DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Saphris (Asenapine) - Off Label Use - Suspected Cause - Side Effect Reports

 
 



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



 Page 1   Next >>

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017