Tenex

Tenex Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Tenex (guanfacine hydrochloride) is an antihypertensive drug used to manage high blood pressure (hypertension). This medication is available in generic form. Common side effects include dry mouth, sleepiness, weakness, dizziness, constipation, and impotence.

The recommended initial dose of Tenex when given alone or in combination with another antihypertensive drug is 1 mg daily given at bedtime. Tenex may interact with valproic acid, azole antifungals, rifamycins, other products that cause drowsiness (such as alcohol, antihistamines, drugs for sleep or anxiety, muscle relaxants, and narcotics), cough-and-cold products, diet aids, or nonsteroidal anti-inflammatory drugs (NSAIDs). Tell your doctor all medications and supplements you use. During pregnancy, Tenex should be used only if prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Tenex (guanfacine hydrochloride) 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 Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Tenex FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Adverse reactions noted with Tenex (guanfacine hydrochloride) are similar to those of other drugs of the central α2-adrenoreceptor agonist class: dry mouth, sedation (somnolence), weakness (asthenia), dizziness, constipation, and impotence. While the reactions are common, most are mild and tend to disappear on continued dosing.

Skin rash with exfoliation has been reported in a few cases; although clear cause and effect relationships to Tenex could not be established, should a rash occur, Tenex should be discontinued and the patient monitored appropriately.

In the dose-response monotherapy study described under CLINICAL PHARMACOLOGY, the frequency of the most commonly observed adverse reactions showed a dose relationship from 0.5 to 3 mg as follows:

Adverse Reaction Placebo
n=59
0.5 mg
n=60
1 mg
n=61
2 mg
n=60
3 mg
n=59
Dry Mouth 0% 10% 10% 42% 54%
Somnolence 8% 5% 10% 13% 39%
Asthenia 0% 2% 3% 7% 3%
Dizziness 8% 12% 2% 8% 15%
Headache 8% 13% 7% 5% 3%
Impotence 0% 0% 0% 7% 3%
Constipation 0% 2% 0% 5% 15%
Fatigue 2% 2% 5% 8% 10%

The percent of patients who dropped out because of adverse reactions are shown below for each dosage group.

  Placebo 0.5 mg 1 mg 2 mg 3 mg
Percent dropouts 0% 2.0% 5.0% 13% 32%

The most common reasons for dropouts among patients who received guanfacine were dry mouth, somnolence, dizziness, fatigue, weakness, and constipation.

In the 12-week, placebo-controlled, dose-response study of guanfacine administered with 25 mg chlorthalidone at bedtime, the frequency of the most commonly observed adverse reactions showed a clear dose relationship from 0.5 to 3 mg as follows:

Adverse Reaction Placebo
n=73
0.5 mg
n=72
1 mg
n=72
2 mg
n=72
3 mg
n=72
Dry Mouth 5 (7%) 4 (5%) 6 (8%) 8 (11%) 20 (28%)
Somnolence 1 (1%) 3 (4%) 0 (0%) 1 (1%) 10 (14%)
Asthenia 0 (0%) 2 (3%) 0 (0%) 2 (2%) 7 (10%)
Dizziness 2 (2%) 1 (1%) 3 (4%) 6 (8%) 3 (4%)
Headache 3 (4%) 4 (3%) 3 (4%) 1 (1%) 2 (2%)
Impotence 1 (1%) 1 (0%) 0 (0%) 1 (1%) 3 (4%)
Constipation 0 (0%) 0 (0%) 0 (0%) 1 (1%) 1 (1%)
Fatigue 3 (3%) 2 (3%) 2 (3%) 5 (6%) 3 (4%)

There were 41 premature terminations because of adverse reactions in this study. The percent of patients who dropped out and the dose at which the dropout occurred were as follows:

Dose Placebo 0.5 mg 1 mg 2 mg 3 mg
Percent dropouts 6.9% 4.2% 3.2% 6.9% 8.3%

Reasons for dropouts among patients who received guanfacine were: somnolence, headache, weakness, dry mouth, dizziness, impotence, insomnia, constipation, syncope, urinary incontinence, conjunctivitis, paresthesia, and dermatitis.

In a second 12-week placebo-controlled combination therapy study in which the dose could be adjusted upward to 3 mg per day in 1-mg increments at 3-week intervals, i.e., a setting more similar to ordinary clinical use, the most commonly recorded reactions were: dry mouth, 47%; constipation, 16%; fatigue, 12%; somnolence, 10%; asthenia, 6%; dizziness, 6%; headache, 4%; and insomnia, 4%.

Reasons for dropouts among patients who received guanfacine were: somnolence, dry mouth, dizziness, impotence, constipation, confusion, depression, and palpitations.

In the clonidine/guanfacine comparison described in CLINICAL PHARMACOLOGY, the most common adverse reactions noted were as follows:

Adverse Reactions Guanfacine
(n=279)
Clonidine
(n=278)
Dry Mouth 30% 37%
Somnolence 21% 35%
Dizziness 11% 8%
Constipation 10% 5%
Fatigue 9% 8%
Headache 4% 4%
Insomnia 4% 3%

Adverse reactions occurring in 3% or less of patients in the three controlled trials of Tenex (guanfacine hydrochloride) with a diuretic were:

Cardiovascular- bradycardia, palpitations, substernal pain

Gastrointestinal- abdominal pain, diarrhea, dyspepsia, dysphagia, nausea

CNS- amnesia, confusion, depression, insomnia, libido decrease

ENT disorders- rhinitis, taste perversion, tinnitus

Eye disorders- conjunctivitis, iritis, vision disturbance

Musculoskeletal- leg cramps, hypokinesia

Respiratory- dyspnea

Dermatologic- dermatitis, pruritus, purpura, sweating

Urogenital- testicular disorder, urinary incontinence

Other- malaise, paresthesia, paresis

Adverse reaction reports tend to decrease over time. In an open-label trial of one year's duration, 580 hypertensive subjects were given guanfacine, titrated to achieve goal blood pressure, alone (51%), with diuretic (38%), with beta blocker (3%), with diuretic plus beta blocker (6%), or with diuretic plus vasodilator (2%). The mean daily dose of guanfacine reached was 4.7 mg.

Adverse Reaction Incidence of adverse reactions at any time during the study
n = 580
Incidence of adverse reactions at end of one year
n = 580
Dry Mouth 60% 15%
Drowsiness 33% 6%
Dizziness 15% 1%
Constipation 14% 3%
Weakness 5% 1%
Headache 4% 0.2%
Insomnia 5% 0%

There were 52 (8.9%) dropouts due to adverse effects in this 1-year trial. The causes were: dry mouth (n = 20), weakness (n = 12), constipation (n = 7), somnolence (n = 3), nausea (n = 3), orthostatic hypotension (n = 2), insomnia (n = 1), rash (n = 1), nightmares (n = 1), headache (n = 1), and depression (n = 1).

Postmarketing Experience

An open-label postmarketing study involving 21,718 patients was conducted to assess the safety of Tenex (guanfacine hydrochloride) 1 mg/day given at bedtime for 28 days. Tenex was administered with or without other antihypertensive agents. Adverse events reported in the postmarketing study at an incidence greater than 1% included dry mouth, dizziness, somnolence, fatigue, headache and nausea. The most commonly reported adverse events in this study were the same as those observed in controlled clinical trials.

Less frequent, possibly Tenex-related events observed in the postmarketing study and/or reported spontaneously include:

Body As A Whole: asthenia, chest pain, edema, malaise, tremor

Cardiovascular: bradycardia, palpitations, syncope, tachycardia

Central Nervous System: paresthesias, vertigo

Eye Disorders: blurred vision

Gastrointestinal System: abdominal pain, constipation, diarrhea, dyspepsia

Liver And Billiary System: abnormal liver function tests

Musculoskeletal System: arthralgia, leg cramps, leg pain, myalgia

Psychiatric: agitation, anxiety, confusion, depression, insomnia, nervousness

Rreproductive System: Male- impotence

Respiratory System: dyspnea

Skin And Appendages: alopecia, dermatitis, exfoliative dermatitis, pruritus, rash

Special Senses: alterations in taste

Urinary System: nocturia, urinary frequency

Rare, serious disorders with no definitive cause and effect relationship to Tenex have been reported spontaneously and/or in the postmarketing study. These events include acute renal failure, cardiac fibrillation, cerebrovascular accident, congestive heart failure, heart block, and myocardial infarction.

Drug Abuse And Dependence

No reported abuse or dependence has been associated with the administration of Tenex (guanfacine hdyrochloride).

Read the entire FDA prescribing information for Tenex (Guanfacine Hydrochloride Tablets) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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