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Ultracet

Last reviewed on RxList: 7/17/2017
Ultracet Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 7/17/2017

Ultracet (tramadol and acetaminophen) is a combination medication belonging to the drug class known as nonopiod analgesic. Ultracet is prescribed for the short-term relief of moderate to moderately-severe pain. Common side effects of Ultracet include:

  • constipation
  • tiredness
  • increased sweating
  • dizziness
  • drowsiness
  • weakness
  • stomach pain
  • loss of appetite
  • dry mouth
  • blurred vision
  • nervousness
  • anxiety
  • itching, and
  • sleep problems (insomnia)

Tell your doctor if you experience serious side effects of Ultracet including seizure (convulsions); agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting; a red, blistering, peeling skin rash; shallow breathing, or weak pulse.

Ultracet usual adult dose is 2 tablets every 4-6 hours as need for pain, up to 8 tablets maximum a day. Drug interactions include carbamazepine (Tegretol), isoniazid, rifampin, and quinidine. There are no adequate studies of Ultracet in pregnant women and Ultracet is secreted in human breast milk. Safety in nursing mothers has not been established. Consult your doctor before breastfeeding.

Our Ultracet Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication. articles.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Ultracet Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using acetaminophen and tramadol and call your doctor at once if you have any of these serious side effects:

  • seizure (convulsions);
  • agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting;
  • a red, blistering, peeling skin rash; or
  • shallow breathing, weak pulse.

Less serious side effects may include:

  • dizziness, drowsiness, weakness, tired feeling;
  • stomach pain, constipation, loss of appetite;
  • dry mouth, blurred vision;
  • feeling nervous or anxious;
  • sweating, itching; or
  • sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Ultracet (Tramadol Hydrochloride and Acetaminophen Tablets)

Ultracet Professional Information

SIDE EFFECTS

The following serious adverse reactions are discussed, or described in greater detail, in other sections:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The most common incidence of treatment-emergent adverse events ( ≥ 3.0%) in subjects from clinical trials was constipation, diarrhea, nausea, somnolence, anorexia, dizziness, and sweating increased.

Table 1 shows the incidence rate of treatment-emergent adverse events reported in ≥ 2.0% of subjects over five days of ULTRACET use in clinical trials (subjects took an average of at least 6 tablets per day).

Table 1: Incidence of Treatment-Emergent Adverse Events ( ≥ 2.0%)

Body System
Preferred Term
ULTRACET
(N=142) (%)
Gastrointestinal System Disorders
  Constipation 6
  Diarrhea 3
  Nausea 3
  Dry Mouth 2
Psychiatric Disorders
  Somnolence 6
  Anorexia 3
  Insomnia 2
Central & Peripheral Nervous System
  Dizziness 3
Skin and Appendages
  Sweating Increased 4
  Pruritus 2
Reproductive Disorders, Male*
  Prostatic Disorder 2
*Number of males = 62

Incidence at least 1%, causal relationship at least possible or greater:

The following lists adverse reactions that occurred with an incidence of at least 1% in single-dose or repeated-dose clinical trials of ULTRACET.

Body as a Whole - Asthenia, fatigue, hot flushes

Central and Peripheral Nervous System - Dizziness, headache, tremor

Gastrointestinal System - Abdominal pain, constipation, diarrhea, dyspepsia, flatulence, dry mouth, nausea, vomiting

Psychiatric Disorders - Anorexia, anxiety, confusion, euphoria, insomnia, nervousness, somnolence

Skin and Appendages - Pruritus, rash, increased sweating

Selected Adverse events occurring at less than 1%:

The following lists clinically relevant adverse reactions that occurred with an incidence of less than 1% in ULTRACET clinical trials.

Body as a Whole - Chest pain, rigors, syncope, withdrawal syndrome

Cardiovascular Disorders - Hypertension, aggravated hypertension, hypotension

Central and Peripheral Nervous System - Ataxia, convulsions, hypertonia, migraine, aggravated migraine, involuntary muscle contractions, paresthesias, stupor, vertigo

Gastrointestinal System - Dysphagia, melena, tongue edema

Hearing and Vestibular Disorders - Tinnitus

Heart Rate and Rhythm Disorders - Arrhythmia, palpitation, tachycardia

Liver and Biliary System - Hepatic function abnormal

Metabolic and Nutritional Disorders - Weight decrease

Psychiatric Disorders - Amnesia, depersonalization, depression, drug abuse, emotional lability, hallucination, impotence, paroniria, abnormal thinking

Red Blood Cell Disorders - Anemia

Respiratory System - Dyspnea

Urinary System - Albuminuria, micturition disorder, oliguria, urinary retention

Vision Disorders - Abnormal vision

Postmarketing Experience

The following adverse reactions have been identified during post approval use of tramadol-containing products. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Serotonin syndrome: Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs.

Adrenal insufficiency: Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use.

Anaphylaxis: Anaphylaxis has been reported with ingredients contained in ULTRACET.

Androgen deficiency: Cases of androgen deficiency have occurred with chronic use of opioids [see CLINICAL PHARMACOLOGY].

Eye disorders - miosis, mydriasis

Metabolism and nutrition disorders - Cases of hypoglycemia have been reported very rarely in patients taking tramadol. Most reports were in patients with predisposing risk factors, including diabetes or renal insufficiency, or in elderly patients.

Nervous system disorders - movement disorder, speech disorder

Psychiatric disorders - delirium

Other clinically significant adverse experiences previously reported with tramadol hydrochloride:

Other events which have been reported with the use of tramadol products and for which a causal association has not been determined include: vasodilation, orthostatic hypotension, myocardial ischemia, pulmonary edema, allergic reactions (including anaphylaxis and urticaria, Stevens-Johnson syndrome/TENS), cognitive dysfunction, difficulty concentrating, depression, suicidal tendency, hepatitis, liver failure, and gastrointestinal bleeding. Reported laboratory abnormalities included elevated creatinine and liver function tests. Serotonin syndrome (whose symptoms may include mental status change, hyperreflexia, fever, shivering, tremor, agitation, diaphoresis, seizures, and coma) has been reported with tramadol when used concomitantly with other serotonergic agents such as SSRIs and MAOIs.

Read the entire FDA prescribing information for Ultracet (Tramadol Hydrochloride and Acetaminophen Tablets)

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