FDA label d332a12f-931a-4c0b-9b17-04b60725f689
openFDA label record#
This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON
- SPL set ID
- 188b8a95-3db7-4a6a-bddf-48b83a0c8e38
- SPL ID
- d332a12f-931a-4c0b-9b17-04b60725f689
- Version
- 4
- Effective date
- 2011-08-01
- Source export date
- 2026-10-12
- Source partition
- 11
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/a497e765d824a2e2aa9e88d5f0eea2aae9dcba363989e5f163395cda5c3c9dd8/drug-label-0011-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 02:48:14
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| spl id | d332a12f-931a-4c0b-9b17-04b60725f689 | id | |
| spl set id | 188b8a95-3db7-4a6a-bddf-48b83a0c8e38 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS Diazepam is not recommended in the treatment of psychotic patients and should not be employed instead of appropriate treatment. Since diazepam has a central nervous system depressant effect, patients should be advised against the simultaneous ingestion of alcohol and other CNS-depressant drugs during diazepam therapy. As with other agents that have anticonvulsant activity, when diazepam is used as an adjunct in treating convulsive disorders, the possibility of an increase in the frequency and/or severity of grand mal seizures may require an increase in the dosage of standard anticonvulsant medication. Abrupt withdrawal of diazepam in such cases may also be associated with a temporary increase in the frequency and/or severity of seizures.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS Side effects most commonly reported were drowsiness, fatigue, muscle weakness, and ataxia. The following have also been reported: Central Nervous System: confusion, depression, dysarthria, headache, slurred speech, tremor, vertigo Gastrointestinal System: constipation, nausea, gastrointestinal disturbances Special Senses: blurred vision, diplopia, dizziness Cardiovascular System: hypotension Psychiatric and Paradoxical Reactions: stimulation, restlessness, acute hyperexcited states, anxiety, agitation, aggressiveness, irritability, rage, hallucinations, psychoses, delusions, increased muscle spasticity, insomnia, sleep disturbances, and nightmares. Inappropriate behavior and other adverse behavioral effects have been reported when using benzodiazepines. Should these occur, use of the drug should be discontinued. They are more likely to occur in children and in the elderly. Urogenital System: incontinence, changes in libido, urinary retention Skin and Appendages: skin reactions Laboratories: elevated transaminases and alkaline phosphatase Other: changes in salivation, including dry mouth, hypersalivation Antegrade amnesia may occur using therapeutic dosages, the risk increasing at higher dosages. Amnestic effects may be associated with inappropriate behavior. Minor changes in EEG patterns, usually low-voltage fast activity, have been observed in patients during and after diazepam therapy and are of no known significance. Because of isolated reports of neutropenia and jaundice, periodic blood counts and liver function tests are advisable during long-term therapy.
adverse reactions
ADVERSE REACTIONS Oral supplementation with L-tryptophan or choline at high doses up to 15 grams daily is generally well tolerated. The most common adverse reactions of higher doses — from 15 to 30 grams daily — are nausea, abdominal cramps, and diarrhea. Some patients may experience these symptoms at lower doses. The total combined amount of amino acids in each GABAdone capsule does not exceed 400 mg.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.