Flurazepam Side Effects

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Flurazepam Safety Reports

Total Flurazepam reports: 28.
Flurazepam FDA safety alerts: 2007 .
Reported deaths: 6    Reported hospitalizations: 11.
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Reported Flurazepam Side Effects: suicide attempt, somnolence, overdose, intentional overdose, alcohol use, completed suicide, aspiration, cyanosis, coma, ill-defined disorder, hypotension.
Flurazepam Usage.

Flurazepam Side Effects Report #5212829-0
Physician from GERMANY reported FLURAZEPAM problem on Jan 09, 2007. Female patient, 60 years of age, was diagnosed with schizophrenia, depression, gastric disorder and was treated with FLURAZEPAM. After drug was administered, patient experienced the following problems/side effects: colitis, colonoscopy abnormal, diarrhoea. FLURAZEPAM dosage: 30 MG/DAY. During the same period patient was treated with LEPONEX, ESCITALOPRAM OXALATE, LORAZEPAM, PANTOPRAZOLE. Patient recovered.

Flurazepam Side Effects Report #5306147-X
FLURAZEPAM problem was reported by a Consumer or non-health professional from SWITZERLAND on Mar 09, 2007. Female patient, 40 years of age, was treated with FLURAZEPAM. After drug was administered, patient experienced the following problems/side effects: electrocardiogram qt prolonged, overdose, respiratory depression, torsade de pointes, ventricular arrhythmia. FLURAZEPAM dosage: unknown. During the same period patient was treated with METHADONE, CLONAZEPAM. Patient died on 10/09/2006.

Flurazepam Side Effects Report #5343444-6
Physician from GERMANY reported FLURAZEPAM problem on Apr 11, 2006. Male patient, 76 years of age, was treated with FLURAZEPAM. After drug was administered, patient experienced the following problems/side effects: incorrect dose administered, suicide attempt, unevaluable event. FLURAZEPAM dosage: unknown. Patient was hospitalized. Patient recovered.

Flurazepam Side Effects Report #5343445-8
FLURAZEPAM problem was reported by a Consumer or non-health professional from GERMANY on Aug 30, 2006. Female patient, 58 years of age, weighting 154.3 lb, was treated with FLURAZEPAM. After drug was administered, patient experienced the following problems/side effects: intentional overdose, somnolence, suicide attempt. FLURAZEPAM dosage: 1290 MG; X1. Patient recovered.

Flurazepam Side Effects Report #5343446-X
Consumer or non-health professional from GERMANY reported FLURAZEPAM problem on Oct 09, 2006. Female patient was treated with FLURAZEPAM. After drug was administered, patient experienced the following problems/side effects: overdose, somnolence, suicidal ideation. FLURAZEPAM dosage: 540 MG. Patient was hospitalized. Patient recovered.

Flurazepam Side Effects Report #5343447-1
FLURAZEPAM problem was reported by a Consumer or non-health professional from GERMANY on Oct 26, 2006. Female patient, 51 years of age, was treated with FLURAZEPAM. After drug was administered, patient experienced the following problems/side effects: alcohol use, dehydration, mydriasis, sopor, suicide attempt. FLURAZEPAM dosage: 600 MG. During the same period patient was treated with ALCOHOL. Patient recovered.

Flurazepam Side Effects Report #5343448-3
Consumer or non-health professional from GERMANY reported FLURAZEPAM problem on Nov 22, 2006. Male patient, 50 years of age, weighting 198.4 lb, was treated with FLURAZEPAM. After drug was administered, patient experienced the following problems/side effects: alcohol use, overdose, respiratory failure, suicide attempt. FLURAZEPAM dosage: 600 MG. During the same period patient was treated with SENOKORT. Patient was hospitalized. Patient recovered.

Flurazepam Side Effects Report #5343449-5
FLURAZEPAM problem was reported by a Consumer or non-health professional from GERMANY on Nov 29, 2006. Female patient, 70 years of age, was treated with FLURAZEPAM. After drug was administered, patient experienced the following problems/side effects: overdose, suicidal behaviour. FLURAZEPAM dosage: 300 MG; X1; PO. Patient recovered.

Flurazepam Side Effects Report #5343450-1
Consumer or non-health professional from GERMANY reported FLURAZEPAM problem on Dec 27, 2006. Female patient, 77 years of age, weighting 160.9 lb, was treated with FLURAZEPAM. After drug was administered, patient experienced the following problems/side effects: overdose, somnolence, suicide attempt. FLURAZEPAM dosage: 300 MG; ; PO. Patient was hospitalized. Patient recovered.

Flurazepam Side Effects Report #5343452-5
FLURAZEPAM problem was reported by a Consumer or non-health professional from GERMANY on Jan 02, 2007. Female patient, weighting 132.3 lb, was treated with FLURAZEPAM. After drug was administered, patient experienced the following problems/side effects: somnolence, suicide attempt, vomiting. FLURAZEPAM dosage: 1200 MG; X1; PO. During the same period patient was treated with PROMETHAZINE. Patient recovered.

Flurazepam Side Effects Report #5343453-7
Consumer or non-health professional from GERMANY reported FLURAZEPAM problem on Feb 15, 2007. Male patient, 64 years of age, weighting 176.4 lb, was treated with FLURAZEPAM. After drug was administered, patient experienced the following problems/side effects: mydriasis, pupils unequal, somnolence, suicide attempt. FLURAZEPAM dosage: unknown. During the same period patient was treated with DIAZEPAM, DISTRANEURIN, FLUNITRAZEPAM, ROHYPNOL. Patient was hospitalized. Patient recovered.

Flurazepam Side Effects Report #5343455-0
FLURAZEPAM problem was reported by a Consumer or non-health professional from GERMANY on Jan 08, 2007. Male patient, 80 years of age, weighting 176.4 lb, was treated with FLURAZEPAM. After drug was administered, patient experienced the following problems/side effects: bradycardia, hypotension, overdose, somnolence, suicide attempt. FLURAZEPAM dosage: 1800 MG;X1;PO. Patient was hospitalized. Patient recovered.

Flurazepam Side Effects Report #5343456-2
Consumer or non-health professional from GERMANY reported FLURAZEPAM problem on Sept 27, 2006. Female patient, 41 years of age, weighting 143.3 lb, was treated with FLURAZEPAM. After drug was administered, patient experienced the following problems/side effects: incorrect dose administered, suicide attempt. FLURAZEPAM dosage: unknown. During the same period patient was treated with IBUPROFEN, TERAZEPAM, ZOPLICONE. Patient recovered.

Flurazepam Side Effects Report #5343457-4
FLURAZEPAM problem was reported by a Consumer or non-health professional from GERMANY on Mar 27, 2007. Male patient, 63 years of age, weighting 187.4 lb, was treated with FLURAZEPAM. After drug was administered, patient experienced the following problems/side effects: alcohol use, overdose, somnolence, suicide attempt. FLURAZEPAM dosage: unknown. During the same period patient was treated with ALCOHOL. Patient was hospitalized. Patient recovered.

Flurazepam Side Effects Report #5353087-6
Physician from GERMANY reported FLURAZEPAM problem on May 09, 2007. Male patient was diagnosed with sleep disorder and was treated with FLURAZEPAM. After drug was administered, patient experienced the following problems/side effects: abasia, convulsion, delusional disorder, persecutory type, fluorosis, hallucination, ill-defined disorder, joint stiffness, muscle rigidity. FLURAZEPAM dosage: 30 MG; QD; PO. During the same period patient was treated with ZYPREXA, TAVOR. Patient recovered.

Flurazepam Side Effects Report #5364288-5
FLURAZEPAM problem was reported by a Consumer or non-health professional from GERMANY on June 04, 2007. Female patient, 20 years of age, weighting 165.3 lb, was treated with FLURAZEPAM. After drug was administered, patient experienced the following problems/side effects: intentional overdose, restlessness, suicidal ideation. FLURAZEPAM dosage: unknown. During the same period patient was treated with ACETAMINOPHEN, PENICILLIN, DICLOFENAC, ALCOHOL, ZOPICLONE. Patient recovered.

Flurazepam Side Effects Report #5364289-7
Physician from GERMANY reported FLURAZEPAM problem on June 01, 2007. Female patient, 65 years of age, weighting 121.3 lb, was treated with FLURAZEPAM. After drug was administered, patient experienced the following problems/side effects: intentional overdose, somnolence, suicide attempt. FLURAZEPAM dosage: 600 MG, X1. Patient recovered.

Flurazepam Side Effects Report #5368770-6
FLURAZEPAM problem was reported by a Consumer or non-health professional from GERMANY on June 04, 2007. Female patient, 68 years of age, weighting 169.8 lb, was treated with FLURAZEPAM. After drug was administered, patient experienced the following problems/side effects: ill-defined disorder, overdose, suicide attempt. FLURAZEPAM dosage: 150 MG. During the same period patient was treated with ALCOHOL. Patient recovered.

Flurazepam Side Effects Report #5372785-1
Consumer or non-health professional from GERMANY reported FLURAZEPAM problem on June 11, 2007. Male patient, 42 years of age, weighting 154.3 lb, was treated with FLURAZEPAM. After drug was administered, patient experienced the following problems/side effects: alcohol use, coma, intentional overdose, suicide attempt. FLURAZEPAM dosage: unknown. During the same period patient was treated with MORPHINE, ALCOHOL. Patient recovered.

Flurazepam Side Effects Report #5096634-4
FLURAZEPAM problem was reported by a Consumer or non-health professional from GERMANY on June 09, 2006. Female patient, 66 years of age, was treated with FLURAZEPAM. After drug was administered, patient experienced the following problems/side effects: coma, cyanosis, hypotension, suicide attempt. FLURAZEPAM dosage: unknown. During the same period patient was treated with LORAZEPAM, TAXILAN, ANTIDEPRESSANTS, ALCOHOL, TAVOR. Patient was hospitalized. Patient recovered.

Flurazepam Side Effects Report #5097992-7
Consumer or non-health professional from GERMANY reported FLURAZEPAM problem on June 06, 2006. Male patient, 60 years of age, was treated with FLURAZEPAM. After drug was administered, patient experienced the following problems/side effects: loss of consciousness, suicide attempt. FLURAZEPAM dosage: 300 MG; PO. During the same period patient was treated with BISOPROLOL FUMARATE, LORAZEPAM, BISOPROLOL FUMARATE, TAVOR. Patient recovered.

Flurazepam Side Effects Report #5133104-9
FLURAZEPAM problem was reported by a Health Professional from ITALY on Oct 05, 2006. Female patient, 68 years of age, weighting 127.9 lb, was diagnosed with insomnia and was treated with FLURAZEPAM. After drug was administered, patient experienced the following problems/side effects: completed suicide, hepatic congestion, intentional overdose, pulmonary congestion, pulmonary oedema, respiratory depression, spleen congestion. FLURAZEPAM dosage: unknown. Patient died.

Flurazepam Side Effects Report #5143854-6
Physician from CANADA reported FLURAZEPAM problem on Oct 05, 2006. Male patient, 61 years of age, was diagnosed with schizophrenia and was treated with FLURAZEPAM. After drug was administered, patient experienced the following problems/side effects: abdominal distension, abdominal pain, aspiration, constipation, faecaloma, intestinal obstruction, lobar pneumonia, sepsis, vomiting. FLURAZEPAM dosage: 15 MG, QHS. During the same period patient was treated with LAMOTRIGINE, OXYBUTYNIN, ZYPREXA, PROCYCLIDINE HYDROCHLORIDE, CLOZARIL. Patient was hospitalized. Patient died on 09/27/2006.

Flurazepam Side Effects Report #5155822-9
FLURAZEPAM problem was reported by a Physician from UNITED STATES on Oct 24, 2006. Female patient, 52 years of age, was treated with FLURAZEPAM. After drug was administered, patient experienced the following problems/side effects: completed suicide. FLURAZEPAM dosage: unknown. During the same period patient was treated with LOXAPINE, SERTRALINE. Patient died.

Flurazepam Side Effects Report #5429921-8
Physician from ITALY reported FLURAZEPAM problem on Aug 13, 2007. Female patient, 66 years of age, was treated with FLURAZEPAM. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, blood creatine phosphokinase increased, blood lactate dehydrogenase increased, completed suicide, continuous haemodiafiltration, cyanosis, depressed level of consciousness. FLURAZEPAM dosage: unknown. During the same period patient was treated with TRAZODONE, DIPYRONE, PRIDINOL, CHARCOAL. Patient was hospitalized. Patient died.

Flurazepam Side Effects Report #5447433-2
FLURAZEPAM problem was reported by a Consumer or non-health professional from SWITZERLAND on Aug 21, 2007. Female patient was diagnosed with sleep disorder and was treated with FLURAZEPAM. After drug was administered, patient experienced the following problems/side effects: abortion induced, congenital spinal fusion, foetal disorder, foetal movements decreased, hemivertebra, limb malformation, mobility decreased, multiple congenital abnormalities. FLURAZEPAM dosage: unknown. During the same period patient was treated with CITALOPRAM HYDROBROMIDE, TRUXAL, ZOLPIDEM TARTRATE. Patient died on 06/29/2007.

Flurazepam Side Effects Report #5451754-7
Consumer or non-health professional from GERMANY reported FLURAZEPAM problem on Aug 29, 2007. Female patient, 38 years of age, was treated with FLURAZEPAM. After drug was administered, patient experienced the following problems/side effects: intentional overdose, sluggishness, suicide attempt. FLURAZEPAM dosage: unknown. Patient recovered.

Flurazepam Side Effects Report #5468684-7
FLURAZEPAM problem was reported by a Health Professional from GERMANY on Sept 10, 2007. Female patient, 68 years of age, weighting 176.4 lb, was treated with FLURAZEPAM. After drug was administered, patient experienced the following problems/side effects: aspiration, suicide attempt. FLURAZEPAM dosage: unknown. During the same period patient was treated with MIRTAZAPINE, LORAZEPAM, COUGH SYRUP. Patient was hospitalized. Patient recovered.


Drug Information: Flurazepam

URL of this page: http://www.nlm.nih.gov/medlineplus/druginfo/medmaster/a682051.html

(flure az' e pam)

IMPORTANT WARNING:

[Posted 03/14/2007] FDA notified healthcare professionals of its request that all manufacturers of sedative-hypnotic drug products, a class of drugs used to induce and/or maintain sleep, strengthen their product labeling to include stronger language concerning potential risks. These risks include severe allergic reactions and complex sleep-related behaviors, which may include sleep-driving. Sleep driving is defined as driving while not fully awake after ingestion of a sedative-hypnotic product, with no memory of the event. FDA also requested that each product manufacturer send letters to health care providers to notify them about the new warnings, and that manufacturers develop Patient Medication Guides for the products to inform consumers about risks and advise them of potential precautions that can be taken. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Sedative and http://www.fda.gov/bbs/topics/NEWS/2007/NEW01587.html.

Why is this medication prescribed?

See the MedWatch notification at the beginning of the monograph.

Flurazepam is used to treat insomnia (difficulty falling asleep and staying asleep). Flurazepam is in a class of medications called benzodiazepines. It works by slowing activity in the brain.

How should this medicine be used?

See the MedWatch notification at the beginning of the monograph.

Flurazepam comes as a capsule to take by mouth . It usually is taken before bedtime when needed. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take flurazepam exactly as directed.

Flurazepam can be habit-forming. Do not take a larger dose, take it more often, or take it for a longer time than prescribed by your doctor . .

Flurazepam starts working slowly and continues to work for a short time after you stop taking it. It may take two or three nights before you experience the full benefit of flurazepam. You may continue to feel the effects of flurazepam for one to two nights after you stop taking the medication.

Do not stop taking flurazepam without talking to your doctor. Your doctor will probably decrease your dose gradually. If you suddenly stop taking flurazepam, especially after taking it regularly, you may develop withdrawal symptoms such as sadness, difficulty sleeping, seizures, shaking of a part of your body that you cannot control, stomach and muscle cramps, vomiting, and sweating.

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?

See the MedWatch notification at the beginning of the monograph.

Before taking flurazepam,

  • tell your doctor and pharmacist if you are allergic to flurazepam, any other medications, or corn.
  • tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take during your treatment with flurazepam and for several days afterward. Be sure to mention any of the following: antihistamines; medications for anxiety,depression mental illness, or seizures; ; muscle relaxants; sedatives; sleeping pills;andtranquilizers. 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 depression; mental illness; glaucoma; or lung, kidney, or liver disease.
  • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking flurazepam, call your doctor immediately.
  • if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking flurazepam.
  • you should know that this medication may make you drowsy and may increase the risk that you could fall. Take extra care to be sure you do not fall, especially if you get out of bed in the middle of the night.Do not drive a car or operate machinery until you know how this medication affects you.
  • remember that alcohol can add to the drowsiness caused by this medication. Do not drink alcohol while you are taking flurazepam and for several days after you stop taking the medication.
  • tell your doctor if you use tobacco products. Cigarette smoking may decrease the effectiveness of this medication.
  • you should know that your mental health may change in unexpected ways while you are taking this medication. It is hard to tell if these changes are caused by flurazepam or if they are caused by physical or mental illnesses that you already have or suddenly develop. Tell your doctor right away if you experience any of the following symptoms: aggressiveness, strange or unusually outgoing behavior, hallucinations (seeing things or hearing voices that do not exist), feeling as if you are outside of your body, memory problems, new or worsening depression, thinking about killing yourself, confusion, and any other changes in your usual thoughts or behavior. Be sure that your family knows which symptoms may be serious so that they can call the doctor if you are unable to seek treatment on your own.

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?

Flurazepam should only be taken at bedtime. If you forget to take flurazepam at bedtime, you are unable to fall asleep, and you will still be able to stay in bed for a full night's sleep, you may take flurazepam at that time. Do not take a double dose of flurazepam to make up for a missed dose.

What side effects can this medication cause?

See the MedWatch notification at the beginning of the monograph.

Flurazepam may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • drowsiness
  • dizziness or lightheadness
  • loss of coordination
  • headache
  • heartburn
  • upset stomach
  • vomiting
  • stomach pain
  • diarrhea
  • constipation
  • nervousness
  • talking more than usual
  • weakness
  • difficulty urinating

Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them, call your doctor immediately:

  • pounding heartbeat
  • chest pain
  • confusion
  • rash

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.

Symptoms of overdose may include:

  • drowsiness
  • confusion
  • coma

What other information should I know?

See the MedWatch notification at the beginning of the monograph.

Keep all appointments with your doctor.

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.

Brand name(s):

  • Dalmane®

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