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Maalox Side Effects

Common Maalox Side Effects


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

Off Label Use (140)
Therapeutic Response Unexpected (60)
Faeces Discoloured (56)
Incorrect Dose Administered (38)
Gastrooesophageal Reflux Disease (30)
Diarrhoea (30)
Abdominal Pain Upper (28)
Hypertension (25)
Overdose (24)
Diabetes Mellitus (21)
Abdominal Discomfort (19)
Myocardial Infarction (19)
Dyspepsia (18)
Haematochezia (17)
Vomiting (17)
Malaise (17)
Underdose (15)
Asthenia (15)
Hiatus Hernia (14)
Blood Glucose Increased (14)

➢ 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.

Maalox Side Effects Reported to FDA

The following Maalox 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 Maalox 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.
Thyroid Cancer
This is a report of a 47-year-old female patient (weight: NA) from CA, suffering from the following symptoms/conditions: flatulence,abdominal distension,eructation,abdominal pain upper,off label use,hypertension, who was treated with Maalox Regular Strength Chewable (dosage: 2 Df, Prn, start time: NS), combined with: NA. and developed a serious reaction and side effect(s). The consumer presented with:
  • Thyroid Cancer
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Maalox Regular Strength Chewable treatment in female patients, resulting in thyroid cancer side effect.

Vaginal Infection, Therapeutic Response Unexpected, Incorrect Dose Administered
This report suggests a potential Maalox Adv Maximum Strength Antacid/antigas Vaginal Infection, Therapeutic Response Unexpected, Incorrect Dose Administered side effect(s) that can have serious consequences. A 71-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: gastrooesophageal reflux disease,off label use and used Maalox Adv Maximum Strength Antacid/antigas (dosage: 2 Tbsp, Prn) starting NS. Soon after starting Maalox Adv Maximum Strength Antacid/antigas the patient began experiencing various side effects, including:
  • Vaginal Infection
  • Therapeutic Response Unexpected
  • Incorrect Dose Administered
Drugs used concurrently: NA. Although Maalox Adv Maximum Strength Antacid/antigas demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as vaginal infection, may still occur.

Abortion Spontaneous, Exposure During Pregnancy
This Abortion Spontaneous, Exposure During Pregnancy problem was reported by a consumer or non-health professional from CA. A 36-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: dyspepsia. On 2000 this consumer started treatment with Maalox Extra Strength Premium (dosage: 2 Df, Prn). The following drugs were being taken at the same time: NA. When commencing Maalox Extra Strength Premium, the patient experienced the following unwanted symptoms/side effects:
  • Abortion Spontaneous
  • Exposure During Pregnancy
Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as abortion spontaneous, may become evident only after a product is in use by the general population.

Abortion Spontaneous, Exposure During Pregnancy
This is a report of a 36-year-old female patient (weight: NA) from CA. The patient developed the following symptoms/conditions: dyspepsia and was treated with Maalox Extra Strength Premium (dosage: 2 Df, Prn) starting NS. Concurrently used drugs: NA.Soon after that, the consumer experienced the following side effects:
  • Abortion Spontaneous
  • Exposure During Pregnancy
This opens a possibility that Maalox Extra Strength Premium treatment could cause the above reactions, including abortion spontaneous, and some female subjects may be more susceptible.


Myocardial Infarction, Coronary Artery Occlusion, Device Occlusion, Retching, Underdose, Therapeutic Response Unexpected
A 91-year-old female patient (weight: NA) from US with the following symptoms/conditions: dyspepsia,off label use started Maalox Antacid/antigas Max Qdtabs Wildb treatment (dosage: 0.5 Df, Prn) on NS. Soon after starting Maalox Antacid/antigas Max Qdtabs Wildb treatment, the subject experienced various side effects, including:
  • Myocardial Infarction
  • Coronary Artery Occlusion
  • Device Occlusion
  • Retching
  • Underdose
  • Therapeutic Response Unexpected
Concurrently used drugs: NA.The patient was hospitalized. This finding indicates that some female patients could be more vulnerable to Maalox Antacid/antigas Max Qdtabs Wildb.

Cataract, Arthropathy, Underdose
A 83-year-old female patient from US (weight: NA) experienced symptoms, such as: abdominal discomfort and was treated with Maalox Adv Maximum Strength Antacid/antigas Chewable(dosage: 1/2 To 1 Df, Unk). The treatment was initiated on NS. After that a consumer reported the following side effect(s):
  • Cataract
  • Arthropathy
  • Underdose
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Maalox Adv Maximum Strength Antacid/antigas Chewable efficacy: NA.

Tremor, Renal Pain, Abdominal Discomfort, Abdominal Pain Upper, Hepatic Pain, Incorrect Dose Administered
In this report, Maalox Adv Maximum Strength Antacid/antigas was administered for the following condition: abdominal discomfort,immunisation.A 87-year-old female consumer from US (weight: NA) started Maalox Adv Maximum Strength Antacid/antigas treatment (dosage: Unk) on NS.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Tremor
  • Renal Pain
  • Abdominal Discomfort
  • Abdominal Pain Upper
  • Hepatic Pain
  • Incorrect Dose Administered
A possible interaction with other drugs could have contributed to this reaction:
  • Influenza Vaccine
Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Maalox Adv Maximum Strength Antacid/antigas treatment could be related to the listed above side effect(s).

Breast Cancer, Large Intestine Polyp, Incorrect Dose Administered, Therapeutic Response Unexpected
This is a report of the following Maalox Adv Maximum Strength Antacid/antigas side effect(s):
  • Breast Cancer
  • Large Intestine Polyp
  • Incorrect Dose Administered
  • Therapeutic Response Unexpected
A 71-year-old female patient from US (weight: NA) presented with the following condition: dyspepsia and received a treatment with Maalox Adv Maximum Strength Antacid/antigas (dosage: 1-2 Tablespoonfuls; Prn) starting: NS.The following concurrently used drugs could have generated interactions:
  • Maalox Antacid Liq Ext Str Lemon (1-2 Tablespoonfuls; Prn)
This report suggests that a Maalox Adv Maximum Strength Antacid/antigas treatment could be associated with the listed above side effect(s).

Crohn^s Disease
This Maalox Antacid/antigas Max Qdtabs Asst report was submitted by a 53-year-old female consumer from US (weight: NA). The patient was diagnosed with: flatulence,dyspepsia and Maalox Antacid/antigas Max Qdtabs Asst was administered (dosage: Unk, Unk) starting: NS. The consumer developed a set of symptoms:
  • Crohn^s Disease
Other drugs used simultaneously: NA.Those unexpected symptoms could be linked to a Maalox Antacid/antigas Max Qdtabs Asst treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

Anxiety
This is a report of a possible correlation between Maalox Antacid/antigas Max Qdtabs Asst use and the following symptoms/side effect(s):
  • Anxiety
which could contribute to an assessment of Maalox Antacid/antigas Max Qdtabs Asst risk profile.A 81-year-old female consumer from US (weight: NA) was suffering from hiatus hernia,off label use and was treated with Maalox Antacid/antigas Max Qdtabs Asst (dosage: 2 Df, Prn) starting NS.Other concurrent medications: NA.

Gastritis, Dyspepsia, Gastrooesophageal Reflux Disease
A 69-year-old female patient from US (weight: NA) presented with the following symptoms: flatulence,abdominal distension,gastrooesophageal reflux disease,dyspepsia,off label use,arthritis,hypertension and after a treatment with Maalox Antacid/antigas Max Liq (dosage: 2 Tsp, Prn) experienced the following side effect(s):
  • Gastritis
  • Dyspepsia
  • Gastrooesophageal Reflux Disease
The treatment was started on NS. Maalox Antacid/antigas Max Liq was used in combination with the following drugs: NA.This report could alert potential Maalox Antacid/antigas Max Liq consumers.

Crohn^s Disease, Disease Recurrence, Gastrooesophageal Reflux Disease, Therapeutic Response Unexpected
In this report, a 56-year-old female patient from US (weight: NA) was affected by a possible Maalox Antacid Barrier side effect.The patient was diagnosed with crohn^s disease,gastrooesophageal reflux disease,off label use,abdominal discomfort. After a treatment with Maalox Antacid Barrier (dosage: 1 To 2 Df, Prn, start date: NS), the patient experienced the following side effect(s):
  • Crohn^s Disease
  • Disease Recurrence
  • Gastrooesophageal Reflux Disease
  • Therapeutic Response Unexpected
The following simultaneously used drugs could have led to this reaction: NA.The findings here stress that side effects should be taken into consideration when evaluating a Maalox Antacid Barrier treatment.

Crohn^s Disease, Gastrooesophageal Reflux Disease, Incisional Hernia, Intestinal Prolapse, Flatulence, Procedural Nausea, Procedural Vomiting, Stress
This is a report of a 50-year-old female patient from US (weight: NA), who used Maalox Antacid/antigas Rs Liq Cool Mint (dosage: 2 Tsp, Prn) for a treatment of gastrooesophageal reflux disease,crohn^s disease,prophylaxis,off label use,chest pain,back pain,gallbladder disorder. After starting a treatment on 200011, the patient experienced the following side effect(s):
  • Crohn^s Disease
  • Gastrooesophageal Reflux Disease
  • Incisional Hernia
  • Intestinal Prolapse
  • Flatulence
  • Procedural Nausea
  • Procedural Vomiting
  • Stress
The following drugs could possibly have interacted with the Maalox Antacid/antigas Rs Liq Cool Mint treatment NA.Taken together, these observations suggest that a Maalox Antacid/antigas Rs Liq Cool Mint treatment could be related to side effect(s), such as Crohn^s Disease, Gastrooesophageal Reflux Disease, Incisional Hernia, Intestinal Prolapse, Flatulence, Procedural Nausea, Procedural Vomiting, Stress.

Cerebrovascular Accident
This cerebrovascular accident side effect was reported by a consumer or non-health professional from US. A 68-year-old male patient (weight:NA) experienced the following symptoms/conditions: dyspepsia. The patient was prescribed Maalox Antacid Barrier (dosage: Unk, Unk), which was started on NS. Concurrently used drugs: NA. When starting to take Maalox Antacid Barrier the consumer reported the following symptoms:
  • Cerebrovascular Accident
These side effects may potentially be related to Maalox Antacid Barrier.

Fall
This is a Maalox Antacid/antigas Max Liq side effect report of a 65-year-old female patient (weight:NA) from US, suffering from the following symptoms/conditions: abdominal discomfort, who was treated with Maalox Antacid/antigas Max Liq (dosage:Unk, Unk, start time: NS), combined with: NA., and developed a serious reaction and a fall side effect. The patient presented with:
  • Fall
which developed after the beginning of treatment. This side effect report can indicate a possible existence of increased vulnerability to Maalox Antacid/antigas Max Liq treatment in female patients suffering from abdominal discomfort, resulting in fall.

Renal Injury, Vomiting
This report suggests a potential Maalox Quick Dissolve Extra Strength With Antigas renal injury side effect(s) that can have serious consequences. A 79-year-old female patient from US (weight:NA) was diagnosed with the following health condition(s): dyspepsia and used Maalox Quick Dissolve Extra Strength With Antigas (dosage: 1 Df, Prn) starting NS. Soon after starting Maalox Quick Dissolve Extra Strength With Antigas the patient began experiencing various side effects, including:
  • Renal Injury
  • Vomiting
Drugs used concurrently:NA. Although Maalox Quick Dissolve Extra Strength With Antigas demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as renal injury, may still occur.

Ulcer
This ulcer problem was reported by a consumer or non-health professional from US. A 74-year-old female patient (weight: NA) was diagnosed with the following medical condition(s): ulcer,off label use.On NS a consumer started treatment with Maalox Adv Maximum Strength Antacid/antigas (dosage: 1 Tablespoon, 2-3 Times Per Week). The following drugs/medications were being taken at the same time: NA. When commencing Maalox Adv Maximum Strength Antacid/antigas, the patient experienced the following unwanted symptoms /side effects:
  • Ulcer
Although all drugs are carefully tested before they are licensed for use, they carry potential side effect risks. Some side effects, such as ulcer, may become evident only after a product is in use by the general population.

Ulcer, Milk Allergy, Therapeutic Response Unexpected
This is a Maalox Antacid/antigas Max Qdtabs Asst side effect report of a 71-year-old male patient (weight: NA) from US. The patient developed the following symptoms/conditions: gastrooesophageal reflux disease,ulcer,off label use and was treated with Maalox Antacid/antigas Max Qdtabs Asst (dosage: Unk, Unk) starting NS. Concurrently used drugs: NA. Soon after that, the consumer experienced the following of symptoms:
  • Ulcer
  • Milk Allergy
  • Therapeutic Response Unexpected
This opens a possibility that Maalox Antacid/antigas Max Qdtabs Asst could cause ulcer and that some male patients may be more susceptible.

Heart Rate Irregular, Haemorrhage, Incorrect Dose Administered, Therapeutic Response Decreased
A 88-year-old female patient (weight: NA) from US with the following symptoms: dyspepsia started Maalox Antacid/antigas Ms Liq Cool Mint treatment (dosage: 6 Tsp, Unk) on NS. Soon after starting Maalox Antacid/antigas Ms Liq Cool Mint treatment, the consumer experienced several side effects, including:
  • Heart Rate Irregular
  • Haemorrhage
  • Incorrect Dose Administered
  • Therapeutic Response Decreased
. Concurrently used drugs:
  • Baby Aspirin (Unk)
The patient was hospitalized. This finding indicates that some patients can be more vulnerable to developing Maalox Antacid/antigas Ms Liq Cool Mint side effects, such as heart rate irregular.

Hiatus Hernia, Gastrooesophageal Reflux Disease
This hiatus hernia side effect was reported by a consumer or non-health professional from US. A 82-year-old female patient (weight:NA) experienced the following symptoms/conditions: abdominal discomfort,flatulence,irritable bowel syndrome,off label use.The patient was prescribed Maalox Antacid/antigas Max Qdtabs Asst (dosage: Unk, Unk), which was started on NS. Concurrently used drugs: NA..When starting to take Maalox Antacid/antigas Max Qdtabs Asst the consumer reported symptoms, such as:
  • Hiatus Hernia
  • Gastrooesophageal Reflux Disease
These side effects may potentially be related to Maalox Antacid/antigas Max Qdtabs Asst.

Amnesia
This is a report of a 83-year-old male patient (weight: NA) from US, suffering from the following symptoms/conditions: NA, who was treated with Maalox (dosage: Unk,unk, start time: NS), combined with: NA. and developed a serious reaction and side effect(s). The consumer presented with:
  • Amnesia
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Maalox treatment in male patients, resulting in amnesia side effect.

Gallbladder Injury, Biliary Tract Disorder, Gastrointestinal Disorder, Flatulence, Disease Recurrence
This report suggests a potential Maalox Antacid/antigas Max Qdtabs Asst Gallbladder Injury, Biliary Tract Disorder, Gastrointestinal Disorder, Flatulence, Disease Recurrence side effect(s) that can have serious consequences. A 74-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: dyspepsia,flatulence and used Maalox Antacid/antigas Max Qdtabs Asst (dosage: 1-2 Df, Unk) starting NS. Soon after starting Maalox Antacid/antigas Max Qdtabs Asst the patient began experiencing various side effects, including:
  • Gallbladder Injury
  • Biliary Tract Disorder
  • Gastrointestinal Disorder
  • Flatulence
  • Disease Recurrence
Drugs used concurrently: NA. Although Maalox Antacid/antigas Max Qdtabs Asst demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as gallbladder injury, may still occur.

Parkinson^s Disease, Aphagia, Urinary Tract Infection, Gastrointestinal Disorder, Asthenia, Weight Decreased, Off Label Use, Therapeutic Response Unexpected
This Parkinson^s Disease, Aphagia, Urinary Tract Infection, Gastrointestinal Disorder, Asthenia, Weight Decreased, Off Label Use, Therapeutic Response Unexpected problem was reported by a consumer or non-health professional from US. A 73-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: impaired gastric emptying. On NS this consumer started treatment with Maalox Antacid Barrier (dosage: Unk, Prn). The following drugs were being taken at the same time: NA. When commencing Maalox Antacid Barrier, the patient experienced the following unwanted symptoms/side effects:
  • Parkinson^s Disease
  • Aphagia
  • Urinary Tract Infection
  • Gastrointestinal Disorder
  • Asthenia
  • Weight Decreased
  • Off Label Use
  • Therapeutic Response Unexpected
Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as parkinson^s disease, may become evident only after a product is in use by the general population.

Gastric Ulcer, Anxiety, Therapeutic Response Unexpected, Incorrect Dose Administered
This is a report of a 70-year-old female patient (weight: NA) from US. The patient developed the following symptoms/conditions: gastric ulcer and was treated with Maalox Antacid/antigas Rs Liq Cool Mint (dosage: Unk, Unk) starting 2003. Concurrently used drugs: NA.Soon after that, the consumer experienced the following side effects:
  • Gastric Ulcer
  • Anxiety
  • Therapeutic Response Unexpected
  • Incorrect Dose Administered
This opens a possibility that Maalox Antacid/antigas Rs Liq Cool Mint treatment could cause the above reactions, including gastric ulcer, and some female subjects may be more susceptible.

Bone Cancer, Metastases To Lung, Metastases To Central Nervous System, Polyp, Gastric Disorder, Incorrect Dose Administered
A 68-year-old male patient (weight: NA) from US with the following symptoms/conditions: dyspepsia started Maalox Antacid/antigas Rs Liq Cool Mint treatment (dosage: Unk Unk, Prn) on 2010. Soon after starting Maalox Antacid/antigas Rs Liq Cool Mint treatment, the subject experienced various side effects, including:
  • Bone Cancer
  • Metastases To Lung
  • Metastases To Central Nervous System
  • Polyp
  • Gastric Disorder
  • Incorrect Dose Administered
Concurrently used drugs: NA. This finding indicates that some male patients could be more vulnerable to Maalox Antacid/antigas Rs Liq Cool Mint.

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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 Maalox Side Effects

    Did You Have a Maalox Side Effect?

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    How Effective is Maalox for You?

    Exceeded Expectations
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    Maalox Safety Alerts, Active Ingredients, Usage Information

    NDC0067-6280
    TypeHUMAN OTC DRUG
    Proprietary NameMaalox Advanced Maximum Strength Cherry
    NameAluminum Hydroxide, Magnesium Hydroxide,Simethicone
    Dosage FormLIQUID
    RouteORAL
    On market since20080306
    LabelerNovartis Consumer Health, Inc
    Active Ingredient(s)ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE
    Strength(s)400; 40; 400
    Unit(s)mg/5mL; mg/5mL; mg/5mL
    Pharma Class

    More About Maalox

    Side Effects reported to FDA: 455

    Maalox safety alerts: 2010

    Reported deaths: 4

    Reported hospitalizations: 11

    Maalox Total Relief and Maalox Liquid Products: Medication Use Errors

    Audience: Consumers, Healthcare professionals

    [Posted 02/17/2010] FDA notified consumers and healthcare professionals about reports of serious medication errors involving consumers who used Maalox Total Relief when they had intended to use a Maalox liquid antacid product. Maalox Total Relief and the traditional Maalox products are both liquid medications available without a prescription, but are not interchangeable and are intended to treat different medical conditions. Maalox Total Relief is an upset stomach reliever and anti-diarrheal medication, while traditional Maalox liquid products Maalox Advanced Regular Strength and Maalox Advanced Maximum Strength are antacids.

    Maalox Total Relief is not appropriate for individuals who want to use an antacid, since it contains the active ingredient bismuth subsalicylate which is chemically related to aspirin and may cause serious adverse effects such as bleeding. Maalox Total Relief should not be used in people who have or have a history of gastrointestinal ulcers or a bleeding disorder. It also should not be taken by children and teens if they are recovering from a viral infection, nor by individuals who are taking certain medications including: oral antidiabetic drugs (OADs), anticoagulation (thinning the blood) drugs such as warfarin (Coumadin) and clopidogrel (Plavix), non-steroidal anti-inflammatory drugs (NSAIDS), and other anti-inflammatory drugs. 

    The Drug Safety Communication and Consumer Update contain additional information for healthcare professionals and consumers, as well as product label photos.

    [02/17/2010 - Drug Safety Communication - FDA]
    [02/17/2010 - News Release - FDA]
    [02/17/2010 - Consumer Update - FDA]

    Latest Maalox clinical trials