This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Ultram ER (Tramadol) 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 (8)
Reports by Reaction Type
Drug Ineffective (5),
Hypersensitivity (3),
Pruritus (3),
Pain (3),
Skin Burning Sensation (3),
Myalgia (3),
Hypersomnia (3),
Arthralgia (3),
Drug Dose Omission (2),
Neck Pain (2),
Therapy Cessation (2),
Myocardial Infarction (2)
Possible Ultram ER side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-28
Patient: female, weighing 56.7 kg (124.7 pounds)
Reactions: Intervertebral Disc Protrusion, Neck Pain, Drug Ineffective, Maternal Exposure During Pregnancy
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Ultram ER
Dosage: once daily (200 mg out of 300 mg)
Administration route: Oral
Norco
Indication: Neck Pain
Ultram ER
Dosage: once daily (100 mg out of 300 mg)
Administration route: Oral
Indication: Back Pain
Possible Ultram ER side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-22
Patient: female, weighing 56.7 kg (124.7 pounds)
Reactions: Intervertebral Disc Protrusion, Drug Ineffective, Neck Pain, Maternal Exposure During Pregnancy
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Norco
Indication: Neck Pain
Ultram ER
Dosage: once daily (100 mg out of 300 mg)
Administration route: Oral
Indication: Back Pain
Ultram ER
Dosage: once daily (200 mg out of 300 mg)
Administration route: Oral
Possible Ultram ER side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-14
Patient: female, weighing 54.4 kg (119.7 pounds)
Reactions: Drug Dose Omission, Therapy Cessation, Withdrawal Syndrome, Myocardial Infarction
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Ultram ER
Other drugs received by patient: Humalog
Possible Ultram ER side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-06
Patient: female, weighing 54.4 kg (119.7 pounds)
Reactions: Drug Dose Omission, Therapy Cessation, Withdrawal Syndrome, Myocardial Infarction
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Ultram ER
Other drugs received by patient: Humalog
Possible Ultram ER side effects in female
Reported by a physician from United States on 2012-03-29
Patient: female, weighing 87.5 kg (192.6 pounds)
Reactions: Myalgia, Pruritus, Hypersensitivity, Drug Ineffective, Arthralgia, Pain, Skin Burning Sensation, Hypersomnia
Drug(s) suspected as cause:
Benadryl
Dosage: 25 mg, unk
Administration route: Oral
Codeine Sulfate
Dosage: unk
Lyrica
Dosage: 150 mg, 2x/day
Administration route: Oral
Indication: Fibromyalgia
Start date: 2011-08-01
End date: 2012-02-01
Hydrocodone Bitartrate
Dosage: unk
Ultram ER
Dosage: 100 mg, 2x/day
Administration route: Oral
Indication: Fibromyalgia
Other drugs received by patient: Levothyroxine; Bisoprolol Fumarate and Hydrochlorothiazide; Aldactone; Metformin; Glimepiride
Possible Ultram ER side effects in female
Reported by a consumer/non-health professional from United States on 2012-03-06
Patient: female, weighing 87.5 kg (192.6 pounds)
Reactions: Myalgia, Pruritus, Hypersensitivity, Drug Ineffective, Arthralgia, Pain, Skin Burning Sensation, Hypersomnia
Drug(s) suspected as cause:
Hydrocodone Bitartrate
Dosage: unk
Benadryl
Dosage: 25 mg, unk
Administration route: Oral
Codeine Sulfate
Dosage: unk
Lyrica
Dosage: 150 mg, 2x/day
Administration route: Oral
Indication: Fibromyalgia
Start date: 2011-08-01
End date: 2012-02-01
Ultram ER
Dosage: 100 mg, 2x/day
Administration route: Oral
Indication: Fibromyalgia
Other drugs received by patient: Levothyroxine; Aldactone; Metformin; Glimepiride; Bisoprolol Fumarate and Hydrochlorothiazide
Possible Ultram ER side effects in female
Reported by a consumer/non-health professional from United States on 2012-03-02
Patient: female, weighing 87.5 kg (192.6 pounds)
Reactions: Myalgia, Pruritus, Hypersensitivity, Drug Ineffective, Arthralgia, Pain, Skin Burning Sensation, Hypersomnia
Drug(s) suspected as cause:
Benadryl
Dosage: 25 mg, unk
Administration route: Oral
Ultram ER
Dosage: 100 mg, 2x/day
Administration route: Oral
Indication: Fibromyalgia
Lyrica
Dosage: 150 mg, 2x/day
Administration route: Oral
Indication: Fibromyalgia
Start date: 2011-08-01
End date: 2012-02-01
Codeine Sulfate
Dosage: unk
Hydrocodone Bitartrate
Dosage: unk
Other drugs received by patient: Bisoprolol Fumarate and Hydrochlorothiazide; Metformin; Glimepiride; Levothyroxine; Aldactone
Possible Ultram ER side effects in 21 year old female
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2011-10-11
Patient: 21 year old female
Reactions: Pituitary Tumour Benign, Adrenal Insufficiency
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Metoclopramide
Dosage: 3 times a day
Indication: Product Used FOR Unknown Indication
Ultram ER
Dosage: 3 doses a day
Ultram ER
Dosage: once a day
Indication: Abdominal Pain
Other drugs received by patient: Ibuprofen; Sumatriptan Succinate; Omeprazole; Cyclizine
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