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The following serious adverse reactions are discussed in detail elsewhere in the labeling:

  • Withdrawal [see WARNINGS AND PRECAUTIONS]
  • Allergic reactions [see WARNINGS AND PRECAUTIONS]

Jenloga (clonidine tablets) Clinical Trials Experience

Table 1 displays the most common treatment-emergent adverse reactions (ARs) reported by more than one patient in the mild to moderate hypertension study. The incidence of ARs progressively increased with increasing doses and was notably less in the 0.2 mg per day treatment group compared with the 0.4 mg per day and 0.6 mg per day treatments groups. The majority of ARs were mild. ARs of moderate severity occurred in 6 patients and included two reports each of insomnia and dry mouth. One patient (0.4 mg per day group) experienced symptomatic sinus bradycardia two weeks after initiating study drug. This event was the only severe AR, the only serious AR, and the only AR that led to discontinuation of study drug. Because the number of subjects is small and the duration of exposure short, no inferences regarding differences in adverse events between Jenloga (clonidine tablets) and other clonidine formulations is warranted.

Table 1: Incidence of Treatment-Emergent Adverse Reactions by Dosing Group Reported by at least Two Patients in the Safety Population

Adverse Reaction Treatment Group
0.2 mg per day
(N=12)
0.4 mg per day
(N=15)
0.6 mg per day
(N=15)
Total
(N=42)
N % N % N % N %
At least one AR reported 5 42 10 67 12 80 27 64
Dry Mouth 0 0 8 53 8 53 16 38
Fatigue 2 17 4 27 4 27 10 24
Dizziness 0 0 3 20 2 13 5 12
Headache 1 8 1 7 2 13 4 10
Nausea 1 8 1 7 1 7 3 7
Somnolence 0 0 1 7 1 7 2 5
Insomnia 0 0 0 0 2 13 2 5

Experience with Immediate-Release Clonidine

Most adverse reactions are mild and tend to diminish with continued therapy. The most frequent (which also appear to be dose-related) are dry mouth (approximately 40%),; drowsiness (approximately 33%),; dizziness (approximately 16%),; constipation and sedation (approximately 10% each).

The following less frequent adverse reactions have also been reported in patients receiving immediate-release clonidine, but in many cases patients were receiving concomitant medication and a causal relationship has not been established.

Body as a Whole: Fatigue, fever, headache, pallor, weakness, and withdrawal syndrome. Also reported were a weakly positive Coombs' test and increased sensitivity to alcohol.

Cardiovascular: Bradycardia, congestive heart failure, electrocardiographic abnormalities (i.e., sinus node arrest, junctional bradycardia, high degree AV block and arrhythmias), orthostatic symptoms, palpitations, Raynaud's phenomenon, syncope, and tachycardia. Cases of sinus bradycardia and atrioventricular block have been reported, both with and without the use of concomitant digitalis.

Central Nervous System (CMS): Agitation, anxiety, delirium, delusional perception, hallucinations (including visual and auditory), insomnia, mental depression, nervousness, other behavioral changes, paresthesia, restlessness, sleep disorder, and vivid dreams or nightmares.

Dermatoloaical: Alopecia, angioneurotic edema, hives, pruritus, rash, and urticaria.

Gastrointestinal: Abdominal pain, anorexia, constipation, hepatitis, malaise, mild transient abnormalities in liver function tests, nausea, parotitis, pseudo-obstruction (including colonic pseudo-obstruction), salivary gland pain, and vomiting.

Genitourinary: Decreased sexual activity, difficulty in micturition, erectile dysfunction, loss of libido, nocturia, and urinary retention.

Hematoloaic: Thrombocytopenia.

Metabolic: Gynecomastia, transient elevation of blood glucose or serum creatine phosphokinase, and weight gain.

Musculoskeletal: Leg cramps and muscle or joint pain.

Oro-otolarvngeal: Dryness of the nasal mucosa.

Qphthalmological: Accommodation disorder, blurred vision, burning of the eyes, decreased lacrimation, and dryness of eyes.