GRALISE Adverse Events Profile

The majority of TEAEs reported with GRALISE were mild to moderate1

The most common TEAEs with GRALISE were dizziness (11%) and somnolence (5%).1

The overall discontinuation rate in clinical trials was 9.7% (n=359) for GRALISE and 6.9% (n=364) for placebo, with 2.2% (n=8) of GRALISE patients discontinuing due to dizziness and 0.3% (n=1) for somnolence, and 0.5% (n=2) of placebo patients discontinuing due to dizziness and somnolence.12

Discontinuations due to dizziness and somnolence were infrequent2:

DIZZINESS: GRALISE—2.2%, placebo—0.5%;

SOMNOLENCE: GRALISE—0.3%, placebo—0.5%

Body System
Preferred Term
GRALISE %
N=359
Placebo %
N=364
Ear and Labyrinth Disorders
Vertigo1.40.5
Gastrointestinal Disorders
Diarrhea3.32.7
Dry mouth2.81.4
Constipation1.40.3
Dyspepsia1.40.8
General Disorders
Peripheral edema3.90.3
Pain1.10.5
Infections and Infestations
Nasopharyngitis2.52.2
Urinary tract infection1.70.5
Body System
Preferred Term
GRALISE %
N=359
Placebo %
N=364
Investigations
Weight increased1.90.5
Musculoskeletal and Connective Tissue Disorders
Pain in extremity1.90.5
Back pain1.71.1
Nervous System Disorders
Dizziness10.92.2
Somnolence4.52.7
Headache4.24.1
Lethargy1.10.3
Body System
Preferred Term
GRALISE %
N=359
Placebo %
N=364
Ear and Labyrinth Disorders
Vertigo1.40.5
Gastrointestinal Disorders
Diarrhea3.32.7
Dry mouth2.81.4
Constipation1.40.3
Dyspepsia1.40.8
General Disorders
Peripheral edema3.90.3
Pain1.10.5
Infections and Infestations
Nasopharyngitis2.52.2
Urinary tract infection1.70.5
Investigations
Weight increased1.90.5
Musculoskeletal and Connective Tissue Disorders
Pain in extremity1.90.5
Back pain1.71.1
Nervous System Disorders
Dizziness10.92.2
Somnolence4.52.7
Headache4.24.1
Lethargy1.10.3

References:

  1. GRALISE. Prescribing information. Almatica Pharma LLC; 2023.
  2. Data on file. Almatica Pharma LLC; 2009.
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Gabapentin is a controlled substance in several states. Contact local authorities for more information. Advise patients to take GRALISE only as prescribed.