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Butalbital adverse events reported to FDA.

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Summary

FDA Adverse Reports: 10. View All

Butalbital FDA safety alerts: 200*

Reported deaths: 8

Reported hospitalizations: 2

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Often additional risks of using a medication, such as Butalbital, become known after product is used by a larger number of patients, for a longer period of time, and by patients with different health characteristics from those studied before drug approval. This page allows You to Find answers and discuss health symptoms with other Butalbital users, Learn more about unwanted side effects & find ways to reduce them. Browse Butalbital Adverse Reports reported to FDA and participate in Butalbital discussion, find alternative treatments and find ways to avoid or reduce risks associated with using Butalbital. You can also Post a question to users community or Ask a Doctor. PatientsVille.com is Your Complete Guide to all common, undocumented and undisclosed side effects associated with drugs and vaccines. Browse More Drug Reports Here: A  B  C  D  E  F  G  H  I  J  K  L  M  N  O  P  Q  R  S  T  U  V  W  X  Y  Z

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Butalbital Adverse Effect Reports (FDA)

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6639261-7 | Brain Oedema, Bronchitis Bacterial, Completed Suicide, Hepatic Congestion, Hepatic Necrosis, Multi-organ Failure, Pneumonia Aspiration
on Feb 25, 2010 Male patient from UNITED STATES , 59 years of age, was treated with Butalbital (View Usage). Patient experienced the following unwanted or unexpected effects: brain oedema, bronchitis bacterial, completed suicide, hepatic congestion, hepatic necrosis, multi-organ failure, pneumonia aspiration. Butalbital dosage: . During the same period patient was treated with MORPHINE (View Morphine Review and Morphine Label ), OPIOID (View Opioid Review and Opioid Label ), OXYCODONE (View Oxycodone Review and Oxycodone Label ), BENZODIAZEPINE (View Benzodiazepine Review and Benzodiazepine Label ).

6639241-1 | Completed Suicide, Hypotension, Ischaemic Hepatitis, Overdose, Poisoning, Unresponsive To Stimuli
Patient was taking Butalbital (View Usage). Patient had the following side effects: completed suicide, hypotension, ischaemic hepatitis, overdose, poisoning (What is poisoning?), unresponsive to stimuli on Feb 25, 2010 from UNITED STATES Additional patient health information: Female patient , 46 years of age, . Butalbital dosage: . During the same period patient was treated with METHADONE HCL (View Methadone Hcl Review and Methadone Hcl Label ), ALPRAZOLAM (View Alprazolam Review and Alprazolam Label ), OXYCODONE AND ACETAMINOPHEN (View Oxycodone And Acetaminophen Review and Oxycodone And Acetaminophen Label ).

6639240-X | Atrioventricular Block, Cerebrovascular Accident, Hypotension, Hypoxia, Incorrect Dose Administered, Pneumonia Aspiration, Poisoning, Pupils Unequal
Adverse event was reported on Feb 25, 2010 by a Female patient taking Butalbital (View Usage) (Dosage: ) . Location: UNITED STATES , 22 years of age, After Butalbital was administered, patient had the following side effects: atrioventricular block, cerebrovascular accident, hypotension, hypoxia, incorrect dose administered, pneumonia aspiration, poisoning (What is poisoning?), pupils unequal. During the same period patient was treated with ALPRAZOLAM (View Alprazolam Review and Alprazolam Label ), HYDROCODONE BITARTRATE AND ACETAMINOPHEN (View Hydrocodone Bitartrate And Acetaminophen Review and Hydrocodone Bitartrate And Acetaminophen Label ).

6639237-X | Accident, Poisoning
on Feb 25, 2010 Male patient from UNITED STATES , 42 years of age, was treated with Butalbital (View Usage). Patient experienced the following unwanted or unexpected effects: accident, poisoning (What is poisoning?). Butalbital dosage: . During the same period patient was treated with COCAINE (View Cocaine Review and Cocaine Label ), MORPHINE (View Morphine Review and Morphine Label ), CITALOPRAM HYDROBROMIDE (View Citalopram Hydrobromide Review and Citalopram Hydrobromide Label ).


6546771-X |
on Jan 04, 2010 Female patient from UNITED STATES , 22 years of age, was treated with Butalbital (View Usage). . Butalbital dosage: . During the same period patient was treated with ALPRAZOLAM (View Alprazolam Review and Alprazolam Label ), HYDROCODONE BITARTRATE AND ACETAMINOPHEN (View Hydrocodone Bitartrate And Acetaminophen Review and Hydrocodone Bitartrate And Acetaminophen Label ).

6546743-5 | Completed Suicide
Patient was taking Butalbital (View Usage). After Butalbital was administered, patient had the following side effects: completed suicide on Jan 04, 2010 from UNITED STATES Additional patient health information: Male patient , 59 years of age, . Butalbital dosage: . During the same period patient was treated with MORPHINE (View Morphine Review and Morphine Label ), OPIOID (View Opioid Review and Opioid Label ), OXYCODONE (View Oxycodone Review and Oxycodone Label ), BENZODIAZEPINE (View Benzodiazepine Review and Benzodiazepine Label ).

6546740-X | Completed Suicide
Adverse event was reported on Jan 04, 2010 by a Female patient taking Butalbital (View Usage) (Dosage: ) . Location: UNITED STATES , 46 years of age, Patient experienced the following unwanted or unexpected effects: completed suicide. During the same period patient was treated with METHADONE (View Methadone Review and Methadone Label ), ALPRAZOLAM (View Alprazolam Review and Alprazolam Label ), OXYCODONE AND ACETAMINOPHEN (View Oxycodone And Acetaminophen Review and Oxycodone And Acetaminophen Label ).

5818904-1 | Mouth Ulceration, Oral Pain, Oropharyngeal Blistering, Pruritus, Skin Discolouration, Stevens-johnson Syndrome, Tongue Ulceration, Urethral Disorder, Urticaria
on Jul 21, 2008 Female patient from UNITED STATES , 34 years of age, weighting 150.0 lb, was diagnosed with sinus headache and was treated with Butalbital (View Usage). Patient had the following side effects: mouth ulceration, oral pain, oropharyngeal blistering, pruritus, skin discolouration, stevens-johnson syndrome, tongue ulceration, urethral disorder, urticaria. Butalbital dosage: 1 Tablet Prn Po.

5586306-1 | Pain
on Jan 07, 2008 Male patient from UNITED STATES , 63 years of age, weighting 195.0 lb, was diagnosed with pain management and was treated with Butalbital (View Usage). After Butalbital was administered, patient had the following side effects: pain (What is pain?). Butalbital dosage: .

5179224-4 | Dysgeusia, Hypoaesthesia Oral, Lip Swelling, Muscle Spasms, Swollen Tongue
Patient was taking Butalbital (View Usage). Patient experienced the following unwanted or unexpected effects: dysgeusia, hypoaesthesia oral, lip swelling, muscle spasms, swollen tongue on Dec 06, 2006 from UNITED STATES Additional patient health information: Female patient , 42 years of age, was diagnosed with migraine (What is migraine?) and. Butalbital dosage: 3 Per Day, Oral. During the same period patient was treated with LEVOTHROID (View Levothroid Review and Levothroid Label ), ESTRACE (View Estrace Review and Estrace Label ), BENTYL (View Bentyl Review and Bentyl Label ), ACTONEL (View Actonel Review and Actonel Label ), SOMA: DAILY ESGIC PLUS (View Soma: Daily Esgic Plus Review and Soma: Daily Esgic Plus Label ), ABC W/CODEINE (View Abc W/codeine Review and Abc W/codeine Label ), FLONASE (View Flonase Review and Flonase Label ), VENTOLIN (View Ventolin Review and Ventolin Label ).


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To find out about documented side effects or safety concerns read either the drug label or the drug's package insert. You may also want to speak with your pharmacist or healthcare provider. All medicines have benefits and risks. The risks are the chances that something unwanted or unexpected could happen to you when you use them. You can protect yourself by searching summaries of recent safety alerts, adverse reports. Sometimes there are risks that only come to light after a medical product gets on the market and is used in a larger number of patients, for a longer period of time, and in patients whose health characteristics are different from those of the patients studied before approval.

Be aware of the following potential Butalbital risks to be aware of: 1. Watch for any Serious adverse events, such as life-threatening situation, which can require an admission to hospital or longer-than-expected hospital stay, permanent disability, birth defect, miscarriage, stillbirth, or birth with serious disease requires medical care to prevent permanent damage
2. Any potential Butalbital quality problem: suspected counterfeit product, potentially contaminated product indicated by suspicious odor or unusual color, inaccurate or unreadable product labeling
3. Potential Butalbital use error: mixing up products with similar drug names or packaging, taking wrong dose of a drug because of confusing dosing instructions on label
4. When applicable, Problems with different manufacturer of same medicine: not getting same results from a generic drug as a brand name drug, or from another generic

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Right now I am on butalbital/APAP/caffeine and that has stopped working and I am also on amitriptyline every night and while it does not work to prevent migraines I take ...

During the same period patient was treated with HYDROCODONE BITARTRATE AND ACETAMINOPHEN, LORAZEPAM, BUTALBITAL ACETAMINOPHEN AND CAFFEINE. Patient died.

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Butalbital Reactions
Accident
Atrioventricular Block
Brain Death
Brain Oedema
Bronchitis Bacterial
Cerebrovascular Accident
Completed Suicide
Death
Dysgeusia
Hepatic Congestion
Hepatic Necrosis
Hypoaesthesia Oral
Hypotension
Hypoxia
Incorrect Dose Administered
Ischaemic Hepatitis
Lip Swelling
Mouth Ulceration
Multi-organ Failure
Muscle Spasms
Oral Pain
Oropharyngeal Blistering
Overdose
PainWhat is Pain?
Pneumonia Aspiration
PoisoningWhat is Poisoning?
Pruritus
Pupils Unequal
Skin Discolouration
Stevens-johnson Syndrome
Butalbital Side Effects Notice - The material on this site is for informational purposes only, and is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider. PatientsVille.com does not provide medical advice, diagnosis or treatment. The information regarding Butalbital adverse reports, reviews and polls contained on PatientsVille.com site has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of adverse drug reactions or for establishing or changing of patient treatments. Thank you for visiting Patientsville.com!