Drugs & Medications
FDA Approves Gralise
The United States Food and Drug Administration has approved Gralise (gabapentin) Tablets for once-daily treatment of post-herpetic neuralgia (PHN), which is pain following healing of the rash associated with shingles.
Gralise Medication Guide
Read this Medication Guide before you start taking Gralise and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. If you have any questions about Gralise, ask your healthcare provider or pharmacist.
Important information about Gralise
Do not stop taking Gralise without first talking with your healthcare provider. Stopping Gralise suddenly can cause serious problems.
Like other antiepileptic drugs, gabapentin, the active ingredient in Gralise, may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. However, it is not known if Gralise is safe and effective in people with seizure problems (epilepsy). Therefore, Gralise should not be used in place of other gabapentin products.
Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:
What is Gralise?
Gralise is a prescription medicine used in adults, 18 years and older, to treat pain from damaged nerves (neuropathic pain) that follows healing of shingles (a painful rash that comes after a herpes zoster infection).
It is not known if Gralise is safe and effective in people with seizure problems (epilepsy).
It is not known if Gralise is safe and effective in children under 18 years of age with postherpetic pain.
Gralise is not interchangeable with other gabapentin products.
Who should not take Gralise?
Do not take Gralise if you are allergic to gabapentin or any of the ingredients in Gralise.
See the end of this Medication Guide for a complete list of ingredients in Gralise.
Before taking Gralise
Before taking Gralise, tell your healthcare provider if you:
Taking Gralise with certain other medicines can cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider.
Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.
How should I take Gralise?
What should I avoid while taking Gralise?
Gralise side effects
The most common side effect of Gralise is:
These are not all the possible side effects of Gralise. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 .
How should I store Gralise?
Store Gralise at 59°F to 86°F (15°C to 30°C)
Keep Gralise and all medicines out of the reach of children.
General information about the safe and effective use of Gralise
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.
Do not use Gralise for a condition for which it was not prescribed. Do not give Gralise to other people, even if they have the same symptoms you have. It may harm them.
This Medication Guide summarizes the most important information about Gralise. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Gralise that is written for health professionals.
For more information about Gralise, call 1-800-241-1643 .
What are the ingredients in Gralise?
Active ingredient: gabapentin
300 mg tablet: copovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene oxide, and Opadry® II white. Opadry® II white contains polyvinyl alcohol, titanium dioxide, talc, polyethylene glycol 3350, and lecithin (soya).
600 mg tablet: copovidone, hypromellose, magnesium stearate, polyethylene oxide, and Opadry® II beige. Opadry® II beige contains polyvinyl alcohol, titanium dioxide, talc, polyethylene glycol 3350, iron oxide yellow, and iron oxide red.