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Frova Side Effects

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Common Frova Side Effects


The most commonly reported Frova side effects (click to view or check a box to report):

Acute Myocardial Infarction (3)
Dizziness (3)
Mania (2)
Malaise (2)
Nausea (2)
Abortion Spontaneous (2)
Cardiac Arrest (2)
Convulsion (2)
Chest Pain (2)
Chest Discomfort (2)
Ventricular Fibrillation (2)
Serotonin Syndrome (2)
Overdose (2)
Oedema Peripheral (2)
Neonatal Aspiration (2)
Pain (2)
Pharyngeal Oedema (2)
Retrograde Amnesia (2)
Plagiocephaly (2)
Torticollis (2)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Frova Side Effects Reported to FDA



Frova Side Effect Report#9916843
Transaminases Increased
This is a report of a 20-year-old female patient (weight: NA) from FR, suffering from the following health symptoms/conditions: headache, who was treated with Frova Tablets 2.5mg (dosage: More Than 5mg, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Transaminases Increased after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Frova Tablets 2.5mg treatment in female patients, resulting in Transaminases Increased side effect. The patient was hospitalized.
Frova Side Effect Report#9856607
Infectious Mononucleosis, Hypoaesthesia
This report suggests a potential Frova Tablets 2.5mg Infectious Mononucleosis side effect(s) that can have serious consequences. A 20-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: migraine and used Frova Tablets 2.5mg (dosage: NA) starting
Sep 18, 2013. After starting Frova Tablets 2.5mg the patient began experiencing various side effects, including: Infectious Mononucleosis, HypoaesthesiaAdditional drugs used concurrently: NA. Although Frova Tablets 2.5mg demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Infectious Mononucleosis, may still occur.
Frova Side Effect Report#9844829
Psychotic Disorder
This Psychotic Disorder problem was reported by a consumer or non-health professional from NL. A 55-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: migraine. On
Jan 15, 1989 this consumer started treatment with Frova Tablets 2.5mg (dosage: NA). The following drugs were being taken at the same time:
  • Thyrax
  • Lithium
When using Frova Tablets 2.5mg, the patient experienced the following unwanted symptoms/side effects: Psychotic DisorderAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Psychotic Disorder, may become evident only after a product is in use by the general population.
Frova Side Effect Report#9775290
Coronary Artery Disease, Acute Myocardial Infarction, Ventricular Fibrillation, Acute Myocardial Infarction
This Coronary Artery Disease side effect was reported by a physician from DE. A 55-year-old female patient (weight:NA) experienced the following symptoms/conditions: migraine.The patient was prescribed Frova (drug dosage: NA), which was initiated on
May 25, 2013. Concurrently used drugs: NA..After starting to take Frova the consumer reported adverse symptoms, such as: Coronary Artery Disease, Acute Myocardial Infarction, Ventricular Fibrillation, Acute Myocardial InfarctionThese side effects may potentially be related to Frova. The patient was hospitalized.
Frova Side Effect Report#9434808
Pharyngeal Oedema, Dyspnoea, Headache, Nausea
This is a report of a 33-year-old female patient (weight: NA) from DE, suffering from the following health symptoms/conditions: migraine, who was treated with Frova Tablets 2.5mg (dosage: NA, start time:
Jul 17, 2013), combined with: NA. and developed a serious reaction and side effect(s): Pharyngeal Oedema, Dyspnoea, Headache, Nausea after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Frova Tablets 2.5mg treatment in female patients, resulting in Pharyngeal Oedema side effect.
Frova Side Effect Report#9156470
Major Depression, Off Label Use, Withdrawal Syndrome
This report suggests a potential Frova Major Depression side effect(s) that can have serious consequences. A 49-year-old male patient (weight: NA) from DE was diagnosed with the following symptoms/conditions: migraine and used Frova (dosage: NA) starting NS. After starting Frova the patient began experiencing various side effects, including: Major Depression, Off Label Use, Withdrawal SyndromeAdditional drugs used concurrently:
  • Sumatriptan
  • Zolmitriptan
The patient was hospitalized. Although Frova demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Major Depression, may still occur.
Frova Side Effect Report#9133730
Trismus, Oromandibular Dystonia, Drooling, Facial Spasm, Speech Disorder
This Trismus problem was reported by a consumer or non-health professional from US. A 23-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: migraine,fibromyalgia. On
Jan 17, 2011 this consumer started treatment with Frova (dosage: 2.5 Mg). The following drugs were being taken at the same time:
  • Hydromorphone
When using Frova, the patient experienced the following unwanted symptoms/side effects: Trismus, Oromandibular Dystonia, Drooling, Facial Spasm, Speech DisorderAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Trismus, may become evident only after a product is in use by the general population.
Frova Side Effect Report#9133719
Mean Cell Haemoglobin Increased, Mean Cell Volume Increased
This Mean Cell Haemoglobin Increased side effect was reported by a consumer or non-health professional from US. A 49-year-old female patient (weight:NA) experienced the following symptoms/conditions: migraine.The patient was prescribed Frova (drug dosage: 2.5 Mg 3-4x Per Month), which was initiated on 2008. Concurrently used drugs:
  • Indomethacin (3-4x Per Month)
.After starting to take Frova the consumer reported adverse symptoms, such as: Mean Cell Haemoglobin Increased, Mean Cell Volume IncreasedThese side effects may potentially be related to Frova.
Frova Side Effect Report#9133680
Cardiac Disorder, Chest Pain, Dizziness
This is a report of a 53-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: migraine, who was treated with Frova (dosage: NA, start time: 2011), combined with:
  • Clonidine
and developed a serious reaction and side effect(s): Cardiac Disorder, Chest Pain, Dizziness after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Frova treatment in female patients, resulting in Cardiac Disorder side effect. The patient was hospitalized.
Frova Side Effect Report#9115685
Retinal Artery Occlusion
This report suggests a potential Frova Retinal Artery Occlusion side effect(s) that can have serious consequences. A 27-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: migraine and used Frova (dosage: NA) starting
Jan 23, 2013. After starting Frova the patient began experiencing various side effects, including: Retinal Artery OcclusionAdditional drugs used concurrently:
  • Loestin
Although Frova demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Retinal Artery Occlusion, may still occur.
Frova Side Effect Report#8315393-2
Chest Pain, Cardiac Arrest, Ventricular Fibrillation
This Chest Pain problem was reported by a pharmacist from Spain. A 37-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: migraine,depression. On
Feb 11, 2012 this consumer started treatment with Frova (dosage: NA). The following drugs were being taken at the same time:
  • Paroxetine
When using Frova, the patient experienced the following unwanted symptoms/side effects: Chest Pain, Cardiac Arrest, Ventricular FibrillationAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Chest Pain, may become evident only after a product is in use by the general population.
Frova Side Effect Report#8128114-3
Deep Vein Thrombosis, Emotional Distress, Pain In Extremity, Oedema Peripheral
This Deep Vein Thrombosis side effect was reported by a consumer or non-health professional from United States. A 48-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Frova (drug dosage: Unk), which was initiated on
Sep 01, 2006. Concurrently used drugs:
  • Zyrtec (25 Mg, Unk)
  • Yaz
  • Zoloft (25 Mg, Qd)
  • Yasmin (Unk)
  • Antidepressants
  • Propoxyphene Hcl And Acetaminophen (25 Unk, Unk)
  • Yaz (Unk)
  • Sertraline Hydrochloride (25 Mg, Unk)
.After starting to take Frova the consumer reported adverse symptoms, such as: Deep Vein Thrombosis, Emotional Distress, Pain In Extremity, Oedema PeripheralThese side effects may potentially be related to Frova. The patient was hospitalized.
Frova Side Effect Report#7974785-1
Balance Disorder, Depression, Malaise, Fatigue, Multiple Sclerosis Relapse, White Blood Cell Count Decreased, Muscular Weakness
This is a report of a female patient (weight: NA) from United States, suffering from the following health symptoms/conditions: headache,multiple sclerosis,fatigue,depression,anxiety,acne, who was treated with Frova (dosage: NA, start time:
Feb 01, 2011), combined with:
  • Gilenya (0.5 Mg, Qd)
  • Amantadine Hcl
  • Prozac (10 Mg, Daily)
  • Ativan (0.5 Mg, Prn)
  • Minocycline Hcl
and developed a serious reaction and side effect(s): Balance Disorder, Depression, Malaise, Fatigue, Multiple Sclerosis Relapse, White Blood Cell Count Decreased, Muscular Weakness after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Frova treatment in female patients, resulting in Balance Disorder side effect.
Frova Side Effect Report#7909259-7
Anxiety, Pulmonary Embolism, Depression
This report suggests a potential Frova Anxiety side effect(s) that can have serious consequences. A 44-year-old female patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: migraine,acne and used Frova (dosage: Unk) starting
Oct 13, 2008. After starting Frova the patient began experiencing various side effects, including: Anxiety, Pulmonary Embolism, DepressionAdditional drugs used concurrently:
  • Yaz (Unk)
  • Topamax (Unk)
  • Propranolol (Unk)
  • Yaz (Unk)
  • Solodyn (Unk)
  • Maxalt (Unk)
The patient was hospitalized. Although Frova demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Anxiety, may still occur.
Frova Side Effect Report#7833449-5
Pain, Constipation
This Pain problem was reported by a consumer or non-health professional from United States. A 46-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Oct 18, 2010 this consumer started treatment with Frova (dosage: NA). The following drugs were being taken at the same time:
  • Clonazepam
  • Hydrocodone Bitartrate
  • Orphenadrine Citrate
  • Ciprofloxacin (500 Mg, Bid)
  • Flovent
  • Oxybutynin
  • Lexapro
  • Levothyroxine Sodium
When using Frova, the patient experienced the following unwanted symptoms/side effects: Pain, ConstipationAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Pain, may become evident only after a product is in use by the general population.
Frova Side Effect Report#7760785-3
Neonatal Aspiration, Maternal Exposure During Pregnancy, Foetal Heart Rate Abnormal, Torticollis, Plagiocephaly, Lip Disorder
This Neonatal Aspiration side effect was reported by a physician from United States. A male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Frova (drug dosage: NA), which was initiated on
Jan 01, 2010. Concurrently used drugs:
  • Keppra
  • Keppra
  • Folic Acid
  • Prenatal Vitamins (1 Pill)
.After starting to take Frova the consumer reported adverse symptoms, such as: Neonatal Aspiration, Maternal Exposure During Pregnancy, Foetal Heart Rate Abnormal, Torticollis, Plagiocephaly, Lip DisorderThese side effects may potentially be related to Frova.
Frova Side Effect Report#7530350-1
Torticollis, Plagiocephaly, Foetal Heart Rate Abnormal, Neonatal Aspiration
This is a report of a male patient (weight: NA) from United States, suffering from the following health symptoms/conditions: NA, who was treated with Frova (dosage: NA, start time:
Jan 01, 2010), combined with:
  • Folic Acid
  • Keppra
  • Prenatal Vitamins (1 Pill)
  • Keppra
and developed a serious reaction and side effect(s): Torticollis, Plagiocephaly, Foetal Heart Rate Abnormal, Neonatal Aspiration after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Frova treatment in male patients, resulting in Torticollis side effect.
Frova Side Effect Report#7449246-9
Intracranial Venous Sinus Thrombosis, Cerebrovascular Disorder
This report suggests a potential Frova Intracranial Venous Sinus Thrombosis side effect(s) that can have serious consequences. A female patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: NA and used Frova (dosage: Unk Unk, Prn) starting
Jul 05, 2005. After starting Frova the patient began experiencing various side effects, including: Intracranial Venous Sinus Thrombosis, Cerebrovascular DisorderAdditional drugs used concurrently:
  • Yasmin (Unk)
  • Phenergan And Chloral Hydrate (Unk)
  • Hydrocodone Bitartrate (Unk)
  • Dilaudid (Unk)
  • Vigamox (0.5 %, Unk)
  • Prednisone (Unk)
  • Vicodin (Unk Unk, Prn)
The patient was hospitalized. Although Frova demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Intracranial Venous Sinus Thrombosis, may still occur.
Frova Side Effect Report#7433158-0
Gastrooesophageal Reflux Disease, Paraesthesia, Calculus Ureteric, Abdominal Wall Haematoma, Atelectasis, Dyspnoea, Chest Discomfort, Sinus Bradycardia, Gallbladder Disorder
This Gastrooesophageal Reflux Disease problem was reported by a consumer or non-health professional from United States. A 51-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Jan 01, 2006 this consumer started treatment with Frova (dosage: NA). The following drugs were being taken at the same time:
  • Acetaminophen
  • Heparin
  • Nuvaring (1 Df;)
  • Nuvaring (1 Df;)
  • Nuvaring (1 Df;)
  • Activase
When using Frova, the patient experienced the following unwanted symptoms/side effects: Gastrooesophageal Reflux Disease, Paraesthesia, Calculus Ureteric, Abdominal Wall Haematoma, Atelectasis, Dyspnoea, Chest Discomfort, Sinus Bradycardia, Gallbladder DisorderThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Gastrooesophageal Reflux Disease, may become evident only after a product is in use by the general population.
Frova Side Effect Report#7255330-5
Injection Site Pain, Incorrect Dose Administered
This Injection Site Pain side effect was reported by a consumer or non-health professional from United States. A female patient (weight:NA) experienced the following symptoms/conditions: migraine,rheumatoid arthritis,headache,arthralgia.The patient was prescribed Frova (drug dosage: NA), which was initiated on
Jan 01, 2007. Concurrently used drugs:
  • Humira
  • Effexor Xr
  • Celebrex
  • Botox
  • Humira
  • Aleve
.After starting to take Frova the consumer reported adverse symptoms, such as: Injection Site Pain, Incorrect Dose AdministeredThese side effects may potentially be related to Frova.
Frova Side Effect Report#6784106-8
Angioedema, Oedema Peripheral, Pharyngeal Oedema, Swelling Face, Vasoconstriction
This is a report of a 44-year-old female patient (weight: NA) from United States, suffering from the following health symptoms/conditions: migraine, who was treated with Frova (dosage: Oral, start time: NS), combined with:
  • Aleve (Prn)
  • Amitriptyline (amitriptyline) (20 Milligram) (amitriptyline)
and developed a serious reaction and side effect(s): Angioedema, Oedema Peripheral, Pharyngeal Oedema, Swelling Face, Vasoconstriction after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Frova treatment in female patients, resulting in Angioedema side effect.
Frova Side Effect Report#6401612-6
Amnesia, Dizziness, Loss Of Consciousness
This report suggests a potential Frova Amnesia side effect(s) that can have serious consequences. A 77-year-old female patient (weight: NA) from United Kingdom was diagnosed with the following symptoms/conditions: migraine and used Frova (dosage: 2.5 Mg, Oral) starting NS. After starting Frova the patient began experiencing various side effects, including: Amnesia, Dizziness, Loss Of ConsciousnessAdditional drugs used concurrently: NA. Although Frova demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Amnesia, may still occur.
Frova Side Effect Report#6306864-9
Convulsion, Dyskinesia, Dystonia, Grimacing, Muscle Spasms
This Convulsion problem was reported by a consumer or non-health professional from United States. A 40-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: migraine with aura. On NS this consumer started treatment with Frova (dosage: 1 Pill 1 Po Taken Once). The following drugs were being taken at the same time: NA. When using Frova, the patient experienced the following unwanted symptoms/side effects: Convulsion, Dyskinesia, Dystonia, Grimacing, Muscle SpasmsAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Convulsion, may become evident only after a product is in use by the general population.
Frova Side Effect Report#6279130-8
Ear Pain, Haemorrhage, Myocardial Infarction, Pain, Toothache, Vascular Rupture
This Ear Pain side effect was reported by a consumer or non-health professional from United States. A 44-year-old female patient (weight:NA) experienced the following symptoms/conditions: migraine.The patient was prescribed Frova (drug dosage: 1 To 2 Tablets In 24 Hrs. As Needed For Head Po), which was initiated on
Sep 30, 2006. Concurrently used drugs: NA..After starting to take Frova the consumer reported adverse symptoms, such as: Ear Pain, Haemorrhage, Myocardial Infarction, Pain, Toothache, Vascular RuptureThese side effects may potentially be related to Frova. The patient was hospitalized and became disabled.
Frova Side Effect Report#6255715-X
Dizziness, Fatigue, Hypokinesia, Overdose
This is a report of a 2-year-old male patient (weight: NA) from United Kingdom, suffering from the following health symptoms/conditions: NA, who was treated with Frova (dosage: 2.5 Mg, Oral, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Dizziness, Fatigue, Hypokinesia, Overdose after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Frova treatment in male patients, resulting in Dizziness side effect. The patient was hospitalized.

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The appearance of Frova on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.


Track Your Side Effects

Note Your Observations

It is really important to keep track of your health symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

    Frova reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
    FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

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    Frova Safety Alerts, Active Ingredients, Usage Information

    NDC16590-396
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameFROVA
    NameFROVATRIPTAN SUCCINATE
    Dosage FormTABLET, FILM COATED
    RouteORAL
    On market since20011108
    LabelerSTAT RX USA LLC
    Active Ingredient(s)FROVATRIPTAN SUCCINATE
    Strength(s)2.5
    Unit(s)mg/1
    Pharma ClassSerotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin

    Frova Dosage, Warnings, Usage.

    Side Effects reported to FDA: 43

    Frova safety alerts: No

    Reported deaths: 1

    Reported hospitalizations: 16

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