along with its needed effects, monomethyl fumarate 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 monomethyl fumarate:
Less common
- Chills
- cough
- fever
- hoarseness
- lower back or side pain
- painful or difficult urination
Incidence not known
- Chest tightness
- dark urine
- difficulty swallowing
- dizziness
- fast heartbeat
- hives, itching, skin rash
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
- loss of appetite
- painful blisters on trunk of body
- right upper stomach tenderness
- trouble with breathing
- unusual tiredness or weakness
- weight loss
- yellow eyes or skin
Other side effects of Monomethyl fumarate
Some side effects of monomethyl fumarate 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
- Diarrhea
- feeling of warmth
- nausea
- redness of the face, neck, arms, and occasionally, upper chest
- stomach pain
- vomiting
Less common
- Belching
- heartburn
- indigestion
- stomach discomfort or upset
For Healthcare Professionals
Applies to monomethyl fumarate: oral delayed release capsule.
Hematologic
Common (1% to 10%): Lymphopenia[Ref]
Hypersensitivity
Frequency not reported: Anaphylaxis, angioedema[Ref]
Immunologic
Frequency not reported: Herpes zoster, disseminated herpes zoster, herpes zoster ophthalmicus, herpes zoster meningoencephalitis, herpes zoster meningomyelitis, herpes simplex virus, West Nile virus, cytomegalovirus, Candida, Aspergillus, Nocardia, Listeria monocytogenes, Mycobacterium tuberculosis)[Ref]
Genitourinary
Common (1% to 10%): Albumin urine present[Ref]
Hepatic
Common (1% to 10%): Aspartate aminotransferase increased
Frequency not reported: Liver injury[Ref]
Nervous system
Frequency not reported: Progressive Multifocal Leukoencephalopathy (PML)[Ref]
Cardiovascular
Very common (10% or more): Flushing (40%)[Ref]
Dermatologic
Common (1% to 10%): Pruritus, rash, erythema[Ref]
Gastrointestinal
Very common (10% or more): Abdominal pain (18%), diarrhea (14%), nausea (12%)
Common (1% to 10%): Vomiting, dyspepsia[Ref]
