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Gralise

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Gralise

Gralise Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Gralise (gabapentin) is used to treat pain and burning from peripheral neuropathy, and postherpetic neuralgia, a complication of shingles. It is a pain reliever (analgesic). Common side effects include dizziness, sleepiness, headache, swelling of the extremities, and diarrhea.

The dose of Gralise is titrated to 1800 mg taken orally once daily with the evening meal. Gralise may interact with phenytoin, carbamazepine, valproic acid, phenobarbital, naproxen, hydrocodone, morphine, cimetidine, oral contraceptives, antacids, or probenecid. Tell your doctor all medications and supplements you use. During pregnancy, Gralise should be used only if prescribed. Pregnant patients taking Gralise will be advised to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. This drug passes into breast milk when taken orally. The effect on nursing infants is unknown. Consult your doctor before breastfeeding.

Our Gralise (gabapentin) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Gralise in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; fever; swollen glands; painful sores in or around your eyes or mouth; difficulty breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, depression, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have a serious side effect such as:

  • increased seizures;
  • fever, swollen glands, body aches, flu symptoms;
  • skin rash, easy bruising or bleeding, severe tingling, numbness, pain, muscle weakness;
  • upper stomach pain, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes);
  • chest pain, irregular heart rhythm, feeling short of breath;
  • confusion, nausea and vomiting, swelling, rapid weight gain, urinating less than usual or not at all;
  • new or worsening cough, fever, trouble breathing; or
  • rapid back and forth movement of your eyes.

Some side effects are more likely in children taking gabapentin. Contact your doctor if the child taking this medication has any of the following side effects:

  • changes in behavior;
  • memory problems;
  • trouble concentrating; or
  • acting restless, hostile, or aggressive.

Less serious side effects may include:

  • dizziness, drowsiness, weakness, tired feeling;
  • nausea, diarrhea, constipation;
  • blurred vision;
  • headache;
  • breast swelling;
  • dry mouth; or
  • loss of balance or coordination.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Gralise (Gabapentin Tablets) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Gralise FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

A total of 359 patients with neuropathic pain associated with postherpetic neuralgia have received GRALISE at doses up to 1800 mg daily during placebo-controlled clinical studies. In clinical trials in patients with postherpetic neuralgia, 9.7% of the 359 patients treated with GRALISE and 6.9% of 364 patients treated with placebo discontinued prematurely due to adverse reactions. In the GRALISE treatment group, the most common reason for discontinuation due to adverse reactions was dizziness. Of GRALISE-treated patients who experienced adverse reactions in clinical studies, the majority of those adverse reactions were either “mild” or “moderate”.

Table 4 lists all adverse reactions, regardless of causality, occurring in at least 1% of patients with neuropathic pain associated with postherpetic neuralgia in the GRALISE group for which the incidence was greater than in the placebo group.

Table 4: Treatment-Emergent Adverse Reaction Incidence in Controlled Trials in Neuropathic Pain Associated with Postherpetic Neuralgia (Events in at Least 1% of all GRALISE-Treated Patients and More Frequent Than in the Placebo Group)

Body System - Preferred Term GRALISE
N = 359
%
Placebo
N = 364
%
Ear and Labyrinth Disorders
  Vertigo 1.4 0.5
Gastrointestinal Disorders
  Diarrhea 3.3 2.7
  Dry mouth 2.8 1.4
  Constipation 1.4 0.3
  Dyspepsia 1.4 0.8
General Disorders
  Peripheral edema 3.9 0.3
  Pain 1.1 0.5
Infections and Infestations
  Nasopharyngitis 2.5 2.2
  Urinary tract infection 1.7 0.5
Investigations
  Weight increased 1.9 0.5
Musculoskeletal and Connective Tissue Disorders
  Pain in extremity 1.9 0.5
  Back pain 1.7 1.1
Nervous System Disorders
  Dizziness 10.9 2.2
  Somnolence 4.5 2.7
  Headache 4.2 4.1
  Lethargy 1.1 0.3

In addition to the adverse reactions reported in Table 4 above, the following adverse reactions with an uncertain relationship to GRALISE were reported during the clinical development for the treatment of postherpetic neuralgia. Events in more than 1% of patients but equally or more frequently in the GRALISE-treated patients than in the placebo group included blood pressure increase, confusional state, gastroenteritis viral, herpes zoster, hypertension, joint swelling, memory impairment, nausea, pneumonia, pyrexia, rash, seasonal allergy, and upper respiratory infection.

Postmarketing and Other Experience with other Formulations of Gabapentin

In addition to the adverse experiences reported during clinical testing of gabapentin, the following adverse experiences have been reported in patients receiving other formulations of marketed gabapentin. These adverse experiences have not been listed above and data are insufficient to support an estimate of their incidence or to establish causation. The listing is alphabetized: angioedema, blood glucose fluctuation, breast enlargement, elevated creatine kinase, elevated liver function tests, erythema multiforme, fever, hyponatremia, jaundice, movement disorder, Stevens-Johnson syndrome.

Adverse events following the abrupt discontinuation of gabapentin immediate release have also been reported. The most frequently reported events were anxiety, insomnia, nausea, pain and sweating.

Read the entire FDA prescribing information for Gralise (Gabapentin Tablets) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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