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Salsalate (Salsalate) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Salsalate 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 (11)

Reports by Reaction Type

Drug Ineffective (5)Pain (4)Cyst (4)Hypoaesthesia (4)Burning Sensation (4)Grip Strength Decreased (4)Gait Disturbance (4)Diabetes Mellitus (3)Dizziness (3)Thyroid Cancer (3)Blood Potassium Decreased (3)Abdominal Discomfort (1)

Possible Salsalate side effects in male

Reported by a consumer/non-health professional from United States on 2012-06-27

Patient: male, weighing 102.0 kg (224.4 pounds)

Reactions: Burning Sensation, Drug Ineffective, Pain, Grip Strength Decreased, Cyst, Hypoaesthesia, Gait Disturbance

Drug(s) suspected as cause:
Lyrica
    Indication: Arthritis

Salsalate
    Dosage: 750 mg, 3x/day

Lyrica
    Indication: Fibromyalgia

Lyrica
    Indication: Neuralgia

Lyrica
    Dosage: 200 mg, 2x/day
    Administration route: Oral
    Indication: Neuropathy Peripheral
    Start date: 2011-10-01
    End date: 2011-12-01

Other drugs received by patient: Salicylate Sodium; Atenolol



Possible Salsalate side effects in female

Reported by a consumer/non-health professional from United States on 2012-05-31

Patient: female, weighing 108.9 kg (239.5 pounds)

Reactions: Diabetes Mellitus, Thyroid Cancer, Blood Potassium Decreased, Dizziness

Drug(s) suspected as cause:
Salsalate
    Dosage: (1500 mg bid)
    Indication: Arthritis

Salsalate
    Dosage: (1500 mg bid)
    Indication: Pain

Metformin HCL
    Dosage: (50 mg qd)
    Indication: Diabetes Mellitus

Ascorbic Acid W / Vitamin D NOS
    Dosage: (df)
    Indication: Product Used FOR Unknown Indication

Lipitor
    Dosage: (40 mg qd oral)
    Administration route: Oral
    Indication: Blood Cholesterol Increased

Sulfasalazine
    Dosage: (100 mg bid)
    Indication: Arthritis

Sulfasalazine
    Dosage: (100 mg bid)
    Indication: Fibromyalgia

Lyrica
    Dosage: (1500 mg bid oral), (75 mg bid oral)
    Administration route: Oral
    Indication: Fibromyalgia

Cymbalta
    Dosage: (df)
    Indication: Depression

Citalopram Hydrobromide
    Dosage: (df)
    Indication: Depression

Levoxyl
    Dosage: (100 ug qd)
    Indication: Thyroid Therapy

Lomotil
    Dosage: (0.25 mg tid)
    Indication: Colitis
    Start date: 2011-02-01

Hydrochlorothiazide
    Dosage: (25 mg qd)
    Indication: Oedema Peripheral

Hydrochlorothiazide
    Dosage: (25 mg qd)
    Indication: Cardiac Disorder

Klor-CON
    Dosage: (20 meq qd) , (10 meq qd)
    Indication: Blood Potassium Decreased

Calcitriol
    Dosage: (df)
    Indication: Product Used FOR Unknown Indication



Possible Salsalate side effects in male

Reported by a consumer/non-health professional from United States on 2012-05-09

Patient: male, weighing 102.0 kg (224.4 pounds)

Reactions: Burning Sensation, Drug Ineffective, Pain, Grip Strength Decreased, Gait Disturbance, Hypoaesthesia, Cyst

Drug(s) suspected as cause:
Lyrica
    Dosage: 200 mg, 2x/day
    Administration route: Oral
    Indication: Neuropathy Peripheral
    Start date: 2011-10-01
    End date: 2011-12-01

Lyrica
    Indication: Neuralgia

Lyrica
    Indication: Arthritis

Salsalate
    Dosage: 750 mg, 3x/day

Lyrica
    Indication: Fibromyalgia

Other drugs received by patient: Salicylate Sodium; Atenolol



Possible Salsalate side effects in female

Reported by a consumer/non-health professional from United States on 2012-05-02

Patient: female, weighing 109.0 kg (239.8 pounds)

Reactions: Thyroid Cancer, Diabetes Mellitus, Blood Potassium Decreased, Dizziness

Drug(s) suspected as cause:
Lyrica
    Dosage: 150 mg, 2x/day
    Administration route: Oral

Sulfasalazine
    Indication: Fibromyalgia

Citalopram
    Dosage: unk
    Indication: Depression

Cymbalta
    Dosage: unk
    Indication: Depression

Lyrica
    Dosage: 75 mg, 2x/day
    Administration route: Oral
    Indication: Fibromyalgia

Hydrochlorothiazide
    Indication: Left Ventricular Dysfunction

Salsalate
    Dosage: 1500 mg, 2x/day
    Indication: Arthritis

Calcitriol
    Dosage: unk

Hydrochlorothiazide
    Dosage: 25 mg, daily
    Indication: Oedema Peripheral

Vitamin C
    Dosage: unk

Klor-CON
    Dosage: 20 meq, daily

Levoxyl
    Dosage: 100 ug, daily
    Indication: Thyroidectomy

Vitamin D
    Dosage: unk

Lipitor
    Dosage: 40 mg, daily
    Administration route: Oral
    Indication: Blood Cholesterol Increased

Lomotil
    Dosage: ^0.25^ mg, 3x/day
    Indication: Colitis

Metformin HCL
    Dosage: 50 mg, daily
    Indication: Diabetes Mellitus

Sulfasalazine
    Dosage: 1000 mg, 2x/day
    Indication: Arthritis

Klor-CON
    Dosage: 10 meq, daily
    Indication: Blood Potassium Decreased



Possible Salsalate side effects in female

Reported by a consumer/non-health professional from United States on 2012-04-27

Patient: female, weighing 109.0 kg (239.8 pounds)

Reactions: Thyroid Cancer, Blood Potassium Decreased, Diabetes Mellitus, Dizziness

Drug(s) suspected as cause:
Hydrochlorothiazide
    Dosage: 25 mg, daily
    Indication: Oedema Peripheral

Hydrochlorothiazide
    Indication: Left Ventricular Dysfunction

Klor-CON
    Dosage: 20 meq, daily

Lyrica
    Dosage: 150 mg, 2x/day
    Administration route: Oral

Sulfasalazine
    Dosage: 1000 mg, 2x/day
    Indication: Arthritis

Klor-CON
    Dosage: 10 meq, daily
    Indication: Blood Potassium Decreased

Vitamin C
    Dosage: unk

Lipitor
    Dosage: 40 mg, daily
    Administration route: Oral
    Indication: Blood Cholesterol Increased

Calcitriol
    Dosage: unk

Levoxyl
    Dosage: 100 ug, daily
    Indication: Thyroidectomy

Lomotil
    Dosage: ^0.25^ mg, 3x/day
    Indication: Colitis

Sulfasalazine
    Indication: Fibromyalgia

Cymbalta
    Dosage: unk
    Indication: Depression

Salsalate
    Dosage: 1500 mg, 2x/day
    Indication: Arthritis

Lyrica
    Dosage: 75 mg, 2x/day
    Administration route: Oral
    Indication: Fibromyalgia

Citalopram
    Dosage: unk
    Indication: Depression

Metformin Hydrochloride
    Dosage: 50 mg, daily
    Indication: Diabetes Mellitus

Vitamin D
    Dosage: unk



Possible Salsalate side effects in 90 year old male

Reported by a pharmacist from United States on 2012-04-05

Patient: 90 year old male

Reactions: Haematuria

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Warfarin Sodium
    Dosage: 5mg hs po
    Administration route: Oral
    Start date: 2009-06-03
    End date: 2011-01-29

Salsalate
    Dosage: 500 mg every day po
    Administration route: Oral
    Start date: 2009-06-03
    End date: 2012-01-29



Possible Salsalate side effects in male

Reported by a consumer/non-health professional from United States on 2012-02-27

Patient: male, weighing 102.0 kg (224.4 pounds)

Reactions: Burning Sensation, Drug Ineffective, Grip Strength Decreased, Pain, Gait Disturbance, Cyst, Hypoaesthesia

Drug(s) suspected as cause:
Lyrica
    Indication: Neuralgia

Lyrica
    Dosage: 200 mg, 2x/day
    Administration route: Oral
    Indication: Neuropathy Peripheral
    Start date: 2011-10-01
    End date: 2011-12-01

Lyrica
    Indication: Fibromyalgia

Salsalate
    Dosage: 750 mg, 3x/day

Lyrica
    Indication: Arthritis

Other drugs received by patient: Salicylate Sodium; Atenolol



Possible Salsalate side effects in male

Reported by a consumer/non-health professional from United States on 2012-02-15

Patient: male, weighing 102.0 kg (224.4 pounds)

Reactions: Burning Sensation, Drug Ineffective, Grip Strength Decreased, Pain, Hypoaesthesia, Cyst, Gait Disturbance

Drug(s) suspected as cause:
Lyrica
    Indication: Fibromyalgia

Lyrica
    Dosage: 200 mg, 2x/day
    Administration route: Oral
    Indication: Neuropathy Peripheral
    Start date: 2011-10-01
    End date: 2011-12-01

Salsalate
    Dosage: 750 mg, 3x/day

Lyrica
    Indication: Neuralgia

Lyrica
    Indication: Arthritis

Other drugs received by patient: Atenolol; Salicylate Sodium



Possible Salsalate side effects in

Reported by a consumer/non-health professional from United States on 2012-02-02

Patient:

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Trilisate
    Dosage: unk

Daypro
    Dosage: unk

Relafen
    Dosage: unk

Salsalate
    Dosage: unk



Possible Salsalate side effects in 43 year old female

Reported by a physician from United States on 2011-11-06

Patient: 43 year old female

Reactions: Therapeutic Response Decreased, Abdominal Discomfort, Back Pain, Diarrhoea, Chest Pain

Drug(s) suspected as cause:
Salsalate

Enbrel
    Dosage: 50 mg, qwk
    Indication: Rheumatoid Arthritis
    Start date: 2011-02-10

Zonisamide



Possible Salsalate side effects in male

Reported by a consumer/non-health professional from United States on 2011-10-10

Patient: male

Reactions: Cataract, Dysuria

Drug(s) suspected as cause:
Lisinopril
    Administration route: Oral

Finasteride

Amlodipine Besylate

Terazosin HCL

Simvastatin

Flax Seed

Singulair

Vitamin E

Vitamin D

Omeprazole
    Administration route: Oral

Salsalate

Fish OIL

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