SYNDROS SIDE EFFECTS
- Generic Name: c-x dronabinol oral solution
- Brand Name: Syndros
- Drug Class: Antiemetic Agents
SIDE EFFECTS
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The following serious adverse reactions are described below and elsewhere in the labeling.
- Neuropsychiatric Adverse Reactions
- Hemodynamic Instability
- Seizures
- Paradoxical Nausea, Vomiting, and Abdominal Pain
- Toxicity in Preterm Neonates
The safety of SYNDROS has been established based on studies of dronabinol capsules. Studies of AIDS-related weight loss included 157 patients receiving dronabinol capsules and 67 receiving placebo. Studies of nausea and vomiting related to cancer chemotherapy included 317 patients receiving dronabinol capsules and 68 receiving placebo. In the tables below is a summary of the adverse reactions in 474 patients exposed to dronabinol capsules in studies.
Studies of different durations were combined by considering the first occurrence of adverse reactions during the first 28 days.
A cannabinoid dose-related “high” (easy laughing, elation and heightened awareness) has been reported by patients receiving dronabinol capsules in both the antiemetic (24%) and the lower dose appetite stimulant clinical trials (8%). The most frequently reported adverse experiences in patients with AIDS during placebo-controlled clinical trials involved the CNS and were reported by 33% of patients receiving dronabinol capsules. About 25% of patients reported a CNS adverse reaction during the first 2 weeks and about 4% reported such a reaction each week for the next 6 weeks thereafter.
Common Adverse Reactions
The following adverse reactions were reported in clinical trials of dronabinol capsules at an incidence greater than 1%.
| System Organ Class | Adverse Reactions |
| General | Asthenia |
| Cardiovascular | Palpitations, tachycardia, vasodilation/facial flush |
| Gastrointestinal | Abdominal pain*, nausea*, vomiting* |
| Central Nervous System | Dizziness*, euphoria*, paranoid reaction*, somnolence*, thinking abnormal*, amnesia, anxiety/nervousness, ataxia, confusion, depersonalization, hallucination |
| *Actual Incidence 3% to 10% | |
Less Common Adverse Reactions
The following adverse reactions were reported in clinical trials of dronabinol capsules at an incidence less than or equal to 1%.
| System Organ Class | Adverse Reactions |
| General | Chills, headache, malaise |
| Cardiovascular | Hypotension, conjunctival injection |
| Gastrointestinal | Diarrhea, fecal incontinence, anorexia, hepatic enzyme elevation |
| Musculoskeletal | Myalgias |
| Central Nervous System | Depression, nightmares, speech difficulties, tinnitus |
| Respiratory | Cough, rhinitis, sinusitis |
| Skin | Flushing, sweating |
| Sensory | Vision difficulties |
Postmarketing Experience
The following adverse reactions have been identified during post-approval use of another oral formulation of dronabinol. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
General disorders and administration site conditions: fatigue.
Hypersensitivity reactions: lip swelling, hives, disseminated rash, oral lesions, skin burning, flushing, throat tightness
Injury, poisoning and procedural complications: fall
Nervous system disorders: seizures, disorientation, movement disorder, loss of consciousness.
Psychiatric disorders: delirium, insomnia, panic attack.
Vascular disorders: syncope
SRC: NLM .