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Gabarone (Gabapentin): Uses, Side Effects and Dosage

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Prescription (Rx)
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100 mg, 400 mg
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Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Gabarone

What is the most important information I should know about GABARONE?

Do not stop taking GABARONE without first talking to your healthcare provider.

Stopping GABARONE suddenly can cause serious problems.

GABARONE tablets can cause serious side effects including:

1. Suicidal Thoughts. Like other antiepileptic drugs, GABARONE may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.

Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:

  • thoughts about suicide or dying
  • attempts to commit suicide
  • new or worse depression
  • new or worse anxiety
  • feeling agitated or restless
  • panic attacks
  • trouble sleeping (insomnia)
  • new or worse irritability
  • acting aggressive, being angry, or violent
  • acting on dangerous impulses
  • an extreme increase in activity and talking (mania)
  • other unusual changes in behavior or mood

How can I watch for early symptoms of suicidal thoughts and actions?

  • Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.
  • Keep all follow-up visits with your healthcare provider as scheduled.

Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

Do not stop taking GABARONE without first talking to a healthcare provider.

  • Stopping GABARONE suddenly can cause serious problems. Stopping a seizure medicine suddenly in a person who has epilepsy can cause seizures that will not stop (status epilepticus).
  • Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.
  1. 2. Changes in behavior and thinking -Using GABARONE in children 3 to 12 years of age can cause emotional changes, aggressive behavior, problems with concentration, changes in school performance, restlessness, and hyperactivity.
  2. 3. GABARONE may cause serious or life-threatening allergic reactionsthat may affect your skin or other parts of your body such as your liver or blood cells. This may cause you to be hospitalized or to stop GABARONE. You may or may not have a rash with an allergic reaction caused by GABARONE. Call a healthcare provider right away if you have any of the following symptoms:
  • skin rash
  • hives
  • difficulty breathing
  • fever
  • swollen glands that do not go away
  • swelling of your face, lips, throat, or tongue
  • yellowing of your skin or of the whites of the eyes
  • unusual bruising or bleeding
  • severe fatigue or weakness
  • unexpected muscle pain
  • frequent infections

These symptoms may be the first signs of a serious reaction. A healthcare provider should examine you to decide if you should continue taking GABARONE.

  1. 4. Serious breathing problems.Serious breathing problems can happen when GABARONE is taken with other medicines (such as opioid pain medicines) that can cause severe sleepiness or decreased awareness, or when it is taken by someone who already has breathing problems. Call your healthcare provider or get medical help right away if you have any of the following symptoms:
  • feel short of breath
  • feel very tired
  • dizziness
  • breathing slower than normal
  • confusion
  • headache

Be sure that your caregiver or family members know which symptoms may be serious so they can call your healthcare provider or get medical help if you are unable to seek treatment on your own.

Your healthcare provider may lower your dose or stop your treatment with GABARONE if you have serious breathing problems.

What are GABARONE?

GABARONE is a prescription medicine used to treat:

  • pain from damaged nerves (postherpetic pain) that follows healing of shingles (a painful rash that comes after a herpes zoster infection) in adults.
  • partial seizures when taken together with other medicines in adults and children 3 years of age and older with seizures.

It is not known if GABARONE is safe and effective to treat:

  • children with pain from damaged nerves from a painful rash caused by the chicken pox virus.

  • partial seizures in children under 3 years of age.

Do not take GABARONE if you:

  • are allergic to gabapentin or any of the other ingredients in GABARONE. See the end of this Medication Guide for a complete list of ingredients in GABARONE.

Before taking GABARONE, tell your healthcare provider about all of your medical conditions including if you:

  • have or have had kidney problems or are on hemodialysis.
  • have or have had depression, mood problems, or suicidal thoughts or behaviour.
  • have a history of drug abuse.
  • have diabetes.
  • have breathing problems.

  • are pregnant or plan to become pregnant. It is not known if GABARONE can harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking GABARONE. You and your healthcare provider will decide if you should take GABARONE while you are pregnant.

    • Pregnancy Registry: If you become pregnant while taking GABARONE, talk to your healthcare provider about registering with the North American Antiepileptic Drug (NAAED) Pregnancy Registry. The purpose of this registry is to collect information about the safety of antiepileptic drugs during pregnancy. You can enroll in this registry by calling 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/.
  • are breastfeeding or plan to breastfeed. GABARONE can pass into breast milk. You and your healthcare provider should decide how you will feed your baby while you take GABARONE.

Tell your healthcare provider about all the medicines you take,including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Especially tell your healthcare provider if you take:

  • any opioid pain medicine such as morphine, hydrocodone, oxycodone, or buprenorphine.
  • any medicines for anxiety (such as lorazepam) or insomnia (such as zolpidem), or any medicines that make you sleepy. You may have a higher chance for dizziness, sleepiness, or breathing problems if these medicines are taken with GABARONE.

Taking GABARONE with certain other medicines can cause side effects or affect how well they work. Do notstart 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 GABARONE?

  • Take GABARONE exactly as prescribed. Your healthcare provider will tell you how much GABARONE to take.
  • Do notchange your dose of GABARONE without talking to your healthcare provider.

  • GABARONE can be taken with or without food.

  • Swallow GABARONE capsules whole with water.
  • If you take GABARONE and break a tablet in half, the unused half of the tablet should be taken at your next scheduled dose. Half tablets not used within 28 days of breaking should be thrown away.
  • If you take an antacid containing aluminum and magnesium, such as Maalox, Mylanta, Gelusil, Gaviscon, or Di-Gel, you should wait at least 2 hours before taking your next dose of GABARONE.
  • In case of overdose, get medical help or contact a live Poison Center expert right away at 1-800-222-1222. Advice is also available online at poisonhelp.org.

What should I avoid while taking GABARONE?

  • Do notdrink alcohol or take other medicines that make you sleepy or dizzy while taking GABARONE without first talking with your healthcare provider. Taking GABARONE with alcohol or drugs that cause sleepiness or dizziness may make your sleepiness or dizziness worse.
  • Do notdrive, operate heavy machinery, or do other dangerous activities until you know how GABARONE affects you. GABARONE can slow your thinking and motor skills.

What are the possible side effects of GABARONE?

GABARONE may cause serious side effects, including:

  • See " What is the most important information I should know about GABARONE?"
  • problems driving while using GABARONE. See " What should I avoid while taking GABARONE?"
  • sleepiness and dizziness, which could increase your chance of having an accidental injury, including falls.

The most common side effects of GABARONE include:

  • lack of coordination
  • viral infection
  • feeling drowsy
  • nausea and vomiting
  • difficulty with speaking
  • tremor
  • swelling, usually of legs and feet
  • feeling tired
  • fever
  • jerky movements
  • difficulty with coordination
  • double vision
  • unusual eye movement

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of GABARONE. 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 GABARONE?

  • Store at 25°C (77°F); excursions permitted at 15°C to 30°C (59°F to 86°F).

GABARONE come in a child-resistant package. Dispense contents in a tight container as defined in the USP with a child-resistant closure; as required.

KEEP CONTAINER TIGHTLY CLOSED

Keep this and all medication out of the reach of children.

General information about the safe and effective use of GABARONE

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use GABARONE for a condition for which it was not prescribed. Do not give GABARONE to other people, even if they have the same symptoms that you have. It may harm them.

You can ask your pharmacist or healthcare provider for information about GABARONE that is written for healthcare professionals.

What are the ingredients in GABARONE?

Active ingredient:gabapentin

Inactive ingredients:Corn (maize) Starch, Mannitol, Crospovidone, Copovidone, Talc, Magnesium Stearate 50%, Colloidal Silicon Dioxide, Hydroxypropyl Cellulose, Isopropyl alcohol

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Manufactured for:

INA Pharmaceutics Inc.

Fairmont, WV 26554

Revised: 11/2024

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: ANDA 211313 · View the label on DailyMed

Revision date stated in the text: November 2024

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Gabarone

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class Anti-epileptic Agent
Active ingredient Gabapentin
Dosage form Tablet
Route Oral
Marketing status listed in the FDA NDC Directory
Company (applicant) STRIDES PHARMA
FDA approval ANDA 211313Abbreviated New Drug Application (ANDA) – generic drug Approved March 4, 2024
Therapeutic equivalence (TE) code AB1Codes starting with A mean the FDA rates the drug therapeutically equivalent to its reference drug (Orange Book).
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
100 mg – 90 in 1 bottle NDC 74157-013-90
400 mg – 90 in 1 bottle NDC 74157-111-90

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.