Drug information for TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
Form
Dosage
Status
Therapeutic Equivalence
Active Ingred
Ref.
Sponsor
Document
TABLET; ORAL
325MG;37.5MG
Prescription
AB
ACETAMINOPHEN
;
TRAMADOL HYDROCHLORIDE
Ultracet
ALVOGEN INC
202076
TABLET; ORAL
325MG;37.5MG
Prescription
AB
ACETAMINOPHEN
;
TRAMADOL HYDROCHLORIDE
Ultracet
PAR PHARM
76475
2005-04-28 Letter
TABLET; ORAL
325MG;37.5MG
Prescription
AB
ACETAMINOPHEN
;
TRAMADOL HYDROCHLORIDE
Ultracet
WATSON LABS
76914
TABLET; ORAL
325MG;37.5MG
Prescription
AB
ACETAMINOPHEN
;
TRAMADOL HYDROCHLORIDE
Ultracet
CARACO
77184
TABLET; ORAL
325MG;37.5MG
Prescription
AB
ACETAMINOPHEN
;
TRAMADOL HYDROCHLORIDE
Ultracet
MYLAN
77858
2008-10-01 Letter
TABLET; ORAL
325MG;37.5MG
Prescription
AB
ACETAMINOPHEN
;
TRAMADOL HYDROCHLORIDE
Ultracet
AMNEAL PHARMS
90485
Drug Adverse Effects information for TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
Role code
Indications
Reaction
# Reports
PS
ANALGESIC THERAPY
FEELING ABNORMAL
1
PS
ANALGESIC THERAPY
HYPERHIDROSIS
1
PS
ANALGESIC THERAPY
LOSS OF CONSCIOUSNESS
1
PS
ANALGESIC THERAPY
MALAISE
1
PS
ARTHRALGIA
POLLAKIURIA
4
PS
ARTHRALGIA
SOMNOLENCE
4
PS
AUTOIMMUNE THYROIDITIS
ANXIETY
1
PS
AUTOIMMUNE THYROIDITIS
ASTHENIA
1
PS
AUTOIMMUNE THYROIDITIS
ATAXIA
1
PS
AUTOIMMUNE THYROIDITIS
COGNITIVE DISORDER
1
PS
AUTOIMMUNE THYROIDITIS
CONFUSIONAL STATE
1
PS
AUTOIMMUNE THYROIDITIS
CONSTIPATION
1
PS
AUTOIMMUNE THYROIDITIS
DEPRESSION
1
PS
AUTOIMMUNE THYROIDITIS
DIPLOPIA
1
PS
AUTOIMMUNE THYROIDITIS
DIZZINESS
1
PS
AUTOIMMUNE THYROIDITIS
FATIGUE
1
PS
AUTOIMMUNE THYROIDITIS
HEADACHE
1
PS
AUTOIMMUNE THYROIDITIS
NAUSEA
1
PS
AUTOIMMUNE THYROIDITIS
OEDEMA
1
PS
AUTOIMMUNE THYROIDITIS
PAIN
1
PS
AUTOIMMUNE THYROIDITIS
PRURITUS
1
PS
AUTOIMMUNE THYROIDITIS
SEDATION
1
PS
AUTOIMMUNE THYROIDITIS
SYNCOPE
1
PS
AUTOIMMUNE THYROIDITIS
TREATMENT FAILURE
1
PS
AUTOIMMUNE THYROIDITIS
VOMITING
1
PS
HYPOTHYROIDISM
ANXIETY
1
PS
HYPOTHYROIDISM
ASTHENIA
1
PS
HYPOTHYROIDISM
ATAXIA
1
PS
HYPOTHYROIDISM
COGNITIVE DISORDER
1
PS
HYPOTHYROIDISM
CONFUSIONAL STATE
1
PS
HYPOTHYROIDISM
CONSTIPATION
1
PS
HYPOTHYROIDISM
DEPRESSION
1
PS
HYPOTHYROIDISM
DIPLOPIA
1
PS
HYPOTHYROIDISM
DIZZINESS
1
PS
HYPOTHYROIDISM
FATIGUE
1
PS
HYPOTHYROIDISM
HEADACHE
1
PS
HYPOTHYROIDISM
NAUSEA
1
PS
HYPOTHYROIDISM
OEDEMA
1
PS
HYPOTHYROIDISM
PAIN
1
PS
HYPOTHYROIDISM
PRURITUS
1
PS
HYPOTHYROIDISM
SEDATION
1
PS
HYPOTHYROIDISM
SYNCOPE
1
PS
HYPOTHYROIDISM
TREATMENT FAILURE
1
PS
HYPOTHYROIDISM
VOMITING
1
PS
ILL-DEFINED DISORDER
ACUTE RESPIRATORY FAILURE
2
PS
ILL-DEFINED DISORDER
DYSPHAGIA
2
PS
ILL-DEFINED DISORDER
DYSPNOEA
2
PS
ILL-DEFINED DISORDER
SPEECH DISORDER
2
PS
PAIN
DYSURIA
1
PS
PAIN
POLLAKIURIA
3
PS
PAIN
SOMNOLENCE
2
PS
POLLAKIURIA
POLLAKIURIA
2
PS
POLLAKIURIA
SOMNOLENCE
2
PS
PROCEDURAL PAIN
FEELING ABNORMAL
1
PS
PROCEDURAL PAIN
HYPERHIDROSIS
1
PS
PROCEDURAL PAIN
LOSS OF CONSCIOUSNESS
1
PS
PROCEDURAL PAIN
MALAISE
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
ANXIETY
19
PS
PRODUCT USED FOR UNKNOWN INDICATION
APHASIA
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
ASTHENIA
19
PS
PRODUCT USED FOR UNKNOWN INDICATION
ASTHMA
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
ATAXIA
20
PS
PRODUCT USED FOR UNKNOWN INDICATION
CARDIO-RESPIRATORY ARREST
5
PS
PRODUCT USED FOR UNKNOWN INDICATION
COGNITIVE DISORDER
19
PS
PRODUCT USED FOR UNKNOWN INDICATION
COMPLETED SUICIDE
5
PS
PRODUCT USED FOR UNKNOWN INDICATION
CONFUSIONAL STATE
19
PS
PRODUCT USED FOR UNKNOWN INDICATION
CONSTIPATION
19
PS
PRODUCT USED FOR UNKNOWN INDICATION
DEATH
5
PS
PRODUCT USED FOR UNKNOWN INDICATION
DEPRESSION
19
PS
PRODUCT USED FOR UNKNOWN INDICATION
DIPLOPIA
19
PS
PRODUCT USED FOR UNKNOWN INDICATION
DIZZINESS
19
PS
PRODUCT USED FOR UNKNOWN INDICATION
FATIGUE
19
PS
PRODUCT USED FOR UNKNOWN INDICATION
FEELING ABNORMAL
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
HEADACHE
19
PS
PRODUCT USED FOR UNKNOWN INDICATION
HYPERHIDROSIS
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
LOSS OF CONSCIOUSNESS
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
MALAISE
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
MATERNAL EXPOSURE DURING PREGNANCY
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
NAUSEA
19
PS
PRODUCT USED FOR UNKNOWN INDICATION
OEDEMA
19
PS
PRODUCT USED FOR UNKNOWN INDICATION
PAIN
19
PS
PRODUCT USED FOR UNKNOWN INDICATION
POLLAKIURIA
2
PS
PRODUCT USED FOR UNKNOWN INDICATION
PRURITUS
19
PS
PRODUCT USED FOR UNKNOWN INDICATION
SEDATION
19
PS
PRODUCT USED FOR UNKNOWN INDICATION
SOMNOLENCE
2
PS
PRODUCT USED FOR UNKNOWN INDICATION
SYNCOPE
19
PS
PRODUCT USED FOR UNKNOWN INDICATION
TREATMENT FAILURE
19
PS
PRODUCT USED FOR UNKNOWN INDICATION
VOMITING
19
SS
ANAEMIA
PULMONARY OEDEMA
2
SS
ANAEMIA
RESPIRATORY FAILURE
2
SS
ARTHRALGIA
ABDOMINAL PAIN UPPER
2
SS
ARTHRALGIA
ARTERIOSCLEROSIS
1
SS
ARTHRALGIA
ARTHRALGIA
2
SS
ARTHRALGIA
ARTHRITIS
2
SS
ARTHRALGIA
DRUG INEFFECTIVE
2
SS
ARTHRALGIA
DRY MOUTH
2
SS
ARTHRALGIA
DYSPEPSIA
2
SS
ARTHRALGIA
GAIT DISTURBANCE
2
SS
ARTHRALGIA
GASTRIC DISORDER
2
SS
ARTHRALGIA
INFLUENZA
2
SS
ARTHRALGIA
JOINT INJURY
2
SS
ARTHRALGIA
PAIN
2
SS
ARTHRALGIA
PAIN IN EXTREMITY
2
SS
ARTHRALGIA
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE
1
SS
ARTHRALGIA
POLLAKIURIA
28
SS
ARTHRALGIA
RHEUMATOID ARTHRITIS
2
SS
ARTHRALGIA
SOMNOLENCE
28
SS
ARTHRALGIA
STOMATITIS
2
SS
ARTHRALGIA
WEIGHT DECREASED
2
SS
ATRIAL FIBRILLATION
PNEUMONIA
1
SS
AUTOIMMUNE THYROIDITIS
ANXIETY
1
SS
AUTOIMMUNE THYROIDITIS
ASTHENIA
1
SS
AUTOIMMUNE THYROIDITIS
ATAXIA
1
SS
AUTOIMMUNE THYROIDITIS
COGNITIVE DISORDER
1
SS
AUTOIMMUNE THYROIDITIS
CONFUSIONAL STATE
1
SS
AUTOIMMUNE THYROIDITIS
CONSTIPATION
1
SS
AUTOIMMUNE THYROIDITIS
DEPRESSION
1
SS
AUTOIMMUNE THYROIDITIS
DIPLOPIA
1
SS
AUTOIMMUNE THYROIDITIS
DIZZINESS
1
SS
AUTOIMMUNE THYROIDITIS
FATIGUE
1
SS
AUTOIMMUNE THYROIDITIS
HEADACHE
1
SS
AUTOIMMUNE THYROIDITIS
NAUSEA
1
SS
AUTOIMMUNE THYROIDITIS
OEDEMA
1
SS
AUTOIMMUNE THYROIDITIS
PAIN
1
SS
AUTOIMMUNE THYROIDITIS
PRURITUS
1
SS
AUTOIMMUNE THYROIDITIS
SEDATION
1
SS
AUTOIMMUNE THYROIDITIS
SYNCOPE
1
SS
AUTOIMMUNE THYROIDITIS
TREATMENT FAILURE
1
SS
AUTOIMMUNE THYROIDITIS
VOMITING
1
SS
BACK PAIN
PAIN
2
SS
BACK PAIN
PULMONARY OEDEMA
4
SS
BACK PAIN
RESPIRATORY FAILURE
4
SS
HYPOTHYROIDISM
ANXIETY
1
SS
HYPOTHYROIDISM
ASTHENIA
1
SS
HYPOTHYROIDISM
ATAXIA
1
SS
HYPOTHYROIDISM
COGNITIVE DISORDER
1
SS
HYPOTHYROIDISM
CONFUSIONAL STATE
1
SS
HYPOTHYROIDISM
CONSTIPATION
1
SS
HYPOTHYROIDISM
DEPRESSION
1
SS
HYPOTHYROIDISM
DIPLOPIA
1
SS
HYPOTHYROIDISM
DIZZINESS
1
SS
HYPOTHYROIDISM
FATIGUE
1
SS
HYPOTHYROIDISM
HEADACHE
1
SS
HYPOTHYROIDISM
NAUSEA
1
SS
HYPOTHYROIDISM
OEDEMA
1
SS
HYPOTHYROIDISM
PAIN
1
SS
HYPOTHYROIDISM
PRURITUS
1
SS
HYPOTHYROIDISM
SEDATION
1
SS
HYPOTHYROIDISM
SYNCOPE
1
SS
HYPOTHYROIDISM
TREATMENT FAILURE
1
SS
HYPOTHYROIDISM
VOMITING
1
SS
ILL-DEFINED DISORDER
ACUTE RESPIRATORY FAILURE
2
SS
ILL-DEFINED DISORDER
DYSPHAGIA
2
SS
ILL-DEFINED DISORDER
DYSPNOEA
2
SS
ILL-DEFINED DISORDER
SPEECH DISORDER
2
SS
PAIN
ASTHENIA
55
SS
PAIN
ATAXIA
55
SS
PAIN
CONFUSIONAL STATE
55
SS
PAIN
CONSTIPATION
55
SS
PAIN
DIPLOPIA
55
SS
PAIN
DIZZINESS
55
SS
PAIN
DRUG INTERACTION
55
SS
PAIN
DYSURIA
1
SS
PAIN
FATIGUE
55
SS
PAIN
GASTROINTESTINAL MOTILITY DISORDER
55
SS
PAIN
HEADACHE
55
SS
PAIN
NAUSEA
55
SS
PAIN
OEDEMA
55
SS
PAIN
POLLAKIURIA
15
SS
PAIN
PRURITUS
55
SS
PAIN
PULMONARY OEDEMA
4
SS
PAIN
RESPIRATORY FAILURE
4
SS
PAIN
SEDATION
55
SS
PAIN
SOMNOLENCE
14
SS
PAIN
SYNCOPE
55
SS
PAIN
VOMITING
55
SS
POLLAKIURIA
POLLAKIURIA
14
SS
POLLAKIURIA
SOMNOLENCE
14
SS
PRODUCT USED FOR UNKNOWN INDICATION
ANXIETY
19
SS
PRODUCT USED FOR UNKNOWN INDICATION
ASTHENIA
19
SS
PRODUCT USED FOR UNKNOWN INDICATION
ATAXIA
19
SS
PRODUCT USED FOR UNKNOWN INDICATION
COGNITIVE DISORDER
19
SS
PRODUCT USED FOR UNKNOWN INDICATION
CONFUSIONAL STATE
19
SS
PRODUCT USED FOR UNKNOWN INDICATION
CONSTIPATION
19
SS
PRODUCT USED FOR UNKNOWN INDICATION
DEPRESSION
19
SS
PRODUCT USED FOR UNKNOWN INDICATION
DIPLOPIA
19
SS
PRODUCT USED FOR UNKNOWN INDICATION
DIZZINESS
19
SS
PRODUCT USED FOR UNKNOWN INDICATION
FATIGUE
19
SS
PRODUCT USED FOR UNKNOWN INDICATION
HEADACHE
19
SS
PRODUCT USED FOR UNKNOWN INDICATION
NAUSEA
19
SS
PRODUCT USED FOR UNKNOWN INDICATION
OEDEMA
19
SS
PRODUCT USED FOR UNKNOWN INDICATION
PAIN
20
SS
PRODUCT USED FOR UNKNOWN INDICATION
POLLAKIURIA
14
SS
PRODUCT USED FOR UNKNOWN INDICATION
PRURITUS
19
SS
PRODUCT USED FOR UNKNOWN INDICATION
SEDATION
19
SS
PRODUCT USED FOR UNKNOWN INDICATION
SOMNOLENCE
14
SS
PRODUCT USED FOR UNKNOWN INDICATION
SYNCOPE
19
SS
PRODUCT USED FOR UNKNOWN INDICATION
TREATMENT FAILURE
19
SS
PRODUCT USED FOR UNKNOWN INDICATION
VOMITING
19
SS
RHEUMATOID ARTHRITIS
ABDOMINAL PAIN UPPER
6
SS
RHEUMATOID ARTHRITIS
ARTERIOSCLEROSIS
3
SS
RHEUMATOID ARTHRITIS
ARTHRALGIA
6
SS
RHEUMATOID ARTHRITIS
ARTHRITIS
6
SS
RHEUMATOID ARTHRITIS
DRUG INEFFECTIVE
6
SS
RHEUMATOID ARTHRITIS
DRY MOUTH
6
SS
RHEUMATOID ARTHRITIS
DYSPEPSIA
6
SS
RHEUMATOID ARTHRITIS
GAIT DISTURBANCE
6
SS
RHEUMATOID ARTHRITIS
GASTRIC DISORDER
6
SS
RHEUMATOID ARTHRITIS
INFLUENZA
6
SS
RHEUMATOID ARTHRITIS
JOINT INJURY
6
SS
RHEUMATOID ARTHRITIS
PAIN
6
SS
RHEUMATOID ARTHRITIS
PAIN IN EXTREMITY
6
SS
RHEUMATOID ARTHRITIS
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE
3
SS
RHEUMATOID ARTHRITIS
RHEUMATOID ARTHRITIS
6
SS
RHEUMATOID ARTHRITIS
STOMATITIS
6
SS
RHEUMATOID ARTHRITIS
WEIGHT DECREASED
6
SS
SPINAL COLUMN STENOSIS
PNEUMONIA
1
C
ANTIFUNGAL PROPHYLAXIS
DECREASED APPETITE
1
C
ANTIFUNGAL PROPHYLAXIS
HYPONATRAEMIA
1
C
ANTIFUNGAL PROPHYLAXIS
SOMNOLENCE
1
C
COMPLEX REGIONAL PAIN SYNDROME
DECREASED APPETITE
2
C
COMPLEX REGIONAL PAIN SYNDROME
HYPONATRAEMIA
2
C
COMPLEX REGIONAL PAIN SYNDROME
SOMNOLENCE
2
C
FIBROMYALGIA
PROTEINURIA
1
C
FIBROMYALGIA
SOMNOLENCE
1
C
GASTRIC MUCOSAL LESION
DECREASED APPETITE
2
C
GASTRIC MUCOSAL LESION
HYPONATRAEMIA
2
C
GASTRIC MUCOSAL LESION
SOMNOLENCE
2
C
GASTROINTESTINAL DISORDER
DECREASED APPETITE
2
C
GASTROINTESTINAL DISORDER
HYPONATRAEMIA
2
C
GASTROINTESTINAL DISORDER
SOMNOLENCE
2
C
GASTROOESOPHAGEAL REFLUX DISEASE
DECREASED APPETITE
2
C
GASTROOESOPHAGEAL REFLUX DISEASE
HYPONATRAEMIA
2
C
GASTROOESOPHAGEAL REFLUX DISEASE
SOMNOLENCE
2
C
HYPERLIPIDAEMIA
ACUTE RESPIRATORY FAILURE
4
C
HYPERLIPIDAEMIA
AORTIC ANEURYSM
4
C
HYPERLIPIDAEMIA
CYST
4
C
HYPERLIPIDAEMIA
MULTI-ORGAN FAILURE
2
C
HYPERLIPIDAEMIA
OFF LABEL USE
4
C
HYPERLIPIDAEMIA
PANCREATITIS ACUTE
4
C
HYPERLIPIDAEMIA
PANCREATITIS CHRONIC
4
C
HYPERLIPIDAEMIA
PNEUMONIA STAPHYLOCOCCAL
2
C
HYPERLIPIDAEMIA
PROTEINURIA
1
C
HYPERLIPIDAEMIA
PYREXIA
4
C
HYPERLIPIDAEMIA
RENAL FAILURE
4
C
HYPERLIPIDAEMIA
SOMNOLENCE
1
C
HYPERTENSION
ANURIA
1
C
HYPERTENSION
CONFUSIONAL STATE
1
C
HYPERTENSION
DECREASED APPETITE
1
C
HYPERTENSION
DRUG ADMINISTRATION ERROR
1
C
HYPERTENSION
HYPONATRAEMIA
1
C
HYPERTENSION
HYPOTENSION
1
C
HYPERTENSION
PLEURISY
1
C
HYPERTENSION
PROTEINURIA
2
C
HYPERTENSION
SOMNOLENCE
3
C
HYPERTENSION
SOPOR
1
C
HYPERTENSION
URINARY RETENTION
1
C
INFECTION PROPHYLAXIS
DECREASED APPETITE
1
C
INFECTION PROPHYLAXIS
HYPONATRAEMIA
1
C
INFECTION PROPHYLAXIS
SOMNOLENCE
1
C
METASTATIC RENAL CELL CARCINOMA
FALL
2
C
METASTATIC RENAL CELL CARCINOMA
HYPOTENSION
2
C
METASTATIC RENAL CELL CARCINOMA
WRONG DRUG ADMINISTERED
2
C
NEUROPATHY PERIPHERAL
ABDOMINAL PAIN UPPER
1
C
NEUROPATHY PERIPHERAL
ASTHENIA
1
C
NEUROPATHY PERIPHERAL
CHEST PAIN
1
C
NEUROPATHY PERIPHERAL
DECREASED APPETITE
1
C
NEUROPATHY PERIPHERAL
DYSPNOEA
1
C
NEUROPATHY PERIPHERAL
NEUTROPENIA
1
C
NEUROPATHY PERIPHERAL
PALPITATIONS
1
C
OSTEOPOROSIS PROPHYLAXIS
DECREASED APPETITE
1
C
OSTEOPOROSIS PROPHYLAXIS
HYPONATRAEMIA
1
C
OSTEOPOROSIS PROPHYLAXIS
SOMNOLENCE
1
C
PAIN
ABDOMINAL PAIN UPPER
1
C
PAIN
ASTHENIA
1
C
PAIN
CHEST PAIN
1
C
PAIN
DECREASED APPETITE
7
C
PAIN
DYSPNOEA
1
C
PAIN
HYPONATRAEMIA
6
C
PAIN
NEUTROPENIA
1
C
PAIN
PALPITATIONS
1
C
PAIN
SOMNOLENCE
6
C
PARKINSON'S DISEASE
ANURIA
1
C
PARKINSON'S DISEASE
CONFUSIONAL STATE
1
C
PARKINSON'S DISEASE
DRUG ADMINISTRATION ERROR
1
C
PARKINSON'S DISEASE
HYPOTENSION
1
C
PARKINSON'S DISEASE
PLEURISY
1
C
PARKINSON'S DISEASE
SOPOR
1
C
PARKINSON'S DISEASE
URINARY RETENTION
1
C
PRODUCT USED FOR UNKNOWN INDICATION
FALL
2
C
PRODUCT USED FOR UNKNOWN INDICATION
HYPOTENSION
2
C
PRODUCT USED FOR UNKNOWN INDICATION
WRONG DRUG ADMINISTERED
2
C
PROPHYLAXIS
DECREASED APPETITE
6
C
PROPHYLAXIS
HYPONATRAEMIA
6
C
PROPHYLAXIS
SOMNOLENCE
6
C
PROPHYLAXIS OF NAUSEA AND VOMITING
DECREASED APPETITE
1
C
PROPHYLAXIS OF NAUSEA AND VOMITING
HYPONATRAEMIA
1
C
PROPHYLAXIS OF NAUSEA AND VOMITING
SOMNOLENCE
1
C
RHEUMATOID ARTHRITIS
BACK PAIN
2
C
RHEUMATOID ARTHRITIS
GALLBLADDER DISORDER
1
C
RHEUMATOID ARTHRITIS
INJECTION SITE PAIN
2
C
RHEUMATOID ARTHRITIS
IRRITABLE BOWEL SYNDROME
2
C
RHEUMATOID ARTHRITIS
JOINT LOCK
2
C
SCIATICA
BLOOD PRESSURE INCREASED
2
C
SCIATICA
DIZZINESS
2
C
SCLERODERMA
DECREASED APPETITE
2
C
SCLERODERMA
HYPONATRAEMIA
2
C
SCLERODERMA
SOMNOLENCE
2
C
SLEEP DISORDER
DECREASED APPETITE
2
C
SLEEP DISORDER
HYPONATRAEMIA
2
C
SLEEP DISORDER
SOMNOLENCE
2
C
TYPE 1 DIABETES MELLITUS
PROTEINURIA
1
C
TYPE 1 DIABETES MELLITUS
SOMNOLENCE
1
C
VASCULITIS
DECREASED APPETITE
1
C
VASCULITIS
HYPONATRAEMIA
1
C
VASCULITIS
SOMNOLENCE
1
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