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Index of reports
> Cases with Malaise (11)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Ultram (Tramadol) where reactions include malaise. The selected reports were submitted to the FDA during the sample period of about a year.
Possible Ultram side effects in male
Reported by a consumer/non-health professional from United States on 2012-07-02
Patient: male
Reactions: Bedridden, Aggression, Suicidal Ideation, Malaise, Depression, Withdrawal Syndrome, Drug Dependence, Drug Screen False Positive, Muscle Spasms
Drug(s) suspected as cause:
Ultram
Administration route: Oral
Ultram
Dosage: 6 tablets a day (2 tablets three times a aday) started in 1994-95
Administration route: Oral
Indication: Headache
Ultram
Dosage: 6 tablets a day (2 tablets three times a aday) started in 1994-95
Administration route: Oral
Indication: Carpal Tunnel Syndrome
Ultram
Dosage: 6 tablets a day (2 tablets three times a aday) started in 1994-95
Administration route: Oral
Indication: Diabetic Neuropathy
Ultram
Administration route: Oral
Ultram
Administration route: Oral
Indication: Arthritis
Ultram
Dosage: 6 tablets a day (2 tablets three times a aday) started in 1994-95
Administration route: Oral
Ultram
Administration route: Oral
Other drugs received by patient: Insulin
Possible Ultram side effects in male
Reported by a consumer/non-health professional from United States on 2012-06-20
Patient: male
Reactions: Bedridden, Aggression, Suicidal Ideation, Malaise, Depression, Withdrawal Syndrome, Drug Dependence, Muscle Spasms, Drug Screen False Positive
Drug(s) suspected as cause:
Ultram
Dosage: 6 tablets a day (2 tablets three times a aday) started in 1994-95
Administration route: Oral
Ultram
Dosage: 6 tablets a day (2 tablets three times a aday) started in 1994-95
Administration route: Oral
Indication: Diabetic Neuropathy
Ultram
Dosage: 6 tablets a day (2 tablets three times a aday) started in 1994-95
Administration route: Oral
Indication: Carpal Tunnel Syndrome
Ultram
Administration route: Oral
Ultram
Administration route: Oral
Indication: Arthritis
Ultram
Administration route: Oral
Ultram
Administration route: Oral
Ultram
Dosage: 6 tablets a day (2 tablets three times a aday) started in 1994-95
Administration route: Oral
Indication: Headache
Other drugs received by patient: Insulin
Possible Ultram side effects in female
Reported by a consumer/non-health professional from United States on 2012-02-28
Patient: female, weighing 68.0 kg (149.7 pounds)
Reactions: Malaise, Drug Ineffective, Insomnia, Drug Hypersensitivity, Oedema Peripheral, Pain
Drug(s) suspected as cause:
Codeine
Dosage: unk
Lyrica
Dosage: 50 mg, 3x/day
Administration route: Oral
Indication: Fibromyalgia
Start date: 2011-01-17
End date: 2011-07-01
Ultram
Dosage: 100 mg, 3x/day
Indication: Fibromyalgia
Zoloft
Dosage: 1.5 mg tab daily
Administration route: Oral
Indication: Depression
Start date: 2011-07-01
Other drugs received by patient: Levothyroxine; Hydrochlorothiazide
Possible Ultram side effects in male
Reported by a consumer/non-health professional from United States on 2012-02-28
Patient: male
Reactions: Tooth Loss, Portal Hypertension, Diabetes Mellitus, Tooth Erosion, Pain, Hepatic Lesion, Somnolence, Gynaecomastia, Malaise, Hepatic Cirrhosis, Renal Disorder, Tooth Decalcification, Pain in Extremity, Dental Caries, Gingival Disorder, Prostatic Disorder, Spleen Disorder, Prostatomegaly, Pollakiuria, Loose Tooth
Drug(s) suspected as cause:
Anexsia
Dosage: unk
Hydrocodone
Dosage: unk
Morphine Sulfate
Dosage: 20 mg, 4x/day
Indication: Pain
Morphine Sulfate
Dosage: 0.5 ml, daily
Indication: Breakthrough Pain
MS Contin
Dosage: 30 mg, 4x/day
Administration route: Oral
Indication: Pain
Oxycodone HCL
Dosage: 5 mg, unk
Oxycodone HCL
Dosage: 30 mg, unk
Percodan-Demi
Dosage: 1 df, 4x/day, prn
Indication: Pain
Ultram
Dosage: 1 df, as needed
Possible Ultram side effects in male
Reported by a consumer/non-health professional from United States on 2012-02-23
Patient: male
Reactions: Tooth Loss, Portal Hypertension, Diabetes Mellitus, Tooth Erosion, Pain, Hepatic Lesion, Somnolence, Gynaecomastia, Malaise, Hepatic Cirrhosis, Tooth Decalcification, Renal Disorder, Pain in Extremity, Dental Caries, Gingival Disorder, Prostatic Disorder, Spleen Disorder, Prostatomegaly, Pollakiuria, Loose Tooth
Drug(s) suspected as cause:
Anexsia
Indication: Product Used FOR Unknown Indication
Hydrocodone
Dosage: unk, see text
Indication: Product Used FOR Unknown Indication
Morphine Sulfate
Dosage: 20 mg, qid
Indication: Pain
Morphine Sulfate
Dosage: 0.5 ml, daily
Indication: Breakthrough Pain
MS Contin
Dosage: 30 mg, qid
Administration route: Oral
Indication: Pain
Oxycodone HCL
Dosage: 5 mg, unk
Indication: Product Used FOR Unknown Indication
Oxycodone HCL
Dosage: 30 mg, unk
Indication: Product Used FOR Unknown Indication
Percodan
Dosage: 1 tablet, qid prn
Indication: Pain
Ultram
Dosage: 1 tablet, prn
Indication: Product Used FOR Unknown Indication
Possible Ultram side effects in male
Reported by a consumer/non-health professional from United States on 2012-02-21
Patient: male
Reactions: Portal Hypertension, Renal Disorder, Pain in Extremity, Diabetes Mellitus, Pain, Hepatic Lesion, Prostatic Disorder, Somnolence, Gynaecomastia, Malaise, Spleen Disorder, Prostatomegaly, Pollakiuria, Hepatic Cirrhosis
Drug(s) suspected as cause:
Anexsia
Dosage: unk
Hydrocodone
Dosage: unk
Morphine Sulfate
Dosage: 20 mg, 4x/day
Indication: Pain
Morphine Sulfate
Dosage: 0.5 ml, daily
Indication: Breakthrough Pain
MS Contin
Dosage: 30 mg, 4x/day
Administration route: Oral
Indication: Pain
Oxycontin
Dosage: unk
End date: 2011-06-01
Percodan-Demi
Dosage: 1 df, 4x/day, prn
Indication: Pain
Ultram
Dosage: 1 df, as needed
Indication: Product Used FOR Unknown Indication
Possible Ultram side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-02-16
Patient: male
Reactions: Portal Hypertension, Renal Disorder, Pain in Extremity, Diabetes Mellitus, Pain, Hepatic Lesion, Prostatic Disorder, Somnolence, Gynaecomastia, Malaise, Spleen Disorder, Pollakiuria, Prostatomegaly, Hepatic Cirrhosis
Drug(s) suspected as cause:
Anexsia
Indication: Product Used FOR Unknown Indication
Hydrocodone
Dosage: unk, see text
Indication: Product Used FOR Unknown Indication
Morphine Sulfate
Dosage: 20 mg, qid
Indication: Pain
Morphine Sulfate
Dosage: 0.5 ml, daily
Indication: Breakthrough Pain
MS Contin
Dosage: 30 mg, qid
Administration route: Oral
Indication: Pain
Oxycontin
Dosage: unk
Indication: Product Used FOR Unknown Indication
End date: 2011-06-01
Percodan
Dosage: 1 tablet, qid prn
Indication: Pain
Ultram
Dosage: 1 tablet, prn
Indication: Product Used FOR Unknown Indication
Possible Ultram side effects in female
Reported by a consumer/non-health professional from United States on 2012-02-14
Patient: female, weighing 68.0 kg (149.7 pounds)
Reactions: Malaise, Drug Ineffective, Oedema Peripheral, Insomnia, Drug Hypersensitivity, Pain
Drug(s) suspected as cause:
Codeine Sulfate
Dosage: unk
Lyrica
Dosage: 50 mg, 3x/day
Administration route: Oral
Indication: Fibromyalgia
Start date: 2011-01-17
End date: 2011-07-01
Ultram
Dosage: 100 mg, 3x/day
Indication: Fibromyalgia
Zoloft
Dosage: unk
Indication: Depression
Start date: 2011-07-01
Other drugs received by patient: Levothyroxine; Hydrochlorothiazide
Possible Ultram side effects in female
Reported by a consumer/non-health professional from United States on 2011-12-21
Patient: female, weighing 61.7 kg (135.7 pounds)
Reactions: Product Quality Issue, Pruritus, Psychomotor Hyperactivity, Malaise, Nausea, Depression, Treatment Noncompliance, Nervousness
Drug(s) suspected as cause:
Tramadol HCL
Indication: Fibromyalgia
Ultram
Dosage: 50mg + 50mg three times daily
Administration route: Oral
Indication: Fibromyalgia
Start date: 1996-01-01
Ultram
Dosage: three times daily
Administration route: Oral
Unspecified Antidepressants
Indication: Product Used FOR Unknown Indication
Other drugs received by patient: Klonopin
Possible Ultram side effects in female
Reported by a physician from United States on 2011-12-02
Patient: female, weighing 81.2 kg (178.6 pounds)
Reactions: Weight Decreased, Pruritus, Osteoporosis, Drug Ineffective, Fall, Weight Increased, Malaise, Bone Loss, Skin Lesion, Fluid Retention, Lethargy, Restlessness, Osteopenia, Ankle Fracture, Burning Sensation, Device Failure, Insomnia, Loose Tooth
Drug(s) suspected as cause:
Remicade
Indication: Rheumatoid Arthritis
End date: 2008-01-01
Remicade
Start date: 2008-01-01
End date: 2011-07-01
Ultram
Dosage: 50-100mg/tablet/50 mg/1-2 tablets 3-4 times per day/oral
Indication: Pain
Other drugs received by patient: Aspirin; Synthroid; Aspirin; Ibuprofen; Methotrexate; Prilosec
Possible Ultram side effects in female
Reported by a consumer/non-health professional from United States on 2011-11-07
Patient: female, weighing 81.2 kg (178.6 pounds)
Reactions: Weight Decreased, Pruritus, Drug Ineffective, Osteoporosis, Fall, Weight Increased, Malaise, Bone Loss, Skin Lesion, Lethargy, Fluid Retention, Restlessness, Osteopenia, Ankle Fracture, Device Failure, Burning Sensation, Insomnia, Loose Tooth
Drug(s) suspected as cause:
Remicade
Start date: 2008-01-01
End date: 2011-07-01
Remicade
Indication: Rheumatoid Arthritis
End date: 2008-01-01
Ultram
Dosage: 50-100mg/tablet/50 mg/1-2 tablets 3-4 times per day/oral
Indication: Pain
Other drugs received by patient: Aspirin; Aspirin; Synthroid; Methotrexate; Prilosec; Ibuprofen
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