Chemical formula: C₂₆H₂₆F₂N₂ Molecular mass: 404.495 g/mol PubChem compound: 941361
Flunarizine interacts in the following cases:
Excessive sedation can occur when alcohol, hypnotics or tranquillisers are taken simultaneously with flunarizine.
When used in conjunction with anti-hypertensive drugs, dosage of the latter may need adjustment.
There are no data from the use of flunarizine in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development. As a precautionary measure, it is preferable to avoid the use of flunarizine during pregnancy.
It is unknown whether flunarizine is excreted in human milk. Animal studies have shown excretion of flunarizine in breast milk. A decision on whether to discontinue breast-feeding or to continue/discontinue therapy with flunarizine should be made taking into account the benefit of breast-feeding to the child and the benefit of therapy to the woman.
Since somnolence may occur, especially at the start of the treatment, caution should be exercised during activities such as driving or operating dangerous machinery.
The safety of flunarizine (5 to 10mg/day) was evaluated in 247 flunarizine-treated subjects who participated in two placebo-controlled clinical trials in the treatment of vertigo and migraine, and in 476 flunarizine-treated subjects who participated in two comparator-controlled clinical trials in the treatment of vertigo and/or migraine. Based on pooled safety data from these clinical trials, the most commonly reported (≥4% incidence) adverse reactions were: Weight Increased (11%), Somnolence (9%), Depression (5%), Increased Appetite (4%); and Rhinitis (4%).
Including the above-mentioned adverse reactions, the following table displays adverse reactions that have been reported with the use of flunarizine from both clinical trial and post-marketing experiences. The displayed frequency categories use the following convention:
Very common (≥1/10); common (≥1/100 to 1/10); uncommon (≥1/1,00 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data)
| System Organ Class | Adverse Reactions | |||
|---|---|---|---|---|
| Frequency Category | ||||
| Very Common (≥1/10) | Common (≥1/100 to <1/10) | Uncommon (≥1/1,000 to <1/100) | Not known | |
| Immune System Disorders | Hypersensitivity | |||
| Infections and Infestations | Rhinitis | |||
| Metabolism and Nutrition disorders | Increased Appetite | |||
| Psychiatric Disorders | Depression; Insomnia | Depressive Symptom; Sleep Disorder; Apathy; Anxiety | ||
| Nervous System Disorders | Somnolence | Coordination Abnormal; Disorientation; Lethargy; Paraesthesia; Restlessness; Sluggishness: Tinnitus; Torticollis | Akathisia; Bradykinesia; Cogwheel Rigidity; Dyskinesia; Essential Tremor; Extrapyramidal Disorder; Parkinsonism; Gait disturbance; Sedation; Tremor | |
| Cardiac Disorders | Palpitations | |||
| Vascular Disorders | Hypotension; Flushing | |||
| Gastrointestinal Disorders | Constipation; Abdominal pain upper; Nausea | Intestinal Obstruction; Dry Mouth; Gastrointestinal Disorder; Dyspepsia; Vomiting | ||
| Hepatobiliary disorders | Hepatic transaminases increased | |||
| Skin and Subcutaneous tissue disorder | Hyperhidrosis; Urticaria; Rash | Erythema; Angioedema; Pruritis | ||
| Musculoskeletal and Connective Tissue Disorders | Myalgia | Muscle Spasms; Muscle Twitching | Muscle Rigidity | |
| Reproductive System and Breast Disorders | Menstruation Irregular; Breast Pain | Menorrhagia; Menstrual Disorder; Oligomenorrhoea; Hypertrophy Breast; Libido Decreased | Galactorrhoea | |
| General Disorders and Administration Site Conditions | Fatigue | Generalised Oedema; Oedema Peripheral; Asthenia | ||
| Investigations | Weight Increased | |||
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