Temazepam Side Effects

Some side effects of temazepam may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to temazepam: oral capsule

Temazepam may cause a severe allergic reaction. Stop taking temazepam and Get emergency medical help if you have any of these signs of an allergic reaction while taking temazepam: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Get emergency medical help if you have any of these signs of an allergic reaction while taking temazepam: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using temazepam and call your doctor at once if you have any of these serious side effects:

• weak or shallow breathing;

• fast or pounding heartbeats;

• confusion, slurred speech, unusual thoughts or behavior;

• hallucinations, agitation, aggression;

• thoughts of suicide or hurting yourself;

• restless muscle movements in your eyes, tongue, jaw, or neck;

• pale skin, easy bruising or bleeding, unusual weakness;

• fever, chills, body aches, flu symptoms;

• problems with urination; or

• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects of temazepam may include:

• daytime drowsiness (or during hours when you are not normally sleeping);

• amnesia or forgetfulness;

• muscle weakness, lack of balance or coordination;

• numbness, burning, pain, or tingly feeling;

• headache, blurred vision, depressed mood;

• feeling nervous, excited, or irritable;

• nausea, vomiting, stomach discomfort; or

• dry mouth, increased thirst.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

For Healthcare Professionals

Applies to temazepam: oral capsule

Nervous system

Nervous system side effects are common and include drowsiness (9.1%), headache (8.5%), fatigue (4.8%), nervousness (4.6%), dizziness (4.5%), and lethargy (4.5%) most frequently. Sleep disturbances, morning "hangover" symptoms, hyperexcitability, confusion, amnesia, and ataxia have also been observed.

One population- based case control study has suggested that use of temazepam in elderly patients may be associated with an increased risk of hip fractures.

Other

Withdrawal symptoms may include agitation, restlessness, anxiety, insomnia, convulsions, tremor, abdominal cramps, blurred vision, vomiting, and sweating.

Other side effects include withdrawal symptoms after either abrupt cessation or fast tapering of temazepam. Rebound insomnia (a worsening of sleep following cessation of therapy) has also been reported but appears to be less common with temazepam than other benzodiazepines used for hypnosis. Death from pulmonary microembolization has been reported in one patient who crushed temazepam tablets and injected them intravenously. Limb ischemia requiring amputation has also been reported following inadvertent intra-arterial administration of temazepam in drug abusing patients.

Psychiatric

Psychiatric side effects including cognitive disturbances, psychotic symptoms, and euphoria have been reported. One case of visual hallucination has been reported and confirmed upon rechallenge.

Hepatic

Hepatic side effects including hepatitis and elevated liver function tests have been reported rarely.

Gastrointestinal

Gastrointestinal side effects including diarrhea, constipation, nausea, and vomiting have been reported rarely.

Hematologic

Hematologic side effects including blood dyscrasias have been reported rarely.

Hypersensitivity

Hypersensitivity side effects including anaphylaxis have been reported rarely.

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