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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
This is a report of a 65-year-old male patient (weight: NA) from ES, suffering from the following symptoms/conditions: anxiety,agitation,depression, who was treated with Orfidal (dosage: 3 Mg, 1x/day, start time: Apr 09, 2011), combined with: NA. and developed a serious reaction and side effect(s). The consumer presented with:
  • Confusional State
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Orfidal treatment in male patients, resulting in confusional state side effect. The patient was hospitalized.

Hepatitis Cholestatic
This report suggests a potential Orfidal Hepatitis Cholestatic side effect(s) that can have serious consequences. A 39-year-old male patient (weight: NA) from SPAIN was diagnosed with the following symptoms/conditions: anxiety and used Orfidal (dosage: NA) starting May 07, 2007. Soon after starting Orfidal the patient began experiencing various side effects, including:
  • Hepatitis Cholestatic
Drugs used concurrently:
  • Venlafaxine Hcl
  • Trankimazin
The patient was hospitalized. Although Orfidal demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as hepatitis cholestatic, may still occur.

Hepatitis Cholestatic
This Hepatitis Cholestatic problem was reported by a health professional from SPAIN. A 39-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: anxiety. On May 07, 2007 this consumer started treatment with Orfidal (dosage: NA). The following drugs were being taken at the same time:
  • Venlafaxine Hcl
  • Trankimazin
When commencing Orfidal, the patient experienced the following unwanted symptoms/side effects:
  • Hepatitis Cholestatic
The patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as hepatitis cholestatic, may become evident only after a product is in use by the general population.

Atrial Fibrillation, Cytolytic Hepatitis
This is a report of a 73-year-old female patient (weight: NA) from SPAIN. The patient developed the following symptoms/conditions: NA and was treated with Orfidal (dosage: NA) starting Apr 04, 2008. Concurrently used drugs:
  • Dacortin
  • Tramadol Hcl
  • Pantoprazole Sodium
  • Danatrol
  • Metformin Hcl
Soon after that, the consumer experienced the following side effects:
  • Atrial Fibrillation
  • Cytolytic Hepatitis
The patient was hospitalized. This opens a possibility that Orfidal treatment could cause the above reactions, including atrial fibrillation, and some female subjects may be more susceptible.


Bradykinesia, Bradyphrenia, Cytolytic Hepatitis, Hepatomegaly, Portal Hypertension
A 47-year-old female patient (weight: NA) from SPAIN with the following symptoms/conditions: NA started Orfidal (orfidal - Lorazepam) (not Specified) treatment (dosage: (1 Mg Qd Oral)) on Feb 01, 2008. Soon after starting Orfidal (orfidal - Lorazepam) (not Specified) treatment, the subject experienced various side effects, including:
  • Bradykinesia
  • Bradyphrenia
  • Cytolytic Hepatitis
  • Hepatomegaly
  • Portal Hypertension
Concurrently used drugs:
  • Antabuse (500 Mg Bid Oral)
  • Lexatin (lexatin - Bromazepam) (not Specified) (Df Oral)
  • Prozac (20 Mg Qd Oral)
The patient was hospitalized. This finding indicates that some female patients could be more vulnerable to Orfidal (orfidal - Lorazepam) (not Specified).

Blood Creatine Phosphokinase Increased, Blood Osmolarity Abnormal, Confusional State, Disorientation, Expressive Language Disorder, Hypernatraemia, Metabolic Acidosis, Neuroleptic Malignant Syndrome, Pyrexia
A 64-year-old female patient from SPAIN (weight: NA) experienced symptoms, such as: NA and was treated with Orfidal (orfidal - Lorazepam) (1 Mg, 1 Mg) (not Specified)(dosage: (1 Mg Qd Oral, (1 Mg Qd Oral)). The treatment was initiated on Mar 24, 2008. After that a consumer reported the following side effect(s):
  • Blood Creatine Phosphokinase Increased
  • Blood Osmolarity Abnormal
  • Confusional State
  • Disorientation
  • Expressive Language Disorder
  • Hypernatraemia
  • Metabolic Acidosis
  • Neuroleptic Malignant Syndrome
  • Pyrexia
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Orfidal (orfidal - Lorazepam) (1 Mg, 1 Mg) (not Specified) efficacy:
  • 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 )))
The patient was hospitalized.

Hepatitis Cholestatic
In this report, Orfidal (orfidal - Lorazepam) 1 Mg (not Specified) was administered for the following condition: anxiety.A 39-year-old male consumer from SPAIN (weight: NA) started Orfidal (orfidal - Lorazepam) 1 Mg (not Specified) treatment (dosage: 1 Mg Qd Oral) on May 07, 2007.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Hepatitis Cholestatic
A possible interaction with other drugs could have contributed to this reaction:
  • Trankimazin (trankimzin - Alprazolam) (not Specified) (0.25 Mg Tid Oral)
  • Venlafaxine Hcl
The patient was hospitalized.Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Orfidal (orfidal - Lorazepam) 1 Mg (not Specified) treatment could be related to the listed above side effect(s).

Blood Creatine Phosphokinase Increased, Confusional State, Hypernatraemia, Metabolic Acidosis, Neuroleptic Malignant Syndrome, Pyrexia
This is a report of the following Orfidal side effect(s):
  • Blood Creatine Phosphokinase Increased
  • Confusional State
  • Hypernatraemia
  • Metabolic Acidosis
  • Neuroleptic Malignant Syndrome
  • Pyrexia
A 64-year-old female patient from SPAIN (weight: NA) presented with the following condition: NA and received a treatment with Orfidal (dosage: NA) starting: Jan 01, 2006.The following concurrently used drugs could have generated interactions:
  • Haloperidol
  • Lithium Carbonate
  • Antabuse
  • Etumina
  • Vandral Retard
  • Akineton
The patient was hospitalized.This report suggests that a Orfidal treatment could be associated with the listed above side effect(s).

Apathy, Blood Pressure Increased, Cardio-respiratory Arrest, Cystitis Haemorrhagic, Gastritis Haemorrhagic, Hepatic Steatosis, Hepatotoxicity, Lung Disorder, Myocardial Infarction
This Orfidal (orfidal - Lorazepam) 1 Mg report was submitted by a 34-year-old male consumer from SPAIN (weight: NA). The patient was diagnosed with: somnolence,depression and Orfidal (orfidal - Lorazepam) 1 Mg was administered (dosage: 1 Mg Qd Oral) starting: Jan 01, 2008. The consumer developed a set of symptoms:
  • Apathy
  • Blood Pressure Increased
  • Cardio-respiratory Arrest
  • Cystitis Haemorrhagic
  • Gastritis Haemorrhagic
  • Hepatic Steatosis
  • Hepatotoxicity
  • Lung Disorder
  • Myocardial Infarction
Other drugs used simultaneously:
  • Besitran (besitran - Sertraline Hydrochloride) (100 Mg Qd Oral)
  • Lamotrigine
  • Seroquel
The patient was hospitalized.Those unexpected symptoms could be linked to a Orfidal (orfidal - Lorazepam) 1 Mg treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

Hepatitis Cholestatic
This is a report of a possible correlation between Orfidal (orfidal - Lorazepam) 1 Mg use and the following symptoms/side effect(s):
  • Hepatitis Cholestatic
which could contribute to an assessment of Orfidal (orfidal - Lorazepam) 1 Mg risk profile.A 39-year-old male consumer from SPAIN (weight: NA) was suffering from anxiety and was treated with Orfidal (orfidal - Lorazepam) 1 Mg (dosage: 1 Mg Qd Oral) starting May 07, 2007.Other concurrent medications:
  • Trankimazin (trankimazin - Alprazolam) (0.25 Mg 1x/3 Days Oral)
  • Venlafaxine Hcl
The patient was hospitalized.

Disorientation, Dyspnoea, Somnolence
A 92-year-old female patient from SPAIN (weight: NA) presented with the following symptoms: NA and after a treatment with Orfidal (orfidal - Lorazepam) 1 Mg (dosage: 1 Mg Qd Oral A Few Years) experienced the following side effect(s):
  • Disorientation
  • Dyspnoea
  • Somnolence
The treatment was started on Dec 06, 2007. Orfidal (orfidal - Lorazepam) 1 Mg was used in combination with the following drugs:
  • Transtec (transtec - Buprenorphine) (not Specified) (1 Df 1x3 Days Transdermal)
  • Nitroglyn
  • Pantoprazole Sodium
  • Nebivolol Hcl
  • Sibelium
The patient was hospitalized.This report could alert potential Orfidal (orfidal - Lorazepam) 1 Mg consumers.

Blood Chloride Decreased, Disorientation, Hyponatraemia
In this report, a 69-year-old female patient from SPAIN (weight: NA) was affected by a possible Orfidal (orfidal - Lorazepam) 1 Mg side effect.The patient was diagnosed with insomnia,influenza,pain. After a treatment with Orfidal (orfidal - Lorazepam) 1 Mg (dosage: (1 Mg Qd Oral), start date: Oct 01, 2007), the patient experienced the following side effect(s):
  • Blood Chloride Decreased
  • Disorientation
  • Hyponatraemia
The following simultaneously used drugs could have led to this reaction:
  • Frenadol /01380101/ (frenadol - Chlorphenamine Maleate / Dextromethorp ((1 Df Tid Oral))
  • Neurontin ((400 Mg Qd Oral))
  • Enalapril Maleate
  • Paracetamol
The findings here stress that side effects should be taken into consideration when evaluating a Orfidal (orfidal - Lorazepam) 1 Mg treatment.

Loss Of Consciousness, Pco2 Increased, Po2 Decreased, Sensory Loss, White Blood Cell Count Increased
This is a report of a 77-year-old male patient from SPAIN (weight: NA), who used Orfidal (orfidal - Lorazepam) 1 Mg (dosage: (1 Mg Qd Oral)) for a treatment of NA. After starting a treatment on Apr 29, 2007, the patient experienced the following side effect(s):
  • Loss Of Consciousness
  • Pco2 Increased
  • Po2 Decreased
  • Sensory Loss
  • White Blood Cell Count Increased
The following drugs could possibly have interacted with the Orfidal (orfidal - Lorazepam) 1 Mg treatment
  • Haloperidol ((df))
  • Sinogan /00038601/ (sinogan - Levomepromazine) (not Specified) ((df))
The patient was hospitalized.Taken together, these observations suggest that a Orfidal (orfidal - Lorazepam) 1 Mg treatment could be related to side effect(s), such as Loss Of Consciousness, Pco2 Increased, Po2 Decreased, Sensory Loss, White Blood Cell Count Increased.

Psychotic Disorder, Renal Failure Acute, Rhabdomyolysis
This psychotic disorder side effect was reported by a health professional from SPAIN. A 27-year-old male patient (weight:NA) experienced the following symptoms/conditions: insomnia,schizophrenia. The patient was prescribed Orfidal (orfidal - Lorazepam) 1 Mg (dosage: 1 Mg Bid Oral), which was started on Jan 01, 2007. Concurrently used drugs:
  • Zyprexa (30 Mg Bid Oral)
When starting to take Orfidal (orfidal - Lorazepam) 1 Mg the consumer reported the following symptoms:
  • Psychotic Disorder
  • Renal Failure Acute
  • Rhabdomyolysis
The patient was hospitalized. These side effects may potentially be related to Orfidal (orfidal - Lorazepam) 1 Mg.

Somnolence, Vomiting
This is a Orfidal (orfidal - Lorazepam) side effect report of a 68-year-old male patient (weight:NA) from SPAIN, suffering from the following symptoms/conditions: NA, who was treated with Orfidal (orfidal - Lorazepam) (dosage:Df Oral, start time: Jan 06, 2007), combined with: NA., and developed a serious reaction and a somnolence side effect. The patient presented with:
  • Somnolence
  • Vomiting
which developed after the beginning of treatment. The patient was hospitalized. This side effect report can indicate a possible existence of increased vulnerability to Orfidal (orfidal - Lorazepam) treatment in male patients suffering from NA, resulting in somnolence.

Stevens-johnson Syndrome
This report suggests a potential Orfidal (orfidal - Lorazepam) stevens-johnson syndrome side effect(s) that can have serious consequences. A 39-year-old female patient from SPAIN (weight:NA) was diagnosed with the following health condition(s): insomnia,thrombocytopenic purpura and used Orfidal (orfidal - Lorazepam) (dosage: (25 Mg Qd Oral)) starting Jul 12, 2007. Soon after starting Orfidal (orfidal - Lorazepam) the patient began experiencing various side effects, including:
  • Stevens-johnson Syndrome
Drugs used concurrently:
  • Mabthera (mabthera - Rituximab) (not Specified) ((df Intravenous))
  • Vincristine Sulfate ((df Intravenous))
The patient was hospitalized. Although Orfidal (orfidal - Lorazepam) demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as stevens-johnson syndrome, may still occur.

Abdominal Discomfort, Apallic Syndrome, Intentional Overdose, Loss Of Consciousness
This abdominal discomfort problem was reported by a physician from SPAIN. A 75-year-old female patient (weight: NA) was diagnosed with the following medical condition(s): sleep disorder,affective disorder.On Jan 01, 2007 a consumer started treatment with Orfidal (dosage: NA). The following drugs/medications were being taken at the same time:
  • Cymbalta (480 Mg, Eight Tablets Of 60mg)
When commencing Orfidal, the patient experienced the following unwanted symptoms /side effects:
  • Abdominal Discomfort
  • Apallic Syndrome
  • Intentional Overdose
  • Loss Of Consciousness
The patient was hospitalized. Although all drugs are carefully tested before they are licensed for use, they carry potential side effect risks. Some side effects, such as abdominal discomfort, may become evident only after a product is in use by the general population.

Aggression, Agitation, Confusional State, Dry Mouth, Fall, Nausea
This is a Orfidal side effect report of a 84-year-old female patient (weight: NA) from SPAIN. The patient developed the following symptoms/conditions: NA and was treated with Orfidal (dosage: Po) starting Oct 11, 2006. Concurrently used drugs:
  • Cymbalta (60 Mg Q Day Po)
Soon after that, the consumer experienced the following of symptoms:
  • Aggression
  • Agitation
  • Confusional State
  • Dry Mouth
  • Fall
  • Nausea
This opens a possibility that Orfidal could cause aggression and that some female patients may be more susceptible.

Renal Impairment
A 90-year-old female patient (weight: NA) from SPAIN with the following symptoms: NA started Orfidal treatment (dosage: Df Po) on Jan 01, 1995. Soon after starting Orfidal treatment, the consumer experienced several side effects, including:
  • Renal Impairment
. Concurrently used drugs:
  • Dilutol (5 Mg Qd Po)
  • Cesplon Plus (1 Df Qd Po)
The patient was hospitalized. This finding indicates that some patients can be more vulnerable to developing Orfidal side effects, such as renal impairment.

Hepatitis
This hepatitis side effect was reported by a health professional from SPAIN. A 57-year-old female patient (weight:NA) experienced the following symptoms/conditions: colitis ulcerative.The patient was prescribed Orfidal (dosage: 1 Mg Q Day Po), which was started on Jun 28, 2005. Concurrently used drugs:
  • Imurel (50 Mg Q Day Po)
  • Entocort
  • Urbason /00049601/
.When starting to take Orfidal the consumer reported symptoms, such as:
  • Hepatitis
These side effects may potentially be related to Orfidal.

Dyskinesia
This is a report of a 76-year-old female patient (weight: NA) from SPAIN, suffering from the following symptoms/conditions: NA, who was treated with Orfidal (dosage: 1 Mg Q Day Po, start time: Apr 01, 2006), combined with:
  • Deprax (100 Mg Q Day Po)
  • Seroquel (100 Mg Q Day Po)
  • Distraneurine
  • Ebixa
and developed a serious reaction and side effect(s). The consumer presented with:
  • Dyskinesia
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Orfidal treatment in female patients, resulting in dyskinesia side effect.

Fall, Syncope
This report suggests a potential Orfidal Fall, Syncope side effect(s) that can have serious consequences. A 81-year-old female patient (weight: NA) from SPAIN was diagnosed with the following symptoms/conditions: NA and used Orfidal (dosage: 1 Mg Q Day Po) starting NS. Soon after starting Orfidal the patient began experiencing various side effects, including:
  • Fall
  • Syncope
Drugs used concurrently:
  • Nobritol (1 Cap Q Day Po)
The patient was hospitalized. Although Orfidal demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as fall, may still occur.

Stupor
This Stupor problem was reported by a health professional from SPAIN. A 95-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: insomnia. On Jul 08, 2005 this consumer started treatment with Orfidal (dosage: 1 Mg Qd Po). The following drugs were being taken at the same time:
  • Paracetamol
  • Dopamine
  • Seguril
  • Phytomenadione
  • Ventolin
When commencing Orfidal, the patient experienced the following unwanted symptoms/side effects:
  • Stupor
Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as stupor, may become evident only after a product is in use by the general population.

Agitation, Confusional State, Hallucination, Nervousness
This is a report of a 60-year-old female patient (weight: NA) from . The patient developed the following symptoms/conditions: insomnia and was treated with Orfidal (dosage: 1 Mg Q Day Po) starting Feb 01, 2005. Concurrently used drugs:
  • Seroquel (50 Mg Q Day Po)
Soon after that, the consumer experienced the following side effects:
  • Agitation
  • Confusional State
  • Hallucination
  • Nervousness
This opens a possibility that Orfidal treatment could cause the above reactions, including agitation, and some female subjects may be more susceptible.



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

    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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    Side Effects reported to FDA: 24

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    Reported deaths: 2

    Reported hospitalizations: 9

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