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Diarrhea (7)
Black Stools (6)
Poop Changed Color (6)
Headache (3)
Black Stool (2)
Brief Sharp Stomach Pain (2)
Constipation (2)
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Maalox Side Effects and Adverse Effects reported to US Food and Drug Administration (FDA)

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Showing 1-25 of 254 

Therapeutic Response Unexpected (7966005-9)
on Dec 01, 2011 Male from UNITED STATES , 62 years of age, was diagnosed with
  • gastrooesophageal reflux disease
and was treated with Maalox Adv Maximum Strength Antacid/antigas. Directly after, patient experienced the unwanted or unexpected Maalox side effects: therapeutic response unexpected. Maalox Adv Maximum Strength Antacid/antigas dosage: Unk , Unk.

Food Poisoning, Therapeutic Response Unexpected, Gastric Mucosa Erythema, Off Label Use (7959982-3)
Patient was taking Maalox Adv Maximum Strength Antacid/antigas. Patient felt the following Maalox side effects: food poisoning, therapeutic response unexpected, gastric mucosa erythema, off label use on Nov 28, 2011 from UNITED STATES Additional patient health information: Female , 48 years of age, was diagnosed with
  • gastrooesophageal reflux disease
and. Maalox Adv Maximum Strength Antacid/antigas dosage: 4 Tsp, Qhs. Patient was hospitalized.

Condition Aggravated, Urinary Tract Infection, Abdominal Discomfort (7938247-X)
Adverse event was reported on Nov 15, 2011 by a Male taking Maalox Antacid/antigas Rs Liq Cool Mint (Dosage: 2.5 Tsp, Once/single) was diagnosed with
  • abdominal discomfort
and. Location: UNITED STATES , 75 years of age, After Maalox was administered, patient encountered several Maalox side effects: condition aggravated, urinary tract infection, abdominal discomfort. Patient was hospitalized.

Hypotension (7928739-1)
on Nov 10, 2011 Female from UNITED STATES , 67 years of age, was diagnosed with
  • dyspepsia
and was treated with Maalox Adv Maximum Strength Antacid/antigas. Directly after, patient experienced the unwanted or unexpected Maalox side effects: hypotension. Maalox Adv Maximum Strength Antacid/antigas dosage: 3 Tsp, Prn.


Cardiac Disorder, Diarrhoea, Underdose, Off Label Use, Cardiac Pacemaker Insertion (7885266-8)
on Oct 25, 2011 Female from UNITED STATES , 74 years of age, was diagnosed with
  • dyspepsia
  • constipation
and was treated with Maalox Adv Maximum Strength Antacid/antigas. Patient felt the following Maalox side effects: cardiac disorder, diarrhoea, underdose, off label use, cardiac pacemaker insertion. Maalox Adv Maximum Strength Antacid/antigas dosage: N/A.

Diarrhoea, Hypertension (7861155-X)
Patient was taking Maalox Advanced Regular Strength. After Maalox was administered, patient encountered several Maalox side effects: diarrhoea, hypertension on Oct 24, 2011 from UNITED STATES Additional patient health information: Female , 62 years of age, was diagnosed with
  • dyspepsia
and. Maalox Advanced Regular Strength dosage: 4 Tsp, Qd.

Off Label Use, Systemic Lupus Erythematosus (7779131-4)
Adverse event was reported on Sep 22, 2011 by a Female taking Maalox Adv Maximum Strength Antacid/antigas Chewable (Dosage: 1 Df, Unk) . Location: UNITED STATES , 54 years of age, Directly after, patient experienced the unwanted or unexpected Maalox side effects: off label use, systemic lupus erythematosus.

Concomitant Disease Aggravated, Blood Glucose Increased (7740259-6)
on Sep 06, 2011 Male from UNITED STATES , 83 years of age, was treated with Maalox Antacid Quick Dissolve. Patient felt the following Maalox side effects: concomitant disease aggravated, blood glucose increased. Maalox Antacid Quick Dissolve dosage: 2 Df, Qd.
Multiple prescriptions taken:
  • Lantus (Unk, Bid)


Spinal Compression Fracture, Spinal Cord Compression, Spinal Osteoarthritis, Metastases To Spine (7717157-7)
on Aug 26, 2011 Male from UNITED STATES , 55 years of age, was treated with Maalox. After Maalox was administered, patient encountered several Maalox side effects: spinal compression fracture, spinal cord compression, spinal osteoarthritis, metastases to spine. Maalox dosage: N/A.
Multiple concurrent drugs taken:
  • Rad001 Everolimus (5 Mg Po Daily)
  • Lisinopril
  • Aspirin
  • Lovenox
  • Av-951 (1 Mg Po Daily)
  • Clindamycin
  • Decadron
  • Indocin
Patient was hospitalized.

Fall, Arthralgia, Off Label Use, Tibia Fracture, Constipation, Pain In Extremity (7713340-5)
Patient was taking Maalox Advanced Regular Strength. Directly after, patient experienced the unwanted or unexpected Maalox side effects: fall, arthralgia, off label use, tibia fracture, constipation, pain in extremity on Aug 23, 2011 from UNITED STATES Additional patient health information: Female , 77 years of age, was diagnosed with
  • flatulence
  • constipation
and. Maalox Advanced Regular Strength dosage: 1 Capful Bid, Prn.

Nephrolithiasis, Off Label Use, Urinary Tract Infection (7651606-8)
Adverse event was reported on Jul 29, 2011 by a Female taking Maalox Adv Maximum Strength Antacid/antigas (Dosage: N/A) was diagnosed with
  • gastrooesophageal reflux disease
  • dyspepsia
and. Location: UNITED STATES , 74 years of age, weighting 125.0 lb, Patient felt the following Maalox side effects: nephrolithiasis, off label use, urinary tract infection.

Abdominal Tenderness, Thrombophlebitis Superficial, Bile Duct Stone, Abdominal Pain Upper, Pain In Extremity, Cholelithiasis, Cholecystitis Acute, Nausea, Erythema (7624454-2)
on Jul 13, 2011 Female from UNITED STATES , 46 years of age, weighting 145.0 lb, was treated with Maalox. After Maalox was administered, patient encountered several Maalox side effects: abdominal tenderness, thrombophlebitis superficial, bile duct stone, abdominal pain upper, pain in extremity, cholelithiasis, cholecystitis acute, nausea, erythema. Maalox dosage: Unk Unk, Prn.
Multiple concurrent drugs taken:
  • Yaz (As Used Dose: Unk)
  • Lovenox
  • Nsaid's
  • Yaz
  • Nexium (Unk Unk, Prn)
Patient was hospitalized.

Cholecystectomy, Off Label Use, Diarrhoea, Therapeutic Response Unexpected (7602059-7)
on Jul 01, 2011 Female from UNITED STATES , 57 years of age, was diagnosed with
  • hiatus hernia
and was treated with Maalox Adv Maximum Strength Antacid/antigas. Directly after, patient experienced the unwanted or unexpected Maalox side effects: cholecystectomy, off label use, diarrhoea, therapeutic response unexpected. Maalox Adv Maximum Strength Antacid/antigas dosage: Unk, Prn.
Associated medications used:
  • Maalox Total Relief (Unk, Unk)
  • Mestinon (Unk, Unk)
  • Prednisone (Unk, Unk)
  • Imuran (Unk, Unk)
  • Dexilant (Unk)


Gallbladder Disorder, Gallbladder Non-functioning, Injury, Cholelithiasis, Pain (7599198-6)
Patient was taking Maalox. Patient felt the following Maalox side effects: gallbladder disorder, gallbladder non-functioning, injury, cholelithiasis, pain on May 30, 2011 from UNITED STATES Additional patient health information: Female , 23 years of age, weighting 291.0 lb, . Maalox dosage: N/A.
Multiple prescriptions taken:
  • Reglan
  • Donnatal
  • Ibuprofen (Unk)
  • Dilaudid
  • Yasmin
  • Yaz (1 Tab/day)
  • Drospirenone And Ethinyl Estradiol
Patient was hospitalized.

Incorrect Dose Administered (7563916-3)
Adverse event was reported on Jun 21, 2011 by a Male taking Maalox Antacid/antigas Rs Liq Cool Mint (Dosage: Unk, From The Bottle) was diagnosed with
  • dyspepsia
and. Location: UNITED STATES , 92 years of age, After Maalox was administered, patient encountered several Maalox side effects: incorrect dose administered.

Concomitant Disease Aggravated, Blood Glucose Increased (7532627-2)
on Jun 07, 2011 Male from UNITED STATES , 61 years of age, was diagnosed with
  • dyspepsia
  • diabetes mellitus
and was treated with Maalox Adv Maximum Strength Antacid/antigas. Directly after, patient experienced the unwanted or unexpected Maalox side effects: concomitant disease aggravated, blood glucose increased. Maalox Adv Maximum Strength Antacid/antigas dosage: 2 Tsp, Qd.
Associated medications used:
  • Insulin


Abdominal Pain, Cholelithiasis, Mental Disorder, Cholecystectomy, Cholecystitis Chronic (7511360-7)
on Jan 17, 2011 Female from UNITED STATES , 42 years of age, weighting 180.0 lb, was treated with Maalox [aluminium Hydroxide,magnesium Hydroxide]. Patient felt the following Maalox side effects: abdominal pain, cholelithiasis, mental disorder, cholecystectomy, cholecystitis chronic. Maalox [aluminium Hydroxide,magnesium Hydroxide] dosage: N/A.
Multiple prescriptions taken:
  • Multi-vitamin
  • Anusol Hc [hydrocortisone Acetate]
  • Ascorbic Acid (Unk)
  • Vicodin (Unk)
  • Yasmin (Unk Unk, Unk)
  • Loprox
  • Percodan [acetylsalicylic Acid,oxycodone Hydrochloride]
  • Macrobid
Patient was hospitalized.

Osteonecrosis Of Jaw, Anxiety, Weight Increased, Sinus Tachycardia, Pancreatitis, Papilloma, Hordeolum, Pleural Fibrosis, Hypoaesthesia (7510783-X)
Patient was taking Maalox /net/. After Maalox was administered, patient encountered several Maalox side effects: osteonecrosis of jaw, anxiety, weight increased, sinus tachycardia, pancreatitis, papilloma, hordeolum, pleural fibrosis, hypoaesthesia on May 19, 2011 from UNITED STATES Additional patient health information: Male , weighting 240.0 lb, . Maalox /net/ dosage: N/A.
Multiple concurrent drugs taken:
  • Asacol
  • Peridex (10 Mg, Bid)
Patient was hospitalized.

Off Label Use, Concomitant Disease Aggravated, Blood Glucose Fluctuation (7476533-0)
Adverse event was reported on May 03, 2011 by a Female taking Maalox Adv Maximum Strength Antacid/antigas (Dosage: 4 Tsp, Bid) was diagnosed with
  • abdominal discomfort
and. Location: UNITED STATES , 55 years of age, Directly after, patient experienced the unwanted or unexpected Maalox side effects: off label use, concomitant disease aggravated, blood glucose fluctuation.

Pulmonary Embolism (7474861-6)
on Apr 08, 2011 Female from UNITED STATES , 41 years of age, weighting 131.0 lb, was treated with Maalox [calcium Carbonate]. Patient felt the following Maalox side effects: pulmonary embolism. Maalox [calcium Carbonate] dosage: N/A.
Multiple prescriptions taken:
  • Yaz (Unk)
  • Ibuprofen
  • Nasonex
  • Yasmin (Unk)
Patient was hospitalized.

Diabetes Mellitus, Blood Glucose Increased (7460666-9)
on Apr 29, 2011 Female from UNITED STATES , 69 years of age, weighting 220.0 lb, was treated with Maalox Antacid/antigas Max Qdtabs Asst. After Maalox was administered, patient encountered several Maalox side effects: diabetes mellitus, blood glucose increased. Maalox Antacid/antigas Max Qdtabs Asst dosage: Unk, Prn.

Breast Cancer, Breast Lump Removal (7456307-7)
Patient was taking Maalox Ms Total Stomach Relief. Directly after, patient experienced the unwanted or unexpected Maalox side effects: breast cancer, breast lump removal on Apr 27, 2011 from UNITED STATES Additional patient health information: Female , 73 years of age, weighting 104.0 lb, was diagnosed with
  • dyspepsia
and. Maalox Ms Total Stomach Relief dosage: 1 Tsp, Prn.
Associated medications used:
  • Maalox Adv Maximum Strength Antacid/antigas (1 Tsp, Prn)
  • Maalox Adv Maximum Strength Antacid/antigas


Thyroid Disorder, Hypertension, Cardiac Operation, Diabetes Mellitus, Diarrhoea, Off Label Use (7435948-7)
Adverse event was reported on Apr 20, 2011 by a Female taking Maalox Adv Maximum Strength Antacid/antigas (Dosage: Unk, Unk) was diagnosed with
  • gastrooesophageal reflux disease
and. Location: UNITED STATES , weighting 130.0 lb, Patient felt the following Maalox side effects: thyroid disorder, hypertension, cardiac operation, diabetes mellitus, diarrhoea, off label use.
Multiple prescriptions taken:
  • Maalox Ms Total Stomach Relief (Unk, Unk)


Haemoptysis, Therapeutic Response Decreased, Diarrhoea, Overdose (7421586-9)
on Apr 07, 2011 Male from UNITED STATES , weighting 159.0 lb, was diagnosed with
  • dyspepsia
  • flatulence
and was treated with Maalox Antacid/antigas Rs Liq Cool Mint. After Maalox was administered, patient encountered several Maalox side effects: haemoptysis, therapeutic response decreased, diarrhoea, overdose. Maalox Antacid/antigas Rs Liq Cool Mint dosage: 1/4 Bottle At A Time.
Multiple concurrent drugs taken:
  • Gas-x Extra Strength Softgels (3 Df At A Time)


Blood Creatinine Increased, Tubulointerstitial Nephritis (7394361-1)
on Mar 30, 2011 Female from UNITED STATES , weighting 155.0 lb, was treated with Maalox. Directly after, patient experienced the unwanted or unexpected Maalox side effects: blood creatinine increased, tubulointerstitial nephritis. Maalox dosage: N/A.
Associated medications used:
  • Actemra
  • Effient
  • Actemra (Form: Infusion)
  • Orencia (Second Dose On 4 Dec 2010)
Patient was hospitalized.

Showing 1-25 of 254 

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It is very important to keep track of all side effects and discuss them with your doctor. If you think you may have a medical emergency, call your doctor or 911 immediately.

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Most drugs have a large list of nonsevere or mild adverse effects which do not rule out continued usage. These effects depend on individual sensitivity, and can include nausea, dizziness, diarrhea, malaise, vomiting, headache, dermatitis, dry mouth, etc. Check commonly reported side effects . These can be considered a form of pseudo-allergic reaction, as not all users experience these effects; many users experience none at all.

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.

Maalox Information

Alternative MAALOX Names:ALUMINUM

Active Ingredient: ALUMINUM

More About Maalox

Side Effects reported to FDA: 254. View Maalox Adverse Reports

Maalox safety alerts: 2010

Reported deaths: 1

Reported hospitalizations: 6

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]

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