Drug Safety Information for LAMICTAL CD (Lamotrigine)

FDA Safety Communication for LAMICTAL (LAMOTRIGINE) Rx Drug: FDA Link

Studies show increased risk of heart rhythm problems with seizure and mental health medicine lamotrigine (Lamictal) in patients with heart disease

Safety-related Labeling Changes for LAMICTAL CD (LAMOTRIGINE) Rx Drug: FDA Link

Safety-related Labeling Changes for LAMICTAL XR (LAMOTRIGINE) Rx Drug: FDA Link

Safety-related Labeling Changes for LAMICTAL ODT (LAMOTRIGINE) Rx Drug: FDA Link

Safety-related Labeling Changes for LAMICTAL (LAMOTRIGINE) Rx Drug: FDA Link

Adverse Drug Reactions for LAMICTAL CD* (Lamotrigine)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with LAMICTAL CD
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Rash5006
2Convulsion4331
3Drug ineffective2707
4Pyrexia2135
5Nausea2092
6Dizziness*1997
7Headache*1962
8Depression1719
9Fatigue1676
10Drug interaction1626
11Insomnia*1518
12Vomiting1489
13Pruritus1417
14Anxiety1403
15Stevens-johnson syndrome1392
16Somnolence*1364
17Tremor1247
18Malaise1127
19Pain1069
20Fall1061

* This side effect also appears in "Top 10 Side Effects of LAMICTAL CD " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking LAMICTAL CD
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Epilepsy*28920
2Bipolar disorder*27924
3Product used for unknown indication21444
4Convulsion*10794
5Depression*8049
6Affective disorder2617
7Bipolar i disorder*1997
8Bipolar ii disorder*1732
9Partial seizures*1621
10Grand mal convulsion951

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for LAMICTAL CD

Total Reports Filed with FDA: 193259


Number of FDA Adverse Event Reports by Patient Age for LAMICTAL CD

Total Reports Filed with FDA: 193259*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Lamotrigine (Labileno, Crisomet, Lamictal odt, Lamictal xr, Lamotrigine, Lamictal cd, Lamictal)

Charts are based on 193259 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and LAMICTAL CD Reviews and Review Summary .

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.