Index of reports
> Cases with Off Label Use (32)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Saphris (Asenapine) where reactions include off label use. The selected reports were submitted to the FDA during the sample period of about a year.
Reports 1 - 30 of 32 Next >>
Possible Saphris side effects in 50 year old female
Reported by a physician from Australia on 2012-08-09
Patient: 50 year old female
Reactions: Off Label Use, Incorrect Route of Drug Administration, Wrong Technique in Drug Usage Process, Hypoaesthesia, Tremor
Drug(s) suspected as cause:
Saphris
Other drugs received by patient: Cogentin; Citalopram Hydrobromide; Cholecalciferol; Lithium Carbonate; Levothyroxine Sodium; Metformin Hydrochloride; Nexium
Possible Saphris side effects in
Reported by a physician from United States on 2012-08-01
Patient:
Reactions: Blood Calcium Decreased, Off Label Use
Drug(s) suspected as cause:
Saphris
Possible Saphris side effects in
Reported by a physician from Australia on 2012-07-17
Patient:
Reactions: Incorrect Route of Drug Administration, Off Label Use, Wrong Technique in Drug Usage Process, Hypoaesthesia, Tremor
Adverse event resulted in: death
Drug(s) suspected as cause:
Saphris
Other drugs received by patient: Cholecalciferol; Metformin Hydrochloride; Cogentin; Levothyroxine Sodium; Citalopram Hydrobromide; Lithium Carbonate; Nexium
Possible Saphris side effects in
Reported by a physician from United States on 2012-07-16
Patient:
Reactions: Blood Calcium Decreased, Off Label Use
Adverse event resulted in: death
Drug(s) suspected as cause:
Saphris
Possible Saphris side effects in
Reported by a consumer/non-health professional from United States on 2012-07-16
Patient:
Reactions: Off Label Use, Galactorrhoea, Inappropriate Schedule of Drug Administration, Joint Swelling, Underdose, Oedema
Drug(s) suspected as cause:
Saphris
Dosage: 5 mg, unk
Indication: Schizoaffective Disorder
Start date: 2010-07-23
End date: 2010-08-01
Saphris
Dosage: 10 mg, hs
Start date: 2010-08-01
End date: 2011-01-01
Saphris
Dosage: 5 mg, hs
Start date: 2011-01-01
End date: 2011-05-01
Possible Saphris side effects in
Reported by a health professional (non-physician/pharmacist) from Australia on 2012-07-12
Patient:
Reactions: Off Label Use, Incorrect Route of Drug Administration, Wrong Technique in Drug Usage Process, Hypoaesthesia, Tremor
Drug(s) suspected as cause:
Saphris
Other drugs received by patient: Cogentin; Metformin HCL; Levothyroxine Sodium; Nexium; Cholecalciferol; Lithium Carbonate; Citalopram Hydrobromide
Possible Saphris side effects in 49 year old male
Reported by a consumer/non-health professional from United States on 2012-06-21
Patient: 49 year old male, weighing 86.2 kg (189.6 pounds)
Reactions: Off Label Use, Dysarthria, Contusion, Feeling Hot, Headache, Feeling Abnormal, Dysphemia, Feeling Cold
Drug(s) suspected as cause:
Saphris
Possible Saphris side effects in 67 year old female
Reported by a consumer/non-health professional from United States on 2012-06-21
Patient: 67 year old female
Reactions: Off Label Use, Confusional State, Fatigue, Wrong Technique in Drug Usage Process, Dyspnoea, Medication Error, Asthenia
Drug(s) suspected as cause:
Saphris
Dosage: 10 mg;unk;sl 5 mg;unk;sl 10 mg;bid;sl
Indication: Bipolar Disorder
Start date: 2011-01-31
Saphris
Dosage: 10 mg;unk;sl 5 mg;unk;sl 10 mg;bid;sl
Indication: Depression
Start date: 2011-01-31
Saphris
Dosage: 10 mg;unk;sl 5 mg;unk;sl 10 mg;bid;sl
Indication: Bipolar Disorder
Start date: 2012-05-01
End date: 2012-06-05
Saphris
Dosage: 10 mg;unk;sl 5 mg;unk;sl 10 mg;bid;sl
Indication: Depression
Start date: 2012-05-01
End date: 2012-06-05
Other drugs received by patient: Tofranil; Vesicare; Luvox; Allopurinol; Gemfibrozil
Possible Saphris side effects in
Reported by a physician from Australia on 2012-06-01
Patient:
Reactions: Off Label Use, Insomnia
Drug(s) suspected as cause:
Saphris
Possible Saphris side effects in 39 year old female
Reported by a physician from Australia on 2012-05-30
Patient: 39 year old female, weighing 84.0 kg (184.8 pounds)
Reactions: Off Label Use, Anaphylactic Reaction
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Saphris
Other drugs received by patient: Lithium; Neulactil; Valium; Citalopram Hydrobromide
Possible Saphris side effects in female
Reported by a physician from Australia on 2012-05-23
Patient: female
Reactions: Off Label Use, Drug Hypersensitivity
Drug(s) suspected as cause:
Saphris
Other drugs received by patient: Neulactil; Lithium Carbonate
Possible Saphris side effects in 20 year old male
Reported by a physician from United States on 2012-04-30
Patient: 20 year old male
Reactions: Off Label Use, Dyspnoea, Wrong Technique in Drug Usage Process, Self-Medication
Drug(s) suspected as cause:
Saphris
Other drugs received by patient: Fluoxetine
Possible Saphris side effects in 20 year old female
Reported by a consumer/non-health professional from United States on 2012-04-25
Patient: 20 year old female
Reactions: Glossodynia, Tongue Ulceration, Swollen Tongue, Muscle Twitching, Facial Pain, Off Label Use, TIC, Salivary Hypersecretion
Drug(s) suspected as cause:
Saphris
Saphris
Dosage: 5:15 mg, bid, qd, sl
Indication: Anxiety
Start date: 2012-03-06
Saphris
Dosage: 5:15 mg, bid, qd, sl
Indication: Depression
Start date: 2012-03-06
Saphris
Dosage: 5:15 mg, bid, qd, sl
Indication: Crying
Start date: 2012-03-06
Saphris
Dosage: 5:15 mg, bid, qd, sl
Indication: Anxiety
End date: 2012-03-09
Saphris
Dosage: 5:15 mg, bid, qd, sl
Indication: Depression
End date: 2012-03-09
Saphris
Dosage: 5:15 mg, bid, qd, sl
Indication: Crying
End date: 2012-03-09
Saphris
Dosage: 5:15 mg, bid, qd, sl
Indication: Anxiety
Start date: 2012-02-07
Saphris
Dosage: 5:15 mg, bid, qd, sl
Indication: Depression
Start date: 2012-02-07
Saphris
Dosage: 5:15 mg, bid, qd, sl
Indication: Crying
Start date: 2012-02-07
Other drugs received by patient: Clonopin; Wellbutrin; Vitamin B Complex CAP; Ortho TRI-Cyclen; Pristiq
Possible Saphris side effects in 19 year old male
Reported by a physician from United States on 2012-04-20
Patient: 19 year old male
Reactions: Off Label Use, Rash
Drug(s) suspected as cause:
Saphris
Dosage: 5 mg; qd, sl
Indication: Affective Disorder
Saphris
Dosage: 5 mg; qd, sl
Indication: Disability
Other drugs received by patient: Risperidone; Prozac
Possible Saphris side effects in male
Reported by a physician from United States on 2012-04-18
Patient: male
Reactions: Off Label Use, Pharyngeal Oedema, Dystonia
Drug(s) suspected as cause:
Saphris
Dosage: 5 mg;sl 10 mg 15 mg
Indication: Schizoaffective Disorder
Start date: 2011-08-12
End date: 2011-08-25
Saphris
Dosage: 5 mg;sl 10 mg 15 mg
Indication: Schizoaffective Disorder
Start date: 2011-07-15
End date: 2011-08-11
Saphris
Dosage: 5 mg;sl 10 mg 15 mg
Indication: Schizoaffective Disorder
Start date: 2011-08-26
Possible Saphris side effects in 61 year old male
Reported by a physician from Canada on 2012-03-15
Patient: 61 year old male, weighing 93.6 kg (205.9 pounds)
Reactions: Chest Discomfort, Nausea, Tachycardia, Headache, Off Label Use, Abnormal Dreams, Fatigue, Mood Altered
Drug(s) suspected as cause:
Saphris
Other drugs received by patient: Trazodone HCL; Zopiclone; Sertraline Hydrochloride
Possible Saphris side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-14
Patient: female
Reactions: Off Label Use, Rash
Drug(s) suspected as cause:
Saphris
Possible Saphris side effects in 45 year old female
Reported by a physician from United States on 2012-03-14
Patient: 45 year old female
Reactions: Off Label Use, Anaphylactic Reaction, Dehydration, Fall
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Saphris
Dosage: 5 mg;once;sl
Indication: Delusion
Start date: 2011-08-25
End date: 2011-08-25
Saphris
Dosage: 5 mg;once;sl
Indication: Obsessive-Compulsive Disorder
Start date: 2011-08-25
End date: 2011-08-25
Other drugs received by patient: Celexa; Calium; Theragan
Possible Saphris side effects in 35 year old female
Reported by a physician from United States on 2012-03-13
Patient: 35 year old female
Reactions: Off Label Use, Wheezing, Swollen Tongue, Throat Tightness
Drug(s) suspected as cause:
Saphris
Possible Saphris side effects in 48 year old male
Reported by a consumer/non-health professional from United States on 2012-03-12
Patient: 48 year old male
Reactions: Inappropriate Schedule of Drug Administration, Off Label Use, Drug Effect Decreased, Surgery, Tardive Dyskinesia, Lethargy
Drug(s) suspected as cause:
Saphris
Dosage: 5 mg;qd;sl
Indication: Generalised Anxiety Disorder
Start date: 2010-10-01
End date: 2011-11-01
Saphris
Dosage: 5 mg;qd;sl
Indication: Depression
Start date: 2010-10-01
End date: 2011-11-01
Other drugs received by patient: Lorazepam; Paxil
Possible Saphris side effects in 17 year old female
Reported by a physician from United States on 2012-03-12
Patient: 17 year old female
Reactions: Incorrect Route of Drug Administration, Off Label Use, Dyspnoea, Drug Administered To Patient of Inappropriate AGE, Swollen Tongue
Drug(s) suspected as cause:
Saphris
Dosage: 5 mg; po
Administration route: Oral
Indication: Depression
Start date: 2011-09-01
Saphris
Dosage: 5 mg; po
Administration route: Oral
Indication: Psychotic Disorder
Start date: 2011-09-01
Possible Saphris side effects in male
Reported by a consumer/non-health professional from United States on 2012-03-12
Patient: male
Reactions: Off Label Use, Weight Decreased
Drug(s) suspected as cause:
Saphris
Possible Saphris side effects in 61 year old male
Reported by a physician from Canada on 2012-03-08
Patient: 61 year old male, weighing 93.6 kg (205.9 pounds)
Reactions: Chest Discomfort, Nausea, Tachycardia, Headache, Off Label Use, Abnormal Dreams, Fatigue, Mood Altered
Drug(s) suspected as cause:
Saphris
Other drugs received by patient: Trazodone HCL; Zopiclone; Sertraline Hydrochloride
Possible Saphris side effects in 51 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-07
Patient: 51 year old female
Reactions: Off Label Use, Swollen Tongue
Drug(s) suspected as cause:
Saphris
Possible Saphris side effects in 61 year old male
Reported by a physician from Israel on 2012-01-31
Patient: 61 year old male, weighing 74.0 kg (162.8 pounds)
Reactions: Off Label Use, Drug Hypersensitivity
Drug(s) suspected as cause:
Saphris
Other drugs received by patient: Quetiapine; Valproate Sodium; Albuterol Sulfate Autohaler; Valproic Acid
Possible Saphris side effects in 70 year old female
Reported by a consumer/non-health professional from United States on 2012-01-27
Patient: 70 year old female
Reactions: Abdominal Pain, Dyspnoea, Viral Infection, Nausea, Urinary Incontinence, Headache, Off Label Use, Ageusia, Diarrhoea, Insomnia
Drug(s) suspected as cause:
Saphris
Dosage: 10 mg;bid;sl
Indication: Nervous System Disorder
Start date: 2011-09-01
End date: 2012-01-11
Saphris
Dosage: 10 mg;bid;sl
Indication: Depression
Start date: 2011-09-01
End date: 2012-01-11
Possible Saphris side effects in male
Reported by a physician from United States on 2012-01-27
Patient: male
Reactions: Off Label Use, Pharyngeal Oedema, Dystonia
Drug(s) suspected as cause:
Saphris
Possible Saphris side effects in 59 year old female
Reported by a consumer/non-health professional from United States on 2011-12-16
Patient: 59 year old female
Reactions: Dysgeusia, Off Label Use, Dyspnoea, Joint Swelling, Oedema Peripheral
Drug(s) suspected as cause:
Saphris
Other drugs received by patient: Hydrochlorothiazide; Synthroid; Prozac
Possible Saphris side effects in 17 year old female
Reported by a physician from United States on 2011-12-01
Patient: 17 year old female
Reactions: Off Label Use, Dyspnoea, Swollen Tongue
Drug(s) suspected as cause:
Saphris
Dosage: 5 mg;po
Administration route: Oral
Indication: Psychotic Disorder
Start date: 2011-09-01
Saphris
Dosage: 5 mg;po
Administration route: Oral
Indication: Depression
Start date: 2011-09-01
Possible Saphris side effects in male
Reported by a physician from United States on 2011-11-03
Patient: male
Reactions: Off Label Use, Pharyngeal Oedema, Dystonia
Drug(s) suspected as cause:
Saphris
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