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NEURONTIN can cause anaphylaxis and angioedema after the first dose or at any time during treatmentSigns and symptoms in reported cases have included difficulty breathingswelling of the lipsthroatand tongueand hypotension requiring emergency treatmentPatients should be instructed to discontinue NEURONTIN and seek immediate medical care should they experience signs or symptoms of anaphylaxis or angioedema.

Gabapentin did not demonstrate mutagenic or genotoxic potential in three in vitro and four in vivo assaysIt was negative in the Ames test and the in vitro HGPRT forward mutation assay in Chinese hamster lung cellsit did not produce significant increases in chromosomal aberrations in the in vitro Chinese hamster lung cell assayit was negative in the in vivo chromosomal aberration assay and in the in vivo micronucleus test in Chinese hamster bone marrowit was negative in the in vivo mouse micronucleus assayand it did not induce unscheduled DNA synthesis in hepatocytes from rats given gabapentin.

TABLE 5Adverse Reactions in a Placebo-Controlled Add-On Trial in Pediatric Epilepsy Patients Age 3 to 12 Years.

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