NEWS AND FACTS ABOUT MEDICINES YOU TAKE

“Clonidine can also cause severe depression and is particularly dangerous for anyone with a history of depression.”

ABOVE: Wolfe, S.M. et al. “Worst Pills Best Pills,” Public Citizen Health Research Group, Washington DC (1988).

“Clonidine is among the most commonly prescribed drugs to treat insomnia for children with ADHD... However, the American Academy of Sleep Medicine advises first trying behavioral strategies for pediatric insomnia and using medication sparingly. Consumer Reports medical advisors urge people to avoid taking medication to treat the side effects of another drug unless that drug is essential.”

ABOVE: American Society of Health-System Pharmacists. Off-label use of clonidine: Is it really a wonder drug?; Consumer Reports, Consumers Union of US, Inc. (updated 9/2009).

The use of clonidine and methylphenidate in combination continues to be controversial. Both drugs can adversely affect an irregular heart rate or rhythm (cardiac arrhythmia) and this effect can be worsened when the drugs are combined. Four deaths of children using both drugs were reported to the FDA.

ABOVE: Cantwell D.P., Swanson J., Connor D.F. “Case study: adverse response to clonidine.” J Am Acad Child Adolesc Psychiatry 1997;36:539-44.
Kapvay (clonidine)

“Clonidine can cause severe depression and is particularly dangerous for anyone with a history of depression.” (4)

Clonidine Side Effects and Warnings

Updated January 10, 2019
  • Brand Names: KAPVAY, JENLOGA (extended-release tablets); CATAPRES, DIXARIT (tablets); CATAPRES-TTS (transdermal patch)
  • Generic Names: clonidine hydrochloride, clonidine
  • Categories: CENTRAL ALPHA-2 AGONIST
  • and ANTI-HYPERTENSIVE

How Clonidine Works

Clonidine reduces blood flow in the brain and produces dose-related sedation. (5) The drug lowers blood pressure and heart rate, thereby supressing the body's “fight or flight response” by decreasing that activity of part of the brain known as vasomotor center. Users of clonidine experience typical drowsiness. (1,2)

Used For

  • High blood pressure
  • Attention deficit disorder
  • Narcotic withdrawal syndrome (off-label)

Do Not Use If

  • You have a history of depression. Clonidine can cause severe depression and is particularly dangerous for anyone with a history of depression. (4)
  • You have heart disease, unless your doctor tells you it is okay. (6)
  • You have a problem in your heart that impacts the timing of the heartbeat or transmission of electrical impulses through the heart. (3)
  • You previously had an allergic reaction to clonidine. (3)

DO NOT SKIP A DOSE OR STOP SUDDENLY

Serious Risks Include ACUTE WITHDRAWAL SYMPTOMS (rebound hypertension) with abrupt discontinuation.

Severe cases can result in a very large increase in blood pressure which requires prompt treatment to avoid complications such as organ damage.

ABOVE: Rybacki, J., et al. The Essential Guide to Prescription Drugs, HarperCollins Publishers Inc., NY (1996).

Let Your Doctor Know Before Taking This Drug If

  • you have or have had serious emotional depression
  • you are taking any antidepressant
  • you are taking a tricyclic antidepressant
  • you are taking any sedative
  • you are taking any hypnotic drugs
  • you have a circulatory disorder of the brain
  • you have angina or coronary heart disease
  • you have a very slow heart rate
  • you have Buerger's disease (hands or feet may be pale, red, or bluish and may feel cold; caused by inflammation of blood vessels)
  • you have Raynaud's phenomenon (cold temperatures or strong emotions cause blood vessel spasms that block blood flow to the fingers, toes, ears, and nose)
  • you plan to have surgery under general anesthesia in the near future

Common (Expected) Side Effects

  • Lowering of blood pressure (expected)
  • Lowering of heart rate (expected)
  • Drowsiness and Sedation (sleepiness) (33-35%)
  • Dry Nose and Mouth (40%)
  • Headache (19-29%)
  • Constipation (10%)
  • Upper Abdominal Pain (13-20%)
  • Fatigue (13-16%)
  • Dizziness (16%)
  • Irritability
  • Change in mood
  • Trouble sleeping (insomnia)
  • Light-headedness (caused by lowering of blood pressure)
  • Sore throat
  • Dry eyes (in patients who wear contact lenses)

Possible Adverse Effects

If any of the following develop, consult your physician promptly for guidance.

Mild Adverse Effects

  • Allergic Reactions: Skin rash, hives, localized swellings, itching
  • Headache, dizziness, fatigue, anxiety, nervousness, dryness and burning eyes
  • Painful parotid (salivary) gland, nausea, vomiting
  • Weight gain, urinary retention
  • Dry mouth
  • Urination at night
  • Thinning of hair (rare)

Serious Adverse Effects

  • Raynaud's phenomenon (cold temperatures or strong emotions cause blood vessel spasms that block blood flow to the fingers, toes, ears, and nose)
  • Aggravation of congestive heart failur, heart rhythm disorders, vivid dreaming, nightmares, depression, hallucinations
  • Sleep disorders
  • Corneal ulcers (rare)
  • Acute pancreatitis (rare)
  • Slow heart beat (bradycardia)

Possible Effects On Sexual Functions

  • Decreased libido (10%)
  • Impotence (8-24%)
  • Impaired Ejaculation (rare)
  • Enlargement of male breasts
  • Precocious puberty in females (puberty at an early age)

CAUTION

  1. Do not stop this drug suddenly! Sudden withdrawal can cause a severe and possibly fatal reaction.
  2. Hot weather or fever can reduce blood pressure significantly. Dose adjustments may be necessary.
  3. Report the development of any tendency to emotional depression.

“The main problem with clonidine is that missing one or two doses can have serious effects, including sweating, tremor, flushing, and severe high blood pressure.”

ABOVE: Wolf, S., et al. Worst Pills Best Pills, Public Citizen Health Research Group, Washington DC (1988).

Overdose Side Effects

  • Marked drowsiness
  • Weakness
  • Dry mouth
  • Slow pulse
  • Low blood pressure
  • Vomiting
  • Stupor progressing to coma

A review of 20-years of scientific literature on using stimulant medications, including methylphenidate drugs, to treat children with ADD and ADHD found a consensus: there is no documented long-term benefit (academic achievement or pro-social behavior) in using psychoactive drugs.

ABOVE: Swanson, J.M., et al. "Effect of stimulant medication on children with attention deficit disorder: a review of reviews," Exceptional Children, 60:154-62, 1993.
  • SOURCES:
  • 1. Kapvay Patient Information, Rev. 9/2010.
  • 2. Catapres Medication Guide, rev. 4/2007: www.fda.gov/downloads/Drugs/DrugSafety/ucm089095.pdf
  • 3. Rybacki, J., et al. The Essential Guide to Prescription Drugs, HarperCollins Publishers Inc., NY (1996).
  • 4. Wolf, S., et al. Worst Pills Best Pills, Public Citizen Health Research Group, Washington DC (1988).
  • 5. Jamadarkhana, S., et al. “Clonidine in Adults as a Sedative Agent in the Intensive Care Unit,” J Anaesthesiol Clin Pharmacol. Oct-Dec; 26(4): 439-445 (2010).
  • 6. Gorman, Jack M. The Essential Guide to Psychiatric Drugs—Rev. and updated, 4th ed. New York, NY: St. Martin's Press, 2007.
  • 7. American Society of Health-System Pharmacists. Off-label use of clonidine: Is it really a wonder drug?; Consumer Reports, Consumers Union of US, Inc. (updated 9/2009): consumerreports.org/cro/2012/05/off-label-use-of-clonidine
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“The main problem with clonidine is that missing one or two doses can have serious effects, including sweating, tremor, flushing, and severe high blood pressure.”

ABOVE: Wolf, S., et al. Worst Pills Best Pills, Public Citizen Health Research Group, Washington DC (1988).

Additional safety precaution for ADHD patients:

Cardiovascular risks should be evaluated before starting clonidine for the treatment of ADHD. Some patients have reported changes in heart rate or rhythm.

Patients should be monitored for changes in pulse and blood pressure, and sedation while using clonidine.

ABOVE: American Society of Health-System Pharmacists. Off-label use of clonidine: Is it really a wonder drug?; Consumer Reports, Consumers Union of US, Inc. (updated 9/2009).

The most common side effects of KAPVAY include:

  • sleepiness
  • tiredness
  • upper respiratory tract infection, symptoms may include: cough, runny nose, sneezing
  • irritability
  • sore throat
  • trouble sleeping (insomnia)
  • nightmares
  • change in mood
  • constipation
  • stuffy nose
  • increased body temperature
  • dry mouth
  • ear pain

KAPVAY may cause serious side effects, including:

  • Low blood pressure and low heart rate. Your doctor should check your heart rate and blood pressure before starting treatment and regularly during treatment with KAPVAY.
  • Sleepiness.
  • Withdrawal symptoms: Suddenly stopping KAPVAY may cause withdrawal symptoms including: increased blood pressure, headache, increased heart rate, lightheadedness, tightness in your chest and nervousness.
ABOVE: Kapvay Patient Information, Rev. 9/2010.

Clonidine may worsen heart disease and have heightened effects in people with kidney disease.

SOURCES: American Society of Health-System Pharmacists. Off-label use of clonidine: Is it really a wonder drug?; Consumer Reports, Consumers Union of US, Inc. (updated 9/2009).

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