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Savella (Milnacipran) - Side Effect Reports to FDA

 
 



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

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 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 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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