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Temazepam Side Effects and Adverse Effects reported to US Food and Drug Administration (FDA)

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Showing 1-25 of 589 

Confusional State, Vomiting, Inappropriate Antidiuretic Hormone Secretion, Diarrhoea, Anxiety, Hypophysitis (8357787-5)
on May 04, 2012 Female from UNITED KINGDOM , 62 years of age, weighting 138.9 lb, was treated with Temazepam. Directly after, patient experienced the unwanted or unexpected Temazepam side effects: confusional state, vomiting, inappropriate antidiuretic hormone secretion, diarrhoea, anxiety, hypophysitis. Temazepam dosage: N/A.
Associated medications used:
  • Nystatin
  • Morphine Sulfate
  • Prilosec
  • Carboplatin (Recent: 20jan12)
  • Demeclocycline Hcl
  • Etoposide (Recent Inf: 20jan12)
  • Ipilimumab
Patient was hospitalized.

Nasopharyngitis, Bronchitis (8356268-2)
Patient was taking Temazepam. Patient felt the following Temazepam side effects: nasopharyngitis, bronchitis on May 01, 2012 from UNITED STATES Additional patient health information: Female , 43 years of age, . Temazepam dosage: N/A.
Multiple prescriptions taken:
  • Xyrem
  • Clonazepam
  • Divalproex Sodium


(8349990-5)
Adverse event was reported on May 01, 2012 by a Male taking Temazepam (Dosage: 10 Mg, As Needed) was diagnosed with
  • insomnia
  • nasopharyngitis
and. Location: AUSTRALIA , 72 years of age, weighting 138.9 lb, .
Multiple concurrent drugs taken:
  • Nasonex (100 Ug, 2x/day)
  • Varenicline Tartrate (1 Mg, 2x/day)
  • Varenicline Tartrate (Unk)


Ill-defined Disorder, Aortic Aneurysm, Nausea, Dyspnoea, Urinary Tract Infection, Endotracheal Intubation, Apnoea, Cardiac Failure Congestive, Fatigue (8346192-3)
on Apr 25, 2012 Male from UNITED STATES , weighting 197.0 lb, was treated with Temazepam. Directly after, patient experienced the unwanted or unexpected Temazepam side effects: ill-defined disorder, aortic aneurysm, nausea, dyspnoea, urinary tract infection, endotracheal intubation, apnoea, cardiac failure congestive, fatigue. Temazepam dosage: N/A.
Associated medications used:
  • Phenergan
  • Aciphex
  • Atrovent (2 Puffs)
  • Glipizide
  • Propafenone Hcl
  • Naproxen
  • Hydrocodone Bitartrate And Acetaminophen
  • Avandia
Patient was hospitalized.


Body Temperature Increased, Chills, Vitamin B Complex Deficiency, Crying, Binge Eating, Formication, Anaemia, Nightmare, Abdominal Pain Upper (8344059-8)
on Apr 17, 2012 Female from UNITED STATES , 65 years of age, weighting 200.0 lb, was treated with Temazepam. Patient felt the following Temazepam side effects: body temperature increased, chills, vitamin b complex deficiency, crying, binge eating, formication, anaemia, nightmare, abdominal pain upper. Temazepam dosage: N/A.
Multiple prescriptions taken:
  • Sertraline Hydrochloride (200 Mg, Qd)


(8339876-4)
Patient was taking Temazepam. on May 02, 2012 from FINLAND Additional patient health information: Male , 54 years of age, weighting 205.0 lb, was diagnosed with
  • insomnia
and. Temazepam dosage: 20 Mg, As Needed.
Multiple concurrent drugs taken:
  • Quetiapine (50 Mg, 1x/day)
  • Ramipril (5 Mg, 1x/day)
  • Pemetrexed (1050 Mg, Day 1 Of 21 Day Cycle)
  • Folvite (1 Mg, 1x/day)
  • Circadin (2 Mg, 1x/day)
  • Omeprazole (20 Mg, 1x/day)
  • Cisplatin (155 Mg, Day 1 Of 21 Day Cycle)


Dyspnoea (8334414-4)
Adverse event was reported on Mar 24, 2011 by a Male taking Temazepam (Dosage: N/A) was diagnosed with
  • sleep disorder
  • depression
  • blood cholesterol increased
  • herpes ophthalmic
  • dementia
and. Location: UNITED STATES , 83 years of age, Directly after, patient experienced the unwanted or unexpected Temazepam side effects: dyspnoea.
Associated medications used:
  • Citalopram Hydrobromide
  • Lipitor
  • Acyclovir
  • Aricept /jpn/
  • Vitamin D
  • Lotemax
  • Multi-vitamins


Gastrooesophageal Reflux Disease, Lung Neoplasm, Hiatus Hernia, Bladder Pain, Malaise, Abasia, Osteoporosis, Headache (8334171-1)
on Apr 24, 2012 Female from UNITED STATES , 58 years of age, was treated with Temazepam. Patient felt the following Temazepam side effects: gastrooesophageal reflux disease, lung neoplasm, hiatus hernia, bladder pain, malaise, abasia, osteoporosis, headache. Temazepam dosage: N/A.
Multiple prescriptions taken:
  • Nexium
  • Prilosec
  • Xanax
  • Prevacid
Patient was hospitalized and became disabled.

Pain In Extremity, Weight Increased, Gait Disturbance (8324902-9)
on Apr 25, 2012 Female from UNITED STATES , weighting 180.8 lb, was treated with Temazepam. After Temazepam was administered, patient encountered several Temazepam side effects: pain in extremity, weight increased, gait disturbance. Temazepam dosage: Unk.
Multiple concurrent drugs taken:
  • Norco (Unk)
  • Lyrica (100 Mg, 3x/day)
  • Prednisone (Unk)


Viral Infection (8320252-5)
Patient was taking Temazepam. Directly after, patient experienced the unwanted or unexpected Temazepam side effects: viral infection on Apr 26, 2012 from AUSTRALIA Additional patient health information: Male , weighting 198.4 lb, was diagnosed with
  • insomnia
  • diverticulitis
  • depression
  • pain
and. Temazepam dosage: N/A.
Associated medications used:
  • Mesalamine (Unk Unk, 1x/day:qd)
  • Fluoxetine Hcl
  • Panadon
Patient was hospitalized.

Asthenia, Fatigue, Fall, Syncope, Feeling Abnormal, Tooth Fracture, Nausea (8308643-X)
Adverse event was reported on Apr 07, 2011 by a Male taking Temazepam (Dosage: N/A) . Location: UNITED STATES , weighting 170.2 lb, Patient felt the following Temazepam side effects: asthenia, fatigue, fall, syncope, feeling abnormal, tooth fracture, nausea.
Multiple prescriptions taken:
  • Provigil (200 Milligram;)


Burning Sensation (8300110-2)
on Apr 16, 2012 Female from UNITED STATES , weighting 158.0 lb, was diagnosed with
  • sleep disorder
  • fibromyalgia
  • neuropathy peripheral
  • cerebrovascular accident
  • pain in extremity
  • dyspepsia
  • hypertension
  • blood cholesterol increased
and was treated with Temazepam. After Temazepam was administered, patient encountered several Temazepam side effects: burning sensation. Temazepam dosage: 30 Mg, Daily.
Multiple concurrent drugs taken:
  • Lyrica (50 Mg, 2x/day)
  • Lyrica
  • Aspirin (81 Mg, Daily)
  • Neurontin (100 Mg, 3x/day)
  • Nexium (40 Mg, Daily)
  • Lisinopril And Hydrochlorothiazide (10/12.5 Mg, Daily)
  • Crestor (10 Mg, Daily)


Suicidal Ideation (8297775-0)
on Apr 16, 2012 Female from UNITED STATES , weighting 145.0 lb, was diagnosed with
  • sleep disorder
and was treated with Temazepam. Directly after, patient experienced the unwanted or unexpected Temazepam side effects: suicidal ideation. Temazepam dosage: Unk.
Associated medications used:
  • Chantix (1 Mg, 2x/day)
  • Xanax (Unk)
  • Thyroid Tab (Unk)
  • Paxil (Unk)
  • Chantix (0.5 Mg, 1x/day)


Mental Status Changes, Fall, Upper Limb Fracture (8285873-7)
Patient was taking Temazepam. Patient felt the following Temazepam side effects: mental status changes, fall, upper limb fracture on Apr 04, 2012 from CANADA Additional patient health information: Female , 96 years of age, . Temazepam dosage: 15 Mg, Unk.
Multiple prescriptions taken:
  • Chlorthalidone (25 Mg, Unk)
  • Premarin (0.5 Mg, Unk)
  • Norvasc (10 Mg, Unk)
  • Oscal /00751519/ (500 Mg, Unk)
  • Accupril
  • Senokot
  • Colace
  • Coenzyme
Patient was hospitalized.

Chest Discomfort, Hypoacusis, Bipolar I Disorder, Hypertension, Fatigue, Chronic Obstructive Pulmonary Disease, Stress Urinary Incontinence, Schizophrenia, Muscle Spasms (8284451-3)
Adverse event was reported on Nov 01, 2011 by a Female taking Temazepam (Dosage: N/A) . Location: UNITED STATES , 69 years of age, weighting 143.1 lb, After Temazepam was administered, patient encountered several Temazepam side effects: chest discomfort, hypoacusis, bipolar i disorder, hypertension, fatigue, chronic obstructive pulmonary disease, stress urinary incontinence, schizophrenia, muscle spasms.
Multiple concurrent drugs taken:
  • Xanax
  • Nexium
  • Calcium Carbonate
  • Flovent
  • Vasotec
  • Proair Hfa (Two Puffs Qid)
  • Flonase (Two Spray Qd)
  • Vicodin


Swollen Tongue, Myalgia, Oral Pain (8282301-2)
on Apr 13, 2012 Female from UNITED STATES , 52 years of age, weighting 130.0 lb, was treated with Temazepam. Directly after, patient experienced the unwanted or unexpected Temazepam side effects: swollen tongue, myalgia, oral pain. Temazepam dosage: N/A.
Associated medications used:
  • Adderall 5
  • Fluoxetine
  • Glatiramer Acetate (20 Mg / 1 Ml)


Haemorrhagic Anaemia, Fall, Intervertebral Discitis, International Normalised Ratio Increased, Gastrointestinal Haemorrhage (8282190-6)
on Apr 03, 2012 Female from FRANCE , 85 years of age, was treated with Temazepam. Patient felt the following Temazepam side effects: haemorrhagic anaemia, fall, intervertebral discitis, international normalised ratio increased, gastrointestinal haemorrhage. Temazepam dosage: N/A.
Multiple prescriptions taken:
  • Acetaminophen And Tramadol Hcl
  • Coumadin (4 Mg/d Alternating With 3 Mg/d Every Other Day Orally For 6 Months)
  • Acetaminophen W/ Codeine
  • Coltramyl
  • Sotalol Hcl
  • Ketoprofen
Patient was hospitalized.

Mental Disorder, Feeling Of Despair, Emotional Disorder, Depressed Mood, Insomnia, Paranoia, Anger, Completed Suicide, Anxiety (8268813-6)
Patient was taking Temazepam. After Temazepam was administered, patient encountered several Temazepam side effects: mental disorder, feeling of despair, emotional disorder, depressed mood, insomnia, paranoia, anger, completed suicide, anxiety on Apr 09, 2012 from UNITED STATES Additional patient health information: Male , 19 years of age, weighting 215.0 lb, was diagnosed with
  • sleep disorder
  • headache
  • affective disorder
and. Temazepam dosage: 1 Cap.
Multiple concurrent drugs taken:
  • Topiramate (1 Tab)
  • Topiramate (1 Tab)


Cardiac Arrest, Respiratory Arrest, Completed Suicide (8258690-1)
Adverse event was reported on Mar 22, 2012 by a Female taking Temazepam (Dosage: Unk) . Location: UNITED STATES , 31 years of age, Directly after, patient experienced the unwanted or unexpected Temazepam side effects: cardiac arrest, respiratory arrest, completed suicide.
Associated medications used:
  • Quetiapine (Unk)
  • Cyclobenzaprine Hcl (Unk)
  • Acetaminophen W/ Codeine (Unk)
  • Clonazepam (Unk)


Catatonia, Agitation, Gait Disturbance (8251123-0)
on Mar 19, 2012 Female from , 73 years of age, was treated with Temazepam. Patient felt the following Temazepam side effects: catatonia, agitation, gait disturbance. Temazepam dosage: 40 Mg. Patient was hospitalized.

Suicide Attempt (8247618-6)
on Mar 23, 2012 Female from GERMANY , weighting 143.3 lb, was treated with Temazepam. After Temazepam was administered, patient encountered several Temazepam side effects: suicide attempt. Temazepam dosage: N/A.
Multiple concurrent drugs taken:
  • Topamax
  • Topamax


Tremor, Convulsion (8243242-X)
Patient was taking Temazepam. Directly after, patient experienced the unwanted or unexpected Temazepam side effects: tremor, convulsion on Nov 23, 2010 from UNITED STATES Additional patient health information: Female , 64 years of age, . Temazepam dosage: N/A.
Associated medications used:
  • Levothyroxine Sodium
  • Vanicream(macrogol, Propylene Glycol, Simeticone, Sorbic Acid, Sorbito
  • Flurbiprofen
  • Cyclobenzaprine Hcl
  • Fanapt (6mg, Bid, Oral)
  • Clonazepam
  • Muscle Relaxants (no Ingredients/substances)


Pulmonary Embolism, Injury, Anhedonia, Anxiety, Fear, Post-traumatic Stress Disorder, Pain (8240751-4)
Adverse event was reported on Mar 23, 2012 by a Female taking Temazepam (Dosage: 15 Mg, Hs) . Location: UNITED STATES , 23 years of age, weighting 200.6 lb, Patient felt the following Temazepam side effects: pulmonary embolism, injury, anhedonia, anxiety, fear, post-traumatic stress disorder, pain.
Multiple prescriptions taken:
  • Ativan (2 Mg, Prn)
  • Zanaflex (4 Mg, Qd)
  • Psycholeptics (6 Mg, Qd)
  • Ibuprofen (Unk)
  • Yaz (Unk)
  • Uncodeable ^unclassifiable^ (Unk)
  • Oxycontin (Unk Unk, 5id)
  • Seroquel (50 Mg, Unk)
Patient was hospitalized.

Completed Suicide, Poisoning (8237306-4)
on Mar 20, 2012 Male from FINLAND , 31 years of age, was treated with Temazepam. After Temazepam was administered, patient encountered several Temazepam side effects: completed suicide, poisoning. Temazepam dosage: N/A.
Multiple concurrent drugs taken:
  • Oxazepam
  • Pregabalin (Unk)


Product Taste Abnormal, Malaise (8233300-8)
on Mar 23, 2012 Female from UNITED STATES , 50 years of age, weighting 150.0 lb, was treated with Temazepam. Directly after, patient experienced the unwanted or unexpected Temazepam side effects: product taste abnormal, malaise. Temazepam dosage: 30 1 Day.

Showing 1-25 of 589 

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Most drugs have a large list of nonsevere or mild adverse effects which do not rule out continued usage. These effects depend on individual sensitivity, and can include nausea, dizziness, diarrhea, malaise, vomiting, headache, dermatitis, dry mouth, etc. Check commonly reported side effects . These can be considered a form of pseudo-allergic reaction, as not all users experience these effects; many users experience none at all.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

Temazepam Information

Alternative TEMAZEPAM Names:RESTORIL STRAZEPAM

Active Ingredient: TEMAZEPAM

Temazepam Dosage, Warnings, Usage.

Side Effects reported to FDA: 589. View Temazepam Adverse Reports

Temazepam safety alerts: 2007

Reported deaths: 287

Reported hospitalizations: 114

Restoril (temazepam)

Audience: Healthcare professionals, consumers

[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.

[March 14, 2007 - News Release - FDA]

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