G Gab Side effects

• Side effects of G Gab in details
• G Gab contraindications
• G Gab reviews

What are the possible side effects of G Gab?

Get emergency medical help if you have any of these signs of an allergic reaction to G Gab: hives; 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, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have any of these serious side effects while using G Gab:

• muscle pain, weakness, or tenderness (especially if you also have a fever and feel tired);

• vision problems;

• easy bruising or bleeding; or

• swelling in your hands or feet, rapid weight gain.

Less serious G Gab side effects may include:

• dizziness, drowsiness;

• loss of balance or coordination;

• problems with memory or concentration;

• breast swelling;

• tremors; or

• dry mouth, constipation.

This is not a complete list of G Gab 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 G Gab 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.

In all controlled and uncontrolled trials across various patient populations during the premarketing development of G Gab, more than 10,000 patients have received G Gab. Approximately 5000 patients were treated for 6 months or more, over 3100 patients were treated for 1 year or longer, and over 1400 patients were treated for at least 2 years.

Adverse Reactions Most Commonly Leading To Discontinuation In All Premarketing Controlled Clinical Studies

In premarketing controlled trials of all populations combined, 14% of patients treated with G Gab and 7% of patients treated with placebo discontinued prematurely due to adverse reactions. In the G Gab treatment group, the adverse reactions most frequently leading to discontinuation were dizziness (4%) and somnolence (4%). In the placebo group, 1% of patients withdrew due to dizziness and less than 1% withdrew due to somnolence. Other adverse reactions that led to discontinuation from controlled trials more frequently in the G Gab group compared to the placebo group were ataxia, confusion, asthenia, thinking abnormal, blurred vision, incoordination, and peripheral edema (1% each).

Most Common Adverse Reactions In All Premarketing Controlled Clinical Studies

In premarketing controlled trials of all patient populations combined, dizziness, somnolence, dry mouth, edema, blurred vision, weight gain, and “thinking abnormal” (primarily difficulty with concentration/attention) were more commonly reported by subjects treated with G Gab than by subjects treated with placebo (greater than or equal to 5% and twice the rate of that seen in placebo).

Controlled Studies With Neuropathic Pain Associated With Diabetic Peripheral Neuropathy

Adverse Reactions Leading to Discontinuation

In clinical trials in patients with neuropathic pain associated with diabetic peripheral neuropathy, 9% of patients treated with G Gab and 4% of patients treated with placebo discontinued prematurely due to adverse reactions. In the G Gab treatment group, the most common reasons for discontinuation due to adverse reactions were dizziness (3%) and somnolence (2%). In comparison, less than 1% of placebo patients withdrew due to dizziness and somnolence. Other reasons for discontinuation from the trials, occurring with greater frequency in the G Gab group than in the placebo group, were asthenia, confusion, and peripheral edema. Each of these events led to withdrawal in approximately 1% of patients.

Most Common Adverse Reactions

Table 3 lists all adverse reactions, regardless of causality, occurring in greater than or equal to 1% of patients with neuropathic pain associated with diabetic neuropathy in the combined G Gab group for which the incidence was greater in this combined G Gab group than in the placebo group. A majority of G Gab-treated patients in clinical studies had adverse reactions with a maximum intensity of “mild” or “moderate”.

Table 3: Treatment-emergent adverse reaction incidence in controlled trials in neuropathic pain associated with diabetic peripheral neuropathy (events in at least 1% of all G Gab-treated patients and at least numerically more in all G Gab than in the placebo group)

Controlled Studies In Postherpetic Neuralgia

Adverse Reactions Leading to Discontinuation

In clinical trials in patients with postherpetic neuralgia, 14% of patients treated with G Gab and 7% of patients treated with placebo discontinued prematurely due to adverse reactions. In the G Gab treatment group, the most common reasons for discontinuation due to adverse reactions were dizziness (4%) and somnolence (3%). In comparison, less than 1% of placebo patients withdrew due to dizziness and somnolence. Other reasons for discontinuation from the trials, occurring in greater frequency in the G Gab group than in the placebo group, were confusion (2%), as well as peripheral edema, asthenia, ataxia, and abnormal gait (1% each).

Most Common Adverse Reactions

Table 4 lists all adverse reactions, regardless of causality, occurring in greater than or equal to 1% of patients with neuropathic pain associated with postherpetic neuralgia in the combined G Gab group for which the incidence was greater in this combined G Gab group than in the placebo group. In addition, an event is included, even if the incidence in the all G Gab group is not greater than in the placebo group, if the incidence of the event in the 600 mg/day group is more than twice that in the placebo group. A majority of G Gab-treated patients in clinical studies had adverse reactions with a maximum intensity of &dquo;mild” or “moderate”. Overall, 12.4% of all G Gab-treated patients and 9.0% of all placebo-treated patients had at least one severe event while 8% of G Gab-treated patients and 4.3% of placebo-treated patients had at least one severe treatment-related adverse event.

Table 4: Treatment-emergent adverse reaction incidence in controlled trials in neuropathic pain associated with postherpetic neuralgia (events in at least 1% of all G Gab-treated patients and at least numerically more in all G Gab than in the placebo group)

Controlled Add-On Studies In Adjunctive Therapy For Adult Patients With Partial Onset Seizures

Adverse Reactions Leading to Discontinuation

Approximately 15% of patients receiving G Gab and 6% of patients receiving placebo in add-on epilepsy trials discontinued prematurely due to adverse reactions. In the G Gab treatment group, the adverse reactions most frequently leading to discontinuation were dizziness (6%), ataxia (4%), and somnolence (3%). In comparison, less than 1% of patients in the placebo group withdrew due to each of these events. Other adverse reactions that led to discontinuation of at least 1% of patients in the G Gab group and at least twice as frequently compared to the placebo group were asthenia, diplopia, blurred vision, thinking abnormal, nausea, tremor, vertigo, headache, and confusion (which each led to withdrawal in 2% or less of patients).

Most Common Adverse Reactions

Table 5 lists all dose-related adverse reactions occurring in at least 2% of all G Gab-treated patients. Dose-relatedness was defined as the incidence of the adverse event in the 600 mg/day group was at least 2% greater than the rate in both the placebo and 150 mg/day groups. In these studies, 758 patients received G Gab and 294 patients received placebo for up to 12 weeks. Because patients were also treated with 1 to 3 other AEDs, it is not possible to determine whether the following adverse reactions can be ascribed to G Gab alone, or the combination of G Gab and other AEDs. A majority of G Gab-treated patients in clinical studies had adverse reactions with a maximum intensity of “mild” or “moderate”.

Table 5: Dose-related treatment-emergent adverse reaction incidence in controlled trials in adjunctive therapy for adult patients with partial onset seizures (events in at least 2% of all G Gab-treated patients and the adverse reaction in the 600 mg/day group was greater than or equal to 2% the rate in both the placebo and 150 mg/day groups)

Controlled Studies With Fibromyalgia

Adverse Reactions Leading to Discontinuation

In clinical trials of patients with fibromyalgia, 19% of patients treated with G Gab (150– 600 mg/day) and 10% of patients treated with placebo discontinued prematurely due to adverse reactions. In the G Gab treatment group, the most common reasons for discontinuation due to adverse reactions were dizziness (6%) and somnolence (3%). In comparison, less than 1% of placebo-treated patients withdrew due to dizziness and somnolence. Other reasons for discontinuation from the trials, occurring with greater frequency in the G Gab treatment group than in the placebo treatment group, were fatigue, headache, balance disorder, and weight increased. Each of these adverse reactions led to withdrawal in approximately 1% of patients.

Most Common Adverse Reactions

Table 6 lists all adverse reactions, regardless of causality, occurring in greater than or equal to 2% of patients with fibromyalgia in the 'all G Gab' treatment group for which the incidence was greater than in the placebo treatment group. A majority of G Gab-treated patients in clinical studies experienced adverse reactions with a maximum intensity of “mild” or “moderate”.

Table 6: Treatment-emergent adverse reaction incidence in controlled trials in fibromyalgia (events) in at least 2% of all G Gab-treated patients and occurring more frequently in the all G Gab-group than in the placebo treatment group)

Controlled Studies In Neuropathic Pain Associated With Spinal Cord Injury

Adverse Reactions Leading to Discontinuation

In clinical trials of patients with neuropathic pain associated with spinal cord injury, 13% of patients treated with G Gab and 10% of patients treated with placebo discontinued prematurely due to adverse reactions. In the G Gab treatment group, the most common reasons for discontinuation due to adverse reactions were somnolence (3%) and edema (2%). In comparison, none of the placebo-treated patients withdrew due to somnolence and edema. Other reasons for discontinuation from the trials, occurring with greater frequency in the G Gab treatment group than in the placebo treatment group, were fatigue and balance disorder. Each of these adverse reactions led to withdrawal in less than 2% of patients.

Most Common Adverse Reactions

Table 7 lists all adverse reactions, regardless of causality, occurring ingreater than or equal to 2% of patients with neuropathic pain associated with spinal cord injury in the controlled trials. A majority of G Gab-treated patients in clinical studies experienced adverse reactions with a maximum intensity of “mild” or “moderate”.

Table 7: Treatment-emergent adverse reaction incidence in controlled trials in neuropathic pain associated with spinal cord injury (events in at least 2% of all G Gab-treated patients and occurring more frequently in the all G Gab-group than in the placebo treatment group)

Other Adverse Reactions Observed During The Clinical Studies Of G Gab

Following is a list of treatment-emergent adverse reactions reported by patients treated with G Gab during all clinical trials. The listing does not include those events already listed in the previous tables or elsewhere in labeling, those events for which a drug cause was remote, those events which were so general as to be uninformative, and those events reported only once which did not have a substantial probability of being acutely life-threatening.

Events are categorized by body system and listed in order of decreasing frequency according to the following definitions: frequent adverse reactions are those occurring on one or more occasions in at least 1/100 patients; infrequent adverse reactions are those occurring in 1/100 to 1/1000 patients; rare reactions are those occurring in fewer than 1/1000 patients. Events of major clinical importance are described in the WARNINGS AND PRECAUTIONS).

Body as a Whole – Frequent: Abdominal pain, Allergic reaction, Fever, Infrequent: Abscess, Cellulitis, Chills, Malaise, Neck rigidity, Overdose, Pelvic pain, Photosensitivity reaction, Rare: Anaphylactoid reaction, Ascites, Granuloma, Hangover effect, Intentional Injury, Retroperitoneal Fibrosis, Shock

Cardiovascular System – Infrequent: Deep thrombophlebitis, Heart failure, Hypotension, Postural hypotension, Retinal vascular disorder, Syncope; Rare: ST Depressed, Ventricular Fibrillation

Digestive System – Frequent: Gastroenteritis, Increased appetite; Infrequent: Cholecystitis, Cholelithiasis, Colitis, Dysphagia, Esophagitis, Gastritis, Gastrointestinal hemorrhage, Melena, Mouth ulceration, Pancreatitis, Rectal hemorrhage, Tongue edema; Rare: Aphthous stomatitis, Esophageal Ulcer, Periodontal abscess

Hemic and Lymphatic System – Frequent: Ecchymosis; Infrequent: Anemia, Eosinophilia, Hypochromic anemia, Leukocytosis, Leukopenia, Lymphadenopathy, Thrombocytopenia; Rare: Myelofibrosis, Polycythemia, Prothrombin decreased, Purpura, Thrombocythemia Metabolic and Nutritional Disorders – Rare: Glucose Tolerance Decreased, Urate Crystalluria

Musculoskeletal System – Frequent: Arthralgia, Leg cramps, Myalgia, Myasthenia; Infrequent: Arthrosis; Rare: Chondrodystrophy, Generalized Spasm

Nervous System – Frequent: Anxiety, Depersonalization, Hypertonia, Hypoesthesia, Libido decreased, Nystagmus, Paresthesia, Sedation, Stupor, Twitching; Infrequent: Abnormal dreams, Agitation, Apathy, Aphasia, Circumoral paresthesia, Dysarthria, Hallucinations, Hostility, Hyperalgesia, Hyperesthesia, Hyperkinesia, Hypokinesia, Hypotonia, Libido increased, Myoclonus, Neuralgia, Rare: Addiction, Cerebellar syndrome, Cogwheel rigidity, Coma, Delirium, Delusions, Dysautonomia, Dyskinesia, Dystonia, Encephalopathy, Extrapyramidal syndrome, Guillain-Barré syndrome, Hypalgesia, Intracranial hypertension, Manic reaction, Paranoid reaction, Peripheral neuritis, Personality disorder, Psychotic depression, Schizophrenic reaction, Sleep disorder, Torticollis, Trismus

Respiratory System – Rare: Apnea, Atelectasis, Bronchiolitis, Hiccup, Laryngismus, Lung edema, Lung fibrosis, Yawn

Skin and Appendages – Frequent: Pruritus, Infrequent: Alopecia, Dry skin, Eczema, Hirsutism, Skin ulcer, Urticaria, Vesiculobullous rash; Rare: Angioedema, Exfoliative dermatitis, Lichenoid dermatitis, Melanosis, Nail Disorder, Petechial rash, Purpuric rash, Pustular rash, Skin atrophy, Skin necrosis, Skin nodule, Stevens-Johnson syndrome, Subcutaneous nodule

Special senses – Frequent: Conjunctivitis, Diplopia, Otitis media, Tinnitus; Infrequent: Abnormality of accommodation, Blepharitis, Dry eyes, Eye hemorrhage, Hyperacusis, Photophobia, Retinal edema, Taste loss, Taste perversion; Rare: Anisocoria, Blindness, Corneal ulcer, Exophthalmos, Extraocular palsy, Iritis, Keratitis, Keratoconjunctivitis, Miosis, Mydriasis, Night blindness, Ophthalmoplegia, Optic atrophy, Papilledema, Parosmia, Ptosis, Uveitis

Urogenital System – Frequent: Anorgasmia, Impotence, Urinary frequency, Urinary incontinence; Infrequent: Abnormal ejaculation, Albuminuria, Amenorrhea, Dysmenorrhea, Dysuria, Hematuria, Kidney calculus, Leukorrhea, Menorrhagia, Metrorrhagia, Nephritis, Oliguria, Urinary retention, Urine abnormality; Rare: Acute kidney failure, Balanitis, Bladder Neoplasm, Cervicitis, Dyspareunia, Epididymitis, Female lactation, Glomerulitis, Ovarian disorder, Pyelonephritis

Comparison Of Gender And Race

The overall adverse event profile of G Gab was similar between women and men. There are insufficient data to support a statement regarding the distribution of adverse experience reports by race.

Post-marketing Experience

The following adverse reactions have been identified during postapproval use of G Gab. 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.

Nervous System Disorders – Headache

Gastrointestinal Disorders – Nausea, Diarrhea

Reproductive System and Breast Disorders – Gynecomastia, Breast Enlargement

In addition, there are post-marketing reports of events related to reduced lower gastrointestinal tract function (e.g., intestinal obstruction, paralytic ileus, constipation) when G Gab was co- administered with medications that have the potential to produce constipation, such as opioid analgesics. There are also post-marketing reports of respiratory failure and coma in patients taking G Gab and other CNS depressant medications.

What is the most important information I should know about G Gab?

• G Gab solution may cause drowsiness, dizziness, blurred vision, or light-headedness. These effects may be worse if you take it with alcohol or certain medicines. Use G Gab solution with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Do not drink alcohol while you are taking G Gab solution.
• Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are taking G Gab solution; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
• G Gab solution may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
• Do not suddenly stop taking G Gab solution or change your dose without checking with your doctor. If you stop taking G Gab solution suddenly, you may have headaches, nausea, diarrhea, trouble sleeping, anxiety, or increased sweating. If you have epilepsy and you stop taking G Gab solution suddenly, you may have seizures more often. If you need to stop taking G Gab solution, your dose should be gradually reduced over a period of at least 1 week.
• If you stop taking G Gab solution for any reason, contact your doctor right away. Do not start taking it again unless your doctor tells you to. Discuss any questions or concerns with your doctor.
• If you develop new or worsening seizures, contact your doctor right away.
• Patients who take G Gab solution may be at increased risk of 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 G Gab solution closely. Contact the doctor at once if new, worsened, or sudden symptoms (eg, depressed mood; anxious, restless, or irritable behavior; panic attacks; any unusual change in mood or behavior) occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.
• Tell your doctor or dentist that you take G Gab solution before you receive any medical or dental care, emergency care, or surgery.
• Diabetes patients - Monitor your skin closely for any new or unusual sores while you take G Gab solution.
• In animal studies, birth defects were seen in the babies of male animals who were treated with G Gab solution. It is not known if this may also occur in humans. If you are planning to father a child, discuss the possible risks with your doctor.
• Use G Gab solution with caution in the ELDERLY; they may be more sensitive to its effects.
• G Gab solution should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using G Gab solution while you are pregnant. It is not known if G Gab solution is found in breast milk. Do not breast-feed while taking G Gab solution.

G Gab contraindications

You may have thoughts about suicide while taking this medication. Your doctor will need to check you at regular visits. Do not miss any scheduled appointments.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, anxiety, insomnia, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

If you are taking G Gab to prevent seizures, keep taking the medication even if you feel fine.

Do not stop using G Gab without first talking to your doctor, even if you feel fine. You may have increased seizures or withdrawal symptoms such as headache, sleep problems, nausea, and diarrhea. Ask your doctor how to avoid withdrawal symptoms when you stop using G Gab.

Do not change your dose of G Gab without your doctor's advice. Tell your doctor if the medication does not seem to work as well in treating your condition.

Wear a medical alert tag or carry an ID card stating that you take G Gab. Any medical care provider who treats you should know that you take seizure medication.

References

1. DailyMed. "PREGABALIN: 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).
2. European Chemicals Agency - ECHA. "(3S)-3-(aminomethyl)-5-methylhexanoic: 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).
3. HSDB. "PREGABALIN". https://toxnet.nlm.nih.gov/cgi-bin/s... (accessed September 17, 2018).

Reviews

User reports

Consumer reviews

Information checked by Dr. Sachin Kumar, MD Pharmacology