Alprazolam (Page 5 of 10)

ADVERSE REACTIONS

Side effects to alprazolam tablets, if they occur, are generally observed at the beginning of therapy and usually disappear upon continued medication. In the usual patient, the most frequent side effects are likely to be an extension of the pharmacological activity of alprazolam, eg, drowsiness or light-headedness.

The data cited in the two tables below are estimates of untoward clinical event incidence among patients who participated under the following clinical conditions: relatively short duration (ie, four weeks) placebo-controlled clinical studies with dosages up to 4 mg/day of alprazolam tablets (for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety) and short-term (up to ten weeks) placebo-controlled clinical studies with dosages up to 10 mg/day of alprazolam tablets in patients with panic disorder, with or without agoraphobia.

These data cannot be used to predict precisely the incidence of untoward events in the course of usual medical practice where patient characteristics and other factors often differ from those in clinical trials. These figures cannot be compared with those obtained from other clinical studies involving related drug products and placebo as each group of drug trials are conducted under a different set of conditions.

Comparison of the cited figures, however, can provide the prescriber with some basis for estimating the relative contributions of drug and non-drug factors to the untoward event incidence in the population studied. Even this use must be approached cautiously, as a drug may relieve a symptom in one patient but induce it in others. (For example, an anxiolytic drug may relieve dry mouth [a symptom of anxiety] in some subjects but induce it [an untoward event] in others.)

Additionally, for anxiety disorders the cited figures can provide the prescriber with an indication as to the frequency with which physician intervention (eg, increased surveillance, decreased dosage or discontinuation of drug therapy) may be necessary because of the untoward clinical event.

Treatment-Emergent Adverse Events Reported in Placebo-Controlled Trials of Anxiety Disorders

ANXIETY DISORDERS
Treatment Emergent Symptom Incidence * Incidence of Intervention Because of Symptom
Alprazolam Tablets Placebo Alprazolam Tablets
*
Events reported by 1% or more of Alprazolam Tablets patients are included.
None reported

Number of Patients

565

505

565

% of Patients Reporting:

Central Nervous System

Drowsiness

41.0

21.6

15.1

Light-headedness

20.8

19.3

1.2

Depression

13.9

18.1

2.4

Headache

12.9

19.6

1.1

Confusion

9.9

10.0

0.9

Insomnia

8.9

18.4

1.3

Nervousness

4.1

10.3

1.1

Syncope

3.1

4.0

Dizziness

1.8

0.8

2.5

Akathisia

1.6

1.2

Tiredness/Sleepiness

1.8

Gastrointestinal

Dry Mouth

14.7

13.3

0.7

Constipation

10.4

11.4

0.9

Diarrhea

10.1

10.3

1.2

Nausea/Vomiting

9.6

12.8

1.7

Increased Salivation

4.2

2.4

Cardiovascular

Tachycardia/Palpitations

7.7

15.6

0.4

Hypotension

4.7

2.2

Sensory

Blurred Vision

6.2

6.2

0.4

Musculoskeletal

Rigidity

4.2

5.3

Tremor

4.0

8.8

0.4

Cutaneous

Dermatitis/Allergy

3.8

3.1

0.6

Other

Nasal Congestion

7.3

9.3

Weight Gain

2.7

2.7

Weight Loss

2.3

3.0

In addition to the relatively common (ie, greater than 1%) untoward events enumerated in the table above, the following adverse events have been reported in association with the use of benzodiazepines: dystonia, irritability, concentration difficulties, anorexia, transient amnesia or memory impairment, loss of coordination, fatigue, seizures, sedation, slurred speech, jaundice, musculoskeletal weakness, pruritus, diplopia, dysarthria, changes in libido, menstrual irregularities, incontinence and urinary retention.

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