Side Effects: |
- Due to postherpatic Neuralgia Treatment:
Dizziness, somnolence, and peripheral edema were observed, and were not seen among placebo- treated patients.
The adverse events that most frequently led to withdrawal in gabapentin –treated patients were dizziness, somnolence, and nausea.
Adverse events were usually mild to moderate intensity, other adverse events were reported in a trial on the treatment of postherpatic neuralgia, the incidence of these adverse events was about 1% of gabapentin –treated patients as compared with placebo group:
-Body as a whole: Asthenia, infection, headache, accidental injury, abdominal pain.
-Digestive disorders: diarrhea, dry mouth, constipation, nausea, vomiting, flatulence.
-Metabolic and nutritional disorders: peripheral edema, weight gain,hyperglycemia.
-Nervous system: dizziness, somnolence, ataxia, thiking abnormal, abnormal gait, incoordination, amnesia, hypesthesia.
-Respiratory system: pharyngitis.
-Skin & Appendages: rash.
-Special senses: amblyopia, conjunctivitis , diplopia, otitis media.
- Due To Epilepsy Treatment:
The most commonly observed adverse events associated with the use of gabapentin in combination with other antiepileptic drugs in patients >12 years of age, not seen at an equivalent frequency among placebo-treated paients,were somnolence, dizziness, ataxia, fatigue, and nystagmus. In pediatric patients 3 to 12 years of age, viral infection, fever, nausea, and / or vomiting, somnolence,
and hostility, and 7% of 2074 patients > 12 years of age, and 7% of 449 pediatric patients 3 to 12 years of age who received gabapentin discontinue treatment because of an adverse events.
The adverse events associated with withdrawl of gabapentin from the therapeutic regimen in patients >12 year of age were somnolence, ataxia, fatigue, nausea or vomiting and dizziness, the adverse events most commonly associated with withdrawal of gabapentin from the combination therapy in pediatric patients were emotional lability, hostility and hyperkinesia.
The following adverse events in patients >12 years of age were more frequent than in the placebo group:
- Body as a whole : fatigue, weight increase, back pain, peripheral edema.
- Cardiovasculare: vasodilation.
- Digestive system: dyspepsia, mouth or throat dry , constipation, dental abnormalities, increased appetite.
- Hematologic and lymphatic systems: lenkopenia.
- Musculoskeletal system: maylgia, fructure.
- Nervous system: somnolence, dizziness, ataxia, nystagmus, tremor, nervousness, dysarthria, amnesia, depression, thinking abnormal, twitching, corrdination abnormal.
- Respiratory system : rhinitis, pharyngitis, coughing.
- Skin and appendages: abrasion, pruritus.
- Urogenital system: impotence.
- Special senses: diplopia, amblyopia.
Adverse events that were reported in pediatric patients aged between 3 to 12 years and
incidence were at least 2%:
Viral infections, fever, weight increase, fatigue, nausea and vomiting, somnolence, hostility, emotional lability, dizziness, hyperkinesias, bronchitis, respiratory infection.
Other adverse events observed during all clinical trials in adults and adolescents with epilepsy, when gabapentin has been used as adjunctive therapy in epilepsy treatment in clinical trials, the incidence of occuring of these adverse events were fewer than 1/1000 patients.
- Body as a whole: asthenia, malaise, face edema, allergy, generalized edema.
- Cardiovascular system: hypertension,hypotension (in frequent), angina pectoris, palpitation, tachycardia, migraine, murmur , heart failure.
- Digestive system : anorexia, flatulence, gingivitis.
- Endocrine system: hyperthyroid, hypothyroid, goiter, swollen testicle.
- Hematologic and lymphatic system: purpura, anemia, thrombocytopenia.
- Musculoskeletal system: arthralgia, tendinitis, joint stiffness, joint swelling.
- Nervous system: vertigo, hyperkinesia, decreased or absent reflexes, increased reflexes, anxiety, hostility.
- Respiratory system: pneumonia, dyspnea, apnea.
- Dermatological: alopecia, eczema, seborrhea, photosensetive reaction.
- Urogential system: hematoria, dysuria, urination frequency, cyctitis.
- Special senses: abnormal vision, conjunctivitis, eyes dry, eye pain.
Adverse events occuring during the treatment of epilepsy with gabapentin in pediatric patients 3 to 12 years
- Body as a whole : dehydration, infectious mononucleosis.
- Digestive system: hepatitis.
- Hemic and lymphatic system: coagulation defect.
- Nervous system: aura disappeared, occipital neuralgia.
- Psychobiological function: sleepwalking.
- Respiratory system: pseudocroup, hoarseness.
Adverse events which obtained from clinical trials in adults with neuropathic pain of various etiologies:
- Body as a whole: chest pain, cellulites, malaise, neck pain.
- Cardiovascular system: hypertension, syncope, hypotension, peripheral vascular disorders.
- Digestive system: gastroenteritis, increased appetite, thirst, liver function tests abnormal.
- Edocrine system: infrequent: diabets mellitus.
- Hemic and lymphatic system: ecchymosis, anemia, rare: prothrombin decreased.
- Metabolic and nutritional: gout, hypoglycemia, weight loss.
- Musculoskeletal: arthralgia, myalgia, infrequent arthrosis.
- Nervous system: confusion, depression, infrequent: vertigo, nervousness, abnormal dreams, nystagmus.
- Respiratory system: cough, rhinitis, asthma, pneumonia, all these adverse events are classified between infrequent to rare.
- Special senses: abnormal vision, ear pain, eye disorders, taste perversion, deafness, rare: retinal, vein thrombosis.
- Urogential system: urinary tract infection, dysuria, impotence, urinary incontinence, breast pain, menstrual disorder, polyuria.
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