Last updated on RxList: 12/18/2018
Equetro Side Effects Center

Last reviewed on RxList 12/18/2018

Equetro (carbamazepine xr) is an anticonvulsant (anti-seizure) medication used to treat seizures and nerve pain such as trigeminal neuralgia and diabetic neuropathy. Equetro is also used to treat bipolar disorder. Common side effects of Equetro include nausea, vomiting, dizziness, drowsiness, unsteadiness, dry mouth, swollen tongue, or loss of balance or coordination as your body adjusts to this medication.

The recommended initial dose of Equetro is 400 mg/day given in divided doses, twice daily. Many other medicines could cause a drug interaction if taken together with Equetro. Tell your doctor all medications and supplements you use. During pregnancy, Equetro should be used only when prescribed. It may harm a fetus. Since untreated bipolar disorder or seizures can be serious conditions, do not stop taking this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, consult your doctor. If you are pregnant, prenatal care including tests for defects is recommended. Birth control pills, patches, implants, and injections may not work if taken with this medication. Discuss birth control with your doctor. This medication passes into breast milk. Consult your doctor before breastfeeding.

Our Equetro (carbamazepine xr) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.


What Is Bipolar Disorder? Symptoms, Manic Episodes, Testing See Slideshow
Equetro Consumer Information

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Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Report any new or worsening symptoms to your doctor, such as: sudden mood or behavior changes, depression, anxiety, insomnia, or if you feel agitated, hostile, restless, irritable, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

  • a skin rash, no matter how mild;
  • loss of appetite, right-sided upper stomach pain, dark urine;
  • slow, fast, or pounding heartbeats;
  • anemia or other blood problems--fever, chills, sore throat, mouth sores, bleeding gums, nosebleeds, pale skin, easy bruising, unusual tiredness, feeling light-headed or short of breath; or
  • low levels of sodium in the body--headache, confusion, severe weakness, feeling unsteady, increased seizures.

Common side effects may include:

  • dizziness, loss of coordination, problems with walking;
  • nausea, vomiting; or
  • drowsiness.

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 Equetro (Carbamazepine XR)


Another term that has been previously used for bipolar disorder is ___________________. See Answer
Equetro Professional Information


The following serious adverse reactions are discussed in more detail in other sections of the labeling:

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 clinical practice.

The most commonly reported adverse reactions (>5% in the EQUETRO group and at least twice placebo) in the pooled 3-week placebo-controlled trials in patients with acute mania associated with Bipolar I Disorder (Studies 1 and 2) were dizziness, somnolence, nausea, vomiting, ataxia, constipation, pruritus, dry mouth, asthenia, blurred vision, and speech disorder [see Clinical Studies]. The EQUETRO doses used were 400 to 1600 mg per day.

Table 2. Common Adverse Reactions Reported in Bipolar Disorder Studies 1 and 2 (Incidence > 2% and greater than placebo)

Adverse Reactions EQUETRO®
(N = 251)
(N = 248)
Dizziness 44% 12%
Somnolence 32% 13%
Nausea 29% 10%
Vomiting 18% 3%
Ataxia 15% 0.4%
Constipation 10% 5%
Pruritus 8% 2%
Dry Mouth 8% 3%
Asthenia 8% 4%
Rash 7% 4%
Blurred vision 6% 2%
Speech Disorder 6% 0.4%
Hypertension 3% 0.4%
Paresthesia 2% 1%
Thinking abnormal 2% 0.4%
Tremor 3% 1%
Twitching 2% 1%
Vertigo 2% 1%

Postmarketing Experience

The following adverse reactions have been identified during post approval use of EQUETRO. 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.

Nervous System: confusion, diplopia, oculomotor disturbances, nystagmus, speech disturbances, abnormal involuntary movements, tinnitus.

Digestive System: gastric distress, abdominal pain, diarrhea, anorexia.

Laboratory Tests: thyroid function tests (T3, T4)- decreased values

Other: lupus erythematosus-like syndrome

One case of aseptic meningitis, accompanied by myoclonus and peripheral eosinophilia, has been reported in a patient taking carbamazepine in combination with other medications. The patient was successfully dechallenged, and the meningitis reappeared upon rechallenge with carbamazepine.

Additional Adverse Reactions Associated With Carbamazepine

The following is a list of additional adverse reactions identified in clinical trials or postmarketing reports of other forms of carbamazepine and not reported above for EQUETRO. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure.

Nervous System: Isolated cases of neuroleptic malignant syndrome have been reported in carbamazepine use both with and without concomitant use of other psychotropic drugs.

Skin: onychomadesis, acute generalized exanthematous pustulosis (AGEP).

To report SUSPECTED ADVERSE REACTIONS, contact Validus Pharmaceuticals LLC at 1-8669VALIDUS(1-866-982-5438) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Read the entire FDA prescribing information for Equetro (Carbamazepine XR)

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

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