- So, your physician gave you or someone you know some
Nexium pills for acid reflux problems?
- The doctor didn't say anything about any bad side effects?
- Did the physician pull the bottles from the boxes, and
then put the bottles in a bag first without the side effect sheets? Many
doctors often tell patients "Oh, don't worry about the side effects.
- Want to know what information you're REALLY missing and
need to know?
- SPECIAL NOTE FOR CARDIAC PATIENTS:
- Down near the end of this lengthy insane list, is a comment
that this drug can interefere with Digoxin. This is a very popular
heart drug used for years to treat high blood pressure and other cardiac
problems. (But be sure to read all of the other text.)
- How long it will be before this drug is pulled from the
- The safety of NEXIUM was evaluated in over 15,000 patients
(aged 18-84 years) in clinical trials worldwide including over 8,500 patients
in the United States and over 6,500 patients in Europe and Canada. Over
2,900 patients were treated in long-term studies for up to 6-12 months.
In general, NEXIUM was well tolerated in both short and long-term clinical
- A study was performed evaluating the safety of NEXIUM
in pediatric patients aged 12-17 for the treatment of symptomatic gerd
The safety in the treatment of healing of erosive esophagitis was assessed
in four randomized comparative clinical trials, which included 1,240 patients
on NEXIUM 20 mg, 2,434 patients on NEXIUM 40 mg, and 3,008 patients on
omeprazole 20 mg daily. The most frequently occurring adverse events (>1%)
in all three groups was headache (5.5, 5.0, and 3.8, respectively) and
diarrhea (no difference among the three groups). Nausea, flatulence, abdominal
pain, constipation, and dry mouth occurred at similar rates among patients
taking NEXIUM or omeprazole.
- Additional adverse events that were reported as possibly
or probably related to NEXIUM with an incidence < 1% are listed below
by body system:
- Body as a Whole: abdomen enlarged, allergic reaction,
asthenia, back pain, chest pain, chest pain substernal, facial edema, peripheral
edema, hot flushes, fatigue, fever, flu-like disorder, generalized edema,
leg edema, malaise, pain, rigors; Cardiovascular: flushing, hypertension,
tachycardia; Endocrine: goiter; Gastrointestinal: bowel irregularity, constipation
aggravated, dyspepsia, dysphagia, dysplasia GI, epigastric pain, eructation,
esophageal disorder, frequent stools, gastroenteritis, GI hemorrhage, GI
symptoms not otherwise specified, hiccup, melena, mouth disorder, pharynx
disorder, rectal disorder, serum gastrin increased, tongue disorder, tongue
edema, ulcerative stomatitis, vomiting; Hearing: earache, tinnitus; Hematologic:
anemia, anemia hypochromic, cervical lymphoadenopathy, epistaxis, leukocytosis,
leukopenia, thrombocytopenia; Hepatic: bilirubinemia, hepatic function
abnormal, SGOT increased, SGPT increased; Metabolic/Nutritional: glycosuria,
hyperuricemia, hyponatremia, increased alkaline phosphatase, thirst, vitamin
B12 deficiency, weight increase, weight decrease; Musculoskeletal: arthralgia,
arthritis aggravated, arthropathy, cramps, fibromyalgia syndrome, hernia,
polymyalgia rheumatica; Nervous System/Psychiatric: anorexia, apathy, appetite
increased, confusion, depression aggravated, dizziness, hypertonia, nervousness,
hypoesthesia, impotence, insomnia, migraine, migraine aggravated, paresthesia,
sleep disorder, somnolence, tremor, vertigo, visual field defect; Reproductive:
dysmenorrhea, menstrual disorder, vaginitis; Respiratory: asthma aggravated,
coughing, dyspnea, larynx edema, pharyngitis, rhinitis, sinusitis; Skin
and Appendages: acne, angioedema, dermatitis, pruritus, pruritus ani, rash,
rash erythematous, rash maculo-papular, skin inflammation, sweating increased,
urticaria; Special Senses: otitis media, parosmia, taste loss, taste perversion;
Urogenital: abnormal urine, albuminuria, cystitis, dysuria, fungal infection,
hematuria, micturition frequency, moniliasis, genital moniliasis, polyuria;
Visual: conjunctivitis, vision abnormal.
- Endoscopic findings that were reported as adverse events
include: duodenitis, esophagitis, esophageal stricture, esophageal ulceration,
esophageal varices, gastric ulcer, gastritis, hernia, benign polyps or
nodules, Barrett's esophagus, and mucosal discoloration.
- The incidence of treatment-related adverse events during
6-month maintenance treatment was similar to placebo. There were no differences
in types of related adverse events seen during maintenance treatment up
to 12 months compared to short-term treatment.
- Two placebo-controlled studies were conducted in 710
patients for the treatment of symptomatic gastroesophageal reflux disease.
The most common adverse events that were reported as possibly or probably
related to NEXIUM were diarrhea (4.3%), headache (3.8%), and abdominal
- Postmarketing Reports There have been spontaneous
reports of adverse events with postmarketing use of esomeprazole. These
reports occurred rarely and are listed below by body system: Blood And
Lymphatic System Disorders: agranulocytosis, pancytopenia; Eye Disorders:
blurred vision; Gastrointestinal Disorders: pancreatitis; stomatitis1;
Hepatobiliary Disorders: hepatic failure2; hepatitis with or without jaundice;
Immune System Disorders: anaphylactic reaction/shock; Infections and Infestations:
GI candidiasis3; Musculoskeletal And Connective Tissue Disorders: muscular
weakness4, myalgia; Nervous System Disorders: hepatic encephalopathy5,
taste disturbance 6; Psychiatric Disorders; aggression7, agitation 8, depression,
hallucination9, Renal and Urinary Disorders: interstitial nephritis 10;
Reproductive System and Breast Disorders: gynecomastia11; Respiratory,
Thoracic and Mediastinal Disorders: bronchospasm12; Skin and Subcutaneous
Tissue Disorders: alopecia, erythema multiforme, hyperhidrosis13, photosensitivity14,
Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN, some fatal).
- Other adverse events not observed with NEXIUM, but occurring
with omeprazole can be found in the omeprazole package insert, ADVERSE
- Combination Treatment with Amoxicillin and Clarithromycin
- In clinical trials using combination therapy with NEXIUM
plus amoxicillin and clarithromycin, no adverse events peculiar to these
drug combinations were observed. Adverse events that occurred have been
limited to those that had been observed with either NEXIUM, amoxicillin,
or clarithromycin alone.
- The most frequently reported drug-related adverse events
for patients who received triple therapy for 10 days were diarrhea (9.2%),
taste perversion (6.6%), and abdominal pain (3.7%). No treatment-emergent
adverse events were observed at higher rates with triple therapy than were
observed with NEXIUM alone.
- For more information on adverse events with amoxicillin
or clarithromycin, refer to their package inserts, ADVERSE REACTIONS sections.
- Laboratory Events
- The following potentially clinically significant laboratory
changes in clinical trials, irrespective of relationship to NEXIUM, were
reported in <1% of patients: increased creatinine, uric acid, total
bilirubin, alkaline phosphatase, ALT, AST, hemoglobin, white blood cell
count, platelets, serum gastrin, potassium, sodium, thyroxine and thyroid
stimulating hormone (see CLINICAL PHARMACOLOGY, Endocrine Effects for further
information on thyroid effects). Decreases were seen in hemoglobin, white
blood cell count, platelets, potassium, sodium, and thyroxine.
- In clinical trials using combination therapy with NEXIUM
plus amoxicillin and clarithromycin, no additional increased laboratory
abnormalities particular to these drug combinations were observed.
- For more information on laboratory changes with amoxicillin
or clarithromycin, refer to their package inserts, ADVERSE REACTIONS section.
- DRUG INTERACTIONS
- Esomeprazole is extensively metabolized in the liver
by CYP2C19 and CYP3A4.
- In vitro and in vivo studies have shown that esomeprazole
is not likely to inhibit CYPs 1A2, 2A6, 2C9, 2D6, 2E1 and 3A4. No clinically
relevant interactions with drugs metabolized by these CYP enzymes would
be expected. Drug interaction studies have shown that esomeprazole does
not have any clinically significant interactions with phenytoin, warfarin,
quinidine, clarithromycin or amoxicillin. Post-marketing reports of changes
in prothrombin measures have been received among patients on concomitant
warfarin and esomeprazole therapy. Increases in INR and prothrombin time
may lead to abnormal bleeding and even death. Patients treated with proton
pump inhibitors and warfarin concomitantly may need to be monitored for
increases in INR and prothrombin time.
- Esomeprazole may potentially interfere with CYP2C19,
the major esomeprazole metabolizing enzyme. Coadministration of esomeprazole
30 mg and diazepam, a CYP2C19 substrate, resulted in a 45% decrease in
clearance of diazepam. Increased plasma levels of diazepam were observed
12 hours after dosing and onwards. However, at that time, the plasma levels
of diazepam were below the therapeutic interval, and thus this interaction
is unlikely to be of clinical relevance.
- Coadministration of oral contraceptives, diazepam, phenytoin,
or quinidine did not seem to change the pharmacokinetic profile of esomeprazole.
- Concomitant administration of esomeprazole may reduce
the plasma levels of atazanavir, thus appropriate clinical monitoring is
- Studies evaluating concomitant administration of esomeprazole
and either naproxen (non-selective NSAID) or rofecoxib (COX-2 selective
NSAID) did not identify any clinically relevant changes in the pharmacokinetic
profiles of esomeprazole or these NSAIDs.
- Esomeprazole inhibits gastric acid secretion. Therefore,
esomeprazole may interfere with the absorption of drugs where gastric pH
is an important determinant of bioavailability (e.g., ketoconazole, iron
salts and digoxin).
- Combination Therapy with Clarithromycin
- Co-administration of esomeprazole, clarithromycin, and
amoxicillin has resulted in increases in the plasma levels of esomeprazole
and 14-hydroxyclarithromycin. (See CLINICAL PHARMACOLOGY, Pharmacokinetics:
Combination Therapy with Antimicrobials.)
- Concomitant administration of clarithromycin with pimozide
is contraindicated. (See clarithromycin package insert.)
- CLARITHROMYCIN SHOULD NOT BE USED IN PREGNANT WOMEN EXCEPT
IN CLINICAL CIRCUMSTANCES WHERE NO ALTERNATIVE THERAPY IS APPROPRIATE.
IF PREGNANCY OCCURS WHILE TAKING CLARITHROMYCIN, THE PATIENT SHOULD BE
APPRISED OF THE POTENTIAL HAZARD TO THE FETUS. (See WARNINGS in prescribing
information for clarithromycin.)
- Amoxicillin: Serious and occasionally fatal hypersensitivity
(anaphylactic) reactions have been reported in patients on penicillin therapy.
These reactions are more apt to occur in individuals with a history of
penicillin hypersensitivity and/or a history of sensitivity to multiple
- There have been well documented reports of individuals
with a history of penicillin hypersensitivity reactions who have experienced
severe hypersensitivity reactions when treated with a cephalosporin. Before
initiating therapy with any penicillin, careful inquiry should be made
concerning previous hypersensitivity reactions to penicillins, cephalosporins,
and other allergens. If an allergic reaction occurs, amoxicillin should
be discontinued and the appropriate therapy instituted.
- SERIOUS ANAPHYLACTIC REACTIONS REQUIRE IMMEDIATE EMERGENCY
TREATMENT WITH EPINEPHRINE. OXYGEN, INTRAVENOUS STEROIDS, AND AIRWAY MANAGEMENT,
INCLUDING INTUBATION, SHOULD ALSO BE ADMINISTERED AS INDICATED.
- PSEUDOMEMBRANOUS COLITIS HAS BEEN REPORTED WITH NEARLY
ALL ANTIBACTERIAL AGENTS, INCLUDING CLARITHROMYCIN AND AMOXICILLIN, AND
MAY RANGE IN SEVERITY FROM MILD TO LIFE THREATENING. THEREFORE, IT IS IMPORTANT
TO CONSIDER THIS DIAGNOSISIN PATIENTS WHO PRESENT WITH DIARRHEA SUBSEQUENT
TO THE ADMINISTRATION OF ANTIBACTERIAL AGENTS.
- Treatment with antibacterial agents alters the normal
flora of the colon and may permit overgrowth of clostridia. Studies indicate
that a toxin produced by Clostridium difficile is a primary cause of "antibiotic-associated
- After the diagnosis of pseudomembranous colitis has been
established, therapeutic measures should be initiated. Mild cases of pseudomembranous
colitis usually respond to discontinuation of the drug alone. In moderate
to severe cases, consideration should be given to management with fluids
and electrolytes, protein supplementation, and treatment with an antibacterial
drug clinically effective against Clostridium difficile colitis.
- Symptomatic response to therapy with NEXIUM does not
preclude the presence of gastric malignancy.
- Atrophic gastritis has been noted occasionally in gastric
corpus biopsies from patients treated long-term with omeprazole, of which
NEXIUM is an enantiomer.
- Carcinogenesis, Mutagenesis, Impairment of Fertility
- The carcinogenic potential of esomeprazole was assessed
using omeprazole studies. In two 24-month oral carcinogenicity studies
in rats, omeprazole at daily doses of 1.7, 3.4, 13.8, 44.0 and 140.8 mg/kg/day
(about 0.7 to 57 times the human dose of 20 mg/day expressed on a body
surface area basis) produced gastric ECL cell carcinoids in a dose-related
manner in both male and female rats; the incidence of this effect was markedly
higher in female rats, which had higher blood levels of omeprazole. Gastric
carcinoids seldom occur in the untreated rat. In addition, ECL cell hyperplasia
was present in all treated groups of both sexes. In one of these studies,
female rats were treated with 13.8 mg omeprazole/kg/day (about 5.6 times
the human dose on a body surface area basis) for 1 year, then followed
for an additional year without the drug. No carcinoids were seen in these
rats. An increased incidence of treatment-related ECL cell hyperplasia
was observed at the end of 1 year (94% treated vs 10% controls). By the
second year the difference between treated and control rats was much smaller
(46% vs 26%) but still showed more hyperplasia in the treated group. Gastric
adenocarcinoma was seen in one rat (2%). No similar tumor was seen in male
or female rats treated for 2 years. For this strain of rat no similar tumor
has been noted historically, but a finding involving only one tumor is
difficult to interpret. A 78-week mouse carcinogenicity study of omeprazole
did not show increased tumor occurrence, but the study was not conclusive.
- Esomeprazole was negative in the Ames mutation test,
in the in vivo rat bone marrow cell chromosome aberration test, and the
in vivo mouse micronucleus test. Esomeprazole, however, was positive in
the in vitro human lymphocyte chromosome aberration test. Omeprazole was
positive in the in vitro human lymphocyte chromosome aberration test, the
in vivo mouse bone marrow cell chromosome aberration test, and the in vivo
mouse micronucleus test.
- The potential effects of esomeprazole on fertility and
reproductive performance were assessed using omeprazole studies. Omeprazole
at oral doses up to 138 mg/kg/day in rats (about 56 times the human dose
on a body surface area basis) was found to have no effect on reproductive
performance of parental animals.
- Teratogenic Effects. Pregnancy Category B
- Teratology studies have been performed in rats at oral
doses up to 280 mg/kg/day (about 57 times the human dose on a body surface
area basis) and in rabbits at oral doses up to 86 mg/kg/day (about 35 times
the human dose on a body surface area basis) and have revealed no evidence
of impaired fertility or harm to the fetus due to esomeprazole.
- There are, however, no adequate and well-controlled studies
in pregnant women. Because animal reproduction studies are not always predictive
of human response, this drug should be used during pregnancy only if clearly
- Teratology studies conducted with omeprazole in rats
at oral doses up to 138 mg/kg/day (about 56 times the human dose on a body
surface area basis) and in rabbits at doses up to 69 mg/kg/day (about 56
times the human dose on a body surface area basis) did not disclose any
evidence for a teratogenic potential of omeprazole. In rabbits, omeprazole
in a dose range of 6.9 to 69.1 mg/kg/day (about 5.5 to 56 times the human
dose on a body surface area basis) produced dose-related increases in embryo-lethality,
fetal resorptions, and pregnancy disruptions. In rats, dose-related embryo/fetal
toxicity and postnatal developmental toxicity were observed in offspring
resulting from parents treated with omeprazole at 13.8 to 138.0 mg/kg/day
(about 5.6 to 56 times the human doses on a body surface area basis). There
are no adequate and well-controlled studies in pregnant women. Sporadic
reports have been received of congenital abnormalities occurring in infants
born to women who have received omeprazole during pregnancy.
- Pregnancy Category B. See full prescribing information
for amoxicillin before using in pregnant women.
- Pregnancy Category C. See WARNINGS (above) and full prescribing
information for clarithromycin before using in pregnant women.
- Nursing Mothers
- The excretion of esomeprazole in milk has not been studied.
However, omeprazole concentrations have been measured in breast milk of
a woman following oral administration of 20 mg. Because esomeprazole is
likely to be excreted in human milk, because of the potential for serious
adverse reactions in nursing infants from esomeprazole, and because of
the potential for tumorigenicity shown for omeprazole in rat carcinogenicity
studies, a decision should be made whether to discontinue nursing or to
discontinue the drug, taking into account the importance of the drug to
- Pediatric Use
- Use of NEXIUM in adolescent patients 12 to 17 years of
age for short-term treatment of GERD is supported by a) extrapolation of
results, already included in the currently approved labeling, from adequate
and well-controlled studies that supported the approval of NEXIUM for adults,
and b) safety and pharmacokinetic studies performed in adolescent patients.
- (See CLINICAL PHARMACOLOGY, Pharmacokinetics, Pediatric
for pharmacokinetic information.) The safety and effectiveness of NEXIUM
for the treatment of symptomatic GERD in patients <12 years of age have
not been established. The safety and effectiveness of NEXIUM for other
pediatric uses have not been established.
- 12 to 17 Years of Age
- In a multicenter, randomized, double-blind, parallel-group
study, 149 adolescent patients (12 to 17 years of age; 89 female; 124 Caucasian,
15 Black, 10 Other) with clinically diagnosed GERD were treated with either
NEXIUM 20 mg or NEXIUM 40 mg once daily for up to 8 weeks to evaluate safety
and tolerability. Patients were not endoscopically characterized as to
the presence or absence of erosive esophagitis.
- The most frequently reported (at least 2%) treatment
related adverse events in these patients were headache (8.1%), abdominal
pain (2.7%), diarrhea (2%) and nausea (2%). No new safety concerns were
- Geriatric Use
- Of the total number of patients who received NEXIUM in
clinical trials, 1459 were 65 to 74 years of age and 354 patients were
>75 years of age.
- No overall differences in safety and efficacy were observed
between the elderly and younger individuals, and other reported clinical
experience has not identified differences in responses between the elderly
and younger patients, but greater sensitivity of some older individuals
cannot be ruled out.
- A single oral dose of esomeprazole at 510 mg/kg (about
103 times the human dose on a body surface area basis), was lethal to rats.
The major signs of acute toxicity were reduced motor activity, changes
in respiratory frequency, tremor, ataxia, and intermittent clonic convulsions.
- There have been some reports of overdosage with esomeprazole.
Reports have been received of overdosage with omeprazole in humans. Doses
ranged up to 2,400 mg (120 times the usual recommended clinical dose).
Manifestations were variable, but included confusion, drowsiness, blurred
vision, tachycardia, nausea, diaphoresis, flushing, headache, dry mouth,
and other adverse reactions similar to those seen in normal clinical experience
(see omeprazole package insert - ADVERSE REACTIONS). No specific antidote
for esomeprazole is known. Since esomeprazole is extensively protein bound,
it is not expected to be removed by dialysis. In the event of overdosage,
treatment should be symptomatic and supportive.
- As with the management of any overdose, the possibility
of multiple drug ingestion should be considered. For current information
on treatment of any drug overdose, a certified Regional Poison Control
Center should be contacted. Telephone numbers are listed in the Physicians'
Desk Reference (PDR) or local telephone book.
- NEXIUM is contraindicated in patients with known hypersensitivity
to any component of the formulation or to substituted benzimidazoles.
- Clarithromycin is contraindicated in patients with a
known hypersensitivity to any macrolide antibiotic.
- Concomitant administration of clarithromycin with pimozide
is contraindicated. There have been post-marketing reports of drug interactions
when clarithromycin and/or erythromycin are co-administered with pimozide
resulting in cardiac arrhythmias (QT prolongation, ventricular tachycardia,
ventricular fibrillation, and torsade de pointes) most likely due to inhibition
of hepatic metabolism of pimozide by erythromycin and clarithromycin. Fatalities
have been reported. (Please refer to full prescribing information for clarithromycin.)
- Amoxicillin is contraindicated in patients with a known
hypersensitivity to any penicillin. (Please refer to full prescribing information
- PATIENT INFORMATION
- Patients should be informed of the following:
- NEXIUM Delayed-Release Capsules should be taken at least
one hour before meals.
- For patients who have difficulty swallowing capsules,
one tablespoon of applesauce can be added to an empty bowl and the NEXIUM
Delayed-Release Capsule can be opened, and the pellets inside the capsule
carefully emptied onto the applesauce. The pellets should be mixed with
the applesauce and then swallowed immediately. The applesauce used should
not be hot and should be soft enough to be swallowed without chewing. The
pellets should not be chewed or crushed. The pellet/applesauce mixture
should not be stored for future use.
- Antacids may be used while taking NEXIUM.
- Ted Twietmeyer
- Source: http://www.rxlist.com/cgi/generic/esomeprazole_ad.htm
- Horse Hockey!
- I've been taking Prilosec and Nexium for nigh onto fifteen
years. I've not ONE side effect.
- Well, I do have the one side effect. But it's meaningless.
I can't recall anything past the last five or ten seconds. Uh, wait ...
what was I talking about? Oh, yeah ... Nexium.
- Mexium is a perfect acid pump turner offer. I have absolutely
no stomach acid. As for the headaches and aggravated stomach pains, nausea,
vomiting and other assorted minor stuff ... this product ... Mexty Yum,
is perfect and has done a magnificent yob of caring for my coming delivery.
- We think it's gonna be a boy.
- So, Mr. Tweet ... something or other ... this essay of
yours about Mixitup eeeyum, is irreverent. I mean, irrelevunt. My memory
is fine. And the other side effects can be controlled with other drugs.
- I take stuff for the headaches, for the depression (I
forgotted to mention depression) and the nasueumyum is controlled by something
which name I forgot. Oh, these other meds which control the side effects
are expensive, but my HMO pays for most of it.
- Except the Nexium. They don't pay for that.
- I estimate that because of this marvelous Nexteeyum,
I take thirty-three other drugs, all of which solve ALL the side effect
issues. The only problem is that each of the thirty-nine, or izzit thirty-seven?
Oh well, all the other drugs also have side effects. So I take more and
more meds which negate the side effects of the Mixitupium.
- The drug companies are happy as a pig in doodoo over
this MessEEEYum, because the same companies what make Nextoomium, also
make the four hundred other drugs to make me feel better.
- Tomorrow I begin taking the latest drug which will end
all the side effects.
- It's called rat poisen. Or izzit poison? Maybe it's poisin.
Oh well. You get the meaning.
- And stop this rediculous campain agenst Nextwomeyum.
I abhor anyone who louses up a good thing for the drug companies. Drugs
are my life. Meaning if I don't take them, I don't live. Did I tell you
I am addicted (they call it "dependent') on morphine and thorazine?
I feel so much better since I've been on those meds.
- Now I betcha your gonna belch out another song concerning
the side effects of thorazine and morphine?
- Well, don't even try. Because even though these drugs
have massively numerous side effects, when you take thorazine and morphine,
you just don't give a hoot.
- Morty - I think.
- Jim Mortellaro,
- AKA, Morty
- Web Site: http://www.mortyscabin.net/
- Email us At:
- Mary Sparrowdancer
- It should be noted that GERD, or inflammation of the
epigastric area appears to be related to ingestion of fluoride. Rather
than taking medications that might treat the symptom rather than addressing
the cause, I would suggest that each person stop ingesting fluorides,
including in toothpastes. Treating the symptom might allow further ingestion
of fluoride to occur w/o gastric symptoms, therefore creating a host of
other symptoms due to fluoride build-up. Fluoride is a HAZMAT chemical
pollutant that is NOT needed by the human body, and it will eat its way
out of a titanium container if water is present. It is allowed to be added
into Americans' drinking water as a way of helpfully giving corporations
a way of disposing of their HAZMAT chemicals while also enjoying corporate
gains. If the corporations weren't selling their fluoride sludge to municipalities,
they would have to pay exhorbitant fees to dispose of it because it is,
again, a HAZMAT. It is a hazardous material.
- mary sparrowdancer