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Neurontin

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Neurontin

Neurontin Side Effects Center

Medical Editor: Melissa Conrad Stöppler, MD

Neurontin (gabapentin) is an anti-epileptic medication used to treat seizures. It is used alone or in combination with other medications to treat seizures caused by epilepsy in adults and children who are at least 12 years old. It is also used to treat nerve pain caused by shingles (herpes zoster). Common Side effects can include dizziness, drowsiness, and unsteadiness. Other side effects can be mood or behavior changes, depression, or anxiety. This is not a complete list of side effects and others may occur.

Neurontin is available as tablets, capsules, or oral solution. Antacids containing aluminum or magnesium may interfere with the absorption of this medication. Hydrocodone (Lortab, Vicodin, and others), morphine (Kadian, MS Contin, and others), and naproxen can interact with this medication. Caution is advised during pregnancy, and the drug should only be taken if its benefits outweigh the potential risks. Some conditions such as seizures may become worse when the drug is abruptly stopped.

Our Neurontin 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.

Neurontin 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 Neurontin (Gabapentin) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Neurontin Overview - Patient Information: Side Effects

SIDE EFFECTS: Drowsiness, dizziness, loss of coordination, tiredness, blurred/double vision, unusual eye movements, or shaking (tremor) may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these unlikely but serious side effects occur: swelling of the hands/ankles/feet, signs of infection (such as fever, cough, persistent sore throat).

A small number of people who take anticonvulsants for any condition (such as seizures, bipolar disorder, pain) may experience depression, suicidal thoughts/attempts, or other mental/mood problems. Tell your doctor immediately if you or your family/caregiver notice any unusual/sudden changes in your mood, thoughts, or behavior including signs of depression, suicidal thoughts/attempts, thoughts about harming yourself.

Get medical help right away if you have any serious side effects, including: unusual fever, swollen glands, yellowing skin/eyes, unusual tiredness, dark urine, change in the amount of urine, chest pain.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Neurontin (Gabapentin)»

What is Prescribing information?

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

Neurontin FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following serious adverse reactions are discussed in greater detail in other sections:

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.

Postherpetic Neuralgia

The most commonly observed adverse reactions associated with the use of NEURONTIN in adults, not seen at an equivalent frequency among placebo-treated patients, were dizziness, somnolence, and peripheral edema.

In the 2 controlled studies in postherpetic neuralgia, 16% of the 336 patients who received NEURONTIN and 9% of the 227 patients who received placebo discontinued treatment because of an adverse reaction. The adverse reactions that most frequently led to withdrawal in NEURONTIN-treated patients were dizziness, somnolence, and nausea.

Incidence in Controlled Clinical Trials

Table 3 lists treatment-emergent signs and symptoms that occurred in at least 1% of NEURONTIN-treated patients with postherpetic neuralgia participating in placebo-controlled trials and that were numerically more frequent in the NEURONTIN group than in the placebo group. Adverse reactions were usually mild to moderate in intensity.

TABLE 3: Treatment-Emergent Adverse Reaction Incidence in Controlled Trials in Postherpetic Neuralgia (Reactions in at least 1% of NEURONTIN -Treated Patients and Numerically More Frequent Than in the Placebo Group)

Body System/ Preferred Term NEURONTIN
N=336 %
Placebo
N=227 %
Body as a Whole
  Asthenia 6 5
  Infection 5 4
  Accidental injury 3 1
Digestive System
  Diarrhea 6 3
  Dry mouth 5 1
  Constipation 4 2
  Nausea 4 3
  Vomiting 3 2
Metabolic and Nutritional Disorders
  Peripheral edema 8 2
  Weight gain 2 0
  Hyperglycemia 1 0
Nervous System
  Dizziness 28 8
  Somnolence 21 5
  Ataxia 3 0
  Thinking abnormal 3 0
  Abnormal gait 2 0
  Incoordination 2 0
Respiratory System
  Pharyngitis 1 0
Special Senses
  Amblyopiaa 3 1
  Conjunctivitis 1 0
  Diplopia 1 0
  Otitis media 1 0
aReported as blurred vision

Other reactions in more than 1% of patients but equally or more frequent in the placebo group included pain, tremor, neuralgia, back pain, dyspepsia, dyspnea, and flu syndrome.

There were no clinically important differences between men and women in the types and incidence of adverse reactions. Because there were few patients whose race was reported as other than white, there are insufficient data to support a statement regarding the distribution of adverse reactions by race.

Epilepsy

The most commonly observed adverse reactions associated with the use of NEURONTIN in combination with other antiepileptic drugs in patients > 12 years of age, not seen at an equivalent frequency among placebo-treated patients, were somnolence, dizziness, ataxia, fatigue, and nystagmus. The most commonly observed adverse reactions reported with the use of NEURONTIN in combination with other antiepileptic drugs in pediatric patients 3 to 12 years of age, not seen at an equal frequency among placebo-treated patients, were viral infection, fever, nausea and/or vomiting, somnolence, and hostility [see WARNINGS AND PRECAUTIONS].

Approximately 7% of the 2074 patients > 12 years of age and approximately 7% of the 449 pediatric patients 3 to 12 years of age who received NEURONTIN in premarketing clinical trials discontinued treatment because of an adverse reaction. The adverse reactions most commonly associated with withdrawal in patients > 12 years of age were somnolence (1.2%), ataxia (0.8%), fatigue (0.6%), nausea and/or vomiting (0.6%), and dizziness (0.6%). The adverse reactions most commonly associated with withdrawal in pediatric patients were emotional lability (1.6%), hostility (1.3%), and hyperkinesia (1.1%).

Incidence in Controlled Adjunctive Clinical Trials

Table 4 lists treatment-emergent signs and symptoms that occurred in at least 1% of NEURONTIN-treated patients > 12 years of age with epilepsy participating in placebo-controlled trials and were numerically more common in the NEURONTIN group. In these studies, either NEURONTIN or placebo was added to the patient's current antiepileptic drug therapy. Adverse reactions were usually mild to moderate in intensity.

TABLE 4: Treatment-Emergent Adverse Reaction Incidence in Controlled Add-On Trials In Patients > 12 years of age (Reactions in at least 1% of NEURONTIN patients and numerically more frequent than in the placebo group)

Body System/ Adverse Reaction NEURONTINa
N=543 %
Placeboa
N=378 %
Body As A Whole
  Fatigue 11 5
  Weight Increase 3 2
  Back Pain 2 1
  Peripheral Edema 2 1
Cardiovascular
  Vasodilatation 1 0
Digestive System
  Dyspepsia 2 1
  Mouth or Throat Dry 2 1
  Constipation 2 1
  Dental Abnormalities 2 0
Nervous System
  Somnolence 19 9
  Dizziness 17 7
  Ataxia 13 6
  Nystagmus 8 4
  Tremor 7 3
  Dysarthria 2 1
  Amnesia 2 0
  Depression 2 1
  Thinking Abnormal 2 1
  Coordination Abnormal 1 0
Respiratory System
  Pharyngitis 3 2
  Coughing 2 1
Skin and Appendages
  Abrasion 1 0
Urogenital System
  Impotence 2 1
Special Senses
  Diplopia 6 2
  Amblyopiab 4 1
aPlus background antiepileptic drug therapy
bAmblyopia was often described as blurred vision.

Among the treatment-emergent adverse reactions occurring at an incidence of at least 10% in NEURONTIN-treated patients, somnolence and ataxia appeared to exhibit a positive dose-response relationship.

The overall incidence of adverse reactions and the types of adverse reactions seen were similar among men and women treated with NEURONTIN. The incidence of adverse reactions increased slightly with increasing age in patients treated with either NEURONTIN or placebo. Because only 3% of patients (28/921) in placebo-controlled studies were identified as nonwhite (black or other), there are insufficient data to support a statement regarding the distribution of adverse reactions by race.

Table 5 lists treatment-emergent signs and symptoms that occurred in at least 2% of NEURONTIN-treated patients, age 3 to 12 years of age with epilepsy participating in placebo-controlled trials, and which were numerically more common in the NEURONTIN group. Adverse reactions were usually mild to moderate in intensity.

TABLE 5: Treatment-Emergent Adverse Reaction Incidence in Pediatric Patients Age 3 to 12 Years in a Controlled Add-On Trial (Reactions in at least 2% of NEURONTIN patients and numerically more frequent than in the placebo group)

Body System/Adverse Reaction NEURONTINa
N=119%
Placeboa
N=128%
Body As A Whole
  Viral Infection 11 3
  Fever 10 3
  Weight Increase 3 1
  Fatigue 3 2
Digestive System
  Nausea and/or Vomiting 8 7
Nervous System
  Somnolence 8 5
  Hostility 8 2
  Emotional Lability 4 2
  Dizziness 3 2
  Hyperkinesia 3 1
Respiratory System
  Bronchitis 3 1
  Respiratory Infection 3 1
aPlus background antiepileptic drug therapy

Other reactions in more than 2% of pediatric patients 3 to 12 years of age but equally or more frequent in the placebo group included: pharyngitis, upper respiratory infection, headache, rhinitis, convulsions, diarrhea, anorexia, coughing, and otitis media.

Postmarketing Experience

The following adverse reactions have been identified during postmarketing use of NEURONTIN. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

General disorders and administration site conditions: fever

Hepatobiliary disorders: jaundice

Investigations: blood glucose fluctuation, elevated creatine kinase, elevated liver function tests

Metabolism and nutrition disorders: hyponatremia

Nervous system disorders: movement disorder

Musculoskeletal and connective tissue disorders: rhabdomyolysis

Reproductive system and breast disorders: breast enlargement

Skin and subcutaneous tissue disorders: angioedema, erythema multiforme, Stevens-Johnson syndrome.

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

Read the entire FDA prescribing information for Neurontin (Gabapentin) »

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Neurontin - User Reviews

Neurontin User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Neurontin sorted by most helpful. Patient Discussions FAQs

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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