This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Savella (Milnacipran) 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 (276)
Death (5)
Life Threatening Events (14)
Disability (11)
Reports by Reaction Type
Nausea (47),
Headache (33),
Insomnia (24),
Vomiting (23),
Hyperhidrosis (22),
Pain (21),
Blood Pressure Increased (21),
Dizziness (20),
Depression (20),
Heart Rate Increased (18),
Drug Ineffective (16),
Anxiety (16)
Below are a few examples of reports where side effects / adverse reactions may be related to Savella (Milnacipran). For a complete list or a specific selection of reports, please use the links above.
Possible Savella side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-23
Patient: male, weighing 163.3 kg (359.2 pounds)
Reactions: Painful Ejaculation, Sexual Dysfunction, Testicular Pain, Prostatic Pain
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Savella
Dosage: 100 mg, po
Administration route: Oral
Start date: 2012-05-15
End date: 2012-05-15
Savella
Dosage: titration pack,, po
Administration route: Oral
Indication: Sciatica
Start date: 2012-05-15
End date: 2012-05-15
Savella
Dosage: titration pack,, po
Administration route: Oral
Indication: Neuralgia
Start date: 2012-05-15
End date: 2012-05-15
Savella
Dosage: titration pack,, po
Administration route: Oral
Indication: Fibromyalgia
Start date: 2012-05-15
End date: 2012-05-15
Savella
Dosage: titration pack,, po
Administration route: Oral
Indication: Sciatica
Start date: 2012-03-15
End date: 2012-05-15
Savella
Dosage: titration pack,, po
Administration route: Oral
Indication: Neuralgia
Start date: 2012-03-15
End date: 2012-05-15
Savella
Dosage: titration pack,, po
Administration route: Oral
Indication: Fibromyalgia
Start date: 2012-03-15
End date: 2012-05-15
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 female
Reported by a physician from United States on 2012-08-22
Patient: female
Reactions: Vomiting, Dyspnoea, Chest Discomfort, Nausea, Hyperhidrosis, Blood Glucose Increased, Hypovolaemia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Savella
Other drugs received by patient: Carisoprodol; Crestor; Effexor; Aspirin; Coumadin; Enalapril Maleate; Evamist; Lasix; Lisinopril; Zetia; Atacand; Ranexa; Amiodarone HCL; Nexium; Nitrostat; Provigil; Spironolactone; Levemir; Lortab; Coreg CR; Novolog; Potassium Chloride
Possible Savella side effects in 66 year old female
Reported by a consumer/non-health professional from United States on 2012-08-21
Patient: 66 year old female
Reactions: Insomnia, Orthostatic Hypotension, Nervousness
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Savella
Dosage: 25 mg qod
Administration route: Oral
Indication: Fibromyalgia
Start date: 2011-01-01
End date: 2011-01-01
Savella
Dosage: 25 mg
Administration route: Oral
Start date: 2011-01-01
End date: 2012-07-01
Possible Savella side effects in
Reported by a individual with unspecified qualification from United States on 2012-08-21
Patient:
Reactions: Flushing, Headache, Lymphoedema, Fall, Asthenia, Decreased Appetite
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 2012-08-20
Patient: 48 year old female, weighing 70.3 kg (154.7 pounds)
Reactions: Accident, Neck Pain, Palpitations
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Lyrica
Dosage: 75 mg, 3x/day
Indication: Fibromyalgia
Lyrica
Dosage: 75 mg, 2x/day
Savella
Dosage: 12.5 mg, 2x/day
Savella
Dosage: 25 mg, 2x/day
Indication: Fibromyalgia
Other drugs received by patient: Toprol-XL; Estradiol
Possible Savella side effects in 43 year old female
Reported by a consumer/non-health professional from United States on 2012-08-14
Patient: 43 year old female
Reactions: Movement Disorder, Pain, Depression
Drug(s) suspected as cause:
Cymbalta
Indication: Depression
Gabapentin
Indication: Fibromyalgia
Ibuprofen
Ibuprofen
Indication: Fibromyalgia
Savella
Indication: Fibromyalgia
Possible Savella side effects in 55 year old female
Reported by a consumer/non-health professional from United States on 2012-08-10
Patient: 55 year old female, weighing 61.2 kg (134.7 pounds)
Reactions: Myalgia, Movement Disorder, Migraine, Fatigue, Feeling Abnormal, Hyperhidrosis, Loss of Consciousness
Drug(s) suspected as cause:
Savella
Dosage: titration pack
Indication: Myalgia
Start date: 2012-08-07
End date: 2012-08-08
Savella
Dosage: titration pack
Indication: Pain
Start date: 2012-08-07
End date: 2012-08-08
Possible Savella side effects in 43 year old female
Reported by a consumer/non-health professional from United States on 2012-08-03
Patient: 43 year old female
Reactions: Movement Disorder, Pain, Depression
Drug(s) suspected as cause:
Cymbalta
Dosage: unk
Indication: Depression
Gabapentin
Dosage: unk
Indication: Fibromyalgia
Ibuprofen
Dosage: unk
Indication: Fibromyalgia
Savella
Dosage: unk
Indication: Fibromyalgia
Possible Savella side effects in male
Reported by a physician from United States on 2012-07-31
Patient: male, weighing 86.1 kg (189.4 pounds)
Reactions: Completed Suicide
Adverse event resulted in: death
Drug(s) suspected as cause:
Savella
Dosage: 12.5 mg
Administration route: Oral
Indication: Fibromyalgia
Start date: 2012-03-27
End date: 2012-03-27
Savella
Dosage: 25 mg
Administration route: Oral
Start date: 2012-03-28
End date: 2012-03-29
Savella
Dosage: 50 mg
Administration route: Oral
Start date: 2012-03-30
End date: 2012-04-02
Savella
Dosage: 100 mg
Administration route: Oral
Start date: 2012-04-03
End date: 2012-01-01
Other drugs received by patient: Zanaflex; Vitamin D; Citracal; Reclast; Oxycodone HCL; Xanax; Protonix; Glucosamine; Claritin; Lyrica
Possible Savella side effects in male
Reported by a physician from United States on 2012-07-30
Patient: male
Reactions: NO Adverse Event
Drug(s) suspected as cause:
Benzathine Penicillin G
Dosage: unk
Savella
Dosage: unk
Possible Savella side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-26
Patient: female
Reactions: Weight Decreased, Night Sweats, Breakthrough Pain, Glucose Tolerance Impaired, Paraesthesia, Tremor, Benign Intracranial Hypertension, Fatigue, Withdrawal Syndrome
Drug(s) suspected as cause:
Duragesic-100
Start date: 2004-01-01
Duragesic-100
Indication: Fibromyalgia
Duragesic-100
Start date: 2012-01-01
End date: 2012-05-01
Duragesic-100
Start date: 2004-01-01
Duragesic-100
Start date: 2012-01-01
End date: 2012-05-01
Duragesic-100
Indication: Pain
Savella
Administration route: Oral
Start date: 2012-01-01
End date: 2012-01-01
Savella
Administration route: Oral
Indication: Fibromyalgia
Start date: 2012-05-01
End date: 2012-01-01
Savella
Administration route: Oral
Start date: 2012-01-01
End date: 2012-01-01
Savella
Administration route: Oral
Start date: 2012-01-01
Savella
Administration route: Oral
Indication: Pain
Start date: 2012-05-01
End date: 2012-01-01
Savella
Administration route: Oral
Start date: 2012-01-01
Other drugs received by patient: Lasix; Celebrex; Potassium Chloride; Neurontin; Nexium; Neurontin; Celebrex; Lipitor
Possible Savella side effects in male
Reported by a physician from United States on 2012-07-24
Patient: male
Reactions: NO Adverse Event
Drug(s) suspected as cause:
Potassium Penicillin G
Dosage: unk
Savella
Dosage: unk
Possible Savella side effects in female
Reported by a physician from United States on 2012-07-20
Patient: female, weighing 69.0 kg (151.8 pounds)
Reactions: Hellp Syndrome, Maternal Exposure During Pregnancy
Drug(s) suspected as cause:
Savella
Other drugs received by patient: Prenatal Vitamin with Folic Acid; Prozac; Vitamin B-12
Possible Savella side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-18
Patient: female
Reactions: Haemorrhage, International Normalised Ratio Increased, Onychoclasis
Drug(s) suspected as cause:
Coumadin
Dosage: interpd and restarted,dose decreased
Savella
Indication: Fibromyalgia
Possible Savella side effects in male
Reported by a pharmacist from United States on 2012-07-18
Patient: male
Reactions: Gastrointestinal Haemorrhage
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Coumadin
End date: 2011-09-29
Savella
End date: 2011-01-01
Possible Savella side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-16
Patient: female, weighing 73.9 kg (162.7 pounds)
Reactions: Mydriasis, Vision Blurred
Drug(s) suspected as cause:
Savella
Dosage: 25 mg 2x daily; 12-5-11 starter kit to 1-5-12
Indication: Fibromyalgia
Start date: 2011-12-05
End date: 2012-01-05
Savella
Dosage: 25 mg 2x daily; 12-5-11 starter kit to 1-5-12
Indication: Fibromyalgia
Start date: 2012-01-07
Possible Savella side effects in 66 year old female
Reported by a consumer/non-health professional from United States on 2012-07-13
Patient: 66 year old female
Reactions: Insomnia, Orthostatic Hypotension, Nervousness
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Savella
Dosage: 25 mg
Administration route: Oral
Start date: 2011-01-01
Savella
Dosage: 25 mg qod
Administration route: Oral
Indication: Fibromyalgia
Start date: 2011-01-01
End date: 2011-01-01
Possible Savella side effects in 52 year old female
Reported by a physician from United States on 2012-07-11
Patient: 52 year old female, weighing 68.2 kg (150.0 pounds)
Reactions: Tachycardia, Myofascial Pain Syndrome, Joint Dislocation, Serotonin Syndrome, Headache, Tremor, Fibromyalgia, Radiculitis, Depression, Hypertension
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Savella
Dosage: savella 12.5 mg qd po
Administration route: Oral
Indication: Myofascial Pain Syndrome
Start date: 2012-06-29
Savella
Dosage: savella 12.5 mg qd po
Administration route: Oral
Indication: Fibromyalgia
Start date: 2012-06-29
Other drugs received by patient: Buspar; Percocet; Valium; Gabapentin; Doxepin; Paxil
Possible Savella side effects in 44 year old male
Reported by a physician from United States on 2012-07-10
Patient: 44 year old male
Reactions: Completed Suicide
Adverse event resulted in: death
Drug(s) suspected as cause:
Savella
Dosage: 25 mg
Administration route: Oral
Start date: 2012-03-01
End date: 2012-01-01
Savella
Dosage: 100 mg
Administration route: Oral
Start date: 2012-01-01
End date: 2012-01-01
Savella
Dosage: 50 mg
Administration route: Oral
Start date: 2012-01-01
End date: 2012-01-01
Savella
Dosage: 12.5 mg
Administration route: Oral
Indication: Fibromyalgia
Start date: 2012-03-01
End date: 2012-03-01
Other drugs received by patient: Zanaflex; Claritin; Citracal; Vitamin D; Oxycodone HCL; Xanax; Protonix; Glucosamine
Possible Savella side effects in 48 year old female
Reported by a consumer/non-health professional from United States on 2012-07-03
Patient: 48 year old female
Reactions: Pain, Cognitive Disorder, Fall, Malaise, Fatigue, Fibromyalgia, Systemic Lupus Erythematosus, Depression, Memory Impairment, Gait Disturbance
Drug(s) suspected as cause:
Hydrocodone
Dosage: unk
Lyrica
Dosage: 100 mg, 2x/day
Administration route: Oral
Savella
Dosage: unk
Other drugs received by patient: Cerefolin; Zegerid; CO-Q-10; Ropinirole; Hydrochlorothiazide; Alpha Lipoic Acid; Methotrexate; SAM-E; Maxalt; Zanaflex; Flector; Lisinopril; Lortab
Possible Savella side effects in female
Reported by a physician from United States on 2012-07-02
Patient: female, weighing 180.0 kg (396.0 pounds)
Reactions: Diarrhoea, Anaphylactic Shock, Dermatitis Exfoliative
Adverse event resulted in: hospitalization, disablity
Drug(s) suspected as cause:
Ibuprofen
Dosage: 2400 milligram;
Administration route: Oral
Start date: 2011-06-01
Lovaza
Administration route: Oral
Start date: 2011-09-07
Omeprazole
Dosage: 20 milligram;
Administration route: Oral
Rosuvastatin
Dosage: 20 milligram;
Administration route: Oral
Start date: 2011-06-01
Savella
Dosage: 50 milligram;
Administration route: Oral
Start date: 2011-09-10
End date: 2011-09-12
Savella
Dosage: 12.5 milligram;
Administration route: Oral
Indication: Fibromyalgia
Start date: 2011-09-07
End date: 2011-09-07
Torsemide
Dosage: 80 milligram;
Administration route: Oral
Start date: 2011-07-13
Other drugs received by patient: Metformin Hydrochloride; Potassium; Amoxicillin; Cinnamon; Vaccinium Macrocarpon; Bupropion HCL; Lisinopril; M.v.i.; Warfarin Sodium; Allopurinol; Amitriptyline HCL; Glimepiride; Propranolol; Fenofibrate; Oxybutynin; Colecalciferol; Vicodin; Phentermine Hydrochloride; Levothyroxine Sodium
Possible Savella side effects in 46 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-02
Patient: 46 year old female, weighing 180.0 kg (396.0 pounds)
Reactions: Skin Chapped, Dyspnoea, Excoriation, Skin Exfoliation, Adverse Drug Reaction, Pain, Urticaria, Anaphylactic Shock, Faecal Incontinence, Skin Irritation, Diarrhoea, Rash Erythematous, Skin Lesion, Dermatitis Exfoliative, Rash Vesicular
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Crestor
Dosage: 20mg per day
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2011-06-01
Ibuprofen
Dosage: 800mg three times per day
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2011-06-01
Lovaza
Dosage: 4g per day
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2011-09-07
Prilosec
Dosage: 20mg per day
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2011-06-01
Savella
Administration route: Oral
Indication: Fibromyalgia
Start date: 2011-09-07
End date: 2011-09-12
Torsemide
Dosage: 40mg per day
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2011-07-13
Other drugs received by patient: Propranolol; Synthroid; Glimepiride; Adipex-P; Cinnamon; Cranberry; Fenofibrate; Vitamin D; Potassium; Warfarin Sodium; Vicodin; Metformin HCL; Oxybutynin; Amitriptyline HCL; Lisinopril; Amoxicillin; M.v.i.; Allopurinol; Wellbutrin
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 male
Reported by a physician from United States on 2012-06-29
Patient: male
Reactions: Drug Hypersensitivity
Drug(s) suspected as cause:
Potassium Penicillin G
Dosage: unk
Savella
Dosage: unk
Possible Savella side effects in
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-28
Patient:
Reactions: Abdominal Pain, Fibromyalgia, Diarrhoea, Dehydration
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Savella
Possible Savella side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-26
Patient: female
Reactions: Dysstasia, Pain, Muscular Weakness
Drug(s) suspected as cause:
Lyrica
Dosage: 75 mg, 2x/day
Administration route: Oral
Indication: Neuralgia
Lyrica
Dosage: 150 mg, 2x/day
Administration route: Oral
End date: 2012-05-01
Lyrica
Dosage: unk
Administration route: Oral
Start date: 2012-06-01
Savella
Dosage: unk
Indication: Neuralgia
Start date: 2012-05-01
Other drugs received by patient: Trazodone
Possible Savella side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-26
Patient: female
Reactions: Drug Ineffective
Drug(s) suspected as cause:
Lyrica
Dosage: 50 mg, 1x/day
Indication: Fibromyalgia
Savella
Dosage: three times daily
Indication: Fibromyalgia
Vicodin
Dosage: unk
Indication: Pain
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 61 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-21
Patient: 61 year old female, weighing 61.2 kg (134.6 pounds)
Reactions: Akathisia, Pruritus, Rash Papular
Drug(s) suspected as cause:
Savella
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