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Orfidal Side Effects

Common Orfidal Side Effects

The most commonly reported Orfidal side effects (click to view or check a box to report):

Confusional State (5)
Hepatitis Cholestatic (4)
Disorientation (3)
Cytolytic Hepatitis (2)
Agitation (2)
Hypernatraemia (2)
Blood Creatine Phosphokinase Increased (2)
Fall (2)
Loss Of Consciousness (2)
Somnolence (2)
Pyrexia (2)
Neuroleptic Malignant Syndrome (2)
Metabolic Acidosis (2)
Lung Disorder (1)
Intentional Overdose (1)
Myocardial Infarction (1)
Po2 Decreased (1)
Pco2 Increased (1)
Nervousness (1)
Nausea (1)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

Orfidal Side Effects Reported to FDA

The following Orfidal reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.


The appearance of Orfidal on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.
Confusional State
on Nov 27, 2012 Male from ES , 65 years of age, was diagnosed with and was treated with Orfidal. Directly after, patient experienced the unwanted or unexpected Orfidal side effects: confusional state. Orfidal dosage: 3 Mg, 1x/day. Patient was hospitalized.

Hepatitis Cholestatic
Patient was taking Orfidal. Patient felt the following Orfidal side effects: hepatitis cholestatic on Jul 15, 2009 from SPAIN Additional patient health information: Male , 39 years of age, was diagnosed with and. Orfidal dosage: N/A.
Multiple prescriptions taken:
  • Venlafaxine Hcl
  • Trankimazin
Patient was hospitalized.

Hepatitis Cholestatic
Adverse event was reported on Jul 06, 2009 by a Male taking Orfidal (Dosage: N/A) was diagnosed with and. Location: SPAIN , 39 years of age, After Orfidal was administered, patient encountered several Orfidal side effects: hepatitis cholestatic.
Multiple concurrent drugs taken:
  • Venlafaxine Hcl
  • Trankimazin
Patient was hospitalized.

Atrial Fibrillation, Cytolytic Hepatitis
on Jul 31, 2008 Female from SPAIN , 73 years of age, was treated with Orfidal. Directly after, patient experienced the unwanted or unexpected Orfidal side effects: atrial fibrillation, cytolytic hepatitis. Orfidal dosage: N/A.
Associated medications used:
  • Dacortin
  • Tramadol Hcl
  • Pantoprazole Sodium
  • Danatrol
  • Metformin Hcl
Patient was hospitalized.


Bradykinesia, Bradyphrenia, Cytolytic Hepatitis, Hepatomegaly, Portal Hypertension
on Jul 09, 2008 Female from SPAIN , 47 years of age, was treated with Orfidal (orfidal - Lorazepam) (not Specified). Patient felt the following Orfidal side effects: bradykinesia, bradyphrenia, cytolytic hepatitis, hepatomegaly, portal hypertension. Orfidal (orfidal - Lorazepam) (not Specified) dosage: (1 Mg Qd Oral).
Multiple prescriptions taken:
  • 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
Patient was taking Orfidal (orfidal - Lorazepam) (1 Mg, 1 Mg) (not Specified). After Orfidal was administered, patient encountered several Orfidal side effects: blood creatine phosphokinase increased, blood osmolarity abnormal, confusional state, disorientation, expressive language disorder, hypernatraemia, metabolic acidosis, neuroleptic malignant syndrome, pyrexia on Jun 02, 2008 from SPAIN Additional patient health information: Female , 64 years of age, . Orfidal (orfidal - Lorazepam) (1 Mg, 1 Mg) (not Specified) dosage: (1 Mg Qd Oral, (1 Mg Qd Oral).
Multiple concurrent drugs 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
Adverse event was reported on May 23, 2008 by a Male taking Orfidal (orfidal - Lorazepam) 1 Mg (not Specified) (Dosage: 1 Mg Qd Oral) was diagnosed with and. Location: SPAIN , 39 years of age, Directly after, patient experienced the unwanted or unexpected Orfidal side effects: hepatitis cholestatic.
Associated medications used:
  • 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
on Jun 02, 2008 Female from SPAIN , 64 years of age, was treated with Orfidal. Patient felt the following Orfidal side effects: blood creatine phosphokinase increased, confusional state, hypernatraemia, metabolic acidosis, neuroleptic malignant syndrome, pyrexia. Orfidal dosage: N/A.
Multiple prescriptions taken:
  • 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
on Mar 31, 2008 Male from SPAIN , 34 years of age, was diagnosed with and was treated with Orfidal (orfidal - Lorazepam) 1 Mg. After Orfidal was administered, patient encountered several 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 concurrent drugs taken:
  • Besitran (besitran - Sertraline Hydrochloride) (100 Mg Qd Oral)
  • Lamotrigine
  • Seroquel
Patient was hospitalized.

Hepatitis Cholestatic
Patient was taking Orfidal (orfidal - Lorazepam) 1 Mg. Directly after, patient experienced the unwanted or unexpected Orfidal side effects: hepatitis cholestatic on Mar 12, 2008 from SPAIN Additional patient health information: Male , 39 years of age, was diagnosed with and. Orfidal (orfidal - Lorazepam) 1 Mg dosage: 1 Mg Qd Oral.
Associated medications used:
  • Trankimazin (trankimazin - Alprazolam) (0.25 Mg 1x/3 Days Oral)
  • Venlafaxine Hcl
Patient was hospitalized.

Disorientation, Dyspnoea, Somnolence
Adverse event was reported on Feb 26, 2008 by a Female taking Orfidal (orfidal - Lorazepam) 1 Mg (Dosage: 1 Mg Qd Oral A Few Years) . Location: SPAIN , 92 years of age, Patient felt the following Orfidal side effects: disorientation, dyspnoea, somnolence.
Multiple prescriptions taken:
  • Transtec (transtec - Buprenorphine) (not Specified) (1 Df 1x3 Days Transdermal)
  • Nitroglyn
  • Pantoprazole Sodium
  • Nebivolol Hcl
  • Sibelium
Patient was hospitalized.

Blood Chloride Decreased, Disorientation, Hyponatraemia
on Feb 20, 2008 Female from SPAIN , 69 years of age, was diagnosed with and was treated with Orfidal (orfidal - Lorazepam) 1 Mg. After Orfidal was administered, patient encountered several Orfidal side effects: blood chloride decreased, disorientation, hyponatraemia. Orfidal (orfidal - Lorazepam) 1 Mg dosage: (1 Mg Qd Oral).
Multiple concurrent drugs 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
on Jan 02, 2008 Male from SPAIN , 77 years of age, was treated with Orfidal (orfidal - Lorazepam) 1 Mg. Directly after, patient experienced the unwanted or unexpected 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).
Associated medications used:
  • Haloperidol ((df))
  • Sinogan /00038601/ (sinogan - Levomepromazine) (not Specified) ((df))
Patient was hospitalized.

Psychotic Disorder, Renal Failure Acute, Rhabdomyolysis
Patient was taking Orfidal (orfidal - Lorazepam) 1 Mg. Patient felt the following Orfidal side effects: psychotic disorder, renal failure acute, rhabdomyolysis on Nov 26, 2007 from SPAIN Additional patient health information: Male , 27 years of age, was diagnosed with and. Orfidal (orfidal - Lorazepam) 1 Mg dosage: 1 Mg Bid Oral.
Multiple prescriptions taken:
  • Zyprexa (30 Mg Bid Oral)
Patient was hospitalized.

Somnolence, Vomiting
Adverse event was reported on Nov 23, 2007 by a Male taking Orfidal (orfidal - Lorazepam) (Dosage: Df Oral) . Location: SPAIN , 68 years of age, After Orfidal was administered, patient encountered several Orfidal side effects: somnolence, vomiting. Patient was hospitalized.

Stevens-johnson Syndrome
on Sep 20, 2007 Female from SPAIN , 39 years of age, was diagnosed with and was treated with Orfidal (orfidal - Lorazepam). Directly after, patient experienced the unwanted or unexpected Orfidal side effects: stevens-johnson syndrome. Orfidal (orfidal - Lorazepam) dosage: (25 Mg Qd Oral).
Associated medications used:
  • Mabthera (mabthera - Rituximab) (not Specified) ((df Intravenous))
  • Vincristine Sulfate ((df Intravenous))
Patient was hospitalized.

Abdominal Discomfort, Apallic Syndrome, Intentional Overdose, Loss Of Consciousness
on Aug 31, 2007 Female from SPAIN , 75 years of age, was diagnosed with and was treated with Orfidal. Patient felt the following Orfidal side effects: abdominal discomfort, apallic syndrome, intentional overdose, loss of consciousness. Orfidal dosage: N/A.
Multiple prescriptions taken:
  • Cymbalta (480 Mg, Eight Tablets Of 60mg)
Patient was hospitalized.

Aggression, Agitation, Confusional State, Dry Mouth, Fall, Nausea
Patient was taking Orfidal. After Orfidal was administered, patient encountered several Orfidal side effects: aggression, agitation, confusional state, dry mouth, fall, nausea on Dec 29, 2006 from SPAIN Additional patient health information: Female , 84 years of age, . Orfidal dosage: Po.
Multiple concurrent drugs taken:
  • Cymbalta (60 Mg Q Day Po)


Renal Impairment
Adverse event was reported on Sep 11, 2006 by a Female taking Orfidal (Dosage: Df Po) . Location: SPAIN , 90 years of age, Directly after, patient experienced the unwanted or unexpected Orfidal side effects: renal impairment.
Associated medications used:
  • Dilutol (5 Mg Qd Po)
  • Cesplon Plus (1 Df Qd Po)
Patient was hospitalized.

Hepatitis
on Sep 11, 2006 Female from SPAIN , 57 years of age, was diagnosed with and was treated with Orfidal. Patient felt the following Orfidal side effects: hepatitis. Orfidal dosage: 1 Mg Q Day Po.
Multiple prescriptions taken:
  • Imurel (50 Mg Q Day Po)
  • Entocort
  • Urbason /00049601/


Dyskinesia
on Aug 03, 2006 Female from SPAIN , 76 years of age, was treated with Orfidal. After Orfidal was administered, patient encountered several Orfidal side effects: dyskinesia. Orfidal dosage: 1 Mg Q Day Po.
Multiple concurrent drugs taken:
  • Deprax (100 Mg Q Day Po)
  • Seroquel (100 Mg Q Day Po)
  • Distraneurine
  • Ebixa


Fall, Syncope
Patient was taking Orfidal. Directly after, patient experienced the unwanted or unexpected Orfidal side effects: fall, syncope on Apr 25, 2006 from SPAIN Additional patient health information: Female , 81 years of age, . Orfidal dosage: 1 Mg Q Day Po.
Associated medications used:
  • Nobritol (1 Cap Q Day Po)
Patient was hospitalized.

Stupor
Adverse event was reported on Sep 07, 2005 by a Male taking Orfidal (Dosage: 1 Mg Qd Po) was diagnosed with and. Location: SPAIN , 95 years of age, Patient felt the following Orfidal side effects: stupor.
Multiple prescriptions taken:
  • Paracetamol
  • Dopamine
  • Seguril
  • Phytomenadione
  • Ventolin


Agitation, Confusional State, Hallucination, Nervousness
on Apr 15, 2005 Female from , 60 years of age, was diagnosed with and was treated with Orfidal. After Orfidal was administered, patient encountered several Orfidal side effects: agitation, confusional state, hallucination, nervousness. Orfidal dosage: 1 Mg Q Day Po.
Multiple concurrent drugs taken:
  • Seroquel (50 Mg Q Day Po)


Keep Track of Side Effects

Note Your Observations

It is really important to keep of your symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:

     

    Side Effects

    Scale

    Date & Time

    Other Medicine(s) or Treatment(s)

     

     

     

     

    Scale: 1 = very mild to 10 = very bad


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  • 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.

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    Safety Alerts, Active Ingredients, Usage Information

    More About Orfidal

    Side Effects reported to FDA: 24

    Orfidal safety alerts: No

    Reported deaths: 2

    Reported hospitalizations: 9

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