What are the possible side effects of Phl-Gabapentin?
Get emergency medical help if you have signs of an allergic reaction to Phl-Gabapentin: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Seek medical treatment if you have a skin rash with symptoms of a serious allergic reaction that can affect other parts of your body, including: fever, dark urine, blood in your urine, swollen glands, sore throat, extreme weakness or tiredness, unusual bruising or bleeding, muscle pain, or jaundice (yellowing of the skin or eyes).
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:
-
increased seizures;
-
severe weakness or tiredness;
-
upper stomach pain;
-
chest pain, new or worsening cough with fever, trouble breathing;
-
severe tingling or numbness;
-
rapid back and forth movement of your eyes;
-
kidney problems--little or no urination, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath; or
-
severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.
Some side effects are more likely in children taking Phl-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.
Common Phl-Gabapentin side effects may include:
-
dizziness, drowsiness; or
-
headache.
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 of Phl-Gabapentin in details
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.
A total of 359 patients with neuropathic pain associated with postherpetic neuralgia have received Phl-Gabapentin at doses up to 1800 mg daily during placebo-controlled clinical studies. In clinical trials in patients with postherpetic neuralgia, 9.7% of the 359 patients treated with
Phl-Gabapentin and 6.9% of 364 patients treated with placebo discontinued prematurely due to adverse reactions. In the Phl-Gabapentin treatment group, the most common reason for discontinuation due to adverse reactions was dizziness. Of Phl-Gabapentin-treated patients who experienced adverse reactions in clinical studies, the majority of those adverse reactions were either “mild” or “moderate”.
Table 4 lists all adverse reactions, regardless of causality, occurring in at least 1% of patients with neuropathic pain associated with postherpetic neuralgia in the Phl-Gabapentin group for which the incidence was greater than in the placebo group.
Table 4: Treatment-Emergent Adverse Reaction Incidence in Controlled Trials in Neuropathic Pain Associated with Postherpetic Neuralgia (Events in at Least 1% of all Phl-Gabapentin-Treated Patients and More Frequent Than in the Placebo Group)
| Body System - Preferred Term | Phl-Gabapentin N = 359 % | Placebo N = 364 % |
| Ear and Labyrinth Disorders | ||
| Vertigo | 1.4 | 0.5 |
| Gastrointestinal Disorders | ||
| Diarrhea | 3.3 | 2.7 |
| Dry mouth | 2.8 | 1.4 |
| Constipation | 1.4 | 0.3 |
| Dyspepsia | 1.4 | 0.8 |
| General Disorders | ||
| Peripheral edema | 3.9 | 0.3 |
| Pain | 1.1 | 0.5 |
| Infections and Infestations | ||
| Nasopharyngitis | 2.5 | 2.2 |
| Urinary tract infection | 1.7 | 0.5 |
| Investigations | ||
| Weight increased | 1.9 | 0.5 |
| Musculoskeletal and Connective Tissue Disorders | ||
| Pain in extremity | 1.9 | 0.5 |
| Back pain | 1.7 | 1.1 |
| Nervous System Disorders | ||
| Dizziness | 10.9 | 2.2 |
| Somnolence | 4.5 | 2.7 |
| Headache | 4.2 | 4.1 |
| Lethargy | 1.1 | 0.3 |
In addition to the adverse reactions reported in Table 4 above, the following adverse reactions with an uncertain relationship to Phl-Gabapentin were reported during the clinical development for the treatment of postherpetic neuralgia. Events in more than 1% of patients but equally or more frequently in the Phl-Gabapentin-treated patients than in the placebo group included blood pressure increase, confusional state, gastroenteritis viral, herpes zoster, hypertension, joint swelling, memory impairment, nausea, pneumonia, pyrexia, rash, seasonal allergy, and upper respiratory infection.
Postmarketing And Other Experience With Other Formulations Of Phl-Gabapentin
In addition to the adverse experiences reported during clinical testing of Phl-Gabapentin, the following adverse experiences have been reported in patients receiving other formulations of marketed Phl-Gabapentin. These adverse experiences have not been listed above and data are insufficient to support an estimate of their incidence or to establish causation. The listing is alphabetized: angioedema, blood glucose fluctuation, breast enlargement, elevated creatine kinase, elevated liver function tests, erythema multiforme, fever, hyponatremia, jaundice, movement disorder, Stevens-Johnson syndrome.
Adverse events following the abrupt discontinuation of Phl-Gabapentin immediate release have also been reported. The most frequently reported events were anxiety, insomnia, nausea, pain and sweating.
What is the most important information I should know about Phl-Gabapentin?
- Phl-Gabapentin capsules may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Phl-Gabapentin capsules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Do not change your dose of Phl-Gabapentin capsules without checking with your doctor.
- Check with your doctor before you drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Phl-Gabapentin capsules; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
- Patients who take Phl-Gabapentin capsules may be at increased risk for suicidal thoughts or actions. The risk may be greater in patients who have had suicidal thoughts or actions in the past. Watch patients who take Phl-Gabapentin capsules closely. Contact the doctor at once if new, worsened, or sudden symptoms such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.
- Phl-Gabapentin capsules may cause a serious or life-threatening allergic reaction that may affect your skin or other parts of your body (eg, liver, blood cells). A rash may or may not occur along with this reaction. Contact your doctor right away if you develop symptoms such as rash; red, swollen, blistered, or peeling skin; swollen glands or lymph nodes; swelling of the lip or tongue; yellowing of the skin or eyes; unusual bruising or bleeding; severe tiredness or weakness; unusual muscle pain; or symptoms of infection (eg, fever, chills, sore throat).
- Phl-Gabapentin capsules may interfere with certain lab tests, including a certain urine protein test. Be sure your doctor and lab personnel know you are taking Phl-Gabapentin capsules.
- Lab tests, including liver function, kidney function, and complete blood cell counts, may be performed while you use Phl-Gabapentin capsules. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Phl-Gabapentin capsules with caution in the ELDERLY; they may be more sensitive to its effects.
- Phl-Gabapentin capsules may cause emotional or behavioral side effects in CHILDREN 3 to 12 years old. If the following side effects occur, notify your doctor immediately: emotional "swings," hostile or aggressive behavior, problems concentrating, decreased performance at school, an increase in restlessness or hyperactivity.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Phl-Gabapentin capsules while you are pregnant. Phl-Gabapentin capsules is found in breast milk. If you are or will be breast-feeding while you use Phl-Gabapentin capsules, check with your doctor. Discuss any possible risks to your baby.
Phl-Gabapentin contraindications
You should not use this medication if you are allergic to Phl-Gabapentin.
Before taking Phl-Gabapentin, tell your doctor if you have kidney, liver, or heart disease.
You may have thoughts about suicide while taking Phl-Gabapentin. Your doctor will need to check you at regular visits. Do not miss any scheduled appointments.
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.
Do not stop taking Phl-Gabapentin for seizures without first talking to your doctor, even if you feel fine. You may have increased seizures if you stop using Phl-Gabapentin suddenly. You may need to use less and less before you stop the medication completely.
Contact your doctor if your seizures get worse or you have them more often while taking Phl-Gabapentin.
Wear a medical alert tag or carry an ID card stating that you take Phl-Gabapentin. Any doctor, dentist, or emergency medical care provider who treats you should know that you take seizure medication.
References
- DailyMed. "GABAPENTIN: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- DTP/NCI. "gabapentin: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).
- European Chemicals Agency - ECHA. "Gabapentin: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Phl-Gabapentin are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Phl-Gabapentin. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports
Consumer reported side effects
No survey data has been collected yetConsumer reviews
There are no reviews yet. Be the first to write one! |
Information checked by Dr. Sachin Kumar, MD Pharmacology
