Gralise

Last updated on RxList: 11/18/2020
Gralise Side Effects Center

What Is Gralise?

Gralise (gabapentin) is a pain reliever (analgesic) used to treat pain and burning from peripheral neuropathy, and postherpetic neuralgia, a complication of shingles.

What Are Side Effects of Gralise?

Common side effects of Gralise include:

Dosage for Gralise

The dose of Gralise is titrated to 1800 mg taken orally once daily with the evening meal.

What Drugs, Substances, or Supplements Interact with Gralise?

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.

Gralise During Pregnancy and Breastfeeding

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.

Additional Information

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.

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Gralise Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, upper stomach pain, or yellowing of your skin or eyes.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

  • weak or shallow breathing;
  • blue-colored skin, lips, fingers, and toes;
  • confusion, extreme drowsiness or weakness;
  • problems with balance or muscle movement;
  • unusual or involuntary eye movements; or
  • increased seizures.

Gabapentin can cause life-threatening breathing problems. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up. Breathing problems may be more likely in older adults or in people with COPD.

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

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

Common side effects may include:

  • fever, chills, sore throat, body aches, unusual tiredness;
  • jerky movements;
  • headache;
  • double vision;
  • swelling of your legs and feet;
  • tremors;
  • trouble speaking;
  • dizziness, drowsiness, tiredness;
  • problems with balance or eye movements; or
  • nausea, vomiting.

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)

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Gralise Professional Information

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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© Gralise Patient Information is supplied by Cerner Multum, Inc. and Gralise Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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