CYPROHEPTADINE HYDROCHLORIDE

N/A

Manufactured by Chartwell RX, LLC

9,068 FDA adverse event reports analyzed

Last updated: 2026-04-15

About CYPROHEPTADINE HYDROCHLORIDE

CYPROHEPTADINE HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Chartwell RX, LLC. The most commonly reported adverse reactions for CYPROHEPTADINE HYDROCHLORIDE include OFF LABEL USE, DRUG INEFFECTIVE, DIARRHOEA, VOMITING, FATIGUE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for CYPROHEPTADINE HYDROCHLORIDE.

Top Adverse Reactions

OFF LABEL USE304 reports
DRUG INEFFECTIVE282 reports
DIARRHOEA239 reports
VOMITING228 reports
FATIGUE224 reports
NAUSEA223 reports
PNEUMONIA197 reports
HEADACHE191 reports
ANXIETY187 reports
SEROTONIN SYNDROME178 reports
WEIGHT DECREASED169 reports
DECREASED APPETITE162 reports
PYREXIA153 reports
ABDOMINAL PAIN147 reports
PAIN146 reports
COUGH135 reports
RASH133 reports
DIZZINESS132 reports
CONDITION AGGRAVATED122 reports
PRODUCT DOSE OMISSION ISSUE122 reports
DYSPNOEA121 reports
INFECTIVE PULMONARY EXACERBATION OF CYSTIC FIBROSIS115 reports
PRODUCT USE IN UNAPPROVED INDICATION113 reports
ABDOMINAL PAIN UPPER112 reports
DEATH111 reports
DEPRESSION110 reports
INSOMNIA109 reports
MALAISE107 reports
PRURITUS107 reports
HOSPITALISATION106 reports
AGITATION102 reports
MIGRAINE101 reports
URTICARIA98 reports
ACUTE KIDNEY INJURY93 reports
CONSTIPATION92 reports
DRUG INTERACTION89 reports
CHRONIC KIDNEY DISEASE87 reports
ASTHENIA86 reports
SEIZURE86 reports
FEELING ABNORMAL79 reports
FALL78 reports
INFECTION78 reports
SINUSITIS78 reports
TOXICITY TO VARIOUS AGENTS78 reports
HYPERTENSION77 reports
TREMOR77 reports
NASOPHARYNGITIS73 reports
DEHYDRATION72 reports
PAIN IN EXTREMITY70 reports
ARTHRALGIA69 reports
HYPERHIDROSIS69 reports
RENAL FAILURE69 reports
BRONCHITIS67 reports
WEIGHT INCREASED67 reports
HALLUCINATION66 reports
IRRITABILITY66 reports
PRODUCT USE ISSUE66 reports
CYSTIC FIBROSIS64 reports
INTENTIONAL OVERDOSE64 reports
COVID 1963 reports
URINARY TRACT INFECTION62 reports
HYPOTENSION61 reports
INJECTION SITE PAIN61 reports
RESPIRATORY FAILURE61 reports
VISION BLURRED59 reports
STOMATITIS58 reports
SOMNOLENCE57 reports
MYOCARDIAL INFARCTION56 reports
INFLUENZA55 reports
ASTHMA54 reports
MUSCLE SPASMS53 reports
TACHYCARDIA53 reports
NASAL CONGESTION52 reports
DRUG HYPERSENSITIVITY51 reports
GAIT DISTURBANCE51 reports
SLEEP APNOEA SYNDROME50 reports
AGGRESSION48 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION47 reports
ILLNESS47 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION47 reports
PALPITATIONS47 reports
ABDOMINAL DISCOMFORT46 reports
DYSPEPSIA46 reports
HYPERSENSITIVITY46 reports
SYNCOPE46 reports
CARDIAC ARREST45 reports
EMOTIONAL DISTRESS45 reports
GASTROINTESTINAL DISORDER44 reports
RESTLESSNESS44 reports
TINNITUS44 reports
BACK PAIN43 reports
CONFUSIONAL STATE43 reports
SLEEP DISORDER43 reports
CHEST PAIN42 reports
DRUG ABUSE42 reports
DRUG DEPENDENCE42 reports
FIBROMYALGIA42 reports
INTENTIONAL PRODUCT MISUSE42 reports
OVERDOSE42 reports
RHINORRHOEA42 reports

Report Outcomes

Out of 4,178 classified reports for CYPROHEPTADINE HYDROCHLORIDE:

Serious 68.5%Non-Serious 31.5%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female2,136 (55.9%)
Male1,685 (44.1%)
Unknown3 (0.1%)

Reports by Age

Age 12108 reports
Age 14106 reports
Age 1698 reports
Age 1094 reports
Age 1392 reports
Age 1784 reports
Age 1583 reports
Age 971 reports
Age 1170 reports
Age 1869 reports
Age 667 reports
Age 865 reports
Age 464 reports
Age 560 reports
Age 5360 reports
Age 2054 reports
Age 252 reports
Age 751 reports
Age 350 reports
Age 2448 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with CYPROHEPTADINE HYDROCHLORIDE?

This profile reflects 9,068 FDA FAERS reports that mention CYPROHEPTADINE HYDROCHLORIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for CYPROHEPTADINE HYDROCHLORIDE?

Frequently reported terms in FAERS include OFF LABEL USE, DRUG INEFFECTIVE, DIARRHOEA, VOMITING, FATIGUE, NAUSEA. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures CYPROHEPTADINE HYDROCHLORIDE?

Labeling and FAERS entries often list Chartwell RX, LLC in connection with CYPROHEPTADINE HYDROCHLORIDE. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.