Drug information for LAMICTAL XR

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
TABLET, EXTENDED RELEASE; ORAL 100MG Prescription   LAMOTRIGINE lamotrigine SMITHKLINE BEECHAM 22115
2011-12-21 Other Important Information from FDA

2011-12-08 Label

2011-12-02 Letter

2011-08-08 Letter

2011-08-05 Label

2011-06-29 Label

2011-06-27 Letter

2011-04-28 Letter

2011-04-25 Label

2010-10-27 Letter

2010-10-27 Letter

2010-10-26 Medication Guide

2010-10-26 Medication Guide

2010-10-26 Other

2010-10-26 Other

2010-10-26 Label

2010-10-26 Label

2010-04-19 Medication Guide

2010-04-19 Medication Guide

2010-04-19 Label

2010-04-19 Label

2010-04-19 Letter

2010-04-19 Letter

2010-02-14 Summary Review

2010-02-14 Review

2009-09-29 Other

2009-09-25 Medication Guide

2009-06-10 Label

2009-06-10 Letter
TABLET, EXTENDED RELEASE; ORAL 200MG Prescription   LAMOTRIGINE lamotrigine SMITHKLINE BEECHAM   "
TABLET, EXTENDED RELEASE; ORAL 250MG Prescription   LAMOTRIGINE lamotrigine SMITHKLINE BEECHAM   "
TABLET, EXTENDED RELEASE; ORAL 25MG Prescription   LAMOTRIGINE lamotrigine SMITHKLINE BEECHAM   "
TABLET, EXTENDED RELEASE; ORAL 300MG Prescription   LAMOTRIGINE lamotrigine SMITHKLINE BEECHAM   "
TABLET, EXTENDED RELEASE; ORAL 50MG Prescription  (Reference Drug) LAMOTRIGINE lamotrigine SMITHKLINE BEECHAM   "
TABLET, EXTENDED RELEASE; ORAL 100MG Prescription   LAMOTRIGINE lamotrigine SMITHKLINE BEECHAM 22509
2011-12-21 Other Important Information from FDA

2011-05-06 Medication Guide

2011-02-17 Summary Review

2010-12-01 Review

2010-03-01 Other

2010-02-17 Letter

2010-02-16 Label
TABLET, EXTENDED RELEASE; ORAL 200MG Prescription   LAMOTRIGINE lamotrigine SMITHKLINE BEECHAM   "
TABLET, EXTENDED RELEASE; ORAL 25MG Prescription   LAMOTRIGINE lamotrigine SMITHKLINE BEECHAM   "
TABLET, EXTENDED RELEASE; ORAL 50MG Prescription   LAMOTRIGINE lamotrigine SMITHKLINE BEECHAM   "

Drug Adverse Effects information for LAMICTAL XR

Role code Indications Reaction # Reports
PS CONVULSION AMNESIA 2
PS CONVULSION BLISTER 1
PS CONVULSION BRONCHITIS 1
PS CONVULSION CONVULSION 3
PS CONVULSION DIPLOPIA 2
PS CONVULSION DRUG LEVEL DECREASED 3
PS CONVULSION ERYTHEMA MULTIFORME 1
PS CONVULSION GRAND MAL CONVULSION 3
PS CONVULSION HEADACHE 1
PS CONVULSION LUNG ABSCESS 1
PS CONVULSION MIGRAINE 2
PS CONVULSION MOUTH ULCERATION 1
PS CONVULSION MUSCULOSKELETAL CHEST PAIN 1
PS CONVULSION NAUSEA 2
PS CONVULSION PAIN 1
PS CONVULSION PNEUMOTHORAX 1
PS CONVULSION PRODUCT QUALITY ISSUE 3
PS CONVULSION RENAL FAILURE 1
PS CONVULSION SKIN DISCOLOURATION 1
PS CONVULSION SKIN EXFOLIATION 1
PS CONVULSION SPUTUM INCREASED 1
PS CONVULSION STEVENS-JOHNSON SYNDROME 2
PS CONVULSION THERMAL BURN 1
PS CONVULSION URINARY TRACT INFECTION 1
PS CONVULSION URTICARIA 1
PS CONVULSION VISION BLURRED 2
PS CONVULSION VISUAL ACUITY REDUCED 2
PS CONVULSION VISUAL IMPAIRMENT 2
PS CONVULSION VOMITING 2
PS EPILEPSY CONVULSION 1
PS EPILEPSY ILL-DEFINED DISORDER 1
PS EPILEPSY JOINT INJURY 1
PS EPILEPSY LIMB INJURY 1
PS EPILEPSY WHITE BLOOD CELL COUNT ABNORMAL 1
PS GRAND MAL CONVULSION DRUG INEFFECTIVE 2
PS GRAND MAL CONVULSION GRAND MAL CONVULSION 2
PS HEADACHE ABDOMINAL DISCOMFORT 1
PS HEADACHE ABDOMINAL PAIN UPPER 1
PS HEADACHE CHILLS 1
PS HEADACHE CONDITION AGGRAVATED 1
PS HEADACHE CONSTIPATION 1
PS HEADACHE DIARRHOEA 1
PS HEADACHE FLATULENCE 1
PS HEADACHE HYPERHIDROSIS 1
PS HEADACHE LIP SWELLING 1
PS HEADACHE MALAISE 1
PS HEADACHE MYALGIA 1
PS HEADACHE OEDEMA 1
PS HEADACHE OEDEMA PERIPHERAL 1
PS HEADACHE ORAL DISCOMFORT 1
PS HEADACHE PRURITUS 1
PS HEADACHE SWELLING 1
PS HEADACHE SWOLLEN TONGUE 1
PS HEADACHE VOMITING 1
PS HEADACHE WEIGHT INCREASED 1
PS PRODUCT USED FOR UNKNOWN INDICATION ANGER 1
PS PRODUCT USED FOR UNKNOWN INDICATION BRONCHITIS 1
PS PRODUCT USED FOR UNKNOWN INDICATION CARDIAC DISORDER 1
PS PRODUCT USED FOR UNKNOWN INDICATION CONVULSION 1
PS PRODUCT USED FOR UNKNOWN INDICATION COUGH 1
PS PRODUCT USED FOR UNKNOWN INDICATION HALLUCINATION 1
PS PRODUCT USED FOR UNKNOWN INDICATION ILL-DEFINED DISORDER 1
SS BIPOLAR DISORDER DIARRHOEA 1
SS BIPOLAR DISORDER SINUSITIS 1
SS CONVULSION CONVULSION 2
SS CONVULSION MATERNAL EXPOSURE DURING PREGNANCY 2
SS CONVULSION OVERDOSE 2
SS CONVULSION STARING 2
SS CONVULSION TREMOR 2
SS DEPRESSION DIARRHOEA 1
SS DEPRESSION SINUSITIS 1
SS PRODUCT USED FOR UNKNOWN INDICATION CONVULSION 1
SS PRODUCT USED FOR UNKNOWN INDICATION MATERNAL EXPOSURE DURING PREGNANCY 1
SS PRODUCT USED FOR UNKNOWN INDICATION OVERDOSE 1
SS PRODUCT USED FOR UNKNOWN INDICATION STARING 1
SS PRODUCT USED FOR UNKNOWN INDICATION TREMOR 1
C ABDOMINAL DISCOMFORT ANGINA PECTORIS 1
C ARTHRALGIA ANGINA PECTORIS 1
C CONSTIPATION ANGINA PECTORIS 1
C CONVULSION ANGINA PECTORIS 4
C DEPRESSION ANGINA PECTORIS 1
C HEADACHE ANGINA PECTORIS 2
C MIGRAINE ANGINA PECTORIS 1
C MULTIPLE SCLEROSIS ANGINA PECTORIS 2
C MUSCLE SPASTICITY ANGINA PECTORIS 1
C PAIN ANGINA PECTORIS 1
C PRODUCT USED FOR UNKNOWN INDICATION ANGINA PECTORIS 2
C PROPHYLAXIS ANGINA PECTORIS 3
C SEASONAL ALLERGY ANGINA PECTORIS 1
C VITAMIN SUPPLEMENTATION ANGINA PECTORIS 3
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