This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Evoxac (Cevimeline) 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 (13)
Life Threatening Events (1)
Reports by Reaction Type
Hyperhidrosis (2),
Abdominal Pain Upper (2),
Localised Infection (2),
Weight Decreased (1),
Deafness (1),
Drug Interaction (1),
Headache (1),
Chronic Obstructive Pulmonary Disease (1),
Fatigue (1),
Palpitations (1),
Procedural Haemorrhage (1),
DRY Mouth (1)
Possible Evoxac side effects in 59 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-17
Patient: 59 year old female, weighing 42.6 kg (93.8 pounds)
Reactions: Incoherent, Nausea, Chorea, Tremor
Drug(s) suspected as cause:
Evoxac
Possible Evoxac side effects in 50 year old female
Reported by a consumer/non-health professional from United States on 2012-07-12
Patient: 50 year old female, weighing 59.9 kg (131.7 pounds)
Reactions: Weight Decreased, Tinnitus, Dyskinesia, Altered Visual Depth Perception, Deafness, Hyperhidrosis, Abdominal Pain Upper, Herpes Zoster, Impaired Driving Ability, Hot Flush, DRY Mouth, Uterine Leiomyoma, Condition Aggravated, Anxiety, Panic Attack, Diarrhoea, Uterine Dilation and Curettage, Insomnia, Dysuria, DRY Eye
Drug(s) suspected as cause:
Evoxac
Other drugs received by patient: Plaquenil (Hydroxychloroquine)(hydroxychloroquine); Unspecified Bioidentical Hormone Therapy (Ingredients Unknown)(hormone; Synthroid (Levothyroxine Sodium)(levothyroxine Sodium)
Possible Evoxac side effects in 72 year old female
Reported by a consumer/non-health professional from United States on 2012-06-18
Patient: 72 year old female, weighing 44.5 kg (97.8 pounds)
Reactions: Osteoporosis, Aphasia, Chills, Chronic Obstructive Pulmonary Disease, Hyperhidrosis, Fatigue, Procedural Haemorrhage, Pharyngeal Haemorrhage, Gastrooesophageal Reflux Disease, Scar, Vocal Cord Polyp
Drug(s) suspected as cause:
Evoxac
Other drugs received by patient: Lisinopril; Cartia XT
Possible Evoxac side effects in female
Reported by a individual with unspecified qualification from United States on 2012-06-05
Patient: female, weighing 101.6 kg (223.5 pounds)
Reactions: Migraine, Malaise, Quality of Life Decreased
Drug(s) suspected as cause:
Evoxac
Possible Evoxac side effects in female
Reported by a pharmacist from United States on 2012-05-17
Patient: female
Reactions: Haemorrhagic Stroke
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Evoxac
Possible Evoxac side effects in 60 year old male
Reported by a consumer/non-health professional from United States on 2012-04-13
Patient: 60 year old male, weighing 78.0 kg (171.6 pounds)
Reactions: Protein Urine Present, Blood Urea Increased, Drug Interaction, Atrial Fibrillation, Headache, Abdominal Pain Upper, Heart Rate Increased, Feeling Abnormal, Asthenia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Evoxac
Dosage: 15-30mg (30 mg,tid),per oral
Administration route: Oral
Indication: DRY Mouth
Start date: 2007-09-01
End date: 2012-02-29
Metoprolol (Metoprolol) (Tablet) (Metoprolol )
Dosage: per oral
Administration route: Oral
Indication: Atrial Fibrillation
Start date: 2012-02-15
End date: 2012-02-26
Other drugs received by patient: Citrical with D (Calcium Carbonate) (Calcium Carbonate); B12 (Cyanocobalamin-Tannin Complex) (50 Milligram) (Cyanocobalamin-COM; Fish OIL (Fish Oil) (1000 Milligram) (Fish Oil); B6 (Pyridoxine Hydrochloride) (25 Milligram) (Pyridoxine Hydrochloride; Aspirin; Calcium (Calcium) (1400 Milligram) (Calcium); Magnesium (Magnesium) (250 Milligram) (Magnesium); Rythmol (Propafenone) (150 Milligram) (Propafenone0; Vitamin D (Ergocalciferol) (500 IU (International Unit)) (Ergocalcifer; Biotene Tothpaste and Mouthwash (Glucose Oxidase) (Glucose Oxidase)
Possible Evoxac side effects in female
Reported by a consumer/non-health professional from United States on 2012-04-10
Patient: female
Reactions: Systemic Lupus Erythematosus, Cardiac Operation
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Evoxac
Possible Evoxac side effects in 65 year old female
Reported by a individual with unspecified qualification from United States on 2012-02-22
Patient: 65 year old female, weighing 46.3 kg (101.8 pounds)
Reactions: Glaucoma, Eye Irritation
Drug(s) suspected as cause:
Restasis
Dosage: ophthalmic
Indication: Glaucoma
Evoxac
Dosage: 90 mg (30 mg,tid),per oral ; 60 mg (30 mg,bid),per oral
Administration route: Oral
Indication: Sjogren's Syndrome
Start date: 2010-12-01
Evoxac
Dosage: 90 mg (30 mg,tid),per oral ; 60 mg (30 mg,bid),per oral
Administration route: Oral
Indication: Sjogren's Syndrome
Start date: 2002-04-08
End date: 2010-12-01
Other drugs received by patient: Lorazepam (Lorazepam) (Tablet) (Lorazepam); Zyrtec (Cetirizine Hydrochloride) (Tablet) (Cetirizine Hydrochloride); I-Flora Probiotic (Lactobacillus Reuteri) (Lactobacillus Reuteri); Sertraline (Sertraline) (Tablet) (Sertraline); Fiber Supplement (Polycarbophil Calcium) (Polycarbophil Calcium)
Possible Evoxac side effects in 73 year old female
Reported by a physician from United States on 2012-02-22
Patient: 73 year old female
Reactions: Atrioventricular Block
Drug(s) suspected as cause:
Evoxac
Other drugs received by patient: Fosamax; Plaquenil (Hydroxychloroquine) (Hydroxychloroquine)
Possible Evoxac side effects in 72 year old female
Reported by a consumer/non-health professional from United States on 2012-01-10
Patient: 72 year old female, weighing 76.2 kg (167.6 pounds)
Reactions: Pain in Extremity, Musculoskeletal Pain, Myalgia, Neck Pain, NO Therapeutic Response, Tooth Disorder, Neuralgia, Muscle Spasms
Drug(s) suspected as cause:
Evoxac
Dosage: 30
Administration route: Oral
Indication: Sjogren's Syndrome
Start date: 2011-12-22
End date: 2012-01-06
Evoxac
Dosage: 30
Administration route: Oral
Indication: DRY Mouth
Start date: 2011-12-22
End date: 2012-01-06
Possible Evoxac side effects in female
Reported by a individual with unspecified qualification from United States on 2011-11-02
Patient: female
Reactions: Localised Infection
Drug(s) suspected as cause:
Tylenol-500
Dosage: 650 mg, bid
Actonel
Dosage: 150 mg, qmo
Furosemide
Dosage: 20 mg, qd
Symbicort
Dosage: 1 df, bid
Miralax
Dosage: 1 df, qd
Folic Acid
Dosage: 1 mg, qd
Hydroxychloroquine Sulfate
Dosage: 200 mg, bid
Protonix
Dosage: 40 mg, qd
Aspirin
Dosage: 325 mg, qd
Albuterol
Dosage: 1 df, tid
Ambien
Dosage: 10 mg, qd
Methadone HCL
Dosage: 5 mg, bid
Evoxac
Dosage: 30 mg, tid
Prednisone
Dosage: 5 mg, bid
Exforge
Dosage: 1 df, qd (5/320 mg)
Metoprolol Tartrate
Dosage: 25 mg, bid
Onglyza
Dosage: 5 mg, qd
Possible Evoxac side effects in female
Reported by a consumer/non-health professional from United States on 2011-11-02
Patient: female
Reactions: Localised Infection
Drug(s) suspected as cause:
Hydroxychloroquine Sulfate
Dosage: 200 mg, bid
Furosemide
Dosage: 20 mg, qd
Tylenol-500
Dosage: 650 mg, bid
Prednisone
Dosage: 5 mg, bid
Aspirin
Dosage: 325 mg, qd
Albuterol
Dosage: 1 df, tid
Exforge
Dosage: 1 df, qd (5/320 mg)
Onglyza
Dosage: 5 mg, qd
Miralax
Dosage: 1 df, qd
Actonel
Dosage: 150 mg, qmo
Ambien
Dosage: 10 mg, qd
Folic Acid
Dosage: 1 mg, qd
Protonix
Dosage: 40 mg, qd
Methadone HCL
Dosage: 5 mg, bid
Evoxac
Dosage: 30 mg, tid
Symbicort
Dosage: 1 df, bid
Metoprolol Tartrate
Dosage: 25 mg, bid
Possible Evoxac side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-18
Patient: female, weighing 68.9 kg (151.7 pounds)
Reactions: Sick Sinus Syndrome, Dyspnoea, Palpitations, Bradycardia
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Evoxac
Dosage: 30 mg once tid oral
Administration route: Oral
Indication: Sjogren's Syndrome
Start date: 2009-01-01
End date: 2009-01-01
Amitriptyline HCL
Dosage: 10mg twice qhs oral
Administration route: Oral
Indication: Migraine
Start date: 2009-02-10
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