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Saphris (Asenapine) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Saphris (Asenapine) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (953)
Death (34)
Life Threatening Events (43)
Disability (30)

Reports by Reaction Type

Inappropriate Schedule of Drug Administration (141)Underdose (92)Swollen Tongue (56)Weight Increased (47)Dyspnoea (40)Dizziness (38)Hypoaesthesia Oral (37)Rash (35)Off Label Use (32)Nausea (32)Sedation (30)Incorrect Route of Drug Administration (29)

Below are a few examples of reports where side effects / adverse reactions may be related to Saphris (Asenapine). For a complete list or a specific selection of reports, please use the links above.

Possible Saphris side effects in

Reported by a pharmacist from United States on 2012-08-27

Patient:

Reactions: Angioedema

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Saphris



Possible Saphris side effects in

Reported by a physician from United States on 2012-08-27

Patient:

Reactions: Myocardial Infarction

Adverse event resulted in: death

Drug(s) suspected as cause:
Saphris



Possible Saphris side effects in male

Reported by a physician from United States on 2012-08-27

Patient: male, weighing 122.0 kg (268.4 pounds)

Reactions: Hospitalisation, Drug Ineffective, Treatment Noncompliance

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Invega Sustenna
    Indication: Bipolar Disorder
    Start date: 2012-07-01

Invega Sustenna
    Indication: Psychotic Disorder
    Start date: 2012-07-01

Saphris
    Dosage: 5-10 mg
    Indication: Bipolar Disorder
    Start date: 2012-07-01

Saphris
    Dosage: 5-10 mg
    Indication: Psychotic Disorder
    Start date: 2012-07-01

Sertraline Hydrochloride
    Indication: Bipolar Disorder
    Start date: 2012-01-01

Sertraline Hydrochloride
    Indication: Psychotic Disorder
    Start date: 2012-01-01

Topamax
    Indication: Psychotic Disorder
    Start date: 2012-01-01

Topamax
    Indication: Bipolar Disorder
    Start date: 2012-01-01

Wellbutrin
    Dosage: 300-450 mg
    Administration route: Oral
    Indication: Psychotic Disorder
    Start date: 2010-11-01

Wellbutrin
    Dosage: 300-450 mg
    Administration route: Oral
    Indication: Bipolar Disorder
    Start date: 2010-11-01



Possible Saphris side effects in

Reported by a physician from United States on 2012-08-25

Patient:

Reactions: Vomiting, Dyspnoea, Pneumonia, Suffocation Feeling, Flatulence, Underdose, Bruxism, Abdominal Pain Upper, Anxiety, Hypoaesthesia Oral, Fatigue, DRY Mouth, Choking, Salivary Hypersecretion, Decreased Appetite

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Saphris

Other drugs received by patient: Synthroid; Metoprolol Succinate



Possible Saphris side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-25

Patient:

Reactions: Nausea, Chest Pain, Hyperhidrosis

Drug(s) suspected as cause:
Saphris
    Dosage: 5 mg, bid
    Indication: Schizophrenia
    Start date: 2012-02-25
    End date: 2012-02-28

Saphris
    Dosage: 5 mg, unk
    Start date: 2012-05-24



Possible Saphris side effects in

Reported by a consumer/non-health professional from United States on 2012-08-25

Patient:

Reactions: Incorrect Route of Drug Administration, Fatigue, Listless, Dyspnoea

Drug(s) suspected as cause:
Saphris

Other drugs received by patient: Gemfibrozil; Allopurinol; Cough, Cold, and FLU Therapies (Unspecified); Bactrim



Possible Saphris side effects in

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient:

Reactions: Haematemesis

Drug(s) suspected as cause:
Saphris



Possible Saphris side effects in

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient:

Reactions: Hypoaesthesia Oral

Drug(s) suspected as cause:
Saphris

Other drugs received by patient: Lamictal



Possible Saphris side effects in

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient:

Reactions: Blood Prolactin Increased

Drug(s) suspected as cause:
Saphris

Other drugs received by patient: Lamictal; Cymbalta; Clonapine



Possible Saphris side effects in 60 year old female

Reported by a physician from United States on 2012-08-24

Patient: 60 year old female, weighing 59.0 kg (129.7 pounds)

Reactions: Depersonalisation, Dissociation, Derealisation

Drug(s) suspected as cause:
Saphris



Possible Saphris side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-24

Patient:

Reactions: Oral Discomfort

Drug(s) suspected as cause:
Saphris



Possible Saphris side effects in

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient:

Reactions: Dissociation, Abnormal Behaviour

Drug(s) suspected as cause:
Saphris



Possible Saphris side effects in

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient:

Reactions: Mania

Drug(s) suspected as cause:
Saphris

Other drugs received by patient: Depakote; Zyprexa



Possible Saphris side effects in 61 year old female

Reported by a physician from United States on 2012-08-24

Patient: 61 year old female, weighing 95.3 kg (209.6 pounds)

Reactions: Hallucinations, Mixed, Oedema Peripheral, Disorientation

Drug(s) suspected as cause:
Saphris



Possible Saphris side effects in

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient:

Reactions: Akathisia, Increased Appetite, Underdose

Drug(s) suspected as cause:
Saphris

Other drugs received by patient: Celexa; Depakote; Ambien



Possible Saphris side effects in

Reported by a consumer/non-health professional from Canada on 2012-08-24

Patient:

Reactions: Nausea, Sedation, Oedema Peripheral, Dizziness, Swollen Tongue

Drug(s) suspected as cause:
Saphris
    Dosage: 5 mg, bid
    Indication: Bipolar Disorder
    Start date: 2012-06-01
    End date: 2012-06-01

Saphris
    Indication: Affective Disorder

Other drugs received by patient: Synthroid; Wellbutrin; Lithium Carbonate; Abilify; Clonazepam



Possible Saphris side effects in

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient:

Reactions: Weight Increased, Headache, Rash

Drug(s) suspected as cause:
Saphris



Possible Saphris side effects in

Reported by a individual with unspecified qualification from United States on 2012-08-24

Patient:

Reactions: Oedema Peripheral, Drug Prescribing Error

Drug(s) suspected as cause:
Saphris
    Dosage: 5 mg, qd
    Indication: Bipolar Disorder
    Start date: 2012-08-03

Saphris
    Dosage: half the medication, qd
    End date: 2012-08-08

Other drugs received by patient: Lithium Carbonate



Possible Saphris side effects in 44 year old female

Reported by a physician from United States on 2012-08-24

Patient: 44 year old female, weighing 117.0 kg (257.5 pounds)

Reactions: Weight Increased, Hypoaesthesia Oral, Nausea, Increased Appetite, Headache, Abdominal Pain Upper

Drug(s) suspected as cause:
Saphris

Other drugs received by patient: Trazodone HCL



Possible Saphris side effects in

Reported by a physician from United States on 2012-08-23

Patient:

Reactions: Inappropriate Schedule of Drug Administration, Syncope, Hypotension, Underdose

Drug(s) suspected as cause:
Saphris



Possible Saphris side effects in

Reported by a physician from United States on 2012-08-23

Patient:

Reactions: Inappropriate Schedule of Drug Administration, Oedema Mouth, Swollen Tongue

Drug(s) suspected as cause:
Saphris



Possible Saphris side effects in

Reported by a physician from United States on 2012-08-23

Patient:

Reactions: Weight Increased, Hypoaesthesia

Drug(s) suspected as cause:
Saphris

Other drugs received by patient: Lamictal



Possible Saphris side effects in

Reported by a pharmacist from United States on 2012-08-23

Patient:

Reactions: Dysgeusia

Drug(s) suspected as cause:
Saphris
    Dosage: 5 mg, bid
    Indication: Product Used FOR Unknown Indication

Saphris
    Dosage: 10 mg, bid



Possible Saphris side effects in

Reported by a physician from United States on 2012-08-23

Patient:

Reactions: Agitation, Nightmare, Medication Error, Insomnia

Drug(s) suspected as cause:
Saphris

Other drugs received by patient: Flexeril; Fiorinal (Acetaminophen (+) Aspirin (+) Caffeine); Celexa; Synthroid; Xanax



Possible Saphris side effects in

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient:

Reactions: Blood Pressure Decreased

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Saphris

Other drugs received by patient: Seroquel



Possible Saphris side effects in

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient:

Reactions: Dyskinesia, Muscle Twitching

Drug(s) suspected as cause:
Saphris

Other drugs received by patient: Serzone



Possible Saphris side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-23

Patient:

Reactions: Dysgeusia

Drug(s) suspected as cause:
Saphris
    Dosage: 10 mg, bid
    Start date: 2012-06-01

Saphris
    Dosage: 5 mg, qd
    Start date: 2012-06-01



Possible Saphris side effects in

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient:

Reactions: Vomiting, Hypoaesthesia Oral, Dysphagia, Incorrect Dose Administered, Dyskinesia, Dizziness, Motion Sickness

Drug(s) suspected as cause:
Saphris

Other drugs received by patient: Zolpidem Tartrate



Possible Saphris side effects in

Reported by a consumer/non-health professional from Canada on 2012-08-23

Patient:

Reactions: Schizophrenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Saphris



Possible Saphris side effects in

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient:

Reactions: Swelling Face

Drug(s) suspected as cause:
Saphris

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