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Tolep Side Effects and Adverse Effects reported to US Food and Drug Administration (FDA)

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Mania (7421580-8)
on Apr 14, 2011 Female from ITALY , 58 years of age, was treated with Tolep. Directly after, patient experienced the unwanted or unexpected Tolep side effects: mania. Tolep dosage: Tolep 300mg Tabsx2.
Associated medications used:
  • Abilify (14-23nov10(15mg),24nov-26dec10(30mg) Dose Increased To 30mg)
  • Tavor (Tavor 4mg/ml Injectable Solution)
  • Talofen (Talofen 25mg/ml Injectable Solution)
Patient was hospitalized.

Medulloblastoma Recurrent (7230821-1)
Patient was taking Tolep. Patient felt the following Tolep side effects: medulloblastoma recurrent on Jan 13, 2011 from ITALY Additional patient health information: Female , weighting 99.21 lb, . Tolep dosage: 300 Mg, Unk.
Multiple prescriptions taken:
  • Somatropin Rdna (0.2 Mg, Daily (1/d))
  • Eutirox (75 Mg, Oral)


Gastritis Haemorrhagic (6087633-4)
Adverse event was reported on Feb 12, 2009 by a Male taking Tolep (Dosage: N/A) . Location: ITALY , 16 years of age, After Tolep was administered, patient encountered several Tolep side effects: gastritis haemorrhagic.

Caesarean Section, Normal Newborn (5956324-X)
on Nov 11, 2008 Female from ITALY , 38 years of age, was diagnosed with
  • grand mal convulsion
and was treated with Tolep. Directly after, patient experienced the unwanted or unexpected Tolep side effects: caesarean section, normal newborn. Tolep dosage: 600 Mg/day.
Associated medications used:
  • Folic Acid



Bilirubin Conjugated Increased, Blood Bilirubin Increased, Jaundice (5719398-7)
on Apr 21, 2008 Male from ITALY , 77 years of age, was diagnosed with
  • epilepsy
and was treated with Tolep. Patient felt the following Tolep side effects: bilirubin conjugated increased, blood bilirubin increased, jaundice. Tolep dosage: 300 Mg/day. Patient was hospitalized.

Bilirubin Conjugated Increased, Blood Bilirubin Increased, Jaundice (5714478-4)
Patient was taking Tolep. After Tolep was administered, patient encountered several Tolep side effects: bilirubin conjugated increased, blood bilirubin increased, jaundice on Apr 15, 2008 from ITALY Additional patient health information: Male , 77 years of age, was diagnosed with
  • epilepsy
and. Tolep dosage: 300 Mg/day. Patient was hospitalized.

Bilirubin Conjugated Increased, Blood Bilirubin Increased, Jaundice (5713081-X)
Adverse event was reported on Apr 15, 2008 by a Male taking Tolep (Dosage: 300 Mg/day) was diagnosed with
  • epilepsy
and. Location: ITALY , 77 years of age, Directly after, patient experienced the unwanted or unexpected Tolep side effects: bilirubin conjugated increased, blood bilirubin increased, jaundice. Patient was hospitalized.

Arteriosclerosis Obliterans, Prosthesis Implantation (5642870-5)
on Feb 19, 2008 Male from ITALY , 51 years of age, was diagnosed with
  • epilepsy
and was treated with Tolep. Patient felt the following Tolep side effects: arteriosclerosis obliterans, prosthesis implantation. Tolep dosage: 750mg/day. Patient was hospitalized.

Arteriosclerosis Obliterans (5630101-1)
on Feb 04, 2008 Male from ITALY , 51 years of age, was diagnosed with
  • epilepsy
and was treated with Tolep. After Tolep was administered, patient encountered several Tolep side effects: arteriosclerosis obliterans. Tolep dosage: 750mg/day. Patient was hospitalized.

Arteriosclerosis Obliterans (5621749-9)
Patient was taking Tolep. Directly after, patient experienced the unwanted or unexpected Tolep side effects: arteriosclerosis obliterans on Feb 04, 2008 from ITALY Additional patient health information: Male , 51 years of age, was diagnosed with
  • epilepsy
and. Tolep dosage: 750mg/day. Patient was hospitalized.

Arterial Disorder (5619823-6)
Adverse event was reported on Jan 31, 2008 by a Male taking Tolep (Dosage: 750mg/day) was diagnosed with
  • epilepsy
and. Location: ITALY , 51 years of age, Patient felt the following Tolep side effects: arterial disorder. Patient was hospitalized.

Platelet Count Decreased (5607534-2)
on Jan 22, 2008 Female from ITALY , 71 years of age, was diagnosed with
  • partial seizures
and was treated with Tolep. After Tolep was administered, patient encountered several Tolep side effects: platelet count decreased. Tolep dosage: 600 Mg/day.
Multiple concurrent drugs taken:
  • Alcover
  • Alcover (5 Ml, Bid)
  • Aspirin
Patient was hospitalized.

Cardiopulmonary Failure, Rash Morbilliform, Stevens-johnson Syndrome, Toxic Epidermal Necrolysis (5507264-1)
on Nov 03, 2007 Female from ITALY , 49 years of age, was diagnosed with
  • convulsion
and was treated with Tolep. Directly after, patient experienced the unwanted or unexpected Tolep side effects: cardiopulmonary failure, rash morbilliform, stevens-johnson syndrome, toxic epidermal necrolysis. Tolep dosage: 600 Mg/day.
Associated medications used:
  • Gardenale (100 Mg/day)
Patient was hospitalized.

Cardiopulmonary Failure, Rash Morbilliform, Stevens-johnson Syndrome, Toxic Epidermal Necrolysis (5502414-5)
Patient was taking Tolep. Patient felt the following Tolep side effects: cardiopulmonary failure, rash morbilliform, stevens-johnson syndrome, toxic epidermal necrolysis on Oct 25, 2007 from ITALY Additional patient health information: Female , 49 years of age, was diagnosed with
  • convulsion
and. Tolep dosage: 2 Df/day.
Multiple prescriptions taken:
  • Gardenale (1 Df/day)
Patient was hospitalized.

Cardiopulmonary Failure, Rash Morbilliform, Stevens-johnson Syndrome, Toxic Epidermal Necrolysis (5501782-8)
Adverse event was reported on Oct 25, 2007 by a Female taking Tolep (Dosage: 2 Df/day) was diagnosed with
  • convulsion
and. Location: ITALY , 49 years of age, After Tolep was administered, patient encountered several Tolep side effects: cardiopulmonary failure, rash morbilliform, stevens-johnson syndrome, toxic epidermal necrolysis.
Multiple concurrent drugs taken:
  • Gardenale (1 Df/day)
Patient was hospitalized.

Epilepsy (5331995-X)
on May 16, 2007 Female from ITALY , 53 years of age, was diagnosed with
  • prophylaxis
and was treated with Tolep. Directly after, patient experienced the unwanted or unexpected Tolep side effects: epilepsy. Tolep dosage: 300 Mg/day.

Epilepsy (5324917-9)
on May 07, 2007 Female from ITALY , 53 years of age, was diagnosed with
  • cerebral haemorrhage
and was treated with Tolep. Patient felt the following Tolep side effects: epilepsy. Tolep dosage: 300 Mg/day.

Epilepsy, Rib Fracture, Road Traffic Accident (5247533-6)
Patient was taking Tolep. After Tolep was administered, patient encountered several Tolep side effects: epilepsy, rib fracture, road traffic accident on Feb 14, 2007 from ITALY Additional patient health information: Male , 53 years of age, was diagnosed with
  • epilepsy
and. Tolep dosage: 1800 Mg/day.
Multiple concurrent drugs taken:
  • Topamax (150 Mg/day)
  • Topamax (200 Mg/day)
Patient was hospitalized.

Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Gamma-glutamyltransferase Increased, Liver Disorder (5035270-2)
Adverse event was reported on Jun 20, 2006 by a Female taking Tolep (Dosage: 900 Mg/d) was diagnosed with
  • convulsion
and. Location: ITALY , 56 years of age, Directly after, patient experienced the unwanted or unexpected Tolep side effects: alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyltransferase increased, liver disorder.
Associated medications used:
  • Elopram (20 Mg/d)
  • Rivotril (4.5 Mg/d)
Patient was hospitalized.

Blood Alcohol Increased, Blood Pressure Increased, Confusional State, Haemodialysis, Heart Rate Decreased, Hypokalaemia, Intentional Overdose, Intubation, Loss Of Consciousness (5003069-9)
on May 08, 2006 Male from ITALY , 57 years of age, weighting 209.4 lb, was treated with Tolep. Patient felt the following Tolep side effects: blood alcohol increased, blood pressure increased, confusional state, haemodialysis, heart rate decreased, hypokalaemia, intentional overdose, intubation, loss of consciousness. Tolep dosage: N/A. Patient was hospitalized.

Aplasia, Autoimmune Thrombocytopenia, Haemorrhage, Hepatic Failure (4612814-3)
on Mar 09, 2005 Female from , child 11 years of age, was diagnosed with
  • epilepsy
and was treated with Tolep. After Tolep was administered, patient encountered several Tolep side effects: aplasia, autoimmune thrombocytopenia, haemorrhage, hepatic failure. Tolep dosage: Unk, Unk. Patient was hospitalized.

Aplasia, Bone Marrow Depression, Haemorrhage, Hepatic Failure, Thrombocytopenia (4607550-3)
Patient was taking Tolep. Directly after, patient experienced the unwanted or unexpected Tolep side effects: aplasia, bone marrow depression, haemorrhage, hepatic failure, thrombocytopenia on Mar 09, 2005 from Additional patient health information: Female , child 11 years of age, was diagnosed with
  • epilepsy
and. Tolep dosage: N/A. Patient was hospitalized.

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Most drugs have a large list of nonsevere or mild adverse effects which do not rule out continued usage. These effects depend on individual sensitivity, and can include nausea, dizziness, diarrhea, malaise, vomiting, headache, dermatitis, dry mouth, etc. Check commonly reported side effects . These can be considered a form of pseudo-allergic reaction, as not all users experience these effects; many users experience none at all.

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 Information

More About Tolep

Side Effects reported to FDA: 22. View Tolep Adverse Reports

Tolep safety alerts: No

Reported deaths: 3

Reported hospitalizations: 17

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