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Ampyra (Dalfampridine) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Ampyra (Dalfampridine) 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 (673)
Death (52)
Life Threatening Events (15)
Disability (99)

Reports by Reaction Type

Convulsion (149)Fall (90)Gait Disturbance (64)Urinary Tract Infection (63)Abasia (57)Inappropriate Schedule of Drug Administration (57)Multiple Sclerosis Relapse (52)Dizziness (48)Asthenia (40)Nausea (37)Balance Disorder (36)Muscular Weakness (34)

Below are a few examples of reports where side effects / adverse reactions may be related to Ampyra (Dalfampridine). For a complete list or a specific selection of reports, please use the links above.

Possible Ampyra side effects in 55 year old male

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: 55 year old male

Reactions: Pharyngeal Oedema

Drug(s) suspected as cause:
Ampyra
    Dosage: 10mg bid po
    Administration route: Oral
    Indication: Multiple Sclerosis
    Start date: 2012-03-01

Ampyra
    Dosage: 10mg bid po
    Administration route: Oral
    Indication: Multiple Sclerosis
    Start date: 2012-08-01

Other drugs received by patient: Prilosec; Copaxone; Micardis



Possible Ampyra side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-22

Patient:

Reactions: Urinary Incontinence, Mental Disorder, Eye Movement Disorder, Suicidal Ideation, Convulsion

Drug(s) suspected as cause:
Ampyra

Bupropion Hydrochloride

Diazepam

Gabapentin

Rebif

Zocor
    Administration route: Oral



Possible Ampyra side effects in 52 year old female

Reported by a consumer/non-health professional from United States on 2012-08-13

Patient: 52 year old female, weighing 62.1 kg (136.6 pounds)

Reactions: Movement Disorder, Pain in Extremity, Abasia, Cognitive Disorder, Social Problem, Mania, Limb Injury, Arthralgia, Mental Disorder, Asthenia

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Ampyra
    Dosage: 10 mg, bid, oral ; 10 mg, bid, oral
    Administration route: Oral
    Indication: Gait Disturbance
    Start date: 2012-07-09
    End date: 2012-07-23

Ampyra
    Dosage: 10 mg, bid, oral ; 10 mg, bid, oral
    Administration route: Oral
    Indication: Gait Disturbance
    Start date: 2012-08-01

Other drugs received by patient: Hydrocodone Bitartrate; Lamictal; Ergocalciferol; Juice Plus (Amylase, Ascorbic Acid, Cellulase, Folic Acid, Lipase, PRO; Avonex; Duloxetine Hydrochloride



Possible Ampyra side effects in 60 year old female

Reported by a consumer/non-health professional from United States on 2012-08-13

Patient: 60 year old female

Reactions: Dysstasia, Vomiting, Dizziness, Gait Disturbance, Kidney Infection, Fall

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Ampyra
    Dosage: 10 mg, bid, 10 mg, bid
    Indication: Gait Disturbance
    Start date: 2012-05-11
    End date: 2012-05-11

Ampyra
    Dosage: 10 mg, bid, 10 mg, bid
    Indication: Gait Disturbance
    Start date: 2012-06-01



Possible Ampyra side effects in 61 year old female

Reported by a consumer/non-health professional from United States on 2012-08-13

Patient: 61 year old female

Reactions: Nephrolithiasis, Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ampyra

Other drugs received by patient: Betaseron



Possible Ampyra side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-13

Patient: female

Reactions: Thrombosis, Osteoarthritis, Aortic Stenosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ampyra

Other drugs received by patient: Omega-3-Acid Ethyl Esters (Lovaza); Coumadin; Lasix; Vytorin; Boniva; Metformin HCL; B-100 Complex (Nicotinamide, Pyridoxine Hydrochloride, Riboflavin, THI; Vitamin E / 00110501 (Tocopherol); Avonex; Calcium Carbonate; Ditropan XL; Aspirin; Potassium Chloride



Possible Ampyra side effects in 59 year old female

Reported by a consumer/non-health professional from United States on 2012-08-13

Patient: 59 year old female, weighing 56.7 kg (124.7 pounds)

Reactions: Inappropriate Schedule of Drug Administration, Intervertebral Disc Disorder, Sleep Disorder, Abasia, Hangover, Arthritis

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Ampyra
    Dosage: 10mg bid, oral ; 10 mg, qd, oral ; 10 mg, qd
    Administration route: Oral
    Indication: Gait Disturbance
    Start date: 2012-07-29

Ampyra
    Dosage: 10mg bid, oral ; 10 mg, qd, oral ; 10 mg, qd
    Administration route: Oral
    Indication: Gait Disturbance
    Start date: 2011-01-01

Mobic
    Indication: Back Disorder
    Start date: 2012-03-01
    End date: 2012-07-29

Other drugs received by patient: Avonex



Possible Ampyra side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-13

Patient: female

Reactions: Foot Fracture, Fall

Drug(s) suspected as cause:
Ampyra



Possible Ampyra side effects in 50 year old female

Reported by a consumer/non-health professional from United States on 2012-08-13

Patient: 50 year old female

Reactions: Tonic Convulsion

Drug(s) suspected as cause:
Ampyra



Possible Ampyra side effects in 61 year old female

Reported by a consumer/non-health professional from United States on 2012-08-13

Patient: 61 year old female

Reactions: Fatigue, Temperature Intolerance, Stress, Multiple Sclerosis Relapse

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ampyra
    Dosage: 10 mg, bid, oral
    Administration route: Oral
    Indication: Multiple Sclerosis
    Start date: 2012-01-17
    End date: 2012-07-01

Ampyra
    Dosage: 10 mg, bid, oral
    Administration route: Oral
    Indication: Multiple Sclerosis
    Start date: 2012-07-01
    End date: 2012-07-31

Other drugs received by patient: Neurontin



Possible Ampyra side effects in 67 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-13

Patient: 67 year old female

Reactions: Knee Operation, Bronchitis, Eye Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ampyra

Other drugs received by patient: Copaxone; Valium; Provigil; Oxycontin; Oxycodone HCL



Possible Ampyra side effects in 63 year old female

Reported by a consumer/non-health professional from United States on 2012-08-10

Patient: 63 year old female

Reactions: Inappropriate Schedule of Drug Administration, Malaise, Road Traffic Accident, Limb Injury, Feeling Hot, Insomnia, Lower Limb Fracture, Muscle Twitching

Drug(s) suspected as cause:
Ampyra



Possible Ampyra side effects in 52 year old female

Reported by a consumer/non-health professional from United States on 2012-08-10

Patient: 52 year old female

Reactions: Shoulder Operation

Drug(s) suspected as cause:
Ampyra



Possible Ampyra side effects in 30 year old female

Reported by a physician from United States on 2012-08-10

Patient: 30 year old female

Reactions: Paraplegia, Abasia, Multiple Sclerosis Relapse

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Ampyra
    Dosage: 10 mg, bid, oral
    Administration route: Oral
    Indication: Relapsing-Remitting Multiple Sclerosis
    Start date: 2012-04-01

Ampyra
    Dosage: 10 mg, bid, oral
    Administration route: Oral
    Indication: Urinary Retention
    Start date: 2012-04-01

Ampyra
    Dosage: 10 mg, bid, oral
    Administration route: Oral
    Indication: Paraparesis
    Start date: 2012-04-01

Copaxone
    Dosage: 20 mg/ml, qd, intramuscular
    Indication: Relapsing-Remitting Multiple Sclerosis
    Start date: 2012-05-01

Other drugs received by patient: Senna / 00142201 / (Senna Alexandrina); Klonopin; Colace (Docusate Sodium); Baclofen; Ativan; Percocet



Possible Ampyra side effects in 55 year old male

Reported by a consumer/non-health professional from United States on 2012-08-10

Patient: 55 year old male

Reactions: Pneumonia, Depression

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ampyra

Other drugs received by patient: Copaxone



Possible Ampyra side effects in female

Reported by a pharmacist from United States on 2012-08-10

Patient: female

Reactions: Malaise, Aplastic Anaemia

Drug(s) suspected as cause:
Ampyra

Ampyra
    Dosage: 10 mg, q 12 hrs
    Indication: Multiple Sclerosis
    Start date: 2011-07-26



Possible Ampyra side effects in 54 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-10

Patient: 54 year old female

Reactions: Drug Dose Omission, Pain in Extremity, Fall, Balance Disorder, Oedema Peripheral, Musculoskeletal Stiffness, Gait Disturbance, Asthenia, Hallucination

Drug(s) suspected as cause:
Ampyra
    Dosage: 10 mg, q 12 hrs, oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-08-01

Gilenya
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-12-01
    End date: 2012-07-16

Tysabri
    Dosage: 1 dose
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-01
    End date: 2012-07-01



Possible Ampyra side effects in 46 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-10

Patient: 46 year old female

Reactions: Neoplasm Malignant

Drug(s) suspected as cause:
Ampyra

Other drugs received by patient: Tysabri



Possible Ampyra side effects in 66 year old male

Reported by a physician from United States on 2012-08-10

Patient: 66 year old male, weighing 82.1 kg (180.6 pounds)

Reactions: Confusional State, Neck Pain, Muscular Weakness, Asthenia, Paraesthesia, Multiple Sclerosis Relapse

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Ampyra

Other drugs received by patient: Norvasc; Lipitor; Copaxone



Possible Ampyra side effects in 63 year old female

Reported by a consumer/non-health professional from United States on 2012-08-10

Patient: 63 year old female

Reactions: Dysuria, Urinary Incontinence, Urinary Retention, Ankle Fracture

Drug(s) suspected as cause:
Ampyra



Possible Ampyra side effects in 46 year old female

Reported by a consumer/non-health professional from United States on 2012-08-10

Patient: 46 year old female, weighing 59.0 kg (129.8 pounds)

Reactions: Urinary Tract Infection, Dizziness, Loss of Consciousness, Tremor

Drug(s) suspected as cause:
Ampyra
    Dosage: 10 mg, q 12 hrs, oral, 10 mg, q 12 hrs, oral
    Administration route: Oral
    Indication: Gait Disturbance
    Start date: 2012-01-01

Ampyra
    Dosage: 10 mg, q 12 hrs, oral, 10 mg, q 12 hrs, oral
    Administration route: Oral
    Indication: Gait Disturbance
    Start date: 2012-05-01
    End date: 2012-01-01

Cipro
    Indication: Urinary Tract Infection
    Start date: 2012-06-01
    End date: 2012-01-01

Other drugs received by patient: Colon Cleanser Natural Detox Formula (Aloe Vera, Citrus Spp. Peel, GEN; Synthroid; Ibuprofen; Focalin



Possible Ampyra side effects in 62 year old male

Reported by a physician from Canada on 2012-08-09

Patient: 62 year old male

Reactions: Atelectasis, Agitation, Drug Dose Omission, Confusional State, Weight Decreased, Subcutaneous Emphysema, Fall, Pneumothorax, Pneumothorax Traumatic, Carpal Tunnel Syndrome, RIB Fracture, Diet Refusal, Blood Urine Present, Neurogenic Bladder, Urinary Tract Infection, Glucose Urine Present, Aggression

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ampyra



Possible Ampyra side effects in 63 year old female

Reported by a health professional (non-physician/pharmacist) from Australia on 2012-08-09

Patient: 63 year old female

Reactions: Rotator Cuff Syndrome, Osteopenia, Bursitis, Exostosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ampyra

Other drugs received by patient: Fish OIL (Fish Oil); Panadol Osteo (Paracetamol); Baclofen; Metamucil / 00029101 / (Plantago Ovata); Aspirin; Movicol / 01625101 / (Macrogol, Potassium Chloride, Sodium Bicarbonate)



Possible Ampyra side effects in 66 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-08

Patient: 66 year old male

Reactions: Small Cell Lung Cancer Stage Unspecified

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ampyra

Other drugs received by patient: Copaxone



Possible Ampyra side effects in 68 year old female

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-08-08

Patient: 68 year old female

Reactions: Thrombosis, Peripheral Coldness, Blood Thyroid Stimulating Hormone Increased, Blood Calcium Increased, Pulmonary Embolism, Mental Status Changes, Blood Magnesium Decreased, Loss of Consciousness, Haematocrit Decreased, RED Blood Cell Count Decreased, Mean Cell Haemoglobin Increased, Blood Creatinine Increased, Blood Sodium Decreased, White Blood Cell Count Increased, Neutrophil Percentage Increased, Hypotension, Blood Chloride Increased, Muscular Weakness, Troponin T Increased, Livedo Reticularis, Cardiogenic Shock, Respiratory Distress, Convulsion, Grand MAL Convulsion, Haemoglobin Decreased, Aspartate Aminotransferase Increased, Depressed Level of Consciousness, Respiratory Arrest, Carbon Dioxide Decreased, Septic Shock

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Ampyra

Other drugs received by patient: Calcium Carbonate; Fosamax; Effexor; Oxybutynin; Perindopril Erbumine; Plaquenil / 00072602 / (Hydroxychlororoquine Phosphate); Metoprolol Tartrate; Aquify EYE Drops (Hyaluronate Sodium); Gravol (Dimenhydrinate); Baclofen



Possible Ampyra side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-07

Patient: female

Reactions: Foot Fracture

Drug(s) suspected as cause:
Ampyra



Possible Ampyra side effects in male

Reported by a physician from United States on 2012-08-07

Patient: male

Reactions: Hallucination, Visual

Drug(s) suspected as cause:
Ampyra



Possible Ampyra side effects in 32 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-07

Patient: 32 year old female, weighing 45.4 kg (99.9 pounds)

Reactions: Bedridden, Malaise, Nausea

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Ampyra
    Dosage: 10 mg, bid, oral, 10 mg, bid, oral
    Administration route: Oral
    Indication: Gait Disturbance
    Start date: 2011-05-01
    End date: 2011-06-01

Ampyra
    Dosage: 10 mg, bid, oral, 10 mg, bid, oral
    Administration route: Oral
    Indication: Gait Disturbance
    Start date: 2011-07-01
    End date: 2011-07-01

Other drugs received by patient: Seroquel; Wellbutrin; Tysabri; Lithium Carbonate



Possible Ampyra side effects in 57 year old female

Reported by a consumer/non-health professional from United States on 2012-08-07

Patient: 57 year old female, weighing 64.9 kg (142.8 pounds)

Reactions: HIP Fracture, Inappropriate Schedule of Drug Administration, Blood Urine Present, Abasia, Urinary Tract Infection, Muscular Weakness, Gait Disturbance, Fall, Multiple Sclerosis Relapse

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ampyra
    Dosage: 10 mg, qd, oral, 10 mg, bid, oral, 10 mg, bid
    Administration route: Oral
    Indication: Gait Disturbance
    Start date: 2010-03-30
    End date: 2010-01-01

Ampyra
    Dosage: 10 mg, qd, oral, 10 mg, bid, oral, 10 mg, bid
    Administration route: Oral
    Indication: Gait Disturbance
    Start date: 2010-05-10

Ampyra
    Dosage: 10 mg, qd, oral, 10 mg, bid, oral, 10 mg, bid
    Administration route: Oral
    Indication: Gait Disturbance
    Start date: 2012-01-06
    End date: 2012-01-09

Other drugs received by patient: Fentanyl; Avonex; Clonazepam; Amantadine HCL



Possible Ampyra side effects in 35 year old female

Reported by a consumer/non-health professional from United States on 2012-08-06

Patient: 35 year old female

Reactions: Convulsion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ampyra

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