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

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Suicide Attempt, Alcoholism (8365360-8)
on May 14, 2012 Female from FRANCE , 40 years of age, was treated with Tetrazepam. Directly after, patient experienced the unwanted or unexpected Tetrazepam side effects: suicide attempt, alcoholism. Tetrazepam dosage: Unk; Single Intake.
Associated medications used:
  • Mepronizine (Unk; Single Intake)
  • Xanax (Unk; Single Intake)
  • Noctamid
  • Levothyroxine Sodium (100 Ug)
Patient was hospitalized.

Febrile Bone Marrow Aplasia, Pulmonary Alveolar Microlithiasis, Pancytopenia, Epistaxis, Abdominal Wall Cyst, Haematoma, Pyrexia, Asthenia, Portal Hypertension (8055152-1)
Patient was taking Tetrazepam. Patient felt the following Tetrazepam side effects: febrile bone marrow aplasia, pulmonary alveolar microlithiasis, pancytopenia, epistaxis, abdominal wall cyst, haematoma, pyrexia, asthenia, portal hypertension on Jan 13, 2012 from FRANCE Additional patient health information: Female , 62 years of age, . Tetrazepam dosage: 50 Mg, 1x/day.
Multiple prescriptions taken:
  • Caltrate +d (2 Df, 1x/day)
  • Esidrix (25 Mg, 1x/day)
  • Athymil (60 Mg, 1x/day)
  • Structum (1000 Mg, Unk)
  • Ramipril (1.25 Mg, 1x/day)
  • Lyrica (300 Mg, 2x/day)
  • Nebivolol (5 Mg, 1x/day)
  • Ramipril (10 Mg, 1x/day)
Patient was hospitalized.

Suicide Attempt, Intentional Overdose (8022439-8)
Adverse event was reported on Dec 29, 2011 by a Female taking Tetrazepam (Dosage: N/A) . Location: FRANCE , 17 years of age, After Tetrazepam was administered, patient encountered several Tetrazepam side effects: suicide attempt, intentional overdose.
Multiple concurrent drugs taken:
  • Acetaminophen
  • Domperidone
  • Depakene
  • Depakene
  • Loperamide
  • Phloroglucinol
Patient was hospitalized.

Malaise, Pain, Paraesthesia, Dizziness, Hot Flush, Hyperhidrosis, Product Quality Issue, Infusion Related Reaction, Tachycardia (7963428-9)
on Nov 07, 2011 Female from FRANCE , 44 years of age, was treated with Tetrazepam. Directly after, patient experienced the unwanted or unexpected Tetrazepam side effects: malaise, pain, paraesthesia, dizziness, hot flush, hyperhidrosis, product quality issue, infusion related reaction, tachycardia. Tetrazepam dosage: N/A.
Associated medications used:
  • Lyrica
  • Acetaminophen (Iv)



Hepatic Steatosis, Dyskinesia, Headache, Asthenia, Aphasia, Fatigue, Calculus Ureteric, Cerebral Ischaemia, Haematuria (7929540-5)
on Nov 08, 2011 Female from BELGIUM , 53 years of age, was treated with Tetrazepam. Patient felt the following Tetrazepam side effects: hepatic steatosis, dyskinesia, headache, asthenia, aphasia, fatigue, calculus ureteric, cerebral ischaemia, haematuria. Tetrazepam dosage: N/A.
Multiple prescriptions taken:
  • Folic Acid
  • Questran
  • Remicade
  • Effexor
Patient was hospitalized.

Suicide Attempt, Somnolence (7905822-8)
Patient was taking Tetrazepam 50 (tetrazepam). After Tetrazepam was administered, patient encountered several Tetrazepam side effects: suicide attempt, somnolence on Oct 20, 2011 from GERMANY Additional patient health information: Female , 43 years of age, weighting 110.2 lb, . Tetrazepam 50 (tetrazepam) dosage: 15 Dosage Forms, 1 In 1 Total, Oral.
Multiple concurrent drugs taken:
  • Diclofenac Retard 75 (diclofenac) (20 Dosage Forms, 1 In 1 Total, Oral)
  • Ibuprofen (20 Dosage Forms, 1 In 1 Total, Oral)


Alcoholism, Suicide Attempt (7782173-6)
Adverse event was reported on Sep 21, 2011 by a Female taking Tetrazepam (Dosage: N/A) . Location: FRANCE , 40 years of age, Directly after, patient experienced the unwanted or unexpected Tetrazepam side effects: alcoholism, suicide attempt.
Associated medications used:
  • Noctamid
  • Meprobamate
  • Xanax
  • Levothyroxine Sodium (100 Ug)
Patient was hospitalized.

Helicobacter Gastritis, Abdominal Pain Upper (7388541-9)
on Mar 29, 2011 Female from FRANCE , 20 years of age, was treated with Tetrazepam. Patient felt the following Tetrazepam side effects: helicobacter gastritis, abdominal pain upper. Tetrazepam dosage: Unk.
Multiple prescriptions taken:
  • Celebrex (Unk)
Patient was hospitalized.

Headache, Vomiting, Vertigo (7348389-8)
on Mar 08, 2011 Male from GERMANY , 55 years of age, was treated with Tetrazepam. After Tetrazepam was administered, patient encountered several Tetrazepam side effects: headache, vomiting, vertigo. Tetrazepam dosage: N/A.
Multiple concurrent drugs taken:
  • Janumet
Patient was hospitalized.

Headache, Cervicobrachial Syndrome (7316411-0)
Patient was taking Tetrazepam. Directly after, patient experienced the unwanted or unexpected Tetrazepam side effects: headache, cervicobrachial syndrome on Feb 23, 2011 from GERMANY Additional patient health information: Male , 55 years of age, . Tetrazepam dosage: N/A.
Associated medications used:
  • Janumet
Patient was hospitalized.

Leukocytosis, Lymphadenopathy, Rash, Cheilitis, Renal Failure Acute, Inflammation, Band Neutrophil Count Increased (7224931-2)
Adverse event was reported on Dec 15, 2010 by a Female taking Tetrazepam (tetrazepam) (tablets) (tetrazepam) (Dosage: N/A) . Location: DENMARK , 89 years of age, Patient felt the following Tetrazepam side effects: leukocytosis, lymphadenopathy, rash, cheilitis, renal failure acute, inflammation, band neutrophil count increased.
Multiple prescriptions taken:
  • Escitalopram (Oral)
Patient was hospitalized.

Disturbance In Attention, Loss Of Consciousness, Road Traffic Accident (7165833-X)
on Dec 02, 2010 Male from FRANCE , 58 years of age, was diagnosed with
  • muscle spasms
  • insomnia
  • cancer pain
  • anxiety
and was treated with Tetrazepam. After Tetrazepam was administered, patient encountered several Tetrazepam side effects: disturbance in attention, loss of consciousness, road traffic accident. Tetrazepam dosage: N/A.
Multiple concurrent drugs taken:
  • Zopiclone
  • Citalopram Hydrobromide
  • Bromazepam
  • Laroxyl
  • Skenan
  • Skenan
  • Lyrica
  • Lyrica


Disturbance In Attention, Loss Of Consciousness, Road Traffic Accident (7165832-8)
on Dec 02, 2010 Male from FRANCE , 58 years of age, was diagnosed with
  • muscle spasms
  • insomnia
  • cancer pain
  • anxiety
and was treated with Tetrazepam. Directly after, patient experienced the unwanted or unexpected Tetrazepam side effects: disturbance in attention, loss of consciousness, road traffic accident. Tetrazepam dosage: N/A.
Associated medications used:
  • Zopiclone
  • Citalopram Hydrobromide
  • Bromazepam
  • Laroxyl
  • Skenan
  • Skenan
  • Lyrica
  • Lyrica


Disturbance In Attention, Loss Of Consciousness, Road Traffic Accident (7165827-4)
Patient was taking Tetrazepam. Patient felt the following Tetrazepam side effects: disturbance in attention, loss of consciousness, road traffic accident on Dec 02, 2010 from FRANCE Additional patient health information: Male , 58 years of age, was diagnosed with
  • muscle spasms
  • insomnia
  • cancer pain
  • anxiety
and. Tetrazepam dosage: N/A.
Multiple prescriptions taken:
  • Zopiclone
  • Citalopram Hydrobromide
  • Bromazepam
  • Laroxyl
  • Skenan
  • Skenan
  • Lyrica
  • Lyrica


Dermatitis Contact (6907774-6)
Adverse event was reported on Jul 22, 2010 by a Female taking Tetrazepam (Dosage: N/A) . Location: BELGIUM , 51 years of age, After Tetrazepam was administered, patient encountered several Tetrazepam side effects: dermatitis contact.
Multiple concurrent drugs taken:
  • Lorazepam


Dermatitis Contact (6907773-4)
on Jul 22, 2010 Male from BELGIUM , 39 years of age, was treated with Tetrazepam. Directly after, patient experienced the unwanted or unexpected Tetrazepam side effects: dermatitis contact. Tetrazepam dosage: N/A.
Associated medications used:
  • Zolpidem
  • Lorazepam


Back Pain, Chest Injury, Cough, Dehydration, Dyspnoea, Fall, Hyponatraemia, Hypophagia, Hypoproteinaemia (6502857-7)
on Dec 07, 2009 Male from FRANCE , 54 years of age, was treated with Tetrazepam Bayer. Patient felt the following Tetrazepam side effects: back pain, chest injury, cough, dehydration, dyspnoea, fall, hyponatraemia, hypophagia, hypoproteinaemia. Tetrazepam Bayer dosage: N/A.
Multiple prescriptions taken:
  • Coversyl 2mg (Daily Dose: 2 Milligram(s))
  • Ibuprofene
Patient was hospitalized.

Asthenia, Blood Creatinine Increased, C-reactive Protein Increased, Cytomegalovirus Antibody Positive, Gamma-glutamyltransferase Increased, Granulocytosis, Inflammation, Leukocyturia (4611015-2)
Patient was taking Tetrazepam. After Tetrazepam was administered, patient encountered several Tetrazepam side effects: asthenia, blood creatinine increased, c-reactive protein increased, cytomegalovirus antibody positive, gamma-glutamyltransferase increased, granulocytosis, inflammation, leukocyturia on Mar 08, 2005 from Additional patient health information: Female , 53 years of age, weighting 185.2 lb, was diagnosed with
  • viral infection
and. Tetrazepam dosage: 50 Mg, Qd.
Multiple concurrent drugs taken:
  • Omeprazole (20 Mg, Qd)
  • Isobar (1 Df, Qd)
  • Acetaminophen W/ Propoxyphene Hcl (2 Df, Prn)
  • Voltaren (75 Mg, Bid)
Patient was hospitalized.

Asthenia, Blood Creatinine Increased, C-reactive Protein Increased, Cytomegalovirus Antibody Positive, Gamma-glutamyltransferase Increased, Granulocytosis, Inflammation, Leukocyturia (4610958-3)
Adverse event was reported on Mar 08, 2005 by a Female taking Tetrazepam (Dosage: 50 Mg, Qd) was diagnosed with
  • viral infection
and. Location: , 53 years of age, weighting 185.2 lb, Directly after, patient experienced the unwanted or unexpected Tetrazepam side effects: asthenia, blood creatinine increased, c-reactive protein increased, cytomegalovirus antibody positive, gamma-glutamyltransferase increased, granulocytosis, inflammation, leukocyturia.
Associated medications used:
  • Omeprazole (20 Mg, Qd)
  • Isobar (1 Df, Qd)
  • Acetaminophen W/ Propoxyphene Hcl (2 Df, Prn)
  • Voltaren (75 Mg, Bid)
Patient was hospitalized.

Alanine Aminotransferase Increased, Aplastic Anaemia, Febrile Neutropenia, Infection, Pancytopenia, Septic Shock, Shock Haemorrhagic (4559393-7)
on Aug 16, 2004 Female from , 53 years of age, weighting 101.4 lb, was treated with Tetrazepam. Patient felt the following Tetrazepam side effects: alanine aminotransferase increased, aplastic anaemia, febrile neutropenia, infection, pancytopenia, septic shock, shock haemorrhagic. Tetrazepam dosage: 25 Mg, Qd.
Multiple prescriptions taken:
  • Pantozol (40 Mg, Qd)
  • Oxcarbazepine (600 Mg, Bid)
  • Levetiracetam (1000 Mg, Bid)
  • Levothyroxine Sodium (125 Ug, Qd)
  • Oxycodone Hcl (10 Mg, Tid)
Patient was hospitalized.

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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.

Tetrazepam Information

More About Tetrazepam

Side Effects reported to FDA: 20. View Tetrazepam Adverse Reports

Tetrazepam safety alerts: No

Reported deaths: 1

Reported hospitalizations: 11

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