Common Lexomil Side Effects


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

Confusional State (6)
Overdose (5)
Coma (5)
Asthenia (5)
Anaemia (4)
Hyponatraemia (4)
Somnolence (4)
Suicide Attempt (4)
Renal Failure Acute (4)
Cytolytic Hepatitis (3)
Decreased Appetite (3)
Weight Decreased (3)
Hyperkalaemia (3)
Rash (2)
Renal Failure (2)
Polyuria (2)
Osteonecrosis (2)
Malaise (2)
Neutropenia (2)
Pneumonia Aspiration (2)

➢ 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.

Lexomil Side Effects Reported to FDA



Lexomil Side Effect Report#9257555
Suicide Attempt
This is a report of a 24-year-old female patient (weight: NA) from FR, suffering from the following health symptoms/conditions: NA, who was treated with Lexomil (dosage: 4 Tablets Daily, start time: 1988), combined with: NA. and developed a serious reaction and side effect(s): Suicide Attempt after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Lexomil treatment in female patients, resulting in Suicide Attempt side effect.
Lexomil Side Effect Report#8983730
Suicide Attempt, Renal Failure, Hepatitis Fulminant, Liver Transplant, Overdose, Coma
This report suggests a potential Lexomil Suicide Attempt side effect(s) that can have serious consequences. A 18-year-old female patient (weight: NA) from FR was diagnosed with the following symptoms/conditions: NA and used Lexomil (dosage: NA) starting
May 04, 2009. After starting Lexomil the patient began experiencing various side effects, including: Suicide Attempt, Renal Failure, Hepatitis Fulminant, Liver Transplant, Overdose, ComaAdditional drugs used concurrently:
  • Cellcept
  • Bactrim
  • Rivotril
  • Prograf
  • Simulect
  • Bristopen
  • Claforan
  • Tienam
The patient was hospitalized. Although Lexomil demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Suicide Attempt, may still occur.
Lexomil Side Effect Report#8874651
Ischaemic Stroke
This Ischaemic Stroke problem was reported by a physician from FR. A 81-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: anxiety disorder,infection. On
Aug 07, 2012 this consumer started treatment with Lexomil (dosage: NA). The following drugs were being taken at the same time:
  • Rocephine
  • Rocephine
  • Zyprexa
  • Tiapridal
  • Depamide
  • Noctamide
  • Doliprane
  • Omeprazol
When using Lexomil, the patient experienced the following unwanted symptoms/side effects: Ischaemic StrokeThe 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 Ischaemic Stroke, may become evident only after a product is in use by the general population.
Lexomil Side Effect Report#8476619-8
Hypokalaemia, Hypophosphataemia
This Hypokalaemia side effect was reported by a physician from France. A 57-year-old female patient (weight:NA) experienced the following symptoms/conditions: anxiety,breast cancer,tumour pain.The patient was prescribed Lexomil (drug dosage: Unk), which was initiated on
Jan 01, 2006. Concurrently used drugs:
  • Neratinib (240 Mg, 1x/day (once Per Day))
  • Lyrica (Unk)
  • Temsirolimus (15 Mg, Weekly)
  • Paroxetine Hcl (Unk)
  • Zometa (Unk)
.After starting to take Lexomil the consumer reported adverse symptoms, such as: Hypokalaemia, HypophosphataemiaThese side effects may potentially be related to Lexomil.
Lexomil Side Effect Report#8443893-3
Open Wound
This is a report of a 65-year-old male patient (weight: NA) from France, suffering from the following health symptoms/conditions: NA, who was treated with Lexomil (dosage: Unk, start time:
Oct 05, 2011), combined with:
  • Nexium
  • Domperidone
  • Polyethylene Glycol
  • Thiocolchicoside
  • Levothyroxine Sodium (125 ?g, Unk)
  • Oxynorm (5 Mg, Unk)
  • Nexavar (2 Df, Unk)
  • Neurontin
and developed a serious reaction and side effect(s): Open Wound after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Lexomil treatment in male patients, resulting in Open Wound side effect. The patient was hospitalized.
Lexomil Side Effect Report#8443713-7
Hyponatraemia, Blood Pressure Increased
This report suggests a potential Lexomil Hyponatraemia side effect(s) that can have serious consequences. A 73-year-old female patient (weight: NA) from France was diagnosed with the following symptoms/conditions: NA and used Lexomil (dosage: NA) starting
May 01, 2012. After starting Lexomil the patient began experiencing various side effects, including: Hyponatraemia, Blood Pressure IncreasedAdditional drugs used concurrently:
  • Bisoprolol Fumarate (10 Mg, Qd)
  • Oxazepam
  • Prozac
  • Atacand (8 Mg, Qd)
The patient was hospitalized. Although Lexomil demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hyponatraemia, may still occur.
Lexomil Side Effect Report#8435264-0
Escherichia Bacteraemia, Anaemia
This Escherichia Bacteraemia problem was reported by a health professional from France. A female patient (weight: NA) was diagnosed with the following symptoms/conditions: anxiety,hypertension,hepatitis c. On
Jan 01, 2011 this consumer started treatment with Lexomil (dosage: NA). The following drugs were being taken at the same time:
  • Valsartan
  • Incivo (Dosage Form: Tablet)
  • Pegasys
  • Copegus
  • Pegasys
  • Lantus
  • Copegus
  • Lantus
When using Lexomil, the patient experienced the following unwanted symptoms/side effects: Escherichia Bacteraemia, AnaemiaThe 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 Escherichia Bacteraemia, may become evident only after a product is in use by the general population.
Lexomil Side Effect Report#8433938-9
Meningoradiculitis, Lymphopenia, Herpes Zoster
This Meningoradiculitis side effect was reported by a health professional from France. A 49-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Lexomil Roche (drug dosage: NA), which was initiated on
Oct 01, 2008. Concurrently used drugs:
  • Enbrel
  • Levothyroxine Sodium
  • Modane
  • Vitamin D
  • Mabthera
  • Econazole Nitrate
  • Prednisone Tab
.After starting to take Lexomil Roche the consumer reported adverse symptoms, such as: Meningoradiculitis, Lymphopenia, Herpes ZosterThese side effects may potentially be related to Lexomil Roche. The patient was hospitalized.
Lexomil Side Effect Report#8392744-4
Cardio-respiratory Arrest, Craniocerebral Injury, Suicidal Ideation, Status Epilepticus, Agitation, Fall, Pulmonary Embolism
This is a report of a 59-year-old male patient (weight: NA) from France, suffering from the following health symptoms/conditions: NA, who was treated with Lexomil (dosage: NA, start time:
Mar 29, 2012), combined with:
  • Pantoprazole
  • Phenobarbital Tab
  • Vastarel
  • Permixon
  • Phenytoin Sodium
  • Quetiapine Fumarate
  • Escitalopram
and developed a serious reaction and side effect(s): Cardio-respiratory Arrest, Craniocerebral Injury, Suicidal Ideation, Status Epilepticus, Agitation, Fall, Pulmonary Embolism after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Lexomil treatment in male patients, resulting in Cardio-respiratory Arrest side effect. The patient was hospitalized.
Lexomil Side Effect Report#8388400-9
Renal Tubular Necrosis, Rhabdomyolysis, Coma
This report suggests a potential Lexomil Renal Tubular Necrosis side effect(s) that can have serious consequences. A male patient (weight: NA) from France was diagnosed with the following symptoms/conditions: NA and used Lexomil (dosage: NA) starting
Apr 07, 2011. After starting Lexomil the patient began experiencing various side effects, including: Renal Tubular Necrosis, Rhabdomyolysis, ComaAdditional drugs used concurrently:
  • Amlodipine Besilate W/ Olmesartan Medoxomil (1 Df, Qd)
  • Zyprexa (Unk)
  • Depakote (1500 Mg, Qd)
  • Naproxen (Unk, Prn)
  • Colchicine
The patient was hospitalized. Although Lexomil demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Renal Tubular Necrosis, may still occur.
Lexomil Side Effect Report#8382468-1
Visual Impairment, Retinal Disorder, Facial Spasm
This Visual Impairment problem was reported by a consumer or non-health professional from France. A 52-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Jan 01, 2002 this consumer started treatment with Lexomil (dosage: NA). The following drugs were being taken at the same time:
  • Gleevec (400 Mg, Daily)
When using Lexomil, the patient experienced the following unwanted symptoms/side effects: Visual Impairment, Retinal Disorder, Facial SpasmAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Visual Impairment, may become evident only after a product is in use by the general population.
Lexomil Side Effect Report#8355899-3
Neutropenia, Thrombocytopenia, Anaemia
This Neutropenia side effect was reported by a physician from France. A male patient (weight:NA) experienced the following symptoms/conditions: sleep disorder,anxiety,hepatitis c,polyarthritis.The patient was prescribed Lexomil (drug dosage: NA), which was initiated on
Jun 21, 2011. Concurrently used drugs: NA..After starting to take Lexomil the consumer reported adverse symptoms, such as: Neutropenia, Thrombocytopenia, AnaemiaThese side effects may potentially be related to Lexomil.
Lexomil Side Effect Report#8320533-5
Arthralgia, Raynaud's Phenomenon, Interstitial Lung Disease
This is a report of a 51-year-old female patient (weight: NA) from France, suffering from the following health symptoms/conditions: NA, who was treated with Lexomil (dosage: Unk, start time:
Aug 18, 2011), combined with:
  • Acetaminophen (Two Dosages Forms Per Day)
  • Lyrica (Unk)
  • Escitalopram (Unk)
and developed a serious reaction and side effect(s): Arthralgia, Raynaud's Phenomenon, Interstitial Lung Disease after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Lexomil treatment in female patients, resulting in Arthralgia side effect. The patient was hospitalized.
Lexomil Side Effect Report#8297291-6
Angiotensin Converting Enzyme Decreased, Nervousness, Hypercalcaemia, Dehydration, Weight Decreased, Blood Potassium Decreased, Confusional State, Asthenia, Electrocardiogram Qt Shortened
This report suggests a potential Lexomil (bromazepam) Angiotensin Converting Enzyme Decreased side effect(s) that can have serious consequences. A 51-year-old male patient (weight: NA) from France was diagnosed with the following symptoms/conditions: NA and used Lexomil (bromazepam) (dosage: NA) starting
Sep 19, 2011. After starting Lexomil (bromazepam) the patient began experiencing various side effects, including: Angiotensin Converting Enzyme Decreased, Nervousness, Hypercalcaemia, Dehydration, Weight Decreased, Blood Potassium Decreased, Confusional State, Asthenia, Electrocardiogram Qt ShortenedAdditional drugs used concurrently:
  • Cacit (calcium Carbonate)
  • Un-alfa (alfacalcidol)
  • Dedrogyl (calcifediol)
  • Bipreterax (bipredonium) (perindopril, Indapamide) (Oral)
  • Levothyroxine Sodium (1 Df (1 Df, 1 In 1 D), Oral)
  • Levothyroxine Sodium (1 Df (1 Df, 1 In 1 D), Oral)
The patient was hospitalized. Although Lexomil (bromazepam) demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Angiotensin Converting Enzyme Decreased, may still occur.
Lexomil Side Effect Report#8271313-0
Bifascicular Block, Hemiparesis, Syncope
This Bifascicular Block problem was reported by a health professional from France. A 46-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Lexomil (dosage: NA). The following drugs were being taken at the same time:
  • Milnacipran
  • Milnacipran (50-150 Mg Daily)
When using Lexomil, the patient experienced the following unwanted symptoms/side effects: Bifascicular Block, Hemiparesis, SyncopeAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Bifascicular Block, may become evident only after a product is in use by the general population.
Lexomil Side Effect Report#8270288-8
Arthritis, Arthralgia, Hyperthermia, Purpura
This Arthritis side effect was reported by a health professional from France. A 81-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Lexomil (drug dosage: NA), which was initiated on
Mar 01, 2012. Concurrently used drugs:
  • Lovenox
  • Perindopril Erbumine
.After starting to take Lexomil the consumer reported adverse symptoms, such as: Arthritis, Arthralgia, Hyperthermia, PurpuraThese side effects may potentially be related to Lexomil. The patient was hospitalized.
Lexomil Side Effect Report#8265723-5
Treatment Noncompliance
This is a report of a 58-year-old female patient (weight: NA) from France, suffering from the following health symptoms/conditions: NA, who was treated with Lexomil (dosage: 1/4 Tablet In The Morning, 1/ Tablet At Noon And 1/2 Tablet In Evening, start time: NS), combined with:
  • Duragesic-100
  • Duragesic-100
  • Atarax
and developed a serious reaction and side effect(s): Treatment Noncompliance after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Lexomil treatment in female patients, resulting in Treatment Noncompliance side effect.
Lexomil Side Effect Report#8175549-9
Pancreatitis Acute
This report suggests a potential Lexomil Pancreatitis Acute side effect(s) that can have serious consequences. A 82-year-old female patient (weight: NA) from Germany was diagnosed with the following symptoms/conditions: NA and used Lexomil (dosage: NA) starting NS. After starting Lexomil the patient began experiencing various side effects, including: Pancreatitis AcuteAdditional drugs used concurrently:
  • Aspirin
  • Escitalopram Oxalate
  • Lantus
  • Glucophage
  • Valsartan
  • Vitamin B-12
  • Omeprazole
  • Mirtazapine
The patient was hospitalized. Although Lexomil demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Pancreatitis Acute, may still occur.
Lexomil Side Effect Report#8168817-8
Feeling Drunk, Suicide Attempt, Incorrect Dose Administered, Toxicity To Various Agents
This Feeling Drunk problem was reported by a health professional from Denmark. A 43-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: suicide attempt. On
Aug 01, 2011 this consumer started treatment with Lexomil (bramazepam) (dosage: NA). The following drugs were being taken at the same time:
  • Alcohol (ethanol)
  • Propranolol (Overdose: 2 G Once, Oral)
  • Escitalopram Oxalate (20 Mg (20 Mg, 1 In 1 D), Oral Overdose: 280 Mg Once, Oral)
  • Tetrazepam (tetrazepam) (Overdose: 500 Mg Once, Oral)
When using Lexomil (bramazepam), the patient experienced the following unwanted symptoms/side effects: Feeling Drunk, Suicide Attempt, Incorrect Dose Administered, Toxicity To Various AgentsThe 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 Feeling Drunk, may become evident only after a product is in use by the general population.
Lexomil Side Effect Report#8126007-9
Cytolytic Hepatitis, Tumour Haemorrhage, Neutropenia
This Cytolytic Hepatitis side effect was reported by a physician from France. A female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Lexomil (drug dosage: NA), which was initiated on
Dec 08, 2010. Concurrently used drugs:
  • Lorazepam
  • Avastin (Cyclic)
  • Temozolomide
  • Temozolomide
  • Lasix
  • Temozolomide (Last Dose Prior To Sae:03 May 2011)
  • Amitriptyline Hcl
  • Rabeprazole Sodium
.After starting to take Lexomil the consumer reported adverse symptoms, such as: Cytolytic Hepatitis, Tumour Haemorrhage, NeutropeniaThese side effects may potentially be related to Lexomil.
Lexomil Side Effect Report#8095061-5
Asthenia, Blood Thyroid Stimulating Hormone Increased
This is a report of a 65-year-old female patient (weight: NA) from France, suffering from the following health symptoms/conditions: NA, who was treated with Lexomil (bromazepam) (bromazepam) (dosage: NA, start time:
Aug 01, 2011), combined with:
  • Calcium Carbonate (4 Df (2 Df, In The Morning And In The Evening))
  • Fucidine Cap (4 Df (2 Df, In The Morning And In The Evening))
  • Cardensiel (bisoprolol Fumarate) (bisoprolol Hemifumarate)
  • Cordarone
  • Stablon (tianeptine) (tianeptine)
  • Levothyroxine Sodium
  • Levofloxacin (0.5 Df (0.5 Df, In The Morning))
  • Inipomp (pantoprazole) (40 Mg) (pantoprazole)
and developed a serious reaction and side effect(s): Asthenia, Blood Thyroid Stimulating Hormone Increased after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Lexomil (bromazepam) (bromazepam) treatment in female patients, resulting in Asthenia side effect. The patient was hospitalized.
Lexomil Side Effect Report#8076784-0
Delusion, Suicidal Ideation
This report suggests a potential Lexomil Delusion side effect(s) that can have serious consequences. A 21-year-old male patient (weight: NA) from France was diagnosed with the following symptoms/conditions: NA and used Lexomil (dosage: NA) starting
Jan 01, 2007. After starting Lexomil the patient began experiencing various side effects, including: Delusion, Suicidal IdeationAdditional drugs used concurrently:
  • Risperdal Consta
  • Valium
  • Loxapine Hcl
  • Imovane
Although Lexomil demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Delusion, may still occur.
Lexomil Side Effect Report#8065929-4
Agranulocytosis
This Agranulocytosis problem was reported by a health professional from France. A 67-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Nov 25, 2011 this consumer started treatment with Lexomil (dosage: Half Tablet At Night). The following drugs were being taken at the same time:
  • Calciparine (0.4 Ml (10000 Ui/0.4ml))
When using Lexomil, the patient experienced the following unwanted symptoms/side effects: AgranulocytosisAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Agranulocytosis, may become evident only after a product is in use by the general population.
Lexomil Side Effect Report#8043531-8
Pulmonary Oedema, Cardiac Disorder, Renal Failure Acute, Rheumatoid Arthritis
This Pulmonary Oedema side effect was reported by a health professional from France. A 72-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Lexomil (drug dosage: Unk), which was initiated on
May 31, 2011. Concurrently used drugs:
  • Lantus (Unk)
  • Morphine Sulfate (Unk)
  • Polyethylene Glycol (Unk)
  • Prednisone Tab (Unk)
  • Lasix (40 Mg, 2x/day)
  • Duoplavin (Unk)
  • Omnipaque 140 (300 Mg, 1x/day)
  • Morphine Sulfate (Unk)
.After starting to take Lexomil the consumer reported adverse symptoms, such as: Pulmonary Oedema, Cardiac Disorder, Renal Failure Acute, Rheumatoid ArthritisThese side effects may potentially be related to Lexomil. The patient was hospitalized.
Lexomil Side Effect Report#8014578-2
Pleural Effusion, Oedema, Pericardial Effusion
This is a report of a female patient (weight: NA) from France, suffering from the following health symptoms/conditions: NA, who was treated with Lexomil (dosage: 0.5 Df, Qd, start time:
Apr 16, 2009), combined with:
  • Tasigna (400 Mg, Bid)
  • Tasigna
  • Esomeprazole Sodium (20 Mg, Daily)
  • Nebivolol Hcl (1.25 Mg Per Day)
  • Prednisolone (20 Mg, Daily)
and developed a serious reaction and side effect(s): Pleural Effusion, Oedema, Pericardial Effusion after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Lexomil treatment in female patients, resulting in Pleural Effusion side effect. The patient was hospitalized.


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The appearance of Lexomil 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.

What are common Lexomil Side Effects for Women?

Women Side Effects Reports
Overdose 5
Confusional State 4
Anaemia 3
Coma 3
Hyponatraemia 3
Renal Failure Acute 3
Arthralgia 2
Asthenia 2
Atrial Fibrillation 2
Bradycardia 2

What are common Lexomil Side Effects for Men?

Men Side Effects Reports
Asthenia 3
Coma 2
Confusional State 2
Decreased Appetite 2
Dental Care 2
Fall 2
Impaired Healing 2
Incorrect Dose Administered 2
Osteonecrosis 2
Pneumonia Aspiration 2

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It is really important to keep track of your health 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:

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  • 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

    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.

    Lexomil 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 Lexomil

    Side Effects reported to FDA: 72

    Lexomil safety alerts: No

    Reported deaths: 4

    Reported hospitalizations: 40

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