Orbivan Side Effects Center

Last updated on RxList: 8/24/2017
Orbivan Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Orbivan (butalbital, acetaminophen, and caffeine) is a combination of a barbiturate, an analgesic and fever-reducer, and a central nervous system stimulant indicated for the relief of the symptom complex of tension (muscle contraction) headache. Orbivan is available as a generic.

Common side effects of Orbivan include:

  • drowsiness
  • lightheadedness
  • dizziness
  • sedation
  • shortness of breath
  • nausea
  • vomiting
  • abdominal pain
  • intoxicated feeling
  • constipation
  • dry mouth
  • shaking (tremor)
  • increased urination
  • lightheadedness, or
  • rouble sleeping

Seek medical care or call 911 at once if you have the following serious side effects:

  • Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
  • Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheartedness, or passing out;
  • Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

Dosage

  • Orbivan is available in capsules; each capsule contains strengths of butalbital, 50 mg, acetaminophen, 300 mg and caffeine, 40 mg.
  • Orbivan should be taken as 1 or 2 capsules every 4 hours as needed.
  • Total daily dosage should not exceed 6 capsules.
  • Extended and repeated use of this product is not recommended because of the potential for physical dependence.

Adverse Reactions

Serious side effects of Orbivan may occur. Patients should be advised that butalbital is habit-forming and potentially abusable. Butalbital, acetaminophen, and caffeine may enhance the effects of other narcotic analgesics, alcohol, general anesthetics, tranquilizers, sedative-hypnotics, or other central nervous system (CNS) depressants, causing increased CNS depression. Components of this drug, acetaminophen and caffeine, can be reviewed in our Side Effects Drug Center. It is also not known whether Orbivan can cause fetal harm when administered to a pregnant woman.

Warnings

Orbivan should be given to a pregnant woman only when clearly needed. Withdrawal seizures were reported in a two-day-old male infant whose mother had taken a butalbital-containing drug during the last two months of pregnancy. Caffeine, barbiturates, and acetaminophen are excreted in breast milk in small amounts, but the significance of their effects on nursing infants is not known. Because of potential for serious adverse reactions in nursing infants from butalbital, acetaminophen, and caffeine, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Safety and effectiveness in pediatric patients below the age of 12 have not been established for Orbivan.

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.

QUESTION

Who suffers more frequently from migraine headaches? See Answer
Orbivan Consumer Information

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

In rare cases, acetaminophen may cause a severe skin reaction that can be fatal. This could occur even if you have taken acetaminophen in the past and had no reaction. Stop taking this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling. If you have this type of reaction, you should never again take any medicine that contains acetaminophen.

Stop using this medicine and call your doctor at once if you have:

  • confusion, a seizure;
  • shortness of breath;
  • a light-headed feeling, like you might pass out; or
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects may include:

  • drowsiness, dizziness;
  • feeling light-headed;
  • nausea, vomiting, stomach pain;
  • drunk feeling; or
  • shortness of breath.

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.

SLIDESHOW

16 Surprising Headache Triggers and Tips for Pain Relief See Slideshow
Orbivan Professional Information

SIDE EFFECTS

Frequently Observed

The most frequently reported adverse reactions are drowsiness, lightheadedness, dizziness, sedation, shortness of breath, nausea, vomiting, abdominal pain, and intoxicated feeling.

Infrequently Observed

All adverse events tabulated below are classified as infrequent.

Central Nervous System: headache, shaky feeling, tingling, agitation, fainting, fatigue, heavy eyelids, high energy, hot spells, numbness, sluggishness, seizure. Mental confusion, excitement, or depression can also occur due to intolerance, particularly in elderly or debilitated patients, or due to overdosage of butalbital.

Autonomic Nervous System: dry mouth, hyperhidrosis.

Gastrointestinal: difficulty swallowing, heartburn, flatulence, constipation.

Cardiovascular: tachycardia.

Musculoskeletal: leg pain, muscle fatigue. Genitourinary: diuresis.

Miscellaneous: pruritus, fever, earache, nasal congestion, tinnitus, euphoria, allergic reactions.

Several cases of dermatological reactions, including toxic epidermal necrolysis and erythema multiforme, have been reported.

The following adverse drug events may be borne in mind as potential effects of the components of this product. Potential effects of high dosage are listed in the OVERDOSAGE section.

Acetaminophen: allergic reactions, rash, thrombocytopenia, agranulocytosis.

Caffeine: cardiac stimulation, irritability, tremor, dependence, nephrotoxicity, hyperglycemia.

Drug Abuse And Dependence

Abuse and Dependence

Butalbital

Barbiturates may be habit-forming: Tolerance, psychological dependence, and physical dependence may occur especially following prolonged use of high doses of barbiturates. The average daily dose for the barbiturate addict is usually about 1500 mg. As tolerance to barbiturates develops, the amount needed to maintain the same level of intoxication increases; tolerance to a fatal dosage, however, does not increase more than two-fold. As this occurs, the margin between an intoxication dosage and fatal dosage becomes smaller. The lethal dose of a barbiturate is far less if alcohol is also ingested. Major withdrawal symptoms (convulsions and delirium) may occur within 16 hours and last up to 5 days after abrupt cessation of these drugs. Intensity of withdrawal symptoms gradually declines over a period of approximately 15 days. Treatment of barbiturate dependence consists of cautious and gradual withdrawal of the drug. Barbiturate-dependent patients can be withdrawn by using a number of different withdrawal regimens. One method involves initiating treatment at the patient's regular dosage level and gradually decreasing the daily dosage as tolerated by the patient.

Read the entire FDA prescribing information for Orbivan (Butalbital, Acetaminophen, and Caffeine Capsules, USP)

© Orbivan Patient Information is supplied by Cerner Multum, Inc. and Orbivan Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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