Pregabalin Side Effects
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Pregabalin Safety Reports reported to FDA
Total Pregabalin reports: 116.Pregabalin FDA safety alerts: 2008 .
Reported deaths: 11 Reported hospitalizations: 38.
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Reported Pregabalin Side Effects: confusional state, agitation, intentional overdose, tremor, oedema peripheral, depressed level of consciousness, dizziness, convulsion, coordination abnormal, somnolence, haemoglobin decreased.
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Pregabalin Side Effects Report #5392819-8Consumer or non-health professional from MEXICO reported PREGABALIN problem on July 12, 2007. Female patient, weighting 108.0 lb, was diagnosed with epilepsy and was treated with PREGABALIN. After drug was administered, patient experienced the following problems/side effects: labyrinthitis, pneumonia, sinusitis, status epilepticus. PREGABALIN dosage: unknown. During the same period patient was treated with PREDNISON, NIMODIPINE, FLUOXETINE, DIFENIDOL. Patient was hospitalized. Patient recovered.
Pregabalin Side Effects Report #5392880-0
PREGABALIN problem was reported by a Consumer or non-health professional from BELGIUM on July 09, 2007. Male patient, 74 years of age, was diagnosed with phantom pain and was treated with PREGABALIN. After drug was administered, patient experienced the following problems/side effects: creatinine renal clearance decreased. PREGABALIN dosage: unknown. Patient recovered.
Pregabalin Side Effects Report #5393771-1
Pharmacist from UNITED STATES reported PREGABALIN problem on July 19, 2007. Male patient, 30 years of age, was diagnosed with neuralgia and was treated with PREGABALIN. After drug was administered, patient experienced the following problems/side effects: dizziness, headache, malaise, vision blurred. PREGABALIN dosage: 100MG AT BEDTIME PO. During the same period patient was treated with IBUPROFEN, METHYLPHENIDATE, FLUTICASONE PROPIONATE, ADVAIR DISKUS. Patient recovered.
Pregabalin Side Effects Report #5397428-2
PREGABALIN problem was reported by a Pharmacist from UNITED STATES on July 23, 2007. Male patient, 30 years of age, was treated with PREGABALIN. After drug was administered, patient experienced the following problems/side effects: hypoaesthesia, swelling face, trismus. PREGABALIN dosage: unknown. Patient recovered.
Pregabalin Side Effects Report #5398254-0
Consumer or non-health professional from MEXICO reported PREGABALIN problem on July 23, 2007. Female patient, weighting 108.0 lb, was diagnosed with epilepsy and was treated with PREGABALIN. After drug was administered, patient experienced the following problems/side effects: aspiration, blood alcohol increased, labyrinthitis, pneumonia, sinusitis, status epilepticus. PREGABALIN dosage: unknown. During the same period patient was treated with PREDNISON, NIMODIPINE, FLUOXETINE, DIFENIDOL. Patient was hospitalized. Patient recovered.
Pregabalin Side Effects Report #5406578-3
PREGABALIN problem was reported by a Physician from NETHERLANDS on July 31, 2007. Female patient, weighting 187.4 lb, was diagnosed with pain and was treated with PREGABALIN. After drug was administered, patient experienced the following problems/side effects: bradycardia, syncope. PREGABALIN dosage: unknown. During the same period patient was treated with ZYRTEC, OMEPRAZOLE, SYMBICORT. Patient recovered.
Pregabalin Side Effects Report #5406665-X
Consumer or non-health professional from SPAIN reported PREGABALIN problem on July 31, 2007. Male patient, 56 years of age, was diagnosed with neuralgia and was treated with PREGABALIN. After drug was administered, patient experienced the following problems/side effects: anorexia, depression, dry eye, dysphonia, facial palsy, hyperhidrosis, restlessness, somnolence, tachycardia. PREGABALIN dosage: unknown. During the same period patient was treated with NOVONORM, AMERIDE, TENORMIN, ADIRO, OMEPRAZOLE, DIEMIL. Patient recovered.
Pregabalin Side Effects Report #5415702-8
PREGABALIN problem was reported by a Pharmacist from UNITED STATES on Aug 02, 2007. Male patient, 56 years of age, weighting 179.9 lb, was diagnosed with neuropathy peripheral and was treated with PREGABALIN. After drug was administered, patient experienced the following problems/side effects: coordination abnormal, dysarthria, fall, mental status changes. PREGABALIN dosage: unknown. During the same period patient was treated with CARBAMAZEPINE, AMITRIPTYLINE. Patient was hospitalized. Patient recovered.
Pregabalin Side Effects Report #5429248-4
Pharmacist from UNITED STATES reported PREGABALIN problem on Aug 27, 2007. Male patient, 44 years of age, weighting 203.0 lb, was treated with PREGABALIN. After drug was administered, patient experienced the following problems/side effects: blood creatine phosphokinase increased. PREGABALIN dosage: 150 MG DAILY PO. Patient recovered.
Pregabalin Side Effects Report #5430049-1
PREGABALIN problem was reported by a Physician from SOUTH AFRICA on Aug 17, 2007. Female patient, weighting 112.4 lb, was diagnosed with post herpetic neuralgia and was treated with PREGABALIN. After drug was administered, patient experienced the following problems/side effects: amnesia, balance disorder, confusional state, oedema peripheral, tremor. PREGABALIN dosage: unknown. During the same period patient was treated with LEVOTHYROXINE, WARFARIN. Patient recovered.
Pregabalin Side Effects Report #5441192-5
Consumer or non-health professional from FRANCE reported PREGABALIN problem on Aug 21, 2007. Female patient, 43 years of age, was diagnosed with facial pain and was treated with PREGABALIN. After drug was administered, patient experienced the following problems/side effects: abnormal behaviour, anterograde amnesia, confusional state, petit mal epilepsy. PREGABALIN dosage: DAILY DOSE:300MG. During the same period patient was treated with CARBAMAZEPINE. Patient recovered.
Pregabalin Side Effects Report #5442354-3
PREGABALIN problem was reported by a Physician from SOUTH AFRICA on Aug 17, 2007. Female patient, weighting 112.4 lb, was diagnosed with post herpetic neuralgia and was treated with PREGABALIN. After drug was administered, patient experienced the following problems/side effects: amnesia, balance disorder, confusional state, oedema peripheral, tremor. PREGABALIN dosage: unknown. During the same period patient was treated with LEVOTHYROXINE, WARFARIN. Patient recovered.
Pregabalin Side Effects Report #5447913-X
Physician from HONDURAS reported PREGABALIN problem on Aug 29, 2007. Female patient, 72 years of age, was diagnosed with post herpetic neuralgia and was treated with PREGABALIN. PREGABALIN dosage: unknown. Patient died on 08/24/2007.
Pregabalin Side Effects Report #5464782-2
PREGABALIN problem was reported by a Health Professional from UNITED KINGDOM on Sept 11, 2007. Female patient, 72 years of age, was diagnosed with neuralgia and was treated with PREGABALIN. After drug was administered, patient experienced the following problems/side effects: pain in extremity, palpitations, tinnitus. PREGABALIN dosage: unknown. During the same period patient was treated with CLOPIDOGREL, DICLOFENAC, FRUSEMIDE, LANSOPRAZOLE, MOVICOL, PERINDOPRIL ERBUMINE, TRAMADOL. Patient recovered.
Pregabalin Side Effects Report #5464806-2
Physician from HONDURAS reported PREGABALIN problem on Sept 10, 2007. Female patient, 72 years of age, was diagnosed with post herpetic neuralgia and was treated with PREGABALIN. After drug was administered, patient experienced the following problems/side effects: acute hepatic failure, hepatic encephalopathy. PREGABALIN dosage: unknown. During the same period patient was treated with FUROSEMIDE, DIGOXIN. Patient died on 08/24/2007.
Pregabalin Side Effects Report #5467432-4
PREGABALIN problem was reported by a Health Professional from UNITED KINGDOM on Sept 13, 2007. Female patient, 81 years of age, weighting 183.0 lb, was diagnosed with neuropathy and was treated with PREGABALIN. After drug was administered, patient experienced the following problems/side effects: euphoric mood, pressure of speech. PREGABALIN dosage: unknown. During the same period patient was treated with BENDROFLUMETHIAZIDE, LOPERAMIDE, SOTALOL HYDROCHLORIDE, WARFARIN. Patient recovered.
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Drug Information: Pregabalin
URL of this page: http://www.nlm.nih.gov/medlineplus/druginfo/medmaster/a605045.html
(pre gab' a lin)IMPORTANT WARNING:
| [Posted 01/31/2008] FDA informed healthcare professionals that the Agency has analyzed reports of suicidality (suicidal behavior or ideation) from placebo-controlled clinical studies of eleven drugs used to treat epilepsy as well as psychiatric disorders, and other conditions. In the FDA's analysis, patients receiving antiepileptic drugs had approximately twice the risk of suicidal behavior or ideation (0.43%) compared to patients receiving placebo (0.22%). The increased risk of suicidal behavior and suicidal ideation was observed as early as one week after starting the antiepileptic drug and continued through 24 weeks. The results were generally consistent among the eleven drugs. The relative risk for suicidality was higher in patients with epilepsy compared to patients who were given one of the drugs in the class for psychiatric or other conditions.Healthcare professionals should closely monitor all patients currently taking or starting any antiepileptic drug for notable changes in behavior that could indicate the emergence or worsening of suicidal thoughts or behavior or depression.The drugs included in the analyses include (some of these drugs are also available in generic form): Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR)Felbamate (marketed as Felbatol)Gabapentin (marketed as Neurontin) Lamotrigine (marketed as Lamictal) Levetiracetam (marketed as Keppra) Oxcarbazepine (marketed as Trileptal)Pregabalin (marketed as Lyrica) Tiagabine (marketed as Gabitril)Topiramate (marketed as Topamax) Valproate (marketed as Depakote, Depakote ER, Depakene, Depacon) Zonisamide (marketed as Zonegran) Although the 11 drugs listed above were the ones included in the analysis, FDA expects that the increased risk of suicidality is shared by all antiepileptic drugs and anticipates that the class labeling changes will be applied broadly. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Antiepileptic and http://www.fda.gov/cder/drug/InfoSheets/HCP/antiepilepticsHCP.htm. |
Why is this medication prescribed?
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Pregabalin is used to relieve neuropathic pain (pain from damaged nerves) that can occur in your arms, hands, fingers, legs, feet, or toes if you have diabetes or in the area of your rash if you have had shingles (a painful rash that occurs after infection with herpes zoster). It is also used to treat fibromyalgia (a long-lasting condition that may cause pain, muscle stiffness and tenderness, tiredness, and difficulty falling asleep or staying asleep). Pregabalin is used with other medications to treat certain types of seizures in people with epilepsy. Pregabalin is in a class of medications called anticonvulsants. It works by decreasing the number of pain signals that are sent out by damaged nerves in the body.
How should this medicine be used?
Pregabalin comes as a capsule to take by mouth. It is usually taken with or without food two or three times a day. Take pregabalin at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand.
Your doctor will probably start you on a low dose of pregabalin and may gradually increase your dose during the first week of treatment.
Take pregabalin exactly as directed. Pregabalin may be habit forming. Do not take a larger dose, take it more often, or take it for a longer period of time than prescribed by your doctor.
Pregabalin may help control your symptoms but will not cure your condition. It may take several weeks or longer before you feel the full benefit of pregabalin. Continue to take pregabalin even if you feel well. Do not stop taking pregabalin without talking to your doctor. If you suddenly stop taking pregabalin, you may experience withdrawal symptoms, including trouble falling asleep or staying asleep, nausea, diarrhea, headaches. or seizuresYour doctor will probably decrease your dose gradually over at least one week.
Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.
Other uses for this medicine
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What special precautions should I follow?
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Before taking pregabalin,
- tell your doctor and pharmacist if you are allergic to pregabalin, any other medications, or any of the ingredients in pregabalin capsules.Ask your pharmacist for a list of the ingredients.
- tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: angiotensin converting enzyme (ACE) inhibitors such as benazepril (Lotensin, in Lotrel), captopril (Capoten, in Capozide), enalapril (Vasotec, in Vaseretic, Lexxel), fosinopril (Monopril), lisinopril (Prinivil, Zestril, in Prinzide, Zestoretic), moexipril (Univasc, in Uniretic), perindopril (Aceon), quinapril (Accupril, in Accuretic, Quinaretic), ramipril (Altace), and trandolapril (Mavik, in Tarka);antidepressants; antihistamines; medications for anxiety, including lorazepam (Ativan); medications for mental illness or seizures; certain medications for diabetes such as pioglitazone (Actos, in Duetact) and rosiglitazone (Avandia, in Avandaryl, Avandamet); narcotic pain medications, including oxycodone (OxyContin, in Percocet, others);sedatives; sleeping pills; and tranquilizers. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you drink or have ever drunk large amounts of alcohol, use or have ever used street drugs, or have overused prescription medications. Also tell your doctor if you have or have ever had swelling of the eyes, face, lips, tongue, or throat;problems with your vision, bleeding problems or a low number of platelets (type of blood cell needed for blood clotting) in your blood, or heart or kidney disease.
- tell your doctor if you are pregnant, or if you or your partner plans to become pregnant. Also tell your doctor if you are breast-feeding. If you or your partner becomes pregnant while you are taking pregabalin, call your doctor.Pregabalin has caused decreased fertility in male animals and birth defects in the offspring of male and female animals who were treated with the medication. . There is not enough information to tell if pregabalin causes these problems in humans.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking pregabalin.
- you should know that pregabalin may make you dizzy or drowsy. Do not drive a car operate machinery, or do other dangerous activities until you know how this medication affects you. Ask your doctor when you may do these activities.
- Do not drink alcohol while taking pregabalin.Alcohol can add to the drowsiness caused by this medication.
What special dietary instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What should I do if I forget a dose?
If you forget to take a dose and remember a few hours later, take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
What side effects can this medication cause?
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Pregabalin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- tiredness
- dizziness
- headache
- dry mouth
- nausea
- vomiting
- constipation
- gas
- bloating
- "high" or elevated mood
- speech problems
- difficulty concentrating or paying attention
- confusion
- difficulty remembering or forgetfulness
- anxiety
- lack of coordination
- loss of balance or unsteadiness
- uncontrollable shaking or jerking of a part of the body
- muscle twitching
- weakness
- increased appetite
- weight gain
- swelling of the arms, hands, feet, ankles, or lower legs
- back pain
Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:
- blurred vision, double vision, or other changes in eyesight
- hives
- rash
- itching
- blisters
- swelling of the eyes face, throat, mouth, lips, gums, tongue, head or neck
- shortness of breath
- wheezing
- muscle pain, tenderness, soreness, or weakness, especially if it comes along with fever
- chest pain
If you have diabetes, you should know that pregabalin has caused skin sores in animals. Pay extra attention to your skin while taking pregabalin, and tell your doctor if you have any sores, redness, or skin problems.
Pregabalin may cause other side effects.Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/index.html] or by phone [1-800-332-1088].
What storage conditions are needed for this medicine?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
In case of emergency/overdose
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
What other information should I know?
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to pregabalin.
Do not let anyone else take your medication.Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
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