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

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(7404957-6)
on Mar 29, 2011 Female from JAPAN , 83 years of age, was diagnosed with
  • schizophrenia
  • dementia
  • osteoporosis
and was treated with Serenace. . Serenace dosage: 1 Mg, Qd.
Associated medications used:
  • Aricept (5 Mg, Qd)
  • Forteo (20 Ug, Qd)
  • Bonalon (5 Mg, Qd)


Erythema Multiforme, Platelet Count Decreased, Hepatic Function Abnormal, C-reactive Protein Increased, Pyrexia (7338844-9)
Patient was taking Serenace. Patient felt the following Serenace side effects: erythema multiforme, platelet count decreased, hepatic function abnormal, c-reactive protein increased, pyrexia on Mar 03, 2011 from JAPAN Additional patient health information: Female , 73 years of age, weighting 108.0 lb, . Serenace dosage: N/A.
Multiple prescriptions taken:
  • Sunitinib Malate (37.5 Mg, Daily)
  • Norvasc
Patient was hospitalized.

Neurological Symptom (7229029-5)
Adverse event was reported on Jan 07, 2011 by a Male taking Serenace (Dosage: N/A) was diagnosed with
  • bipolar i disorder
and. Location: JAPAN , 50 years of age, After Serenace was administered, patient encountered several Serenace side effects: neurological symptom.
Multiple concurrent drugs taken:
  • Risperdal
  • Fluvoxamine Maleate
Patient was hospitalized.

Chest Pain, Aspartate Aminotransferase Increased, Alanine Aminotransferase Increased, Blood Urea Increased, Abdominal Pain, Occult Blood, Protein Urine Present, Blood Creatinine Increased, Blood Bilirubin Increased (7211558-1)
on Dec 24, 2010 Female from JAPAN , 68 years of age, was treated with Serenace. Directly after, patient experienced the unwanted or unexpected Serenace side effects: chest pain, aspartate aminotransferase increased, alanine aminotransferase increased, blood urea increased, abdominal pain, occult blood, protein urine present, blood creatinine increased, blood bilirubin increased. Serenace dosage: 1.5 Mg, 1x/day.
Associated medications used:
  • Methylnaltrexone Bromide (0.3 Mg/kg, Single)
  • Takepron (15 Mg, 1x/day)
  • Novamin (5 Mg, As Needed)
  • Fentanyl Citrate (4 Mg, 1x/day)
  • Morphine Hydrochloride (10 Mg, As Needed)
  • Fentanyl Citrate (1 Mg, 1x/day)
  • Aldactone (25 Mg, 1x/day)
  • Magnesium Oxide (750 Mg, 1x/day)
Patient was hospitalized and became disabled.


Dystonia, Overdose, Product Name Confusion (6723185-0)
on May 04, 2010 Male from INDIA , child 5 years of age, weighting 33.07 lb, was treated with Serenace. Patient felt the following Serenace side effects: dystonia, overdose, product name confusion. Serenace dosage: N/A.
Multiple prescriptions taken:
  • Serronak


Activities Of Daily Living Impaired, Anxiety, Asocial Behaviour, Disturbance In Attention, Hallucination, Motor Dysfunction, Psychiatric Symptom, Schizophrenia (4742893-4)
Patient was taking Serenace. After Serenace was administered, patient encountered several Serenace side effects: activities of daily living impaired, anxiety, asocial behaviour, disturbance in attention, hallucination, motor dysfunction, psychiatric symptom, schizophrenia on Jun 28, 2005 from AUSTRALIA Additional patient health information: Female , 29 years of age, . Serenace dosage: N/A.
Multiple concurrent drugs taken:
  • Tegretol (100 Mg, Tid)
  • Tegretol (100 Mg, Bid)
  • Epilim (100 Mg, Qd, At Night)
  • Epilim (150 Mg, Qd, At Night)
  • Mellaril (Unk, Unk)
  • Mellaril (100mg(morning And Night) + 50mg(midday))


Activities Of Daily Living Impaired, Anxiety, Asocial Behaviour, Disturbance In Attention, Hallucination, Motor Dysfunction, Psychiatric Symptom, Schizophrenia (4730457-8)
Adverse event was reported on Jun 28, 2005 by a Female taking Serenace (Dosage: N/A) . Location: AUSTRALIA , 29 years of age, Directly after, patient experienced the unwanted or unexpected Serenace side effects: activities of daily living impaired, anxiety, asocial behaviour, disturbance in attention, hallucination, motor dysfunction, psychiatric symptom, schizophrenia.
Associated medications used:
  • Tegretol (100 Mg, Tid)
  • Tegretol (100 Mg, Bid)
  • Epilim (100 Mg, Qd, At Night)
  • Epilim (150 Mg, Qd, At Night)
  • Mellaril (Unk, Unk)
  • Mellaril (100mg(morning And Night) + 50mg(midday))


Activities Of Daily Living Impaired, Anxiety, Asocial Behaviour, Disturbance In Attention, Hallucination, Motor Dysfunction, Psychiatric Symptom, Schizophrenia (4730415-3)
on Jun 28, 2005 Female from AUSTRALIA , 29 years of age, was treated with Serenace. Patient felt the following Serenace side effects: activities of daily living impaired, anxiety, asocial behaviour, disturbance in attention, hallucination, motor dysfunction, psychiatric symptom, schizophrenia. Serenace dosage: N/A.
Multiple prescriptions taken:
  • Tegretol (100 Mg, Tid)
  • Tegretol (100 Mg, Bid)
  • Epilim (100 Mg, Qd, At Night)
  • Epilim (150 Mg, Qd, At Night)
  • Mellaril (Unk, Unk)
  • Mellaril (100mg(morning And Night) + 50mg(midday))


Neuroleptic Malignant Syndrome (4724211-0)
on Jan 07, 2005 Male from JAPAN , 67 years of age, was diagnosed with
  • delusion
  • hallucination
and was treated with Serenace. After Serenace was administered, patient encountered several Serenace side effects: neuroleptic malignant syndrome. Serenace dosage: 2.25 Mg/d.

Neuroleptic Malignant Syndrome (4598333-1)
Patient was taking Serenace. Directly after, patient experienced the unwanted or unexpected Serenace side effects: neuroleptic malignant syndrome on Jan 07, 2005 from Additional patient health information: Male , 67 years of age, was diagnosed with
  • delusion
  • hallucination
and. Serenace dosage: 2.25 Mg/d.

Asthenia, Bladder Catheterisation, Blood Creatine Phosphokinase Increased, Blood Pressure Increased, Body Temperature Increased, Depressed Level Of Consciousness, Feeling Hot, Heart Rate Increased (4576017-3)
Adverse event was reported on Jan 07, 2005 by a Female taking Serenace (Dosage: 3 Mg/day) was diagnosed with
  • schizophrenia
and. Location: , 69 years of age, weighting 143.3 lb, Patient felt the following Serenace side effects: asthenia, bladder catheterisation, blood creatine phosphokinase increased, blood pressure increased, body temperature increased, depressed level of consciousness, feeling hot, heart rate increased.
Multiple prescriptions taken:
  • Mellaril (75 Mg/day)
  • Lamisil (125 Mg, Qd)
Patient was hospitalized.

Asthenia, Bladder Catheterisation, Blood Creatine Phosphokinase Increased, Blood Pressure Increased, Body Temperature Increased, Depressed Level Of Consciousness, Feeling Hot, Heart Rate Increased (4564997-1)
on Jan 07, 2005 Female from , 69 years of age, weighting 143.3 lb, was diagnosed with
  • schizophrenia
and was treated with Serenace. After Serenace was administered, patient encountered several Serenace side effects: asthenia, bladder catheterisation, blood creatine phosphokinase increased, blood pressure increased, body temperature increased, depressed level of consciousness, feeling hot, heart rate increased. Serenace dosage: 3 Mg/day.
Multiple concurrent drugs taken:
  • Mellaril (75 Mg/day)
  • Lamisil (125 Mg, Qd)
Patient was hospitalized.

Blood Pressure Increased, Caesarean Section, Excitability, Foetal Distress Syndrome, Foetal Heart Rate Abnormal, Insomnia, Spinal Anaesthesia (4555685-6)
on Dec 22, 2004 Female from , 38 years of age, was treated with Serenace. Directly after, patient experienced the unwanted or unexpected Serenace side effects: blood pressure increased, caesarean section, excitability, foetal distress syndrome, foetal heart rate abnormal, insomnia, spinal anaesthesia. Serenace dosage: N/A.
Associated medications used:
  • Akineton
  • Hydralazine Hcl
  • Magnesium


Blood Creatine Phosphokinase Increased, Malaise, Rhabdomyolysis (4550983-4)
Patient was taking Serenace. Patient felt the following Serenace side effects: blood creatine phosphokinase increased, malaise, rhabdomyolysis on Jan 07, 2005 from Additional patient health information: Female , 60 years of age, was diagnosed with
  • schizophrenia
and. Serenace dosage: 3 Mg/d.
Multiple prescriptions taken:
  • Melleril (30 Mg/d)
  • Lamisil (125 Mg, Qd)


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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.

Serenace Information

More About Serenace

Side Effects reported to FDA: 14. View Serenace Adverse Reports

Serenace safety alerts: No

Reported deaths: 2

Reported hospitalizations: 5

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