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). Common side effects of Neurontin can include:
- dizziness,
- drowsiness,
- unsteadiness,
- memory loss,
- lack of coordination,
- difficulty speaking,
- viral infections,
- tremors,
- double vision,
- blurred vision,
- fever,
- unusual eye movements,
- jerky movements,
- weakness,
- tired feeling,
- nausea,
- diarrhea,
- constipation,
- headache,
- breast swelling,
- dry mouth,
- mood or behavior changes,
- depression, or
- anxiety.
The dose of Neurontin depends on the condition being treated and the age of the patient. Neurontin may interact with hydrocodone, morphine, and naproxen. Tell your doctor all medications and supplements you use. 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. Consult your doctor before breastfeeding.
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.
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.
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.
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 3-12 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 placebo-controlled 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 | ||
| 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 |
| Abnormal thinking | 3 | 0 |
| Abnormal gait | 2 | 0 |
| Incoordination | 2 | 0 |
| Respiratory System | ||
| Pharyngitis | 1 | 0 |
| Special Senses | ||
| Amblyopia | 3 | 1 |
| Conjunctivitis | 1 | 0 |
| Diplopia | 1 | 0 |
| Otitis media | 1 | 0 |
| *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 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.
TABLE 4. Adverse Reactions in Pooled Placebo-Controlled Add-On Trials In Epileps y Patients >12 years of age
| NEURONTIN* N=543 % |
PLACEBO* N=378 % |
|
| Body As A Whole | ||
| Fatigue | 11 | 5 |
| Increased Weight | 3 | 2 |
| Back Pain | 2 | 1 |
| Peripheral Edema | 2 | 1 |
| Cardiovascular | ||
| Vasodilatation | 1 | 0 |
| Digestive System | ||
| Dyspepsia | 2 | 1 |
| Dry Mouth or Throat | 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 |
| Abnormal thinking | 2 | 1 |
| Abnormal coordination | 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 |
| Amblyopia† | 4 | 1 |
| *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 Infection | 11 | 3 |
| Fever | 10 | 3 |
| Increased Weight | 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 |
| *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
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.