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

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Hepatitis Cholestatic (6269734-0)
on Jul 15, 2009 Male from SPAIN , 39 years of age, was diagnosed with
  • anxiety
and was treated with Orfidal. Directly after, patient experienced the unwanted or unexpected Orfidal side effects: hepatitis cholestatic. Orfidal dosage: N/A.
Associated medications used:
  • Venlafaxine Hcl
  • Trankimazin
Patient was hospitalized.

Hepatitis Cholestatic (6263670-1)
Patient was taking Orfidal. Patient felt the following Orfidal side effects: hepatitis cholestatic on Jul 06, 2009 from SPAIN Additional patient health information: Male , 39 years of age, was diagnosed with
  • anxiety
and. Orfidal dosage: N/A.
Multiple prescriptions taken:
  • Venlafaxine Hcl
  • Trankimazin
Patient was hospitalized.

Atrial Fibrillation, Cytolytic Hepatitis (5839951-X)
Adverse event was reported on Jul 31, 2008 by a Female taking Orfidal (Dosage: N/A) . Location: SPAIN , 73 years of age, After Orfidal was administered, patient encountered several Orfidal side effects: atrial fibrillation, cytolytic hepatitis.
Multiple concurrent drugs taken:
  • Dacortin
  • Tramadol Hcl
  • Pantoprazole Sodium
  • Danatrol
  • Metformin Hcl
Patient was hospitalized.

Bradykinesia, Bradyphrenia, Cytolytic Hepatitis, Hepatomegaly, Portal Hypertension (5827318-X)
on Jul 09, 2008 Female from SPAIN , 47 years of age, was treated with Orfidal (orfidal - Lorazepam) (not Specified). Directly after, patient experienced the unwanted or unexpected Orfidal side effects: bradykinesia, bradyphrenia, cytolytic hepatitis, hepatomegaly, portal hypertension. Orfidal (orfidal - Lorazepam) (not Specified) dosage: (1 Mg Qd Oral).
Associated medications used:
  • Antabuse (500 Mg Bid Oral)
  • Lexatin (lexatin - Bromazepam) (not Specified) (Df Oral)
  • Prozac (20 Mg Qd Oral)
Patient was hospitalized.


Blood Creatine Phosphokinase Increased, Blood Osmolarity Abnormal, Confusional State, Disorientation, Expressive Language Disorder, Hypernatraemia, Metabolic Acidosis, Neuroleptic Malignant Syndrome, Pyrexia (5781848-8)
on Jun 02, 2008 Female from SPAIN , 64 years of age, was treated with Orfidal (orfidal - Lorazepam) (1 Mg, 1 Mg) (not Specified). Patient felt the following Orfidal side effects: blood creatine phosphokinase increased, blood osmolarity abnormal, confusional state, disorientation, expressive language disorder, hypernatraemia, metabolic acidosis, neuroleptic malignant syndrome, pyrexia. Orfidal (orfidal - Lorazepam) (1 Mg, 1 Mg) (not Specified) dosage: (1 Mg Qd Oral, (1 Mg Qd Oral).
Multiple prescriptions taken:
  • Akineton/00079502/ (akineton Biperiden Hyrochloride) (not Specified) ((df Oral), (df Oral))
  • Akineton/00079502/ (akineton Biperiden Hyrochloride) (not Specified) ((df Oral), (df Oral))
  • Lithium Carbonate
  • Antabuse ((250 Mg Qd Oral), (250 Mg Qd Oral))
  • Etumina (eutmina - Clotiapine) (not Specified) ((20 Mg Qd Oral), (20 Mg Qd Oral))
  • Etumina (eutmina - Clotiapine) (not Specified) ((20 Mg Qd Oral), (20 Mg Qd Oral))
  • Haloperidol ((10 Mg Tid Intravenous (not Otherwise Specified), (10 Mg Tid Intravenous (not Otherwise Specified )))
  • Haloperidol ((10 Mg Tid Intravenous (not Otherwise Specified), (10 Mg Tid Intravenous (not Otherwise Specified )))
Patient was hospitalized.

Hepatitis Cholestatic (5766064-8)
Patient was taking Orfidal (orfidal - Lorazepam) 1 Mg (not Specified). After Orfidal was administered, patient encountered several Orfidal side effects: hepatitis cholestatic on May 23, 2008 from SPAIN Additional patient health information: Male , 39 years of age, was diagnosed with
  • anxiety
and. Orfidal (orfidal - Lorazepam) 1 Mg (not Specified) dosage: 1 Mg Qd Oral.
Multiple concurrent drugs taken:
  • Trankimazin (trankimzin - Alprazolam) (not Specified) (0.25 Mg Tid Oral)
  • Venlafaxine Hcl
Patient was hospitalized.

Blood Creatine Phosphokinase Increased, Confusional State, Hypernatraemia, Metabolic Acidosis, Neuroleptic Malignant Syndrome, Pyrexia (5764751-9)
Adverse event was reported on Jun 02, 2008 by a Female taking Orfidal (Dosage: N/A) . Location: SPAIN , 64 years of age, Directly after, patient experienced the unwanted or unexpected Orfidal side effects: blood creatine phosphokinase increased, confusional state, hypernatraemia, metabolic acidosis, neuroleptic malignant syndrome, pyrexia.
Associated medications used:
  • Haloperidol
  • Lithium Carbonate
  • Antabuse
  • Etumina
  • Vandral Retard
  • Akineton
Patient was hospitalized.

Apathy, Blood Pressure Increased, Cardio-respiratory Arrest, Cystitis Haemorrhagic, Gastritis Haemorrhagic, Hepatic Steatosis, Hepatotoxicity, Lung Disorder, Myocardial Infarction (5712003-5)
on Mar 31, 2008 Male from SPAIN , 34 years of age, was diagnosed with
  • somnolence
  • depression
and was treated with Orfidal (orfidal - Lorazepam) 1 Mg. Patient felt the following Orfidal side effects: apathy, blood pressure increased, cardio-respiratory arrest, cystitis haemorrhagic, gastritis haemorrhagic, hepatic steatosis, hepatotoxicity, lung disorder, myocardial infarction. Orfidal (orfidal - Lorazepam) 1 Mg dosage: 1 Mg Qd Oral.
Multiple prescriptions taken:
  • Besitran (besitran - Sertraline Hydrochloride) (100 Mg Qd Oral)
  • Lamotrigine
  • Seroquel
Patient was hospitalized.

Hepatitis Cholestatic (5689696-4)
on Mar 12, 2008 Male from SPAIN , 39 years of age, was diagnosed with
  • anxiety
and was treated with Orfidal (orfidal - Lorazepam) 1 Mg. After Orfidal was administered, patient encountered several Orfidal side effects: hepatitis cholestatic. Orfidal (orfidal - Lorazepam) 1 Mg dosage: 1 Mg Qd Oral.
Multiple concurrent drugs taken:
  • Trankimazin (trankimazin - Alprazolam) (0.25 Mg 1x/3 Days Oral)
  • Venlafaxine Hcl
Patient was hospitalized.

Disorientation, Dyspnoea, Somnolence (5671594-3)
Patient was taking Orfidal (orfidal - Lorazepam) 1 Mg. Directly after, patient experienced the unwanted or unexpected Orfidal side effects: disorientation, dyspnoea, somnolence on Feb 26, 2008 from SPAIN Additional patient health information: Female , 92 years of age, . Orfidal (orfidal - Lorazepam) 1 Mg dosage: 1 Mg Qd Oral A Few Years.
Associated medications used:
  • Transtec (transtec - Buprenorphine) (not Specified) (1 Df 1x3 Days Transdermal)
  • Nitroglyn
  • Pantoprazole Sodium
  • Nebivolol Hcl
  • Sibelium
Patient was hospitalized.

Blood Chloride Decreased, Disorientation, Hyponatraemia (5656229-8)
Adverse event was reported on Feb 20, 2008 by a Female taking Orfidal (orfidal - Lorazepam) 1 Mg (Dosage: (1 Mg Qd Oral)) was diagnosed with
  • insomnia
  • influenza
  • pain
and. Location: SPAIN , 69 years of age, Patient felt the following Orfidal side effects: blood chloride decreased, disorientation, hyponatraemia.
Multiple prescriptions taken:
  • Frenadol /01380101/ (frenadol - Chlorphenamine Maleate / Dextromethorp ((1 Df Tid Oral))
  • Neurontin ((400 Mg Qd Oral))
  • Enalapril Maleate
  • Paracetamol


Loss Of Consciousness, Pco2 Increased, Po2 Decreased, Sensory Loss, White Blood Cell Count Increased (5594665-9)
on Jan 02, 2008 Male from SPAIN , 77 years of age, was treated with Orfidal (orfidal - Lorazepam) 1 Mg. After Orfidal was administered, patient encountered several Orfidal side effects: loss of consciousness, pco2 increased, po2 decreased, sensory loss, white blood cell count increased. Orfidal (orfidal - Lorazepam) 1 Mg dosage: (1 Mg Qd Oral).
Multiple concurrent drugs taken:
  • Haloperidol ((df))
  • Sinogan /00038601/ (sinogan - Levomepromazine) (not Specified) ((df))
Patient was hospitalized.

Psychotic Disorder, Renal Failure Acute, Rhabdomyolysis (5557233-0)
on Nov 26, 2007 Male from SPAIN , 27 years of age, was diagnosed with
  • insomnia
  • schizophrenia
and was treated with Orfidal (orfidal - Lorazepam) 1 Mg. Directly after, patient experienced the unwanted or unexpected Orfidal side effects: psychotic disorder, renal failure acute, rhabdomyolysis. Orfidal (orfidal - Lorazepam) 1 Mg dosage: 1 Mg Bid Oral.
Associated medications used:
  • Zyprexa (30 Mg Bid Oral)
Patient was hospitalized.

Somnolence, Vomiting (5557049-5)
Patient was taking Orfidal (orfidal - Lorazepam). Patient felt the following Orfidal side effects: somnolence, vomiting on Nov 23, 2007 from SPAIN Additional patient health information: Male , 68 years of age, . Orfidal (orfidal - Lorazepam) dosage: Df Oral. Patient was hospitalized.

Stevens-johnson Syndrome (5483231-1)
Adverse event was reported on Sep 20, 2007 by a Female taking Orfidal (orfidal - Lorazepam) (Dosage: (25 Mg Qd Oral)) was diagnosed with
  • insomnia
  • thrombocytopenic purpura
and. Location: SPAIN , 39 years of age, After Orfidal was administered, patient encountered several Orfidal side effects: stevens-johnson syndrome.
Multiple concurrent drugs taken:
  • Mabthera (mabthera - Rituximab) (not Specified) ((df Intravenous))
  • Vincristine Sulfate ((df Intravenous))
Patient was hospitalized.

Abdominal Discomfort, Apallic Syndrome, Intentional Overdose, Loss Of Consciousness (5460566-X)
on Aug 31, 2007 Female from SPAIN , 75 years of age, was diagnosed with
  • sleep disorder
  • affective disorder
and was treated with Orfidal. Directly after, patient experienced the unwanted or unexpected Orfidal side effects: abdominal discomfort, apallic syndrome, intentional overdose, loss of consciousness. Orfidal dosage: N/A.
Associated medications used:
  • Cymbalta (480 Mg, Eight Tablets Of 60mg)
Patient was hospitalized.

Aggression, Agitation, Confusional State, Dry Mouth, Fall, Nausea (5215201-2)
on Dec 29, 2006 Female from SPAIN , 84 years of age, was treated with Orfidal. Patient felt the following Orfidal side effects: aggression, agitation, confusional state, dry mouth, fall, nausea. Orfidal dosage: Po.
Multiple prescriptions taken:
  • Cymbalta (60 Mg Q Day Po)


Renal Impairment (5118905-5)
Patient was taking Orfidal. After Orfidal was administered, patient encountered several Orfidal side effects: renal impairment on Sep 11, 2006 from SPAIN Additional patient health information: Female , 90 years of age, . Orfidal dosage: Df Po.
Multiple concurrent drugs taken:
  • Dilutol (5 Mg Qd Po)
  • Cesplon Plus (1 Df Qd Po)
Patient was hospitalized.

Hepatitis (5118423-4)
Adverse event was reported on Sep 11, 2006 by a Female taking Orfidal (Dosage: 1 Mg Q Day Po) was diagnosed with
  • colitis ulcerative
and. Location: SPAIN , 57 years of age, Directly after, patient experienced the unwanted or unexpected Orfidal side effects: hepatitis.
Associated medications used:
  • Imurel (50 Mg Q Day Po)
  • Entocort
  • Urbason /00049601/


Dyskinesia (5087093-6)
on Aug 03, 2006 Female from SPAIN , 76 years of age, was treated with Orfidal. Patient felt the following Orfidal side effects: dyskinesia. Orfidal dosage: 1 Mg Q Day Po.
Multiple prescriptions taken:
  • Deprax (100 Mg Q Day Po)
  • Seroquel (100 Mg Q Day Po)
  • Distraneurine
  • Ebixa


Fall, Syncope (5003426-0)
on Apr 25, 2006 Female from SPAIN , 81 years of age, was treated with Orfidal. After Orfidal was administered, patient encountered several Orfidal side effects: fall, syncope. Orfidal dosage: 1 Mg Q Day Po.
Multiple concurrent drugs taken:
  • Nobritol (1 Cap Q Day Po)
Patient was hospitalized.

Stupor (4778687-3)
Patient was taking Orfidal. Directly after, patient experienced the unwanted or unexpected Orfidal side effects: stupor on Sep 07, 2005 from SPAIN Additional patient health information: Male , 95 years of age, was diagnosed with
  • insomnia
and. Orfidal dosage: 1 Mg Qd Po.
Associated medications used:
  • Paracetamol
  • Dopamine
  • Seguril
  • Phytomenadione
  • Ventolin


Agitation, Confusional State, Hallucination, Nervousness (4652521-4)
Adverse event was reported on Apr 15, 2005 by a Female taking Orfidal (Dosage: 1 Mg Q Day Po) was diagnosed with
  • insomnia
and. Location: , 60 years of age, Patient felt the following Orfidal side effects: agitation, confusional state, hallucination, nervousness.
Multiple prescriptions taken:
  • Seroquel (50 Mg Q Day Po)


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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.

Orfidal Information

More About Orfidal

Side Effects reported to FDA: 23. View Orfidal Adverse Reports

Orfidal safety alerts: No

Reported deaths: 2

Reported hospitalizations: 7

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