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Tolep Side Effects

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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.

Tolep Side Effects Reported to FDA



Tolep Side Effect Report#9992493
Somnolence
This is a report of a 51-year-old female patient (weight: NA) from IT, suffering from the following health 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): Somnolence 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.
Tolep Side Effect Report#9733679
Sopor, Suicide Attempt
This report suggests a potential Tolep Sopor 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. After starting Tolep the patient began experiencing various side effects, including: Sopor, Suicide AttemptAdditional 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.
Tolep Side Effect Report#9700692
Cardiac Arrest, Bradycardia, Syncope, Pulse Absent
This Cardiac Arrest 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 using Tolep, the patient experienced the following unwanted symptoms/side effects: Cardiac Arrest, Bradycardia, Syncope, Pulse AbsentThe 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.
Tolep Side Effect Report#9596562
Injury, Fall
This Injury side effect was reported by a health professional from IT. A 80-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Tolep (drug dosage: 6 G, Unk), which was initiated on
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)
.After starting to take Tolep the consumer reported adverse symptoms, such as: Injury, FallThese side effects may potentially be related to Tolep.
Tolep Side Effect Report#9537526
Cold Sweat, Hyperhidrosis, Dyspnoea, Loss Of Consciousness
This is a report of a 35-year-old male patient (weight: NA) from IT, suffering from the following health symptoms/conditions: suicide attempt, who was treated with Tolep (dosage: Nine Units Of 300 Mg, start time:
Aug 19, 2013), combined with:
  • Paroxetine (Seven Units Of 20mg)
  • Cocaine (1 G, Unk)
and developed a serious reaction and side effect(s): Cold Sweat, Hyperhidrosis, Dyspnoea, Loss Of Consciousness after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Tolep treatment in male patients, resulting in Cold Sweat side effect. The patient was hospitalized.
Tolep Side Effect Report#9389060
Bradyphrenia, Hyponatraemia
This report suggests a potential Tolep Bradyphrenia side effect(s) that can have serious consequences. A 82-year-old female patient (weight: NA) from IT was diagnosed with the following symptoms/conditions: partial seizures and used Tolep (dosage: 900 Mg, Daily) starting
Jun 18, 2013. After starting Tolep the patient began experiencing various side effects, including: Bradyphrenia, HyponatraemiaAdditional drugs used concurrently:
  • Warfarin
The patient was hospitalized. Although Tolep demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Bradyphrenia, may still occur.
Tolep Side Effect Report#9384302
Sopor, Suicide Attempt
This Sopor problem was reported by a health professional from IT. A 32-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Jun 03, 2013 this consumer started treatment with Tolep (dosage: 12 G, (total Dose) 40 Tablets). The following drugs were being taken at the same time: NA. When using Tolep, the patient experienced the following unwanted symptoms/side effects: Sopor, Suicide AttemptThe 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 Sopor, may become evident only after a product is in use by the general population.
Tolep Side Effect Report#9376991
Sopor, Abdominal Pain
This Sopor side effect was reported by a health professional from IT. A 51-year-old female patient (weight:NA) experienced the following symptoms/conditions: trigeminal neuralgia.The patient was prescribed Tolep (drug dosage: 1 Df, Daily), which was initiated on
May 06, 2013. Concurrently used drugs:
  • Oxycontin (1 Df, Daily)
  • Lyrica (3 Df, Daily)
  • Enalapril (Unk Ukn, Unk)
  • Laroxyl (Unk Ukn, Unk)
.After starting to take Tolep the consumer reported adverse symptoms, such as: Sopor, Abdominal PainThese side effects may potentially be related to Tolep.
Tolep Side Effect Report#9284968
Suffocation Feeling, Rash Pruritic
This is a report of a 52-year-old male patient (weight: NA) from IT, suffering from the following health symptoms/conditions: epilepsy, who was treated with Tolep (dosage: 600 Mg, Daily, start time:
Jan 21, 2013), combined with:
  • Crestor (10 Mg, Unk)
  • Peptazol (40 Mg, Unk)
and developed a serious reaction and side effect(s): Suffocation Feeling, Rash Pruritic after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Tolep treatment in male patients, resulting in Suffocation Feeling side effect.
Tolep Side Effect Report#9184975
Bradykinesia, Depression, Confusional State, Toxicity To Various Agents, Poisoning Deliberate, Heart Rate Abnormal
This report suggests a potential Tolep Bradykinesia side effect(s) that can have serious consequences. A 12-year-old female patient (weight: NA) from IT was diagnosed with the following symptoms/conditions: poisoning deliberate and used Tolep (dosage: 5 Tablets (1500mg)) starting
Nov 11, 2012. After starting Tolep the patient began experiencing various side effects, including: Bradykinesia, Depression, Confusional State, Toxicity To Various Agents, Poisoning Deliberate, Heart Rate AbnormalAdditional drugs used concurrently:
  • Frisium (3 Capsules (30mg))
  • Dintoina (2 Tablets (200mg))
The patient was hospitalized. Although Tolep demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Bradykinesia, may still occur.
Tolep Side Effect Report#8791906
Speech Disorder, Self Injurious Behaviour
This Speech Disorder problem was reported by a health professional from IT. A 43-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Jul 13, 2012 this consumer started treatment with Tolep (dosage: NA). The following drugs were being taken at the same time:
  • Anafranil
  • Trittico (20 Df, Once Daily)
  • Lorazepam
When using Tolep, the patient experienced the following unwanted symptoms/side effects: Speech Disorder, Self Injurious BehaviourThe 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 Speech Disorder, may become evident only after a product is in use by the general population.
Tolep Side Effect Report#8735500
Suicide Attempt, Presyncope, Blood Chloride Decreased, Blood Cholinesterase Decreased, Blood Creatine Phosphokinase Increased, Aggression, Intentional Overdose, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased
This Suicide Attempt side effect was reported by a health professional from IT. A 38-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Tolep (drug dosage: 7 Df, Unk), which was initiated on
Apr 22, 2012. Concurrently used drugs:
  • Zyprexa (4 Df, Unk)
.After starting to take Tolep the consumer reported adverse symptoms, such as: Suicide Attempt, Presyncope, Blood Chloride Decreased, Blood Cholinesterase Decreased, Blood Creatine Phosphokinase Increased, Aggression, Intentional Overdose, Alanine Aminotransferase Increased, Aspartate Aminotransferase IncreasedThese side effects may potentially be related to Tolep. The patient was hospitalized.
Tolep Side Effect Report#8665741
Coma, Respiratory Failure, Feeling Hot, Coordination Abnormal, Mydriasis, Tachycardia, Agitation, Headache
This is a report of a 27-year-old female patient (weight: NA) from IT, suffering from the following health symptoms/conditions: NA, who was treated with Tolep (dosage: 2 Tablets At 8:00 Am And 1 Tablet At 13.00 Pm And 1 Tablet At 8.00 Pm, start time:
Mar 05, 2012), combined with: NA. and developed a serious reaction and side effect(s): Coma, Respiratory Failure, Feeling Hot, Coordination Abnormal, Mydriasis, Tachycardia, Agitation, Headache after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Tolep treatment in female patients, resulting in Coma side effect. The patient was hospitalized.
Tolep Side Effect Report#7421580-8
Mania
This report suggests a potential Tolep Mania side effect(s) that can have serious consequences. A 58-year-old female patient (weight: NA) from Italy was diagnosed with the following symptoms/conditions: NA and used Tolep (dosage: Tolep 300mg Tabsx2) starting
Nov 14, 2010. After starting Tolep the patient began experiencing various side effects, including: ManiaAdditional drugs used concurrently:
  • Abilify (14-23nov10(15mg),24nov-26dec10(30mg) Dose Increased To 30mg)
  • Tavor (Tavor 4mg/ml Injectable Solution)
  • Talofen (Talofen 25mg/ml Injectable Solution)
The patient was hospitalized. Although Tolep demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Mania, may still occur.
Tolep Side Effect Report#7230821-1
Medulloblastoma Recurrent
This Medulloblastoma Recurrent problem was reported by a physician from Italy. A female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Jan 31, 1987 this consumer started treatment with Tolep (dosage: 300 Mg, Unk). The following drugs were being taken at the same time:
  • Somatropin Rdna (0.2 Mg, Daily (1/d))
  • Eutirox (75 Mg, Oral)
When using Tolep, the patient experienced the following unwanted symptoms/side effects: Medulloblastoma RecurrentAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Medulloblastoma Recurrent, may become evident only after a product is in use by the general population.
Tolep Side Effect Report#6087633-4
Gastritis Haemorrhagic
This Gastritis Haemorrhagic side effect was reported by a physician from Italy. A 16-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Tolep (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Tolep the consumer reported adverse symptoms, such as: Gastritis HaemorrhagicThese side effects may potentially be related to Tolep.
Tolep Side Effect Report#5956324-X
Caesarean Section, Normal Newborn
This is a report of a 38-year-old female patient (weight: NA) from Italy, suffering from the following health symptoms/conditions: grand mal convulsion, who was treated with Tolep (dosage: 600 Mg/day, start time: NS), combined with:
  • Folic Acid
and developed a serious reaction and side effect(s): Caesarean Section, Normal Newborn after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Tolep treatment in female patients, resulting in Caesarean Section side effect.
Tolep Side Effect Report#5719398-7
Bilirubin Conjugated Increased, Blood Bilirubin Increased, Jaundice
This report suggests a potential Tolep Bilirubin Conjugated Increased side effect(s) that can have serious consequences. A 77-year-old male patient (weight: NA) from Italy was diagnosed with the following symptoms/conditions: epilepsy and used Tolep (dosage: 300 Mg/day) starting
Feb 10, 2008. After starting Tolep the patient began experiencing various side effects, including: Bilirubin Conjugated Increased, Blood Bilirubin Increased, JaundiceAdditional drugs used concurrently: NA.The patient was hospitalized. Although Tolep demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Bilirubin Conjugated Increased, may still occur.
Tolep Side Effect Report#5714478-4
Bilirubin Conjugated Increased, Blood Bilirubin Increased, Jaundice
This Bilirubin Conjugated Increased problem was reported by a consumer or non-health professional from Italy. A 77-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: epilepsy. On
Feb 10, 2008 this consumer started treatment with Tolep (dosage: 300 Mg/day). The following drugs were being taken at the same time: NA. When using Tolep, the patient experienced the following unwanted symptoms/side effects: Bilirubin Conjugated Increased, Blood Bilirubin Increased, JaundiceThe 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 Bilirubin Conjugated Increased, may become evident only after a product is in use by the general population.
Tolep Side Effect Report#5713081-X
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 (drug dosage: 300 Mg/day), which was initiated on
Feb 10, 2008. Concurrently used drugs: NA..After starting to take Tolep the consumer reported adverse symptoms, such as: Bilirubin Conjugated Increased, Blood Bilirubin Increased, JaundiceThese side effects may potentially be related to Tolep. The patient was hospitalized.
Tolep Side Effect Report#5642870-5
Arteriosclerosis Obliterans, Prosthesis Implantation
This is a report of a 51-year-old male patient (weight: NA) from Italy, suffering from the following health 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): Arteriosclerosis Obliterans, Prosthesis Implantation 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.
Tolep Side Effect Report#5630101-1
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. After starting Tolep the patient began experiencing various side effects, including: Arteriosclerosis ObliteransAdditional 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.
Tolep Side Effect Report#5621749-9
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 using Tolep, the patient experienced the following unwanted symptoms/side effects: Arteriosclerosis ObliteransThe 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.
Tolep Side Effect Report#5619823-6
Arterial Disorder
This Arterial Disorder side effect was reported by a health professional from Italy. A 51-year-old male patient (weight:NA) experienced the following symptoms/conditions: epilepsy.The patient was prescribed Tolep (drug dosage: 750mg/day), which was initiated on
Jun 15, 2003. Concurrently used drugs: NA..After starting to take Tolep the consumer reported adverse symptoms, such as: Arterial DisorderThese side effects may potentially be related to Tolep. The patient was hospitalized.
Tolep Side Effect Report#5607534-2
Platelet Count Decreased
This is a report of a 71-year-old female patient (weight: NA) from Italy, suffering from the following health symptoms/conditions: partial seizures, who was treated with Tolep (dosage: 600 Mg/day, start time:
Jan 12, 2008), combined with:
  • Alcover
  • Alcover (5 Ml, Bid)
  • Aspirin
and developed a serious reaction and side effect(s): Platelet Count Decreased after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Tolep treatment in female patients, resulting in Platelet Count Decreased side effect. The patient was hospitalized.


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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.

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Track Your Side Effects

Note Your Observations

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:

  • 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

    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.

    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.

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    More About Tolep

    Side Effects reported to FDA: 35

    Tolep safety alerts: No

    Reported deaths: 4

    Reported hospitalizations: 31

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