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Tolep Side Effects

Common Tolep Side Effects


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

Epilepsy (3)
Cardiopulmonary Failure (3)
Arteriosclerosis Obliterans (3)
Bilirubin Conjugated Increased (3)
Jaundice (3)
Blood Bilirubin Increased (3)
Rash Morbilliform (3)
Suicide Attempt (3)
Toxic Epidermal Necrolysis (3)
Sopor (3)
Stevens-johnson Syndrome (3)
Aspartate Aminotransferase Increased (2)
Aplasia (2)
Alanine Aminotransferase Increased (2)
Confusional State (2)
Intentional Overdose (2)
Loss Of Consciousness (2)
Hepatic Failure (2)
Haemorrhage (2)
Medulloblastoma Recurrent (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.

Tolep Side Effects Reported to FDA

The following Tolep 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 Tolep 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.
Somnolence
This is a report of a 51-year-old female patient (weight: NA) from IT, suffering from the following symptoms/conditions: NA, who was treated with Tolep (dosage: 600 Mg Unk, start time: Feb 26, 2014), combined with: NA. and developed a serious reaction and side effect(s). The consumer presented with:
  • Somnolence
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Tolep treatment in female patients, resulting in somnolence side effect. The patient was hospitalized.

Sopor, Suicide Attempt
This report suggests a potential Tolep Sopor, Suicide Attempt side effect(s) that can have serious consequences. A 23-year-old female patient (weight: NA) from IT was diagnosed with the following symptoms/conditions: suicide attempt and used Tolep (dosage: 600 Mg, Unk) starting Oct 21, 2013. Soon after starting Tolep the patient began experiencing various side effects, including:
  • Sopor
  • Suicide Attempt
Drugs used concurrently: NA.The patient was hospitalized. Although Tolep demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as sopor, may still occur.

Cardiac Arrest, Bradycardia, Syncope, Pulse Absent
This Cardiac Arrest, Bradycardia, Syncope, Pulse Absent problem was reported by a health professional from IT. A 66-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: epilepsy. On Oct 01, 2010 this consumer started treatment with Tolep (dosage: 600 Mg, Qd). The following drugs were being taken at the same time: NA. When commencing Tolep, the patient experienced the following unwanted symptoms/side effects:
  • Cardiac Arrest
  • Bradycardia
  • Syncope
  • Pulse Absent
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 cardiac arrest, may become evident only after a product is in use by the general population.

Injury, Fall
This is a report of a 80-year-old male patient (weight: NA) from IT. The patient developed the following symptoms/conditions: NA and was treated with Tolep (dosage: 6 G, Unk) starting Sep 19, 2013. Concurrently used drugs:
  • Totalip (200 Mg, Unk)
  • Eutirox (750 Ug, Unk)
  • Lasix (250 Mg, Unk)
  • Triatec (37.5 Mg, Unk)
  • Axagon (400 Mg, Unk)
  • Tiklid (500 Mg, Unk)
  • Congescor (2.5 Mg, Unk)
Soon after that, the consumer experienced the following side effects:
  • Injury
  • Fall
This opens a possibility that Tolep treatment could cause the above reactions, including injury, and some male subjects may be more susceptible.


Cold Sweat, Hyperhidrosis, Dyspnoea, Loss Of Consciousness
A 35-year-old male patient (weight: NA) from IT with the following symptoms/conditions: suicide attempt started Tolep treatment (dosage: Nine Units Of 300 Mg) on Aug 19, 2013. Soon after starting Tolep treatment, the subject experienced various side effects, including:
  • Cold Sweat
  • Hyperhidrosis
  • Dyspnoea
  • Loss Of Consciousness
Concurrently used drugs:
  • Paroxetine (Seven Units Of 20mg)
  • Cocaine (1 G, Unk)
The patient was hospitalized. This finding indicates that some male patients could be more vulnerable to Tolep.

Bradyphrenia, Hyponatraemia
A 82-year-old female patient from IT (weight: NA) experienced symptoms, such as: partial seizures and was treated with Tolep(dosage: 900 Mg, Daily). The treatment was initiated on Jun 18, 2013. After that a consumer reported the following side effect(s):
  • Bradyphrenia
  • Hyponatraemia
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Tolep efficacy:
  • Warfarin
The patient was hospitalized.

Sopor, Suicide Attempt
In this report, Tolep was administered for the following condition: NA.A 32-year-old female consumer from IT (weight: NA) started Tolep treatment (dosage: 12 G, (total Dose) 40 Tablets) on Jun 03, 2013.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Sopor
  • Suicide Attempt
A possible interaction with other drugs could have contributed to this reaction: NA.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 Tolep treatment could be related to the listed above side effect(s).

Sopor, Abdominal Pain
This is a report of the following Tolep side effect(s):
  • Sopor
  • Abdominal Pain
A 51-year-old female patient from IT (weight: NA) presented with the following condition: trigeminal neuralgia and received a treatment with Tolep (dosage: 1 Df, Daily) starting: May 06, 2013.The following concurrently used drugs could have generated interactions:
  • Oxycontin (1 Df, Daily)
  • Lyrica (3 Df, Daily)
  • Enalapril (Unk Ukn, Unk)
  • Laroxyl (Unk Ukn, Unk)
This report suggests that a Tolep treatment could be associated with the listed above side effect(s).

Suffocation Feeling, Rash Pruritic
This Tolep report was submitted by a 52-year-old male consumer from IT (weight: NA). The patient was diagnosed with: epilepsy and Tolep was administered (dosage: 600 Mg, Daily) starting: Jan 21, 2013. The consumer developed a set of symptoms:
  • Suffocation Feeling
  • Rash Pruritic
Other drugs used simultaneously:
  • Crestor (10 Mg, Unk)
  • Peptazol (40 Mg, Unk)
Those unexpected symptoms could be linked to a Tolep treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

Bradykinesia, Depression, Confusional State, Toxicity To Various Agents, Poisoning Deliberate, Heart Rate Abnormal
This is a report of a possible correlation between Tolep use and the following symptoms/side effect(s):
  • Bradykinesia
  • Depression
  • Confusional State
  • Toxicity To Various Agents
  • Poisoning Deliberate
  • Heart Rate Abnormal
which could contribute to an assessment of Tolep risk profile.A 12-year-old female consumer from IT (weight: NA) was suffering from poisoning deliberate and was treated with Tolep (dosage: 5 Tablets (1500mg)) starting Nov 11, 2012.Other concurrent medications:
  • Frisium (3 Capsules (30mg))
  • Dintoina (2 Tablets (200mg))
The patient was hospitalized.

Speech Disorder, Self Injurious Behaviour
A 43-year-old female patient from IT (weight: NA) presented with the following symptoms: NA and after a treatment with Tolep (dosage: NA) experienced the following side effect(s):
  • Speech Disorder
  • Self Injurious Behaviour
The treatment was started on Jul 13, 2012. Tolep was used in combination with the following drugs:
  • Anafranil
  • Trittico (20 Df, Once Daily)
  • Lorazepam
The patient was hospitalized.This report could alert potential Tolep consumers.

Suicide Attempt, Presyncope, Blood Chloride Decreased, Blood Cholinesterase Decreased, Blood Creatine Phosphokinase Increased, Aggression, Intentional Overdose, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased
In this report, a 38-year-old male patient from IT (weight: NA) was affected by a possible Tolep side effect.The patient was diagnosed with NA. After a treatment with Tolep (dosage: 7 Df, Unk, start date: Apr 22, 2012), the patient experienced the following side effect(s):
  • Suicide Attempt
  • Presyncope
  • Blood Chloride Decreased
  • Blood Cholinesterase Decreased
  • Blood Creatine Phosphokinase Increased
  • Aggression
  • Intentional Overdose
  • Alanine Aminotransferase Increased
  • Aspartate Aminotransferase Increased
The following simultaneously used drugs could have led to this reaction:
  • Zyprexa (4 Df, Unk)
The patient was hospitalized.The findings here stress that side effects should be taken into consideration when evaluating a Tolep treatment.

Coma, Respiratory Failure, Feeling Hot, Coordination Abnormal, Mydriasis, Tachycardia, Agitation, Headache
This is a report of a 27-year-old female patient from IT (weight: NA), who used Tolep (dosage: 2 Tablets At 8:00 Am And 1 Tablet At 13.00 Pm And 1 Tablet At 8.00 Pm) for a treatment of NA. After starting a treatment on Mar 05, 2012, the patient experienced the following side effect(s):
  • Coma
  • Respiratory Failure
  • Feeling Hot
  • Coordination Abnormal
  • Mydriasis
  • Tachycardia
  • Agitation
  • Headache
The following drugs could possibly have interacted with the Tolep treatment NA.The patient was hospitalized.Taken together, these observations suggest that a Tolep treatment could be related to side effect(s), such as Coma, Respiratory Failure, Feeling Hot, Coordination Abnormal, Mydriasis, Tachycardia, Agitation, Headache.

Mania
This mania side effect was reported by a consumer or non-health professional from ITALY. A 58-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA. The patient was prescribed Tolep (dosage: Tolep 300mg Tabsx2), which was started on Nov 14, 2010. Concurrently used drugs:
  • Abilify (14-23nov10(15mg),24nov-26dec10(30mg) Dose Increased To 30mg)
  • Tavor (Tavor 4mg/ml Injectable Solution)
  • Talofen (Talofen 25mg/ml Injectable Solution)
When starting to take Tolep the consumer reported the following symptoms:
  • Mania
The patient was hospitalized. These side effects may potentially be related to Tolep.

Medulloblastoma Recurrent
This is a Tolep side effect report of a female patient (weight:NA) from ITALY, suffering from the following symptoms/conditions: NA, who was treated with Tolep (dosage:300 Mg, Unk, start time: Jan 31, 1987), combined with:
  • Somatropin Rdna (0.2 Mg, Daily (1/d))
  • Eutirox (75 Mg, Oral)
, and developed a serious reaction and a medulloblastoma recurrent side effect. The patient presented with:
  • Medulloblastoma Recurrent
which developed after the beginning of treatment. This side effect report can indicate a possible existence of increased vulnerability to Tolep treatment in female patients suffering from NA, resulting in medulloblastoma recurrent.

Gastritis Haemorrhagic
This report suggests a potential Tolep gastritis haemorrhagic side effect(s) that can have serious consequences. A 16-year-old male patient from ITALY (weight:NA) was diagnosed with the following health condition(s): NA and used Tolep (dosage: NA) starting NS. Soon after starting Tolep the patient began experiencing various side effects, including:
  • Gastritis Haemorrhagic
Drugs used concurrently:NA. Although Tolep demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as gastritis haemorrhagic, may still occur.

Caesarean Section, Normal Newborn
This caesarean section problem was reported by a health professional from ITALY. A 38-year-old female patient (weight: NA) was diagnosed with the following medical condition(s): grand mal convulsion.On NS a consumer started treatment with Tolep (dosage: 600 Mg/day). The following drugs/medications were being taken at the same time:
  • Folic Acid
When commencing Tolep, the patient experienced the following unwanted symptoms /side effects:
  • Caesarean Section
  • Normal Newborn
Although all drugs are carefully tested before they are licensed for use, they carry potential side effect risks. Some side effects, such as caesarean section, may become evident only after a product is in use by the general population.

Bilirubin Conjugated Increased, Blood Bilirubin Increased, Jaundice
This is a Tolep side effect report of a 77-year-old male patient (weight: NA) from ITALY. The patient developed the following symptoms/conditions: epilepsy and was treated with Tolep (dosage: 300 Mg/day) starting Feb 10, 2008. Concurrently used drugs: NA. Soon after that, the consumer experienced the following of symptoms:
  • Bilirubin Conjugated Increased
  • Blood Bilirubin Increased
  • Jaundice
The patient was hospitalized. This opens a possibility that Tolep could cause bilirubin conjugated increased and that some male patients may be more susceptible.

Bilirubin Conjugated Increased, Blood Bilirubin Increased, Jaundice
A 77-year-old male patient (weight: NA) from ITALY with the following symptoms: epilepsy started Tolep treatment (dosage: 300 Mg/day) on Feb 10, 2008. Soon after starting Tolep treatment, the consumer experienced several side effects, including:
  • Bilirubin Conjugated Increased
  • Blood Bilirubin Increased
  • Jaundice
. Concurrently used drugs: NA.The patient was hospitalized. This finding indicates that some patients can be more vulnerable to developing Tolep side effects, such as bilirubin conjugated increased.

Bilirubin Conjugated Increased, Blood Bilirubin Increased, Jaundice
This bilirubin conjugated increased side effect was reported by a consumer or non-health professional from ITALY. A 77-year-old male patient (weight:NA) experienced the following symptoms/conditions: epilepsy.The patient was prescribed Tolep (dosage: 300 Mg/day), which was started on Feb 10, 2008. Concurrently used drugs: NA..When starting to take Tolep the consumer reported symptoms, such as:
  • Bilirubin Conjugated Increased
  • Blood Bilirubin Increased
  • Jaundice
These side effects may potentially be related to Tolep. The patient was hospitalized.

Arteriosclerosis Obliterans, Prosthesis Implantation
This is a report of a 51-year-old male patient (weight: NA) from ITALY, suffering from the following symptoms/conditions: epilepsy, who was treated with Tolep (dosage: 750mg/day, start time: Jun 15, 2003), combined with: NA. and developed a serious reaction and side effect(s). The consumer presented with:
  • Arteriosclerosis Obliterans
  • Prosthesis Implantation
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Tolep treatment in male patients, resulting in arteriosclerosis obliterans side effect. The patient was hospitalized.

Arteriosclerosis Obliterans
This report suggests a potential Tolep Arteriosclerosis Obliterans side effect(s) that can have serious consequences. A 51-year-old male patient (weight: NA) from ITALY was diagnosed with the following symptoms/conditions: epilepsy and used Tolep (dosage: 750mg/day) starting Jun 15, 2003. Soon after starting Tolep the patient began experiencing various side effects, including:
  • Arteriosclerosis Obliterans
Drugs used concurrently: NA.The patient was hospitalized. Although Tolep demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as arteriosclerosis obliterans, may still occur.

Arteriosclerosis Obliterans
This Arteriosclerosis Obliterans problem was reported by a health professional from ITALY. A 51-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: epilepsy. On Jun 15, 2003 this consumer started treatment with Tolep (dosage: 750mg/day). The following drugs were being taken at the same time: NA. When commencing Tolep, the patient experienced the following unwanted symptoms/side effects:
  • Arteriosclerosis Obliterans
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 arteriosclerosis obliterans, may become evident only after a product is in use by the general population.

Arterial Disorder
This is a report of a 51-year-old male patient (weight: NA) from ITALY. The patient developed the following symptoms/conditions: epilepsy and was treated with Tolep (dosage: 750mg/day) starting Jun 15, 2003. Concurrently used drugs: NA.Soon after that, the consumer experienced the following side effects:
  • Arterial Disorder
The patient was hospitalized. This opens a possibility that Tolep treatment could cause the above reactions, including arterial disorder, and some male subjects may be more susceptible.

Platelet Count Decreased
A 71-year-old female patient (weight: NA) from ITALY with the following symptoms/conditions: partial seizures started Tolep treatment (dosage: 600 Mg/day) on Jan 12, 2008. Soon after starting Tolep treatment, the subject experienced various side effects, including:
  • Platelet Count Decreased
Concurrently used drugs:
  • Alcover
  • Alcover (5 Ml, Bid)
  • Aspirin
The patient was hospitalized. This finding indicates that some female patients could be more vulnerable to Tolep.

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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: 35

    Tolep safety alerts: No

    Reported deaths: 4

    Reported hospitalizations: 31

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