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 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 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 physician from United States on 2012-08-23
Patient:
Reactions: Pneumonia, Dyspnoea, Vomiting, Suffocation Feeling, Flatulence, Underdose, Bruxism, Abdominal Pain Upper, Anxiety, Hypoaesthesia Oral, Fatigue, Choking, DRY Mouth, Salivary Hypersecretion, Decreased Appetite
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Saphris
Other drugs received by patient: Metoprolol Succinate; Synthroid
Possible Saphris side effects in
Reported by a consumer/non-health professional from United States on 2012-08-23
Patient:
Reactions: Dystonia
Drug(s) suspected as cause:
Saphris
Possible Saphris side effects in
Reported by a physician from United States on 2012-08-23
Patient:
Reactions: Oral Discomfort
Drug(s) suspected as cause:
Saphris
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: 10 mg, bid
Saphris
Dosage: 5 mg, bid
Indication: Product Used FOR Unknown Indication
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
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