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Frova Side Effects

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.

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.

Frova Side Effects Reported to FDA

The following 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.


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.
Transaminases Increased
This is a report of a 20-year-old female patient (weight: NA) from FR, suffering from the following 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). The consumer presented with:
  • Transaminases Increased
which developed 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.

Infectious Mononucleosis, Hypoaesthesia
This report suggests a potential Frova Tablets 2.5mg Infectious Mononucleosis, Hypoaesthesia 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. Soon after starting Frova Tablets 2.5mg the patient began experiencing various side effects, including:
  • Infectious Mononucleosis
  • Hypoaesthesia
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.

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 commencing Frova Tablets 2.5mg, the patient experienced the following unwanted symptoms/side effects:
  • Psychotic Disorder
Although 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.

Coronary Artery Disease, Acute Myocardial Infarction, Ventricular Fibrillation
This is a report of a 55-year-old female patient (weight: NA) from DE. The patient developed the following symptoms/conditions: migraine and was treated with Frova (dosage: NA) starting May 25, 2013. Concurrently used drugs: NA.Soon after that, the consumer experienced the following side effects:
  • Coronary Artery Disease
  • Acute Myocardial Infarction
  • Ventricular Fibrillation
The patient was hospitalized. This opens a possibility that Frova treatment could cause the above reactions, including coronary artery disease, and some female subjects may be more susceptible.


Pharyngeal Oedema, Dyspnoea, Headache, Nausea
A 33-year-old female patient (weight: NA) from DE with the following symptoms/conditions: migraine started Frova Tablets 2.5mg treatment (dosage: NA) on Jul 17, 2013. Soon after starting Frova Tablets 2.5mg treatment, the subject experienced various side effects, including:
  • Pharyngeal Oedema
  • Dyspnoea
  • Headache
  • Nausea
Concurrently used drugs: NA. This finding indicates that some female patients could be more vulnerable to Frova Tablets 2.5mg.

Major Depression, Off Label Use, Withdrawal Syndrome
A 49-year-old male patient from DE (weight: NA) experienced symptoms, such as: migraine and was treated with Frova(dosage: NA). The treatment was initiated on NS. After that a consumer reported the following side effect(s):
  • Major Depression
  • Off Label Use
  • Withdrawal Syndrome
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Frova efficacy:
  • Sumatriptan
  • Zolmitriptan
The patient was hospitalized.

Trismus, Oromandibular Dystonia, Drooling, Facial Spasm, Speech Disorder
In this report, Frova was administered for the following condition: migraine,fibromyalgia.A 23-year-old female consumer from US (weight: NA) started Frova treatment (dosage: 2.5 Mg) on Jan 17, 2011.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Trismus
  • Oromandibular Dystonia
  • Drooling
  • Facial Spasm
  • Speech Disorder
A possible interaction with other drugs could have contributed to this reaction:
  • Hydromorphone
Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Frova treatment could be related to the listed above side effect(s).

Mean Cell Haemoglobin Increased, Mean Cell Volume Increased
This is a report of the following Frova side effect(s):
  • Mean Cell Haemoglobin Increased
  • Mean Cell Volume Increased
A 49-year-old female patient from US (weight: NA) presented with the following condition: migraine and received a treatment with Frova (dosage: 2.5 Mg 3-4x Per Month) starting: 2008.The following concurrently used drugs could have generated interactions:
  • Indomethacin (3-4x Per Month)
This report suggests that a Frova treatment could be associated with the listed above side effect(s).

Cardiac Disorder, Chest Pain, Dizziness
This Frova report was submitted by a 53-year-old female consumer from US (weight: NA). The patient was diagnosed with: migraine and Frova was administered (dosage: NA) starting: 2011. The consumer developed a set of symptoms:
  • Cardiac Disorder
  • Chest Pain
  • Dizziness
Other drugs used simultaneously:
  • Clonidine
The patient was hospitalized.Those unexpected symptoms could be linked to a Frova treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

Retinal Artery Occlusion
This is a report of a possible correlation between Frova use and the following symptoms/side effect(s):
  • Retinal Artery Occlusion
which could contribute to an assessment of Frova risk profile.A 27-year-old female consumer from US (weight: NA) was suffering from migraine and was treated with Frova (dosage: NA) starting Jan 23, 2013.Other concurrent medications:
  • Loestin


Chest Pain, Cardiac Arrest, Ventricular Fibrillation
A 37-year-old female patient from SPAIN (weight: NA) presented with the following symptoms: migraine,depression and after a treatment with Frova (dosage: NA) experienced the following side effect(s):
  • Chest Pain
  • Cardiac Arrest
  • Ventricular Fibrillation
The treatment was started on Feb 11, 2012. Frova was used in combination with the following drugs:
  • Paroxetine
This report could alert potential Frova consumers.

Deep Vein Thrombosis, Emotional Distress, Pain In Extremity, Oedema Peripheral
In this report, a 48-year-old female patient from UNITED STATES (weight: NA) was affected by a possible Frova side effect.The patient was diagnosed with NA. After a treatment with Frova (dosage: Unk, start date: Sep 01, 2006), the patient experienced the following side effect(s):
  • Deep Vein Thrombosis
  • Emotional Distress
  • Pain In Extremity
  • Oedema Peripheral
The following simultaneously used drugs could have led to this reaction:
  • 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)
The patient was hospitalized.The findings here stress that side effects should be taken into consideration when evaluating a Frova treatment.

Balance Disorder, Depression, Malaise, Fatigue, Multiple Sclerosis Relapse, White Blood Cell Count Decreased, Muscular Weakness
This is a report of a female patient from UNITED STATES (weight: NA), who used Frova (dosage: NA) for a treatment of headache,multiple sclerosis,fatigue,depression,anxiety,acne. After starting a treatment on Feb 01, 2011, the patient experienced the following side effect(s):
  • Balance Disorder
  • Depression
  • Malaise
  • Fatigue
  • Multiple Sclerosis Relapse
  • White Blood Cell Count Decreased
  • Muscular Weakness
The following drugs could possibly have interacted with the Frova treatment
  • Gilenya (0.5 Mg, Qd)
  • Amantadine Hcl
  • Prozac (10 Mg, Daily)
  • Ativan (0.5 Mg, Prn)
  • Minocycline Hcl
Taken together, these observations suggest that a Frova treatment could be related to side effect(s), such as Balance Disorder, Depression, Malaise, Fatigue, Multiple Sclerosis Relapse, White Blood Cell Count Decreased, Muscular Weakness.

Anxiety, Pulmonary Embolism, Depression
This anxiety 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,acne. The patient was prescribed Frova (dosage: Unk), which was started on Oct 13, 2008. Concurrently used drugs:
  • Yaz (Unk)
  • Topamax (Unk)
  • Propranolol (Unk)
  • Yaz (Unk)
  • Solodyn (Unk)
  • Maxalt (Unk)
When starting to take Frova the consumer reported the following symptoms:
  • Anxiety
  • Pulmonary Embolism
  • Depression
The patient was hospitalized. These side effects may potentially be related to Frova.

Pain, Constipation
This is a Frova side effect report of a 46-year-old female patient (weight:NA) from UNITED STATES, suffering from the following symptoms/conditions: NA, who was treated with Frova (dosage:NA, start time: Oct 18, 2010), combined with:
  • Clonazepam
  • Hydrocodone Bitartrate
  • Orphenadrine Citrate
  • Ciprofloxacin (500 Mg, Bid)
  • Flovent
  • Oxybutynin
  • Lexapro
  • Levothyroxine Sodium
, and developed a serious reaction and a pain side effect. The patient presented with:
  • Pain
  • Constipation
which developed after the beginning of treatment. This side effect report can indicate a possible existence of increased vulnerability to Frova treatment in female patients suffering from NA, resulting in pain.

Neonatal Aspiration, Maternal Exposure During Pregnancy, Foetal Heart Rate Abnormal, Torticollis, Plagiocephaly, Lip Disorder
This report suggests a potential Frova neonatal aspiration side effect(s) that can have serious consequences. A male patient from UNITED STATES (weight:NA) was diagnosed with the following health condition(s): NA and used Frova (dosage: NA) starting Jan 01, 2010. Soon after starting Frova the patient began experiencing various side effects, including:
  • Neonatal Aspiration
  • Maternal Exposure During Pregnancy
  • Foetal Heart Rate Abnormal
  • Torticollis
  • Plagiocephaly
  • Lip Disorder
Drugs used concurrently:
  • Keppra
  • Keppra
  • Folic Acid
  • Prenatal Vitamins (1 Pill)
Although Frova demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as neonatal aspiration, may still occur.

Torticollis, Plagiocephaly, Foetal Heart Rate Abnormal, Neonatal Aspiration
This torticollis problem was reported by a physician from UNITED STATES. A male patient (weight: NA) was diagnosed with the following medical condition(s): NA.On Jan 01, 2010 a consumer started treatment with Frova (dosage: NA). The following drugs/medications were being taken at the same time:
  • Folic Acid
  • Keppra
  • Prenatal Vitamins (1 Pill)
  • Keppra
When commencing Frova, the patient experienced the following unwanted symptoms /side effects:
  • Torticollis
  • Plagiocephaly
  • Foetal Heart Rate Abnormal
  • Neonatal Aspiration
Although all drugs are carefully tested before they are licensed for use, they carry potential side effect risks. Some side effects, such as torticollis, may become evident only after a product is in use by the general population.

Intracranial Venous Sinus Thrombosis, Cerebrovascular Disorder
This is a Frova side effect report of a female patient (weight: NA) from UNITED STATES. The patient developed the following symptoms/conditions: NA and was treated with Frova (dosage: Unk Unk, Prn) starting Jul 05, 2005. Concurrently used drugs:
  • Yasmin (Unk)
  • Phenergan And Chloral Hydrate (Unk)
  • Hydrocodone Bitartrate (Unk)
  • Dilaudid (Unk)
  • Vigamox (0.5 %, Unk)
  • Prednisone (Unk)
  • Vicodin (Unk Unk, Prn)
Soon after that, the consumer experienced the following of symptoms:
  • Intracranial Venous Sinus Thrombosis
  • Cerebrovascular Disorder
The patient was hospitalized. This opens a possibility that Frova could cause intracranial venous sinus thrombosis and that some female patients may be more susceptible.

Gastrooesophageal Reflux Disease, Paraesthesia, Calculus Ureteric, Abdominal Wall Haematoma, Atelectasis, Dyspnoea, Chest Discomfort, Sinus Bradycardia, Gallbladder Disorder
A 51-year-old female patient (weight: NA) from UNITED STATES with the following symptoms: NA started Frova treatment (dosage: NA) on Jan 01, 2006. Soon after starting Frova treatment, the consumer experienced several side effects, including:
  • Gastrooesophageal Reflux Disease
  • Paraesthesia
  • Calculus Ureteric
  • Abdominal Wall Haematoma
  • Atelectasis
  • Dyspnoea
  • Chest Discomfort
  • Sinus Bradycardia
  • Gallbladder Disorder
. Concurrently used drugs:
  • Acetaminophen
  • Heparin
  • Nuvaring (1 Df;)
  • Nuvaring (1 Df;)
  • Nuvaring (1 Df;)
  • Activase
The patient was hospitalized. This finding indicates that some patients can be more vulnerable to developing Frova side effects, such as gastrooesophageal reflux disease.

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 (dosage: NA), which was started on Jan 01, 2007. Concurrently used drugs:
  • Humira
  • Effexor Xr
  • Celebrex
  • Botox
  • Humira
  • Aleve
.When starting to take Frova the consumer reported symptoms, such as:
  • Injection Site Pain
  • Incorrect Dose Administered
These side effects may potentially be related to Frova.

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 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). The consumer presented with:
  • Angioedema
  • Oedema Peripheral
  • Pharyngeal Oedema
  • Swelling Face
  • Vasoconstriction
which developed 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.

Amnesia, Dizziness, Loss Of Consciousness
This report suggests a potential Frova Amnesia, Dizziness, Loss Of Consciousness 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. Soon after starting Frova the patient began experiencing various side effects, including:
  • Amnesia
  • Dizziness
  • Loss Of Consciousness
Drugs used concurrently: NA. Although Frova demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as amnesia, may still occur.

Convulsion, Dyskinesia, Dystonia, Grimacing, Muscle Spasms
This Convulsion, Dyskinesia, Dystonia, Grimacing, Muscle Spasms 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 commencing Frova, the patient experienced the following unwanted symptoms/side effects:
  • Convulsion
  • Dyskinesia
  • Dystonia
  • Grimacing
  • Muscle Spasms
Although 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.

Ear Pain, Haemorrhage, Myocardial Infarction, Toothache, Vascular Rupture
This is a report of a 44-year-old female patient (weight: NA) from UNITED STATES. The patient developed the following symptoms/conditions: migraine and was treated with Frova (dosage: 1 To 2 Tablets In 24 Hrs. As Needed For Head Po) starting Sep 30, 2006. Concurrently used drugs: NA.Soon after that, the consumer experienced the following side effects:
  • Ear Pain
  • Haemorrhage
  • Myocardial Infarction
  • Toothache
  • Vascular Rupture
The patient was hospitalized and became disabled. This opens a possibility that Frova treatment could cause the above reactions, including ear pain, and some female subjects may be more susceptible.

Dizziness, Fatigue, Hypokinesia, Overdose
A 2-year-old male patient (weight: NA) from UNITED KINGDOM with the following symptoms/conditions: NA started Frova treatment (dosage: 2.5 Mg, Oral) on NS. Soon after starting Frova treatment, the subject experienced various side effects, including:
  • Dizziness
  • Fatigue
  • Hypokinesia
  • Overdose
Concurrently used drugs: NA.The patient was hospitalized. This finding indicates that some male patients could be more vulnerable to Frova.

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Keep Track of Side Effects

Note Your Observations

It is really important to keep of your 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

    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.


    Discuss Frova Side Effects

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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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