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Neurontin

Last reviewed on RxList: 4/13/2020
Neurontin Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Neurontin?

Neurontin (gabapentin) is an anti-epileptic medication used to treat seizures. Neurontin 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. Neurontin is also used to treat nerve pain caused by shingles (herpes zoster).

What Are Side Effects of Neurontin?

Common side effects of Neurontin include:

Other side effects of Neurontin include mood or behavior changes, depression, or anxiety.

Dosage for Neurontin

In adults with postherpetic neuralgia, Neurontin may be initiated on Day 1 as a single 300 mg dose, on Day 2 as 600 mg/day (300 mg two times a day), and on Day 3 as 900 mg/day (300 mg three times a day). The starting dose of Neurontin for epilepsy with partial onset seizures in patients 12 years of age and above is 300 mg three times a day.

What Drugs, Substances, or Supplements Interact with Neurontin?

Neurontin may interact with hydrocodone, morphine, and naproxen. Tell your doctor all medications and supplements you use.

Neurontin During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant while using Neurontin; it is unknown if Neurontin will harm a fetus. Neurontin passes into breast milk and may harm a nursing baby. Breastfeeding while using Neurontin is not recommended.

Additional Information

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.

QUESTION

If you have had a seizure, it means you have epilepsy. See Answer
Neurontin 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, flu-like symptoms, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes. This reaction may occur several weeks after you began using gabapentin.

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:

  • increased seizures;
  • severe weakness or tiredness;
  • problems with balance or muscle movement;
  • upper stomach pain;
  • chest pain, new or worsening cough with fever, trouble breathing;
  • severe tingling or numbness;
  • rapid eye movement; or
  • kidney problems--little or no urination, painful or difficult urination, swelling in your feet or ankles.

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:

  • headache, dizziness, drowsiness, tiredness;
  • swelling in your hands or feet;
  • problems with your eyes;
  • coordination problems; or
  • (in children) fever, 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 Neurontin (Gabapentin)

SLIDESHOW

Epilepsy: Symptoms, Causes and Treatment See Slideshow
Neurontin Professional Information

SIDE EFFECTS

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

  • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity [see WARNINGS AND PRECAUTIONS]
  • Anaphylaxis and Angioedema [see WARNINGS AND PRECAUTIONS]
  • Somnolence/Sedation and Dizziness [see WARNINGS AND PRECAUTIONS]
  • Withdrawal Precipitated Seizure, Status Epilepticus [see WARNINGS AND PRECAUTIONS]
  • Suicidal Behavior and Ideation [see WARNINGS AND PRECAUTIONS]
  • Neuropsychiatric Adverse Reactions (Pediatric Patients 3 to 12 Years of Age) [see WARNINGS AND PRECAUTIONS]
  • Sudden and Unexplained Death in Patients with Epilepsy [see WARNINGS AND PRECAUTIONS]

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 common 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 trials 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.

Table 3 lists adverse reactions that occurred in at least 1% of NEURONTIN-treated patients with postherpetic neuralgia participating in placebocontrolled trials and that were numerically more frequent in the NEURONTIN group than in the placebo group.

TABLE 3. Adverse Reactions in Pooled Placebo-Controlled Trials in Postherpetic Neuralgia

NEURONTIN
N=336
%
Placebo
N=227
%
Body as a Whole
  Asthenia65
  Infection54
  Accidental injury31
Digestive System
  Diarrhea63
  Dry mouth51
  Constipation42
  Nausea43
  Vomiting32
Metabolic and Nutritional Disorders
  Peripheral edema82
  Weight gain20
  Hyperglycemia10
Nervous System
  Dizziness288
  Somnolence215
  Ataxia30
  Abnormal thinking30
  Abnormal gait20
  Incoordination20
Respiratory System
  Pharyngitis10
Special Senses
  Amblyopia*31
  Conjunctivitis10
  Diplopia10
  Otitis media10
*Reported 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 With Partial Onset Seizures (Adjunctive Therapy)

The most common adverse reactions with 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 common adverse reactions with 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%).

Table 4 lists adverse reactions that occurred in at least 1% of NEURONTIN-treated patients >12 years of age with epilepsy participating in placebocontrolled 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.

TABLE 4. Adverse Reactions in Pooled Placebo-Controlled Add-On Trials In Epilepsy Patients >12 years of age

NEURONTIN*
N=543
%
Placebo*
N=378
%
Body As A Whole
  Fatigue115
  Increased Weight32
  Back Pain21
  Peripheral Edema21
Cardiovascular
  Vasodilatation10
Digestive System
  Dyspepsia21
  Dry Mouth or Throat21
  Constipation21
  Dental Abnormalities20
Nervous System
  Somnolence199
  Dizziness177
  Ataxia136
  Nystagmus84
  Tremor73
  Dysarthria21
  Amnesia20
  Depression21
  Abnormal thinking21
  Abnormal coordination10
Respiratory System
  Pharyngitis32
  Coughing21
Skin and Appendages
  Abrasion10
Urogenital System
  Impotence21
Special Senses
  Diplopia62
  Amblyopia41
* Plus background antiepileptic drug therapy
Amblyopia was often described as blurred vision.

Among the 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 adverse reactions 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.

TABLE 5. Adverse Reactions in a Placebo-Controlled Add-On Trial in Pediatric Epilepsy Patients Age 3 to 12 Years

NEURONTIN*
N=119
%
Placebo*
N=128
%
Body As A Whole
  Viral Infection113
  Fever103
  Increased Weight31
  Fatigue32
Digestive System
  Nausea and/or Vomiting87
Nervous System
  Somnolence85
  Hostility82
  Emotional Lability42
  Dizziness32
  Hyperkinesia31
Respiratory System
  Bronchitis31
  Respiratory Infection31
*Plus 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.

Hepatobiliary disorders: jaundice

Investigations: elevated creatine kinase, elevated liver function tests

Metabolism and nutrition disorders: hyponatremia

Musculoskeletal and connective tissue disorder: rhabdomyolysis

Nervous system disorders: movement disorder

Psychiatric disorders: agitation

Reproductive system and breast disorders: breast enlargement, changes in libido, ejaculation disorders and anorgasmia

Skin and subcutaneous tissue disorders: angioedema [see WARNINGS AND PRECAUTIONS], 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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