MARINOL SIDE EFFECTS

  • Generic Name: dronabinol capsules
  • Brand Name: Marinol
  • Drug Class: Antiemetic Agents
Last updated on MDtodate: 10/7/2022

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

Studies of AIDS-related weight loss included 157 patients receiving MARINOL at a dose of 2.5 mg twice daily and 67 receiving placebo. Studies of nausea and vomiting related to cancer chemotherapy included 317 patients receiving MARINOL and 68 receiving placebo. In the tables below is a summary of the adverse reactions in 474 patients exposed to MARINOL in studies.

Studies of different durations were combined by considering the first occurrence of events during the first 28 days.

A cannabinoid dose-related “high” (easy laughing, elation and heightened awareness) has been reported by patients receiving MARINOL 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 MARINOL. 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 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 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 dronabinol capsules. 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 .