Lamictal Starter Kit (Blue) Side Effects
Generic Name: lamotrigine
Please note - some side effects for Lamictal Starter Kit (Blue) may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
Side Effects by Body System - for Healthcare Professionals
Applies to: oral tablet; oral tablet, disintegrating; oral tablet, dispersible; oral tablet, extended release
Hypersensitivity reactions, some of which have been life-threatening or fatal, have been reported. Some of these reactions have included clinical features of multiorgan dysfunction such as hepatic abnormalities and evidence of disseminated intravascular coagulation. It is important to note that early manifestations of hypersensitivity (e.g., fever, lymphadenopathy) may be present even though a rash is not. If such signs or symptoms are present, the patient should be evaluated immediately. Lamotrigine should be discontinued if an alternative etiology for the signs or symptoms cannot be established.
When lamotrigine was added to concurrent antiepileptic drug therapy in controlled clinical studies, rash was reported in approximately 10% of patients. Severe, potentially life-threatening rashes have been reported in approximately 0.01% of patients. Rare deaths have also been reported. (The incidence of rash increases in multiple drug regimens.) Prior to initiation of treatment, patients should be instructed to report the occurrence of any new rashes to their physician.
Multiorgan failure, which in some cases has been fatal or irreversible, has been reported in patients receiving lamotrigine. Fatalities associated with multiorgan failure and various degrees of hepatic failure have been reported in 2 of 3,796 adult patients and 4 of 2,435 pediatric patients who received lamotrigine in clinical trials. No such fatalities have been reported in bipolar patients in clinical trials. Rare fatalities from multiorgan failure have also been reported in compassionate plea and postmarketing use. The majority of these deaths occurred in association with other serious medical events, including status epilepticus and overwhelming sepsis, and hantavirus making it difficult to identify the initial cause.
Three patients developed multiorgan dysfunction and disseminated intravascular coagulation nine to fourteen days after lamotrigine was added to their antiepileptic drug regimens. Rash and elevated transaminases were also present in all patients and rhabdomyolysis was noted in two patients. Two of the patients were receiving concomitant therapy with valproate, while the other patient was being treated with carbamazepine and clonazepam. All patients subsequently recovered with supportive care after treatment with lamotrigine was discontinued.
Rash resulting in hospitalization occurred in 0.3% of subjects who participated in clinical trials. These rashes included Stevens-Johnson syndrome, toxic epidermal necrolysis, angioedema, and rash associated with a number of systemic manifestations.
Unless the potential benefits clearly outweigh the risks, lamotrigine should not be restarted in patients who discontinued treatment due to rash associated with prior treatment with lamotrigine.
Nervous system side effects including dizziness (38%), ataxia (22%), somnolence (14%), incoordination (6%), insomnia (6%), tremor (4%), depression (4%), anxiety (4%), convulsion (3%), irritability (3%), speech disorder (3%), and concentration disturbance (2%) have been reported. Two cases of aseptic meningitis have been reported. Exacerbation of Parkinsonian symptoms in patients with preexisting Parkinson's disease/tics has also been reported.
General side effects including headache (29%), flu syndrome (7%), fever (6%), abdominal pain (5%), neck pain (2%), and seizure exacerbation (2%) have been reported.
Ocular side effects including diplopia (28%), blurred vision (16%), and vision abnormality (3%) have been reported. A case of blepharospasm has also been reported.
Gastrointestinal side effects including nausea (19%), vomiting (9%), diarrhea (6%), dyspepsia (5%), constipation (4%), tooth disorder (3%), anorexia (2%), pancreatitis, and esophagitis have been reported.
Respiratory side effects including rhinitis (14%), pharyngitis (10%), increased cough (8%), and apnea have been reported. A case of interstitial pneumonitis has also been reported.
Dermatologic side effects including rash (10%) and pruritus (3%) have been reported. Alopecia has been reported rarely. A case of toxic epidermal necrolysis has also been reported.
Genitourinary side effects including dysmenorrhea (7%), vaginitis (4%), and amenorrhea (2%) have been reported.
Other side effects including lymphadenopathy (2%) and three cases of dysgeusia have been reported. One study has reported that obese patients with bipolar I disorder lost weight while taking lamotrigine.
Metabolic side effects including edema (2%) have been reported.
Musculoskeletal side effects including arthralgia (2%) have been reported.
Cardiovascular side effects including hemorrhage have been reported.
Hematologic side effects including hemolytic anemia and agranulocytosis have been reported.
Psychiatric side effects including case reports of hypomania, delirium, and hallucinations have been reported. A case of lamotrigine-induced severe manic switch has also been reported.
Hepatic side effects have been reported including a case of acute hepatotoxicity (in the absence of other medications) and a case of fulminant hepatitis that occurred two weeks after introduction of lamotrigine.
Immunologic side effects including lupus-like reaction, vasculitis, and progressive immunosuppression have been reported.Top
- Lamictal Monograph (AHFS DI)
- Lamictal Prescribing Information (FDA)
- Lamictal Consumer Overview
- Lamictal Advanced Consumer (Micromedex) - Includes Dosage Information
- Lamictal MedFacts Consumer Leaflet (Wolters Kluwer)
- Lamictal ODT orally disintegrating tablets MedFacts Consumer Leaflet (Wolters Kluwer)
- Lamictal XR Prescribing Information (FDA)
- Lamictal XR extended-release tablets MedFacts Consumer Leaflet (Wolters Kluwer)
- Lamotrigine Prescribing Information (FDA)
- Lamotrigine Professional Patient Advice (Wolters Kluwer)
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