Chemical formula: C₁₄H₁₇N₃O Molecular mass: 243.304 g/mol PubChem compound: 77992
Frovatriptan interacts in the following cases:
Frovatriptan is not a substrate for MAO-A, however a potential risk of serotonin syndrome or hypertension cannot be excluded.
In female subjects taking oral contraceptives, concentrations of frovatriptan were 30% higher than in females not taking oral contraceptives. No increased incidence in the adverse event profile was reported.
As with other triptans the risk of the occurence of serotonin syndrome may be increased.
Potential risk of hypertension, coronary vasoconstriction or serotonin syndrome.
Strict adherence to the recommended dose is an essential factor to prevent this syndrome.
Fluvoxamine is a potent inhibitor of cytochrome CYP1A2 and has been shown to increase the blood levels of frovatriptan by 27-49%.
Risks of hypertension, coronary artery constriction.
There are no or limited amount of data from the use of frovatriptan in pregnant women. Studies in animals have shown reproductive toxicity. The potential risk for humans is unknown. Frovatriptan is not recommended during pregnancy and in women of childbearing potential not using contraception, unless clearly necessary.
It is unknown whether frovatriptan/metabolites are excreted in human milk.
Frovatriptan and/or its metabolites are excreted in the milk of lactating rats with the maximum concentration in milk being four-fold higher than maximum blood levels.
A risk to the breastfeeding newborns/infants cannot be excluded.
Frovatriptan is not recommended during breast-feeding, unless is clearly needed. In this case, a 24 hours interval must be observed.
No studies on the effects on the ability to drive and use machines have been performed.
Migraine or treatment with frovatriptan may cause somnolence. Patients should be advised to evaluate their ability to perform complex tasks such as driving during migraine attacks and following administration of frovatriptan.
Frovatriptan has been administered to over 2700 patients at the recommended dose of 2.5 mg and the most common side effects (<10%) include dizziness, fatigue, paraesthesia, headache and vascular flushing. The undesirable effects reported in clinical trials with frovatriptan were transient, generally mild to moderate and resolved spontaneously. Some of the symptoms reported as undesirable effects may be associated symptoms of migraine.
The table below shows all the adverse reactions that are considered to be related to treatment with 2.5 mg frovatriptan and showed a greater incidence than with placebo in the 4 placebo controlled trials. They are listed in decreasing incidence by body-system. Adverse reactions collected in the post-marketing experience are noted with an asterisk*.
| System organ class | Common ≥1/100 <1/10 | Uncommon ≥1/1000 <1/100 | Rare ≥1/10,000 <1/1000 | Not known (cannot be estimated from the available data) |
|---|
| Blood and the lymphatic system disorders | Lymphadenopathy | |||
| Immune system disorders | Hypersensitivity reactions* (including cutaneous disorders, angioedema and anaphylaxis) | |||
| Metabolism and nutrition disorders | Dehydration | Hypoglycaemia | ||
| Psychiatric disorders | Anxiety, insomnia, confusional state, nervousness, agitation, depression, depersonalisation | Abnormal dreams, personality disorder | ||
| Nervous system disorders | Dizziness, paraesthesia, headache, somnolence, dysaesthesia, hypoaesthesia | Dysgeusia, tremor, disturbance in attention, lethargy, hyperaesthesia, sedation vertigo, involuntary muscle contractions | Amnesia, Hypertonia, Hypotonia, hyporeflexia, movement disorder | |
| Eye disorders | Visual disturbance | Eye pain, eye irritation, photophobia | Night blindness | |
| Ear and labyrinth disorders | Tinnitus, ear pain | Ear discomfort, ear disorder, ear pruritus, hyperacusis | ||
| Cardiac disorders | Palpitations, tachycardia | Bradycardia | Myocardial infarction*, Arteriospasm coronary* | |
| Vascular disorders | Flushing | Peripheral coldness, Hypertension | ||
| Respiratory, thoracic and mediastinal disorders | Throat tightness | Rhinitis, sinusitis, pharingolaringeal pain | Epistaxis, hiccups, hyperventilation, respiratory disorder, throat irritation | |
| Gastrointestinal disorders | Nausea, dry-mouth, dyspepsia, abdominal pain | Diarrhoea, dysphagia, flatulence, stomach discomfort, abdominal distension | Constipation, eructation, gastroesophageal reflux disease, irritable bowel syndrome, lip blister, lip pain, oesophageal spasm, oral mucosal blistering, peptic ulcer, salivary gland pain, stomatitis, toothache | |
| Skin and subcutaneous tissue disorders | Hyperhidrosis | Pruritus | Erithema, piloerection, purpura, urticaria | |
| Musculoskeletaland connective tissue disorders | Musculoskeletal stiffness, musculoskeletal pain, pain in extremity, back pain, arthralgia | |||
| Renal and urinary disorders | Pollakiuria, polyuria | Nocturia, renal pain | ||
| Reproductive system and breast disorders | Breast tenderness | |||
| General disorders and administration site conditions | Fatigue, chest discomfort | Chest pain, feeling hot, temperature intolerance, pain, asthaenia, thirst, sluggishness, energy increased, malaise | Pyrexia | |
| Investigations | Blood bilirubin increased, blood calcium decreased, urine analysis abnormal | |||
| Injury, poisoning and procedural complications | Bite |
In two open long-term clinical studies the observed effects were not different from those listed above.
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