Glatiramer Side Effects
Some side effects of glatiramer 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 glatiramer: subcutaneous kit, subcutaneous powder for solution, subcutaneous solution
Along with its needed effects, glatiramer 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 glatiramer:More common
- bleeding, hard lump, hives or welts, itching, pain, redness, or swelling at the place of injection
- chest pain
- excessive muscle tone
- fast, irregular, pounding, or racing heartbeat or pulse
- joint pain
- lower back or side pain
- neck pain
- painful or difficult urination
- skin rash
- swelling or puffiness of the face
- swollen lymph glands
- swollen, painful, or tender lymph glands in the neck, armpit, or groin
- troubled breathing
- bloating or swelling
- difficulty with swallowing
- headache, severe and throbbing
- itching of the vagina or outside genitals
- muscle aches
- pain during sexual intercourse
- purple spots under the skin
- rapid weight gain
- red streaks on the skin
- shakiness in the legs, arms, hands, or feet
- small lumps under the skin
- spasm of the throat
- strong urge to urinate
- swelling of the fingers, arms, feet, or legs
- swelling or puffiness of the face
- thick, white curd-like vaginal discharge without odor or with mild odor
- tightness in the chest or wheezing
- tingling of the hands or feet
- trembling or shaking of the hands or feet
- unusual weight gain or loss
- Back pain
- blood in the urine
- burning or stinging of the skin
- continuous, uncontrolled back-and-forth or rolling eye movements
- decreased sexual ability
- difficulty with moving
- ear pain
- fast breathing
- high blood pressure
- irritation of the mouth and tongue (thrush)
- loss of appetite
- menstrual pain or changes
- muscle pain
- painful cold sores or blisters on the lips, nose, eyes, or genitals
- sensation of motion, usually whirling, either of oneself or of one's surroundings
- speech problems
- vision problems
Some side effects of glatiramer 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
- Increased sweating
- lack or loss of strength
- unusual tiredness or weakness
- Double vision
- runny nose
- seeing double
- weight gain
For Healthcare Professionals
Applies to glatiramer: subcutaneous kit, subcutaneous powder for injection, subcutaneous solution
Local side effects have included injection site reactions which have been reported to occur frequently compared to placebo. Injection site reactions have included injection site pain (73%), erythema (66%), inflammation (49%), pruritus (40%), injection site mass (27%), induration (13%), welts (11%), and urticaria (5%).
Cardiovascular side effects noted in premarketing clinical trials have included transient chest pain in approximately 25% of patients. The pain usually lasted only a few minutes, and may or may not have been associated with postinjection reactions. Vasodilation (27%) and palpitations (17%) have been reported. Hypertension has also been frequently reported.
The chest pain did not lead to further adverse clinical sequelae, although EKG monitoring was not performed during initial investigations. The episodes usually begin at least 1 month after initiation of treatment. The etiology and clinical significance of this symptom is unknown.
Hematologic side effects including lymphadenopathy have been reported in up to 25% of patients.
Gastrointestinal symptoms have included nausea (22%) and bowel urgency.
Respiratory side effects have included dyspnea (19%) and hyperventilation.
A 71-year-old male who had suffered from multiple sclerosis since 1992 experienced acute exacerbation of autoimmune hepatitis coincident with glatiramer therapy. He was treated with interferon beta-1b between 1994 and 2004. In January 2004, the interferon treatment was interrupted because of elevated serum liver enzyme activities. Two months later, glatiramer acetate 20 mg once a day was initiated. In May 2004, he presented with malaise and jaundice which was associated with elevated serum liver enzyme activities. In November 2005, the patient re-presented with fever, uncharacteristic abdominal symptoms, and elevated serum liver enzyme activities. At this stage, he was diagnosed with autoimmune hepatitis. As therapy, the patient commenced on budesonide 3 mg three times a day. The treatment led to a significant improvement of liver function tests. He was subsequently put on mycophenolate mofetil.
Hepatic side effects have been reported rarely. At least one case of hepatitis has been reported, in addition to a case of acute exacerbation of autoimmune hepatitis.
More about glatiramer
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