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Orfidal Side Effects

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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.

Orfidal Side Effects Reported to FDA



Orfidal Side Effect Report#8927050
Confusional State
This is a report of a 65-year-old male patient (weight: NA) from ES, suffering from the following health 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): Confusional State 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.
Orfidal Side Effect Report#6269734-0
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. After starting Orfidal the patient began experiencing various side effects, including: Hepatitis CholestaticAdditional 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.
Orfidal Side Effect Report#6263670-1
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 using Orfidal, the patient experienced the following unwanted symptoms/side effects: Hepatitis CholestaticThe 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.
Orfidal Side Effect Report#5839951-X
Atrial Fibrillation, Cytolytic Hepatitis
This Atrial Fibrillation side effect was reported by a physician from Spain. A 73-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Orfidal (drug dosage: NA), which was initiated on
Apr 04, 2008. Concurrently used drugs:
  • Dacortin
  • Tramadol Hcl
  • Pantoprazole Sodium
  • Danatrol
  • Metformin Hcl
.After starting to take Orfidal the consumer reported adverse symptoms, such as: Atrial Fibrillation, Cytolytic HepatitisThese side effects may potentially be related to Orfidal. The patient was hospitalized.
Orfidal Side Effect Report#5827318-X
Bradykinesia, Bradyphrenia, Cytolytic Hepatitis, Hepatomegaly, Portal Hypertension
This is a report of a 47-year-old female patient (weight: NA) from Spain, suffering from the following health symptoms/conditions: NA, who was treated with Orfidal (orfidal - Lorazepam) (not Specified) (dosage: (1 Mg Qd Oral), start time:
Feb 01, 2008), combined with:
  • Antabuse (500 Mg Bid Oral)
  • Lexatin (lexatin - Bromazepam) (not Specified) (Df Oral)
  • Prozac (20 Mg Qd Oral)
and developed a serious reaction and side effect(s): Bradykinesia, Bradyphrenia, Cytolytic Hepatitis, Hepatomegaly, Portal Hypertension after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Orfidal (orfidal - Lorazepam) (not Specified) treatment in female patients, resulting in Bradykinesia side effect. The patient was hospitalized.
Orfidal Side Effect Report#5781848-8
Blood Creatine Phosphokinase Increased, Blood Osmolarity Abnormal, Confusional State, Disorientation, Expressive Language Disorder, Hypernatraemia, Metabolic Acidosis, Neuroleptic Malignant Syndrome, Pyrexia
This report suggests a potential Orfidal (orfidal - Lorazepam) (1 Mg, 1 Mg) (not Specified) Blood Creatine Phosphokinase Increased side effect(s) that can have serious consequences. A 64-year-old female patient (weight: NA) from Spain was diagnosed with the following symptoms/conditions: NA and used Orfidal (orfidal - Lorazepam) (1 Mg, 1 Mg) (not Specified) (dosage: (1 Mg Qd Oral, (1 Mg Qd Oral)) starting
Mar 24, 2008. After starting Orfidal (orfidal - Lorazepam) (1 Mg, 1 Mg) (not Specified) the patient began experiencing various side effects, including: Blood Creatine Phosphokinase Increased, Blood Osmolarity Abnormal, Confusional State, Disorientation, Expressive Language Disorder, Hypernatraemia, Metabolic Acidosis, Neuroleptic Malignant Syndrome, PyrexiaAdditional drugs used concurrently:
  • 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. Although Orfidal (orfidal - Lorazepam) (1 Mg, 1 Mg) (not Specified) demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Blood Creatine Phosphokinase Increased, may still occur.
Orfidal Side Effect Report#5766064-8
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 (orfidal - Lorazepam) 1 Mg (not Specified) (dosage: 1 Mg Qd Oral). The following drugs were being taken at the same time:
  • Trankimazin (trankimzin - Alprazolam) (not Specified) (0.25 Mg Tid Oral)
  • Venlafaxine Hcl
When using Orfidal (orfidal - Lorazepam) 1 Mg (not Specified), the patient experienced the following unwanted symptoms/side effects: Hepatitis CholestaticThe 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.
Orfidal Side Effect Report#5764751-9
Blood Creatine Phosphokinase Increased, Confusional State, Hypernatraemia, Metabolic Acidosis, Neuroleptic Malignant Syndrome, Pyrexia
This Blood Creatine Phosphokinase Increased side effect was reported by a health professional from Spain. A 64-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Orfidal (drug dosage: NA), which was initiated on
Jan 01, 2006. Concurrently used drugs:
  • Haloperidol
  • Lithium Carbonate
  • Antabuse
  • Etumina
  • Vandral Retard
  • Akineton
.After starting to take Orfidal the consumer reported adverse symptoms, such as: Blood Creatine Phosphokinase Increased, Confusional State, Hypernatraemia, Metabolic Acidosis, Neuroleptic Malignant Syndrome, PyrexiaThese side effects may potentially be related to Orfidal. The patient was hospitalized.
Orfidal Side Effect Report#5712003-5
Apathy, Blood Pressure Increased, Cardio-respiratory Arrest, Cystitis Haemorrhagic, Gastritis Haemorrhagic, Hepatic Steatosis, Hepatotoxicity, Lung Disorder, Myocardial Infarction
This is a report of a 34-year-old male patient (weight: NA) from Spain, suffering from the following health symptoms/conditions: somnolence,depression, who was treated with Orfidal (orfidal - Lorazepam) 1 Mg (dosage: 1 Mg Qd Oral, start time:
Jan 01, 2008), combined with:
  • Besitran (besitran - Sertraline Hydrochloride) (100 Mg Qd Oral)
  • Lamotrigine
  • Seroquel
and developed a serious reaction and side effect(s): Apathy, Blood Pressure Increased, Cardio-respiratory Arrest, Cystitis Haemorrhagic, Gastritis Haemorrhagic, Hepatic Steatosis, Hepatotoxicity, Lung Disorder, Myocardial Infarction after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Orfidal (orfidal - Lorazepam) 1 Mg treatment in male patients, resulting in Apathy side effect. The patient was hospitalized.
Orfidal Side Effect Report#5689696-4
Hepatitis Cholestatic
This report suggests a potential Orfidal (orfidal - Lorazepam) 1 Mg 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 (orfidal - Lorazepam) 1 Mg (dosage: 1 Mg Qd Oral) starting
May 07, 2007. After starting Orfidal (orfidal - Lorazepam) 1 Mg the patient began experiencing various side effects, including: Hepatitis CholestaticAdditional drugs used concurrently:
  • Trankimazin (trankimazin - Alprazolam) (0.25 Mg 1x/3 Days Oral)
  • Venlafaxine Hcl
The patient was hospitalized. Although Orfidal (orfidal - Lorazepam) 1 Mg demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hepatitis Cholestatic, may still occur.
Orfidal Side Effect Report#5671594-3
Disorientation, Dyspnoea, Somnolence
This Disorientation problem was reported by a health professional from Spain. A 92-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Dec 06, 2007 this consumer started treatment with Orfidal (orfidal - Lorazepam) 1 Mg (dosage: 1 Mg Qd Oral A Few Years). The following drugs were being taken at the same time:
  • Transtec (transtec - Buprenorphine) (not Specified) (1 Df 1x3 Days Transdermal)
  • Nitroglyn
  • Pantoprazole Sodium
  • Nebivolol Hcl
  • Sibelium
When using Orfidal (orfidal - Lorazepam) 1 Mg, the patient experienced the following unwanted symptoms/side effects: Disorientation, Dyspnoea, SomnolenceThe 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 Disorientation, may become evident only after a product is in use by the general population.
Orfidal Side Effect Report#5656229-8
Blood Chloride Decreased, Disorientation, Hyponatraemia
This Blood Chloride Decreased side effect was reported by a health professional from Spain. A 69-year-old female patient (weight:NA) experienced the following symptoms/conditions: insomnia,influenza,pain.The patient was prescribed Orfidal (orfidal - Lorazepam) 1 Mg (drug dosage: (1 Mg Qd Oral)), which was initiated on
Oct 01, 2007. Concurrently used drugs:
  • Frenadol /01380101/ (frenadol - Chlorphenamine Maleate / Dextromethorp ((1 Df Tid Oral))
  • Neurontin ((400 Mg Qd Oral))
  • Enalapril Maleate
  • Paracetamol
.After starting to take Orfidal (orfidal - Lorazepam) 1 Mg the consumer reported adverse symptoms, such as: Blood Chloride Decreased, Disorientation, HyponatraemiaThese side effects may potentially be related to Orfidal (orfidal - Lorazepam) 1 Mg.
Orfidal Side Effect Report#5594665-9
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 (weight: NA) from Spain, suffering from the following health symptoms/conditions: NA, who was treated with Orfidal (orfidal - Lorazepam) 1 Mg (dosage: (1 Mg Qd Oral), start time:
Apr 29, 2007), combined with:
  • Haloperidol ((df))
  • Sinogan /00038601/ (sinogan - Levomepromazine) (not Specified) ((df))
and developed a serious reaction and side effect(s): Loss Of Consciousness, Pco2 Increased, Po2 Decreased, Sensory Loss, White Blood Cell Count Increased after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Orfidal (orfidal - Lorazepam) 1 Mg treatment in male patients, resulting in Loss Of Consciousness side effect. The patient was hospitalized.
Orfidal Side Effect Report#5557233-0
Psychotic Disorder, Renal Failure Acute, Rhabdomyolysis
This report suggests a potential Orfidal (orfidal - Lorazepam) 1 Mg Psychotic Disorder side effect(s) that can have serious consequences. A 27-year-old male patient (weight: NA) from Spain was diagnosed with the following symptoms/conditions: insomnia,schizophrenia and used Orfidal (orfidal - Lorazepam) 1 Mg (dosage: 1 Mg Bid Oral) starting
Jan 01, 2007. After starting Orfidal (orfidal - Lorazepam) 1 Mg the patient began experiencing various side effects, including: Psychotic Disorder, Renal Failure Acute, RhabdomyolysisAdditional drugs used concurrently:
  • Zyprexa (30 Mg Bid Oral)
The patient was hospitalized. Although Orfidal (orfidal - Lorazepam) 1 Mg demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Psychotic Disorder, may still occur.
Orfidal Side Effect Report#5557049-5
Somnolence, Vomiting
This Somnolence problem was reported by a health professional from Spain. A 68-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Jan 06, 2007 this consumer started treatment with Orfidal (orfidal - Lorazepam) (dosage: Df Oral). The following drugs were being taken at the same time: NA. When using Orfidal (orfidal - Lorazepam), the patient experienced the following unwanted symptoms/side effects: Somnolence, VomitingThe 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 Somnolence, may become evident only after a product is in use by the general population.
Orfidal Side Effect Report#5483231-1
Stevens-johnson Syndrome
This Stevens-johnson Syndrome side effect was reported by a consumer or non-health professional from Spain. A 39-year-old female patient (weight:NA) experienced the following symptoms/conditions: insomnia,thrombocytopenic purpura.The patient was prescribed Orfidal (orfidal - Lorazepam) (drug dosage: (25 Mg Qd Oral)), which was initiated on
Jul 12, 2007. Concurrently used drugs:
  • Mabthera (mabthera - Rituximab) (not Specified) ((df Intravenous))
  • Vincristine Sulfate ((df Intravenous))
.After starting to take Orfidal (orfidal - Lorazepam) the consumer reported adverse symptoms, such as: Stevens-johnson SyndromeThese side effects may potentially be related to Orfidal (orfidal - Lorazepam). The patient was hospitalized.
Orfidal Side Effect Report#5460566-X
Abdominal Discomfort, Apallic Syndrome, Intentional Overdose, Loss Of Consciousness
This is a report of a 75-year-old female patient (weight: NA) from Spain, suffering from the following health symptoms/conditions: sleep disorder,affective disorder, who was treated with Orfidal (dosage: NA, start time:
Jan 01, 2007), combined with:
  • Cymbalta (480 Mg, Eight Tablets Of 60mg)
and developed a serious reaction and side effect(s): Abdominal Discomfort, Apallic Syndrome, Intentional Overdose, Loss Of Consciousness after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Orfidal treatment in female patients, resulting in Abdominal Discomfort side effect. The patient was hospitalized.
Orfidal Side Effect Report#5215201-2
Aggression, Agitation, Confusional State, Dry Mouth, Fall, Nausea
This report suggests a potential Orfidal Aggression side effect(s) that can have serious consequences. A 84-year-old female patient (weight: NA) from Spain was diagnosed with the following symptoms/conditions: NA and used Orfidal (dosage: Po) starting
Oct 11, 2006. After starting Orfidal the patient began experiencing various side effects, including: Aggression, Agitation, Confusional State, Dry Mouth, Fall, NauseaAdditional drugs used concurrently:
  • Cymbalta (60 Mg Q Day Po)
Although Orfidal demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Aggression, may still occur.
Orfidal Side Effect Report#5118905-5
Renal Impairment
This Renal Impairment problem was reported by a consumer or non-health professional from Spain. A 90-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Jan 01, 1995 this consumer started treatment with Orfidal (dosage: Df Po). The following drugs were being taken at the same time:
  • Dilutol (5 Mg Qd Po)
  • Cesplon Plus (1 Df Qd Po)
When using Orfidal, the patient experienced the following unwanted symptoms/side effects: Renal ImpairmentThe 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 Renal Impairment, may become evident only after a product is in use by the general population.
Orfidal Side Effect Report#5118423-4
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 (drug dosage: 1 Mg Q Day Po), which was initiated on
Jun 28, 2005. Concurrently used drugs:
  • Imurel (50 Mg Q Day Po)
  • Entocort
  • Urbason /00049601/
.After starting to take Orfidal the consumer reported adverse symptoms, such as: HepatitisThese side effects may potentially be related to Orfidal.
Orfidal Side Effect Report#5087093-6
Dyskinesia
This is a report of a 76-year-old female patient (weight: NA) from Spain, suffering from the following health 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): Dyskinesia 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.
Orfidal Side Effect Report#5003426-0
Fall, Syncope
This report suggests a potential Orfidal Fall 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. After starting Orfidal the patient began experiencing various side effects, including: Fall, SyncopeAdditional 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.
Orfidal Side Effect Report#4778687-3
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 using Orfidal, the patient experienced the following unwanted symptoms/side effects: StuporAlthough 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.
Orfidal Side Effect Report#4652521-4
Agitation, Confusional State, Hallucination, Nervousness
This Agitation side effect was reported by a health professional from . A 60-year-old female patient (weight:NA) experienced the following symptoms/conditions: insomnia.The patient was prescribed Orfidal (drug dosage: 1 Mg Q Day Po), which was initiated on
Feb 01, 2005. Concurrently used drugs:
  • Seroquel (50 Mg Q Day Po)
.After starting to take Orfidal the consumer reported adverse symptoms, such as: Agitation, Confusional State, Hallucination, NervousnessThese side effects may potentially be related to Orfidal.



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.


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  • 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

    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.

    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 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.

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    More About Orfidal

    Side Effects reported to FDA: 24

    Orfidal safety alerts: No

    Reported deaths: 2

    Reported hospitalizations: 9

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