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Index of reports
> Life Threatening Events (14)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Savella (Milnacipran) life threatening events. The selected reports were submitted to the FDA during the sample period of about a year.
Possible Savella side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-23
Patient: female, weighing 60.8 kg (133.8 pounds)
Reactions: Agitation, Restlessness, Impulsive Behaviour, Aggression, Anxiety, Hostility, Irritability, Panic Attack, Insomnia, Memory Impairment, Heart Rate Irregular, Depression, Unevaluable Event, Hypertension
Adverse event resulted in: life threatening event, hospitalization, disablity
Drug(s) suspected as cause:
Savella
Possible Savella side effects in 46 year old female
Reported by a physician from United States on 2012-06-29
Patient: 46 year old female, weighing 180.0 kg (396.0 pounds)
Reactions: Diarrhoea, Adverse Drug Reaction, Anaphylactic Shock, Dermatitis Exfoliative
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Crestor
Administration route: Oral
Start date: 2011-06-01
Ibuprofen
Start date: 2011-06-01
Lovaza
Administration route: Oral
Start date: 2011-09-07
Prilosec
Administration route: Oral
Start date: 2011-06-01
Savella
Administration route: Oral
Indication: Fibromyalgia
Start date: 2011-09-07
End date: 2011-09-07
Savella
Administration route: Oral
Start date: 2011-09-08
End date: 2011-09-09
Savella
Administration route: Oral
Start date: 2011-09-10
End date: 2011-09-12
Torsemide
Start date: 2011-07-13
Other drugs received by patient: Allopurinol; Propranolol; Amitriptyline HCL; Amoxicillin; Potassium Acetate; Metformin HCL; Multi-Vitamin; Cranberry; Synthroid; Lisinopril; Oxybutynin; Vicodin; Adipex-P; Glimepiride; Warfarin Sodium; Vitamin D; Cinnamon; Fenofibrate; Wellbutrin
Possible Savella side effects in 55 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-21
Patient: 55 year old male, weighing 70.3 kg (154.7 pounds)
Reactions: Confusional State, Fear of Death, Social Fear, Urticaria, Pain, Rash, Suicidal Ideation, Off Label Use, Thinking Abnormal, Mood Altered, Activities of Daily Living Impaired, Sleep Disorder, Depression, Frustration, Decreased Appetite
Adverse event resulted in: life threatening event, hospitalization, disablity
Drug(s) suspected as cause:
Savella
Possible Savella side effects in 49 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-20
Patient: 49 year old female, weighing 129.0 kg (283.8 pounds)
Reactions: Vomiting, Nausea, Tooth Erosion, Food Poisoning, Hypotension, Hyperhidrosis, Hypertensive Crisis, Panic Attack, Dehydration, Suicide Attempt, Emotional Disorder, Hypertension
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Savella
Possible Savella side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-19
Patient: female, weighing 60.8 kg (133.7 pounds)
Reactions: Agitation, Chest Discomfort, Restlessness, Aggression, Hostility, Irritability, Anxiety, Panic Attack, Heart Rate Increased, Memory Impairment, Heart Rate Irregular, Depression, Hypertension
Adverse event resulted in: life threatening event, hospitalization, disablity
Drug(s) suspected as cause:
Savella
Possible Savella side effects in 48 year old female
Reported by a consumer/non-health professional from United States on 2012-05-02
Patient: 48 year old female, weighing 90.7 kg (199.6 pounds)
Reactions: Blood Pressure Increased
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Savella
Possible Savella side effects in 63 year old female
Reported by a consumer/non-health professional from United States on 2012-04-18
Patient: 63 year old female, weighing 70.3 kg (154.7 pounds)
Reactions: Pyrexia, Hyperhidrosis, Eating Disorder, Abdominal Pain Upper, Suicidal Ideation, Pruritus Generalised, Fatigue, Anhedonia, Crying
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Savella
Possible Savella side effects in 49 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-18
Patient: 49 year old female, weighing 129.3 kg (284.4 pounds)
Reactions: Tooth Loss, Vomiting, Nausea, Dental Caries, Tooth Extraction, Hypotension, Condition Aggravated, Hyperhidrosis, Hypertensive Crisis, Panic Attack, Dehydration, Suicide Attempt, Emotional Disorder
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Savella
Possible Savella side effects in 55 year old male
Reported by a consumer/non-health professional from United States on 2012-04-06
Patient: 55 year old male, weighing 70.3 kg (154.7 pounds)
Reactions: Confusional State, Social Fear, Urticaria, Pain, Abnormal Behaviour, Rash, Suicidal Ideation, Thinking Abnormal, Mood Altered, Sleep Disorder, Activities of Daily Living Impaired, Disturbance in Attention, Depression, Frustration, Decreased Appetite
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Savella
Possible Savella side effects in 47 year old female
Reported by a consumer/non-health professional from United States on 2012-03-19
Patient: 47 year old female, weighing 55.3 kg (121.7 pounds)
Reactions: Aphagia, Abnormal Behaviour, Constipation, Hyperhidrosis, Suicidal Ideation, Abdominal Pain Upper, Thinking Abnormal, Euphoric Mood, Pathological Gambling, Insomnia, Mental Disorder, Compulsive Shopping, Depression, Crying
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Savella
Possible Savella side effects in female
Reported by a consumer/non-health professional from United States on 2012-02-13
Patient: female, weighing 71.7 kg (157.7 pounds)
Reactions: Catheter Site Discharge, Thrombosis, Cardio-Respiratory Arrest, Staphylococcal Infection, Abasia, Pulmonary Oedema, Circulatory Collapse
Adverse event resulted in: life threatening event, hospitalization, disablity
Drug(s) suspected as cause:
Savella
Possible Savella side effects in 64 year old female
Reported by a consumer/non-health professional from United States on 2011-11-09
Patient: 64 year old female, weighing 80.3 kg (176.6 pounds)
Reactions: Suicidal Ideation
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Savella
Dosage: 50 mg 2 x daily
Indication: Depression
Savella
Dosage: 50 mg 2 x daily
Indication: Pain
Possible Savella side effects in 51 year old female
Reported by a consumer/non-health professional from United States on 2011-10-21
Patient: 51 year old female
Reactions: Agitation, Tinnitus, Impulsive Behaviour, Headache, Abdominal Discomfort, Thinking Abnormal, Malaise, Balance Disorder, Therapy Cessation, Palpitations, Mood Altered, DRY Mouth, Oedema Peripheral, Chest Discomfort, Dysphagia, Angina Pectoris, Abnormal Behaviour, Hypoaesthesia, Paraesthesia, Flushing, Dysphonia, Activities of Daily Living Impaired, Mental Disorder, Suicide Attempt, Vision Blurred, Nerve Injury, Confusional State, Chills, Dyskinesia, Somnolence, Fall, Constipation, Impaired Driving Ability, Fatigue, Clumsiness, Dizziness, Coordination Abnormal, Depression, Hallucination, Dyspnoea, Nausea, Incorrect Dose Administered, Condition Aggravated, Amnesia, Anxiety, Syncope, Diarrhoea, Visual Impairment, Dysuria, Gait Disturbance, Feeling Abnormal, Asthenia
Adverse event resulted in: life threatening event, hospitalization, disablity
Drug(s) suspected as cause:
Amitriptyline HCL
Dosage: 150 mg (150 mg, at bedtime) oral
Administration route: Oral
Indication: Insomnia
Start date: 2010-11-02
End date: 2011-04-21
Savella
Dosage: 12.5 mg (12.5 mg, at bedtime), oral 25 mg at bedtime oral 50 mg at bedtime oral 100 mg at bedtime or
Administration route: Oral
Indication: Insomnia
Start date: 2010-11-02
End date: 2010-11-01
Savella
Dosage: 12.5 mg (12.5 mg, at bedtime), oral 25 mg at bedtime oral 50 mg at bedtime oral 100 mg at bedtime or
Administration route: Oral
Indication: Insomnia
Start date: 2010-11-18
End date: 2011-04-21
Other drugs received by patient: Woman's Daily Vitamin (Vitamin) (Vitamin); Fish OIL (Fish Oil) (Fish Oil); Mucinex (Guaifenesin) (Guaifenesin); Activ-ON RUB (Menthol) (Menthol); Hydrocodone / Apap (Hydrocodone, Acetaminophen) (Hydrocodone, Acetaminop; Nexium; Propanolol (Propanolol) (Propanolol); Potassium (Potassium) (Potassium); Calcium Citrate + VIT D (Calcium Citrate, Vitamin D) (Calcium Citrate,; Magnesium / Chelated Zinc (Magnesium, Zinc) (Magnesium, Zinc); Cranberry (Cranberry) (Pill) (Cranberry)
Possible Savella side effects in 47 year old female
Reported by a consumer/non-health professional from United States on 2011-10-20
Patient: 47 year old female, weighing 66.8 kg (147.0 pounds)
Reactions: Drug Ineffective, Nausea, Pain, Condition Aggravated, Headache, Drug Withdrawal Syndrome, Muscle Twitching, Muscle Tightness, Gastric Disorder, Tremor, Fibromyalgia, Heart Rate Increased, Hallucination, Muscle Spasms, Crying
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Adderall XR 10
Dosage: 50 mg (50 mg, 1 in 1 d), oral
Administration route: Oral
Indication: Attention Deficit / Hyperactivity Disorder
Start date: 2010-05-02
End date: 2011-04-25
Savella
Dosage: 100 mg (100 mg, 1 in 1 d), oral
Administration route: Oral
Indication: Fibromyalgia
Start date: 2009-10-20
End date: 2011-03-30
Savella
Dosage: oral
Administration route: Oral
Indication: Fibromyalgia
Start date: 2009-10-01
End date: 2009-10-19
Savella
Dosage: 75 mg (75 mg, 1 in 1 d), oral
Administration route: Oral
Indication: Fibromyalgia
Start date: 2011-01-01
End date: 2011-01-01
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